Clinical Trial Results:
A Phase II, Open-label, Single-arm, Multicenter Study to Evaluate Efficacy and Safety of Pembrolizumab Monotherapy in Subjects with Advanced Recurrent Ovarian Cancer (KEYNOTE-100)
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Summary
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EudraCT number |
2015-003338-29 |
Trial protocol |
SE ES LT DE FI NO BE NL FR PL GB IT |
Global end of trial date |
18 Mar 2021
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Results information
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Results version number |
v1(current) |
This version publication date |
13 Mar 2022
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First version publication date |
13 Mar 2022
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
3475-100
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02674061 | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
JAPIC-CTI: 163237 | ||
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Sponsors
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Sponsor organisation name |
Merck Sharp & Dohme Corp.
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Sponsor organisation address |
2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
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Public contact |
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
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Scientific contact |
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
18 Mar 2021
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
18 Sep 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
18 Mar 2021
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
This study will assess the efficacy and safety of pembrolizumab (MK-3475) monotherapy in female participants with recurrent ovarian cancer (ROC) who have received up to 5 prior lines of treatment including platinum-based treatment for ROC (1 to 6 total prior lines counting front line therapy). Participants will be enrolled into two separate cohorts based on the number of prior lines of treatment received for ROC.
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Protection of trial subjects |
This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
25 Feb 2016
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Australia: 15
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Country: Number of subjects enrolled |
Belgium: 7
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Country: Number of subjects enrolled |
Canada: 14
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Country: Number of subjects enrolled |
Finland: 9
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Country: Number of subjects enrolled |
France: 21
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Country: Number of subjects enrolled |
Germany: 22
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Country: Number of subjects enrolled |
Israel: 29
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Country: Number of subjects enrolled |
Italy: 44
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Country: Number of subjects enrolled |
Japan: 21
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Country: Number of subjects enrolled |
Lithuania: 10
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Country: Number of subjects enrolled |
Netherlands: 23
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Country: Number of subjects enrolled |
Norway: 13
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Country: Number of subjects enrolled |
Poland: 5
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Country: Number of subjects enrolled |
Russian Federation: 27
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Country: Number of subjects enrolled |
South Africa: 7
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Country: Number of subjects enrolled |
Spain: 23
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Country: Number of subjects enrolled |
Sweden: 5
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Country: Number of subjects enrolled |
United Kingdom: 17
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Country: Number of subjects enrolled |
United States: 64
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Worldwide total number of subjects |
376
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EEA total number of subjects |
182
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
236
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From 65 to 84 years |
138
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85 years and over |
2
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Recruitment
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Recruitment details |
Per protocol, Progression-free survival by Blinded Independent Central Review, Overall Survival, adverse events in all participants from end of trial database (cutoff 18-Mar-2021). Objective Response Rate, Duration of Response, Disease Control Rate, safety outcomes, sub-group analyses of PFS and OS from final analysis database (cutoff 18-Sep-2019). | ||||||||||||||||||||||||
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Pre-assignment
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Screening details |
Seven participants (Cohorts A=5; B = 2) received a second course of pembrolizumab at the investigator's discretion per protocol. Response/progression or adverse events (AEs) that occurred during second course of pembrolizumab were not counted towards efficacy or safety outcome measures. | ||||||||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Cohort A: Pembrolizumab | ||||||||||||||||||||||||
Arm description |
Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
pembrolizumab
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Investigational medicinal product code |
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Other name |
MK-3475
KEYTRUDA®
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Administered at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle
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Arm title
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Cohort B: Pembrolizumab | ||||||||||||||||||||||||
Arm description |
Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
pembrolizumab
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Investigational medicinal product code |
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Other name |
MK-3475 KEYTRUDA®
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Administered at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle
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Baseline characteristics reporting groups
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Reporting group title |
Cohort A: Pembrolizumab
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Reporting group description |
Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Cohort B: Pembrolizumab
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Reporting group description |
Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Cohort A: Pembrolizumab
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Reporting group description |
Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). | ||
Reporting group title |
Cohort B: Pembrolizumab
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Reporting group description |
Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). | ||
Subject analysis set title |
Cohort A Participants with PD-L1 CPS ≥1
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Participants in Cohort A with Programmed Cell Death Ligand-1 (PD-L1) Combined Positive Score (CPS) ≥1 received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year).
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Subject analysis set title |
Cohort B Participants with PD-L1 CPS ≥1
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Participants in Cohort B with PD-L1 CPS ≥1 received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year).
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Subject analysis set title |
Cohort A Participants with PD-L1 CPS ≥10
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Participants in Cohort A with PD-L1 CPS ≥10 received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year).
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Subject analysis set title |
Cohort B Participants with PD-L1 CPS ≥10
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Participants in Cohort B with PD-L1 CPS ≥10 received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year).
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Subject analysis set title |
Cohort A Participants with PFI/TFI ≥3-6 Months
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Participants in Cohort A with a platinum-free interval (PFI)/treatment-free interval (TFI) ≥3-6 Months (based on last regimen received) received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year).
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Subject analysis set title |
Cohort A Participants with PFI/TFI >6-12 Months
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Participants in Cohort A with a platinum-free interval (PFI)/treatment-free interval (TFI) >6-12 Months (based on last regimen received) received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year).
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End point title |
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in all Cohort A and Cohort B Participants [1] | ||||||||||||
End point description |
ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters [SOD] of target lesions) using RECIST 1.1 based on BICR. ORR was analyzed by test of binomial parameter and reported as the percentage of participants who experienced CR or PR per RECIST 1.1 by BICR. The analysis population included all participants in Cohort A and Cohort B who received ≥1 dose of study drug.
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End point type |
Primary
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End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: There were no statistical analyses planned for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
ORR per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants with Programmed Cell Death Ligand-1 (PD-L1) Combined Positive Score (CPS) ≥10 [2] | ||||||||||||
End point description |
ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on BICR. ORR was analyzed by test of binomial parameter and reported as the percentage of participants who experienced CR or PR per RECIST 1.1 by BICR. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by immunohistochemistry (IHC) as CPS ≥10 and received ≥1 dose of study drug.
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End point type |
Primary
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End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: There were no statistical analyses planned for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
ORR per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥1 [3] | ||||||||||||
End point description |
ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on BICR. ORR was analyzed by test of binomial parameter and reported as the percentage of participants who experienced CR or PR per RECIST 1.1 by BICR. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1 and received ≥1 dose of study drug.
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End point type |
Primary
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End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: There were no statistical analyses planned for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Duration of Response (DOR) per RECIST 1.1 by BICR in all Cohort A and Cohort B Participants | ||||||||||||
End point description |
For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 based on BICR, DOR was defined as time from first documented CR or PR until progressive disease (PD) or death, whichever occurs first. DOR for participants who didn’t progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD is a ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. DOR was analyzed by Kaplan-Meier (KM) method and reported as Median DOR with a full range. The analysis population included all participants in Cohort A and Cohort B who had a confirmed CR or PR per RECIST 1.1 by BICR and received ≥1 dose of study drug.
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End point type |
Secondary
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End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
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| No statistical analyses for this end point | |||||||||||||
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End point title |
DOR per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥10 | ||||||||||||
End point description |
For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 based on BICR, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn’t progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD was defined as ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. DOR was analyzed by KM method and reported as Median DOR with a full range. A value of 9999=Median and upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10, had a confirmed CR or PR per RECIST 1.1 by BICR, and received ≥1 dose of study drug.
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End point type |
Secondary
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End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
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| No statistical analyses for this end point | |||||||||||||
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End point title |
DOR per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥1 | ||||||||||||
End point description |
For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 based on BICR, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn’t progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD was defined as ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. DOR was analyzed by KM method and reported as Median DOR with a full range. A value of 9999=Median and upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1, had a confirmed CR or PR per RECIST 1.1 by BICR, and received ≥1 dose of study drug.
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End point type |
Secondary
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End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Disease Control Rate (DCR) per RECIST 1.1 by BICR in all Cohort A and Cohort B Participants | ||||||||||||
End point description |
DCR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or Stable Disease (SD: Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or Non-CR/Non-PD (NN: does not qualify for CR or PD) for ≥24 weeks per RECIST 1.1 based on BICR. DCR was analyzed by test of binomial parameter and reported as the percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by BICR. The analysis population included all participants in Cohort A and Cohort B who received ≥1 dose of study drug.
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End point type |
Secondary
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End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
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| No statistical analyses for this end point | |||||||||||||
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End point title |
DCR per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥10 | ||||||||||||
End point description |
DCR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (does not qualify for CR or PD) for ≥24 weeks per RECIST 1.1 based on BICR. DCR was analyzed by test of binomial parameter and reported as the percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by BICR. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10 and received ≥1 dose of study drug.
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End point type |
Secondary
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End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
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| No statistical analyses for this end point | |||||||||||||
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End point title |
DCR per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥1 | ||||||||||||
End point description |
DCR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (does not qualify for CR or PD) for ≥24 weeks per RECIST 1.1 based on BICR. DCR was analyzed by test of binomial parameter and reported as the percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by BICR. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1 and received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Progression Free Survival (PFS) per RECIST 1.1 by BICR in all Cohort A and Cohort B Participants | ||||||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method and reported as Median PFS per RECIST 1.1 by BICR with a 95% confidence interval (CI). The analysis population included all participants in Cohort A and Cohort B who received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Up to ~58.8 months (through database cut-off date of 18-March-2021)
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of Participants with PFS (PFS Rate) at Month 6 per RECIST 1.1 by BICR in all Cohort A and Cohort B Participants | ||||||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by BICR is reported. The analysis population included all participants in Cohort A and Cohort B who received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Month 6
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of Participants with PFS (PFS Rate) at Month 18 per RECIST 1.1 by BICR in all Cohort A and Cohort B Participants | ||||||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by BICR is reported. The analysis population included all participants in Cohort A and Cohort B who received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Month 18
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of Participants with PFS (PFS Rate) at Month 12 per RECIST 1.1 by BICR in all Cohort A and Cohort B Participants | ||||||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by BICR is reported. The analysis population included all participants in Cohort A and Cohort B who received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Month 12
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
PFS per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥10 | ||||||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method and reported as Median PFS per RECIST 1.1 by BICR with a 95% CI. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10 and received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of Participants with PFS (PFS Rate) at Month 6 per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥10 | ||||||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by BICR is reported. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10 and received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Month 6
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of Participants with PFS (PFS Rate) at Month 12 per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥10 | ||||||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by BICR is reported. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10 and received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Month 12
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of Participants with PFS (PFS Rate) at Month 18 per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥10 | ||||||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by BICR is reported. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10 and received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Month 18
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
PFS per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥1 | ||||||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method and reported as Median PFS per RECIST 1.1 by BICR with a 95% CI. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1 and received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of Participants with PFS (PFS Rate) at Month 6 per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥1 | ||||||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by BICR is reported. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1 and received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Month 6
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of Participants with PFS (PFS Rate) at Month 12 per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥1 | ||||||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by BICR is reported. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1 and received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Month 12
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of Participants with PFS (PFS Rate) at Month 18 per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥1 | ||||||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by BICR is reported. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1 and received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Month 18
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
ORR per RECIST 1.1 by Investigator in all Cohort A and Cohort B Participants | ||||||||||||
End point description |
ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on investigator assessment. ORR was analyzed by test of binomial parameter and reported as the percentage of participants who experienced CR or PR per RECIST 1.1 by investigator. The analysis population included all participants in Cohort A and Cohort B that received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
ORR per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥10 | ||||||||||||
End point description |
ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on investigator assessment. ORR was analyzed by test of binomial parameter and reported as the percentage of participants who experienced CR or PR per RECIST 1.1 by investigator. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10 and received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
ORR per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥1 | ||||||||||||
End point description |
ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on investigator assessment. ORR was analyzed by test of binomial parameter and reported as the percentage of participants who experienced CR or PR per RECIST 1.1 by investigator. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1 and received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
DOR per RECIST 1.1 by Investigator in all Cohort A and Cohort B Participants | ||||||||||||
End point description |
For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 by investigator assessment, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn’t progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD is a ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. DOR was analyzed by KM method and reported as Median DOR with a full range. The analysis population included all participants in Cohort A and Cohort B who had a confirmed CR or PR per RECIST 1.1 by investigator and received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
DOR per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥10 | ||||||||||||
End point description |
For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 by investigator assessment, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn’t progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD was defined as ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. DOR was analyzed by KM method and reported as Median DOR with a full range. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10, had a confirmed CR or PR per RECIST 1.1 by investigator, and received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
DOR per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥1 | ||||||||||||
End point description |
For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 by investigator assessment, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn’t progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD was defined as ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. DOR analyzed by KM method and reported as Median DOR with a full range. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1, had confirmed CR or PR per RECIST 1.1 by investigator, and received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
DCR per RECIST 1.1 by Investigator in all Cohort A and Cohort B Participants | ||||||||||||
End point description |
DCR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (does not qualify for CR or PD) for ≥24 weeks per RECIST 1.1 by investigator assessment. DCR was analyzed by test of binomial parameter and reported as the percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by investigator. The analysis population included all participants in Cohort A and Cohort B who received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
DCR per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥10 | ||||||||||||
End point description |
DCR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (does not qualify for CR or PD) for ≥24 weeks per RECIST 1.1 by investigator assessment. DCR was analyzed by test of binomial parameter and reported as the percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by investigator. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10 and received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
DCR per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥1 | ||||||||||||
End point description |
DCR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (does not qualify for CR or PD) for ≥24 weeks per RECIST 1.1 by investigator assessment. DCR was analyzed by test of binomial parameter and reported as the percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by investigator. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1 and received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
PFS per RECIST 1.1 by Investigator in all Cohort A and Cohort B Participants | ||||||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method and reported as Median PFS per RECIST 1.1 by investigator with a 95% CI. The analysis population included all participants in Cohort A and Cohort B who received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of Participants with PFS (PFS Rate) at Month 6 per RECIST 1.1 by Investigator in all Cohort A and Cohort B Participants | ||||||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by investigator is reported. The analysis population included all participants in Cohort A and Cohort B who received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Month 6
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of Participants with PFS (PFS Rate) at Month 12 per RECIST 1.1 by Investigator in all Cohort A and Cohort B Participants | ||||||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by investigator is reported. The analysis population included all participants in Cohort A and Cohort B who received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Month 12
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of Participants with PFS (PFS Rate) at Month 18 per RECIST 1.1 by Investigator in all Cohort A and Cohort B Participants | ||||||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by investigator is reported. The analysis population included all participants in Cohort A and Cohort B who received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Month 18
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
PFS per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥10 | ||||||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method and reported as Median PFS per RECIST 1.1 by investigator with a 95% CI. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10 and received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of Participants with PFS (PFS Rate) at Month 6 per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥10 | ||||||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by investigator is reported. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10 and received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Month 6
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of Participants with PFS (PFS Rate) at Month 12 per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥10 | ||||||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by investigator is reported. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10 and received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Month 12
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of Participants with PFS (PFS Rate) at Month 18 per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥10 | ||||||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by investigator is reported. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10 and received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Month 18
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
PFS per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥1 | ||||||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method and reported as Median PFS per RECIST 1.1 by investigator with a 95% CI. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1 and received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of Participants with PFS (PFS Rate) at Month 6 per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥1 | ||||||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS Rate) at Month 6 per RECIST 1.1 by investigator is reported. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1 and received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Month 6
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of Participants with PFS (PFS Rate) at Month 12 per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥1 | ||||||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS Rate) at Month 12 per RECIST 1.1 by investigator is reported. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1 and received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Month 12
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of Participants with PFS (PFS Rate) at Month 18 per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥1 | ||||||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS Rate) at Month 18 per RECIST 1.1 by investigator is reported. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1 and received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Month 18
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||
End point title |
ORR per RECIST 1.1 by BICR in Subgroup of Cohort A Participants with Platinum-Free Interval (PFI)/Treatment-Free Interval (TFI) ≥3-6 Months | ||||||||
End point description |
ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on BICR. ORR was analyzed by test of binomial parameter and reported as the percentage of participants who experienced CR or PR per RECIST 1.1 by BICR. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months and received ≥1 dose of study drug. Per protocol PFI/TFI ≥3-6 months subgroup analysis of ORR per RECIST 1.1 by BICR was not planned or executed in Cohort B.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
ORR per RECIST 1.1 by BICR in Subgroup of Cohort A Participants with PFI/ TFI >6-12 Months | ||||||||
End point description |
ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on BICR. ORR was analyzed by test of binomial parameter and reported as the percentage of participants who experienced CR or PR per RECIST 1.1 by BICR. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months and received ≥1 dose of study drug. Per protocol PFI/TFI >6-12 months subgroup analysis of ORR per RECIST 1.1 by BICR was not planned or executed in Cohort B.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
DOR per RECIST 1.1 by BICR in Subgroup of Cohort A Participants with PFI/TFI ≥3-6 Months | ||||||||
End point description |
For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 based on BICR, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn’t progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD is a ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. DOR was analyzed by KM method and reported as Median DOR with a full range. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months, had a confirmed CR or PR per RECIST 1.1 by BICR, and received ≥1 dose of study drug. Per protocol PFI/TFI ≥3-6 months subgroup analysis of DOR per RECIST 1.1 by BICR was not planned or executed in Cohort B.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
DOR per RECIST 1.1 by BICR in Subgroup of Cohort A Participants with PFI/TFI >6-12 Months | ||||||||
End point description |
For participants who demonstrated confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 based on BICR, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn’t progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD is a ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. DOR was analyzed by KM method and reported as a Median DOR with a full range. Per protocol PFI/TFI >6-12 months subgroup analysis of DOR per RECIST 1.1 by BICR was not planned or executed in Cohort B. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months, had a confirmed CR or PR per RECIST 1.1 by BICR, and received ≥1 dose of study drug.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
DCR per RECIST 1.1 by BICR in Subgroup of Cohort A Participants with PFI/TFI ≥3-6 Months | ||||||||
End point description |
DCR was defined as the percentage of participants in the analysis population who have a CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (does not qualify for CR or PD) for ≥24 weeks per RECIST 1.1 based on BICR. DCR was analyzed by test of binomial parameter and reported as the percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by BICR. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months and received ≥1 dose of study drug. Per protocol PFI/TFI ≥3-6 months subgroup analysis of DCR per RECIST 1.1 by BICR was not planned or executed in Cohort B.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
DCR per RECIST 1.1 by BICR in Subgroup of Cohort A Participants with PFI/TFI >6-12 Months | ||||||||
End point description |
DCR was defined as the percentage of participants in the analysis population who have a CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage to for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (does not qualify for CR or PD) for ≥24 weeks per RECIST 1.1 based on BICR. DCR was analyzed by test of binomial parameter and reported as the percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by BICR. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months and received ≥1 dose of study drug. Per protocol PFI/TFI >6-12 months subgroup analysis of DCR per RECIST 1.1 by BICR was not planned or executed in Cohort B.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
PFS per RECIST 1.1 by BICR in Subgroup of Cohort A Participants with PFI/TFI ≥3-6 Months | ||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method and reported as a Median PFS per RECIST 1.1 by BICR with a 95% CI. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months and received ≥1 dose of study drug. Per protocol PFI/TFI ≥3-6 months subgroup analysis of PFS per RECIST 1.1 by BICR was not planned or executed in Cohort B.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Participants with PFS (PFS Rate) at Month 6 per RECIST 1.1 by BICR in Subgroup of Cohort A Participants with PFI/TFI ≥3-6 Months | ||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by BICR is reported. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months and received ≥1 dose of study drug. Per protocol PFI/TFI ≥3-6 months subgroup analysis of PFS rate at Month 6 per RECIST 1.1 by BICR was not planned or executed in Cohort B.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Month 6
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Participants with PFS (PFS Rate) at Month 12 per RECIST 1.1 by BICR in Subgroup of Cohort A Participants with PFI/TFI ≥3-6 Months | ||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by BICR is reported. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months and received ≥1 dose of study drug. Per protocol PFI/TFI ≥3-6 months subgroup analysis of PFS rate at Month 12 per RECIST 1.1 by BICR was not planned or executed in Cohort B.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Month 12
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Participants with PFS (PFS Rate) at Month 18 per RECIST 1.1 by BICR in Subgroup of Cohort A Participants with PFI/TFI ≥3-6 Months | ||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by BICR is reported. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months and received ≥1 dose of study drug. Per protocol PFI/TFI ≥3-6 months subgroup analysis of PFS rate at Month 18 per RECIST 1.1 by BICR was not planned or executed in Cohort B.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Month 18
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
PFS per RECIST 1.1 by BICR in Subgroup of Cohort A Participants with PFI/TFI >6-12 Months | ||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method and reported as Median PFS per RECIST 1.1 by investigator with a 95% CI. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months and received ≥1 dose of study drug. Per protocol PFI/TFI >6-12 months subgroup analysis of PFS per RECIST 1.1 by BICR was not planned or executed in Cohort B.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Participants with PFS (PFS Rate) at Month 6 per RECIST 1.1 by BICR in Subgroup of Cohort A Participants with PFI/TFI >6-12 Months | ||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by BICR is reported. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months and received ≥1 dose of study drug. Per protocol PFI/TFI >6-12 months subgroup analysis of PFS rate at Month 6 per RECIST 1.1 by BICR was not planned or executed in Cohort B.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Month 6
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Participants with PFS (PFS Rate) at Month 12 per RECIST 1.1 by BICR in Subgroup of Cohort A Participants with PFI/TFI >6-12 Months | ||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by BICR is reported. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months and received ≥1 dose of study drug. Per protocol PFI/TFI >6-12 months subgroup analysis of PFS rate at Month 12 per RECIST 1.1 by BICR was not planned or executed in Cohort B.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Month 12
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Participants with PFS (PFS Rate) at Month 18 per RECIST 1.1 by BICR in Subgroup of Cohort A Participants with PFI/TFI >6-12 Months | ||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by BICR is reported. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months and received ≥1 dose of study drug. Per protocol PFI/TFI >6-12 months subgroup analysis of PFS rate at Month 18 per RECIST 1.1 by BICR was not planned or executed in Cohort B.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Month 18
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
ORR per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants with PFI/ TFI ≥3-6 Months | ||||||||
End point description |
ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on investigator assessment. ORR was analyzed by test of binomial parameter and reported as the percentage of participants who experienced CR or PR per RECIST 1.1 by investigator. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months and received ≥1 dose of study drug. Per protocol PFI/TFI ≥3-6 months subgroup analysis of ORR per RECIST 1.1 by investigator was not planned or executed in Cohort B.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
ORR per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants with PFI/ TFI >6-12 Months | ||||||||
End point description |
ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on investigator assessment. ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on investigator assessment. ORR was analyzed by test of binomial parameter and reported as the percentage of participants who experienced CR or PR per RECIST 1.1 by investigator. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months and received ≥1 dose of study drug. Per protocol PFI/TFI >6-12 months subgroup analysis of ORR per RECIST 1.1 by investigator was not planned or executed in Cohort B.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
DOR per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants with PFI/TFI ≥3-6 Months | ||||||||
End point description |
For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 by investigator assessment, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn’t progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD is ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. DOR was analyzed by KM method and reported as Median DOR with a full range. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months, had a confirmed CR or PR per RECIST 1.1 by BICR, and received ≥1 dose of study drug. Per protocol PFI/TFI ≥3-6 months subgroup analysis of DOR per RECIST 1.1 by investigator was not planned or executed in Cohort B.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
DOR per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants with PFI/TFI >6-12 Months | ||||||||
End point description |
For participants who demonstrated confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 by investigator assessment, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn’t progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD is ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. DOR was analyzed by KM method and reported as Median DOR with a full range. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months, had a confirmed CR or PR per RECIST 1.1 by BICR, and received ≥1 dose of study drug. Per protocol PFI/TFI >6-12 months subgroup analysis of DOR per RECIST 1.1 by investigator was not planned or executed in Cohort B.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
DCR per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants with PFI/TFI ≥3-6 Months | ||||||||
End point description |
DCR was defined as the percentage of participants in the analysis population who have CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (doesn’t qualify for CR or PD) for ≥24 weeks per RECIST 1.1 by investigator assessment. DCR was analyzed by test of binomial parameter and reported as the percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by investigator. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months and received ≥1 dose of study drug. Per protocol PFI/TFI ≥3-6 months subgroup analysis of DCR per RECIST 1.1 by investigator was not planned or executed in Cohort B.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
DCR per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants with PFI/TFI >6-12 Months | ||||||||
End point description |
DCR was defined as the percentage of participants in the analysis population who have CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (doesn’t qualify for CR or PD) for ≥24 weeks per RECIST 1.1 by investigator assessment. DCR was analyzed by test of binomial parameter and reported as the percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by investigator. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months and received ≥1 dose of study drug. Per protocol PFI/TFI >6-12 months subgroup analysis of DCR per RECIST 1.1 by investigator was not planned or executed in Cohort B.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
PFS per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants with PFI/TFI ≥3-6 Months | ||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method and reported as a Median PFS per RECIST 1.1 by investigator with a 95% CI. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months and received ≥1 dose of study drug. Per protocol PFI/TFI ≥3-6 months subgroup analysis of PFS per RECIST 1.1 by investigator was not planned or executed in Cohort B.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Participants with PFS (PFS Rate) at Month 6 per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants with PFI/TFI ≥3-6 Months | ||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by investigator is reported. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months and received ≥1 dose of study drug. Per protocol PFI/TFI ≥3-6 months subgroup analysis of PFS rate at Month 6 per RECIST 1.1 by investigator was not planned or executed in Cohort B.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Month 6
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Participants with PFS (PFS Rate) at Month 12 per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants with PFI/TFI ≥3-6 Months | ||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by investigator is reported. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months and received ≥1 dose of study drug. Per protocol PFI/TFI ≥3-6 months subgroup analysis of PFS rate at Month 12 per RECIST 1.1 by investigator was not planned or executed in Cohort B.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Month 12
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Participants with PFS (PFS Rate) at Month 18 per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants with PFI/TFI ≥3-6 Months | ||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by investigator is reported. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months and received ≥1 dose of study drug. Per protocol PFI/TFI ≥3-6 months subgroup analysis of PFS rate at Month 18 per RECIST 1.1 by investigator was not planned or executed in Cohort B.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Month 18
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
PFS per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants with PFI/TFI >6-12 Months | ||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method and reported as a Median PFS per RECIST 1.1 by investigator with a 95% CI. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months and received ≥1 dose of study drug. Per protocol PFI/TFI >6-12 months subgroup analysis of PFS per RECIST 1.1 by investigator was not planned or executed in Cohort B.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Participants with PFS (PFS Rate) at Month 6 per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants with PFI/TFI >6-12 Months | ||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by investigator is reported. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months and received ≥1 dose of study drug. Per protocol PFI/TFI >6-12 months subgroup analysis of PFS rate at Month 6 per RECIST 1.1 by investigator was not planned or executed in Cohort B.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Month 6
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Participants with PFS (PFS Rate) at Month 12 per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants with PFI/TFI >6-12 Months | ||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by investigator is reported. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months and received ≥1 dose of study drug. Per protocol PFI/TFI >6-12 months subgroup analysis of PFS rate at Month 12 per RECIST 1.1 by investigator was not planned or executed in Cohort B.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Month 12
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Participants with PFS (PFS Rate) at Month 18 per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants with PFI/TFI >6-12 Months | ||||||||
End point description |
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by investigator is reported. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months and received ≥1 dose of study drug. Per protocol PFI/TFI >6-12 months subgroup analysis of PFS rate at Month 18 per RECIST 1.1 by investigator was not planned or executed in Cohort B.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Month 18
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||||||
End point title |
Overall Survival (OS) in all Cohort A and Cohort B Participants | ||||||||||||
End point description |
OS was defined as the time from the first dose of study drug to death due to any cause. OS was analyzed by KM method and reported as Median OS with a 95% CI. The analysis population was all participants in Cohort A and Cohort B that received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Up to ~58.8 months (through database cut-off date of 18-March-2021)
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of Participants with OS (OS Rate) at Month 6 in all Cohort A and Cohort B Participants | ||||||||||||
End point description |
OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 6 is reported. The analysis population was all participants in Cohort A and Cohort B that received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Month 6
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of Participants with OS (OS Rate) at Month 12 in all Cohort A and Cohort B Participants | ||||||||||||
End point description |
OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 12 is reported. The analysis population was all participants in Cohort A and Cohort B that received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Month 12
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of Participants with OS (OS Rate) at Month 18 in all Cohort A and Cohort B Participants | ||||||||||||
End point description |
OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 18 is reported. The analysis population was all participants in Cohort A and Cohort B that received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Month 18
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of Participants with OS (OS Rate) at Month 24 in all Cohort A and Cohort B Participants | ||||||||||||
End point description |
OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 24 is reported. The analysis population was all participants in Cohort A and Cohort B that received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Month 24
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
OS in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥10 | ||||||||||||
End point description |
OS was defined as the time from the first dose of study drug to death due to any cause. OS was analyzed by KM method and is reported as Median OS with a 95% CI. A value of 9999 = Based on the statistical model used for data analysis, upper limit of 95% CI was not reached by the data cut-off date. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10 and received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of Participants with OS (OS Rate) at Month 6 in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥10 | ||||||||||||
End point description |
OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 6 is reported. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10 and received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Month 6
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of Participants with OS (OS Rate) at Month 12 in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥10 | ||||||||||||
End point description |
OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 12 is reported. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10 and received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Month 12
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of Participants with OS (OS Rate) at Month 18 in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥10 | ||||||||||||
End point description |
OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 18 is reported. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10 and received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Month 18
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
OS in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥1 | ||||||||||||
End point description |
OS was defined as the time from the first dose of study drug to death due to any cause. OS was analyzed by KM method and is reported as Median OS with a 95% CI. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1 and received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of Participants with OS (OS Rate) at Month 6 in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥1 | ||||||||||||
End point description |
OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 6 is reported. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1 and received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Month 6
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of Participants with OS (OS Rate) at Month 12 in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥1 | ||||||||||||
End point description |
OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 12 is reported. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1 and received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Month 12
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of Participants with OS (OS Rate) at Month 18 in Subgroup of Cohort A and Cohort B Participants with PD-L1 CPS ≥1 | ||||||||||||
End point description |
OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 18 is reported. The analysis population included a subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1 and received ≥1 dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Month 18
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||
End point title |
OS in Subgroup of Cohort A Participants with PFI/TFI ≥3-6 Months | ||||||||
End point description |
OS was defined as the time from the first dose of study drug to death due to any cause. OS was analyzed by KM method and is reported as Median OS with a 95% CI. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months and received ≥1 dose of study drug. Per protocol PFI/TFI ≥3-6 months subgroup analysis of OS was not planned or executed in Cohort B.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Participants with OS (OS Rate) at Month 6 in Subgroup of Cohort A Participants with PFI/TFI ≥3-6 Months | ||||||||
End point description |
OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 6 is reported. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months and received ≥1 dose of study drug. Per protocol PFI/TFI >3-6 months subgroup analysis of OS rate at Month 6 was not planned or executed in Cohort B.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Month 6
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Participants with OS (OS Rate) at Month 12 in Subgroup of Cohort A Participants with PFI/TFI ≥3-6 Months | ||||||||
End point description |
OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 12 is reported. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months and received ≥1 dose of study drug. Per protocol PFI/TFI >3-6 months subgroup analysis of OS rate at Month 12 was not planned or executed in Cohort B.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Month 12
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Participants with OS (OS Rate) at Month 18 in Subgroup of Cohort A Participants with PFI/TFI ≥3-6 Months | ||||||||
End point description |
OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 18 is reported. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months and received ≥1 dose of study drug. Per protocol PFI/TFI >3-6 months subgroup analysis of OS rate at Month 18 was not planned or executed in Cohort B.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Month 18
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
OS in Subgroup of Cohort A Participants with PFI/TFI >6-12 Months | ||||||||
End point description |
OS was defined as the time from the first dose of study drug to death due to any cause. OS was analyzed by KM method and is reported as Median OS with a 95% CI. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months and received ≥1 dose of study drug. Per protocol PFI/TFI >6-12 months subgroup analysis of OS was not planned or executed in Cohort B.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to ~43 months (through database cut-off date of 18-September-2019)
|
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|
|||||||||
| No statistical analyses for this end point | |||||||||
|
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End point title |
Percentage of Participants with OS (OS Rate) at Month 6 in Subgroup of Cohort A Participants with PFI/TFI >6-12 Months | ||||||||
End point description |
OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 6 is reported. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months and received ≥1 dose of study drug. Per protocol PFI/TFI >6-12 months subgroup analysis of OS rate at Month 6 was not planned or executed in Cohort B.
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||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Month 6
|
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|
|||||||||
| No statistical analyses for this end point | |||||||||
|
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End point title |
Percentage of Participants with OS (OS Rate) at Month 12 in Subgroup of Cohort A Participants with PFI/TFI >6-12 Months | ||||||||
End point description |
OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 12 is reported. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months and received ≥1 dose of study drug. Per protocol PFI/TFI >6-12 months subgroup analysis of OS rate at Month 12 was not planned or executed in Cohort B.
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||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Month 12
|
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|
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants with OS (OS Rate) at Month 18 in Subgroup of Cohort A Participants with PFI/TFI >6-12 Months | ||||||||
End point description |
OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 18 is reported. The analysis population included a subgroup of participants in Cohort A who had a PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months and received ≥1 dose of study drug. Per protocol PFI/TFI >6-12 months subgroup analysis of OS rate at Month 18 was not planned or executed in Cohort B.
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||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Month 18
|
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|
|||||||||
| No statistical analyses for this end point | |||||||||
|
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End point title |
Number of Participants Who Experienced an Adverse Event (AE) | |||||||||
End point description |
An AE was defined as any untoward medical occurrence in a pharmaceutical product which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. As specified by the protocol, the number of participants who experienced at least one AE is reported here for all participants in Cohort A and Cohort B who received ≥1 dose of study drug.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
Up to ~58.8 months (through database cut-off date of 18-March-2021)
|
|||||||||
|
||||||||||
| No statistical analyses for this end point | ||||||||||
|
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End point title |
Number of Participants Who Discontinued Study Treatment due to an AE | |||||||||
End point description |
An AE was defined as any untoward medical occurrence in a pharmaceutical product which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. As specified by the protocol, the number of participants who discontinued study treatment due to an AE is reported here for all participants in Cohort A and Cohort B who received ≥1 dose of study drug.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
Up to ~58.8 months (through database cut-off date of 18-March-2021)
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|||||||||
|
||||||||||
| No statistical analyses for this end point | ||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Up to approximately 58.8 months (based on the database cut-off date of 18-March-2021)
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Adverse event reporting additional description |
All participants who received ≥1 dose of study drug. Per protocol, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" considered not related to study drug are excluded as AEs. Second course pembrolizumab AEs are presented separately per protocol.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
23.1
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Reporting groups
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Reporting group title |
Cohort A: Pembrolizumab
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Reporting group description |
Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Cohort B: Pembrolizumab
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Reporting group description |
Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Cohort A: Second Course Pembrolizumab
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Reporting group description |
Eligible participants in Cohort A who stopped pembrolizumab with stable disease (SD) or better but progressed after stopping study treatment initiated a second course of pembrolizumab at the investigator's discretion at the same dose and schedule (200 mg Q3W) for up to 17 cycles (up to approximately 1 additional year). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Cohort B: Second Course Pembrolizumab
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Reporting group description |
Eligible participants in Cohort B who stopped pembrolizumab with SD or better but progressed after stopping study treatment initiated a second course of pembrolizumab at the investigator's discretion at the same dose and schedule (200 mg Q3W) for up to 17 cycles (up to approximately 1 additional year). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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19 Jan 2018 |
Amendment 1 expanded on biomarker cutpoint language to provide maximum flexibility to perform additional data analysis, updated language related to pharmacokinetics (PK), and revised guidelines for immune-related adverse events. |
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21 Feb 2020 |
Amendment 2 added standard pembrolizumab extension study language. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
