Clinical Trial Results:
An Open-label, Phase IIIb, Single Arm, Multicenter Safety Study of Atezolizumab (Tecentriq) Plus Nab-paclitaxel in the Treatment of Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer
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Summary
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EudraCT number |
2019-002488-91 |
Trial protocol |
PT SI FR HU SK IT RO |
Global end of trial date |
15 Dec 2024
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Results information
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Results version number |
v1(current) |
This version publication date |
12 Dec 2025
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First version publication date |
12 Dec 2025
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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 |
MO39874
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04148911 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
F. Hoffmann-La Roche AG
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Sponsor organisation address |
Grenzacherstrasse 124, Basel, Switzerland, CH-4058
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Public contact |
F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com
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Scientific contact |
F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.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 |
15 Dec 2024
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
15 Dec 2024
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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 |
The main objective of the study is to evaluate the safety of atezolizumab plus nab-paclitaxel in participants with programmed death-ligand 1 (PD-L1)-positive unresectable locally advanced or metastatic triple-negative adenocarcinoma of the breast (TNBC) who have not received prior systemic therapy.
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Protection of trial subjects |
All study subjects were required to read and sign an Informed Consent Form (ICF).
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
10 Dec 2019
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety | ||
Long term follow-up duration |
60 Months | ||
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 |
Argentina: 10
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Country: Number of subjects enrolled |
Chile: 4
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Country: Number of subjects enrolled |
Mexico: 6
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Country: Number of subjects enrolled |
Peru: 12
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Country: Number of subjects enrolled |
Czechia: 6
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Country: Number of subjects enrolled |
Spain: 25
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Country: Number of subjects enrolled |
France: 11
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Country: Number of subjects enrolled |
Hungary: 10
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Country: Number of subjects enrolled |
Italy: 46
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Country: Number of subjects enrolled |
Poland: 13
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Country: Number of subjects enrolled |
Portugal: 19
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Country: Number of subjects enrolled |
Romania: 13
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Country: Number of subjects enrolled |
Slovenia: 7
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Worldwide total number of subjects |
182
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EEA total number of subjects |
150
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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) |
141
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From 65 to 84 years |
41
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85 years and over |
0
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Recruitment
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Recruitment details |
Participants with unresectable locally advanced or metastatic PD-L1-positive TNBC took part in the study at 67 centers in 13 countries from 10 Dec 2019 to 15 Dec 2024. | ||||||||||||||||
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Pre-assignment
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Screening details |
Participants received atezolizumab in combination with nab-paclitaxel until disease progression (PD) or unacceptable toxicity or loss of clinical benefit. A total of 184 participants were enrolled in the study. However, two participants discontinued the study before receiving any treatment. Hence, data is presented for 182 participants. | ||||||||||||||||
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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 |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||
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Arms
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Arm title
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Atezolizumab + Nab-paclitaxel | ||||||||||||||||
Arm description |
Participants received atezolizumab 840 milligrams (mg) as intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle along with nab-paclitaxel, 100 milligrams per square meter (mg/m^2) as IV infusion on Days 1, 8 and 15 of each 28-day cycle until PD, unacceptable toxicity, loss of clinical benefit or participant or investigator decision to discontinue treatment. | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
Nab-paclitaxel
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Investigational medicinal product code |
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Other name |
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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 |
Nab-paclitaxel, 100 mg/m^2, IV on Days 1, 8 and 15 of each 28-day cycle until PD, unacceptable toxicity, loss of clinical benefit or participant or investigator decision to discontinue treatment.
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Investigational medicinal product name |
Atezolizumab
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Investigational medicinal product code |
RO5541267
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Other name |
Tecentriq
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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 |
Atezolizumab, 840 mg, IV on Days 1 and 15 of each 28-day cycle until PD, unacceptable toxicity, loss of clinical benefit or participant or investigator decision to discontinue treatment.
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Baseline characteristics reporting groups
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Reporting group title |
Atezolizumab + Nab-paclitaxel
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Reporting group description |
Participants received atezolizumab 840 milligrams (mg) as intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle along with nab-paclitaxel, 100 milligrams per square meter (mg/m^2) as IV infusion on Days 1, 8 and 15 of each 28-day cycle until PD, unacceptable toxicity, loss of clinical benefit or participant or investigator decision to discontinue treatment. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Atezolizumab + Nab-paclitaxel
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Reporting group description |
Participants received atezolizumab 840 milligrams (mg) as intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle along with nab-paclitaxel, 100 milligrams per square meter (mg/m^2) as IV infusion on Days 1, 8 and 15 of each 28-day cycle until PD, unacceptable toxicity, loss of clinical benefit or participant or investigator decision to discontinue treatment. | ||
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End point title |
Percentage of Participants With Treatment-emergent Grade ≥3 Adverse Events (AEs) [1] | ||||||||
End point description |
AE=untoward medical occurrence in participant administered pharmaceutical product (PP), regardless of causal attribution. AE=any unfavorable & unintended sign, symptom/disease temporally associated with the use of PP, whether/not considered related to it. Severity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0). Grade 1=Mild; asymptomatic/mild symptoms; clinical/diagnostic observations only; intervention not indicated; Grade 2=Moderate; minimal, local/non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living; Grade 3=Severe/medically significant, but not immediately life-threatening; hospitalization/prolongation of hospitalization; disabling; limiting self-care activities of daily living; Grade 4=Life-threatening consequences/urgent intervention indicated; Grade 5=Death related to AE. Percentages have been rounded off. Safety-evaluable population.
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End point type |
Primary
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End point timeframe |
Up to 60 months
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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: Only descriptive statistics were planned for this endpoint |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants With Treatment-emergent Grade ≥2 Immune-mediated AEs (imAEs) [2] | ||||||||
End point description |
AE=any untoward medical occurrence in participant administered PP, regardless of causal attribution. AE=any unfavorable and unintended sign, symptom/disease temporally associated with the use of a PP, whether/not considered related to it. Severity was graded per NCI CTCAE v5.0. Grade 1=Mild; asymptomatic/mild symptoms; clinical/diagnostic observations only; or intervention not indicated; Grade 2=Moderate; minimal, local/non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living (ADL); Grade 3=Severe/medically significant, but not immediately life-threatening; hospitalization/prolongation of hospitalization indicated; disabling; or limiting self-care ADL; Grade 4=Life-threatening consequences/urgent intervention indicated; Grade 5=Death related to AE. imAEs are events that resemble autoimmune diseases and are known side effects of immune checkpoint inhibitors. Percentages have been rounded off. Safety-evaluable population.
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End point type |
Primary
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End point timeframe |
Up to 60 months
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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: Only descriptive statistics were planned for this endpoint |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants With all Treatment-emergent AEs | ||||||||
End point description |
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the PP. Percentages have been rounded off. Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
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End point type |
Secondary
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End point timeframe |
Up to 60 months
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants With all Treatment-emergent Serious Adverse Events (SAEs) | ||||||||
End point description |
AE=untoward medical occurrence in a participant administered PP and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of PP, whether or not considered related to the pharmaceutical product. SAEs were defined as any AE that fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/ birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here. Percentages have been rounded off. Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment.
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End point type |
Secondary
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End point timeframe |
Up to 60 months
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| No statistical analyses for this end point | |||||||||
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End point title |
Overall Survival (OS) in Safety-evaluable Population | ||||||||
End point description |
OS was defined as time from initiation of study treatment to death from any cause. OS was estimated using Kaplan-Meier (K-M) method. Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
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End point type |
Secondary
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End point timeframe |
Up to 60 months
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| No statistical analyses for this end point | |||||||||
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End point title |
OS in PD-L1-positive Population | ||||||||
End point description |
OS was defined as time from initiation of study treatment to death from any cause. OS was estimated using K-M method. PD-L1 positive population included all participants with centrally confirmed PD-L1 positive tumor status. 999=Median and upper limit of 95% CI were not estimable due to an insufficient number of participants with events.
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End point type |
Secondary
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End point timeframe |
Up to 60 months
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| No statistical analyses for this end point | |||||||||
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End point title |
Progression Free Survival (PFS) in Safety-evaluable Population | ||||||||
End point description |
PFS was defined as the time from initiation of study treatment to the first occurrence of PD, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline), and must also demonstrate an absolute increase of ≥ 5 millimeters (mm). PFS was estimated using K-M method. Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
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End point type |
Secondary
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End point timeframe |
Up to 60 months
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| No statistical analyses for this end point | |||||||||
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End point title |
PFS in PD-L1-positive Population | ||||||||
End point description |
PFS was defined as the time from initiation of study treatment to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline), and must also demonstrate an absolute increase of ≥ 5 mm. PFS was estimated using K-M method. PD-L1 positive population included all participants with centrally confirmed PD-L1 positive tumor status.
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End point type |
Secondary
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End point timeframe |
Up to 60 months
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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 60 months
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Adverse event reporting additional description |
Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
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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 |
27.1
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Reporting groups
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Reporting group title |
Atezolizumab + Nab-paclitaxel
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Reporting group description |
Participants received atezolizumab 840 mg as IV infusion on Days 1 and 15 of each 28-day cycle along with nab-paclitaxel, 100 mg/m^2 as IV infusion on Days 1, 8 and 15 of each 28-day cycle until PD, unacceptable toxicity, loss of clinical benefit or participant or investigator decision to discontinue treatment. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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13 Feb 2020 |
The following updates were included as per the latest Atezolizumab Investigator's Brochure (IB) v15:
The latest safety updates from studies evaluating atezolizumab in combination with chemotherapy in participants with TNBC (including studies GP28328 and WO29522 [IMpassion 130]); Results of the second interim analysis of overall survival (OS) for Study WO29522 (IMpassion 130); An update on immunogenicity test results ADA development in clinical trials of atezolizumab.
- Corrected previous inconsistency within the protocol, to clarify that confirmed ORR (C-ORR) and duration of response for confirmed responders (C-DoR) will be analysed based on two consecutive investigator assessments (after 8 weeks for the first 12 months following enrolment, and after 6 months [as opposed to 12 weeks] thereafter).
- A second footnote was added for completeness, to indicate additional reasons for study treatment discontinuation.
- Corrected previous inconsistency within the protocol, to clarify that the treatment-free interval (TFI) to be observed prior to the first dose of study treatment (Cycle 1, Day 1) is 12 months for PD-1/PD-L1-based regimens.
- Inclusion criterion #6 was updated to indicate that Chinese traditional medicines with an approved indication for cancer treatment are permitted as long as the last administration occurred at least 2 weeks prior to enrolment.
- For consistency within the protocol, exclusion criterion #25 was updated to confirm that the exclusion of prior immune checkpoint blockade therapies do not include anti-PD-1 or anti-PD-L1 antibodies. |
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08 Feb 2021 |
- The list of approved indications for atezolizumab was updated to include unresectable or metastatic hepatocellular carcinoma and BRAF V600 mutation-positive unresectable or metastatic melanoma.
- The following updates were included as per the latest Atezolizumab IB v17: The latest efficacy and safety updates from studies evaluating atezolizumab in combination with chemotherapy in participants with TNBC (including studies WO29522 [IMpassion130] and MO39196 [IMpassion131]); An update on immunogenicity test results ADA development) in clinical trials of atezolizumab.
- Subgroup efficacy analysis based on centrally confirmed PD-L1-positive tumor status was added as a secondary objective.
- All references to paclitaxel being a combination therapy option were removed from the protocol.
- AE reporting period was clarified in Sections 3.1.1 and 5.1: The total length of the study was updated from 4 to 4.5 years; The anticipated length of recruitment was revised from 18 to 19 months; The number of participating countries was updated from 20 to approximately 15.
- Inclusion criterion #4a was updated to clarify that HER2-negativity is to be determined according to the current ASCO-CAP guideline.
- Inclusion criterion #12 was updated to clarify the requirements for hepatitis B testing at screening.
- Exclusion criterion #23: It was clarified that the restriction related to receiving a live, attenuated vaccine applies to, the duration of atezolizumab treatment and within 5 months following the last dose of atezolizumab.
- It was clarified that AEs will be reported until 30 days after the last dose of study treatment.
- The estimated timeline for the primary analysis was clarified (approximately 36 months after the last patient was enrolled).
- The sample size was revised from 280 to 180 participants.
- The estimated number of screened participants were updated from approximately 700 to approximately 450 participants . |
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20 Feb 2022 |
- Text was added regarding exclusion of subjects with any active infection
4 weeks prior to the first dose of the study treamment at the investigator’s discretion.
- The risk associated with nab-paclitaxel was updated.
- The AE management guidelines wereupdated to align with the atezolizumab IB, Version 18. |
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22 Feb 2023 |
- The list of identified risks for atezolizumab were revised to include pericardial disorders, myelitis, and facial paresis.
- To provide additional flexibility for participants and study sites, the timing of the Day 8 and Day 15 study treatment administrations was extended to Days 8-11 and
Days 15-18, respectively.
- The adverse event management guidelines were updated to align with the Atezolizumab Investigator's Brochure, Version 19, including Addenda 1 and 2.
- |
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10 Nov 2023 |
- The list of approved indications for atezolizumab were updated to include
alveolar soft part sarcoma.
- The AE management guidelines were updated to align with the atezolizumab IB, Version 20 |
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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 | |||
