Clinical Trial Results:
A Phase 2 Randomized Study of BMS-986207 in Combination with Nivolumab and Ipilimumab as First-line Treatment for Participants with Stage IV Non-Small Cell Lung Cancer
Summary
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EudraCT number |
2021-000039-29 |
Trial protocol |
BE FR DE ES PL |
Global end of trial date |
27 Dec 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
31 Dec 2023
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First version publication date |
31 Dec 2023
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Other versions |
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 |
CA020-016
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT05005273 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Bristol-Myers Squibb
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Sponsor organisation address |
Chaussée de la Hulpe 185, Brussels, Belgium, 1170
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Public contact |
EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com
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Scientific contact |
Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@BMS.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 |
27 Dec 2022
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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 |
27 Dec 2022
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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 |
To compare the PFS of BMS-986207 in combination with nivolumab plus ipilimumab versus nivolumab plus ipilimumab.
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Protection of trial subjects |
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
26 Sep 2022
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
United States: 1
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Worldwide total number of subjects |
1
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EEA total number of subjects |
0
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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) |
0
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||
Pre-assignment
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Screening details |
1 participant randomized and treated in arm 1. No enrollment in Arm 2 (nivolumab 360mg Q3W Ipilimumab 1mg/kg Q6W Placebo Q3W). | ||||||||||
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 |
Randomised - controlled
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Blinding used |
Single blind | ||||||||||
Roles blinded |
Subject | ||||||||||
Arms
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Arm title
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Treatment 1 | ||||||||||
Arm description |
nivolumab 360mg Q3W Ipilimumab 1mg/kg Q6W BMS-986207 600mg Q3W | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
niovolumab
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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 |
Intravascular use
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Dosage and administration details |
360mg Q3W
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Investigational medicinal product name |
BMS-986207
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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 |
Intravascular use
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Dosage and administration details |
600mg Q3W
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Investigational medicinal product name |
ipilimumab
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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 |
Intravascular use
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Dosage and administration details |
1mg/kg Q6W
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Baseline characteristics reporting groups
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Reporting group title |
Treatment 1
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Reporting group description |
nivolumab 360mg Q3W Ipilimumab 1mg/kg Q6W BMS-986207 600mg Q3W | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Treatment 1
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Reporting group description |
nivolumab 360mg Q3W Ipilimumab 1mg/kg Q6W BMS-986207 600mg Q3W |
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End point title |
Progression Free Survival by BICR [1] | ||||||||
End point description |
PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression by BICR or death due to any cause, whichever is earlier.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
here "99999" means NA
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End point type |
Primary
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End point timeframe |
From first dose to progression or death, 2.3 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: Not enough subjects for statistical analysis |
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Notes [2] - no subjects with BICR analysis |
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No statistical analyses for this end point |
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End point title |
Overall Response Rate (ORR) by BICR | ||||||||
End point description |
ORR is defined as the percentage of participants with a confirmed Best overall response of Complete Response (CR) or Partial Response (PR) by RECIST v1.1.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
here "99999" means NA
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End point type |
Secondary
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End point timeframe |
From first dose to progression or death, 2.3 months
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Notes [3] - no subjects with CR or PR |
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No statistical analyses for this end point |
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End point title |
Duration of Response (DOR) by Investigator | ||||||||
End point description |
DOR is defined for participants who have a confirmed CR or PR as the date from first documented CR or PR per RECIST v1.1 to the date of the documentation of disease progression or death due to any cause, whichever is earlier.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
here "99999" means NA
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End point type |
Secondary
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End point timeframe |
From first dose to progression or death, 2.3 months
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Notes [4] - no subjects with CR or PR |
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No statistical analyses for this end point |
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End point title |
Overall Survival (OS) | ||||||||
End point description |
OS is defined as the time from randomization to the time of death due to any cause.
Here "99999" means NA
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End point type |
Secondary
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End point timeframe |
From randomization to time of death, 2.3 months
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No statistical analyses for this end point |
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End point title |
Number of participants who had AEs, SAEs, AEs Leading to discontinuation and Deaths. | ||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
From first dose to progression or death, 2.3 months
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No statistical analyses for this end point |
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End point title |
Progression Free Survival by Investigator | ||||||||
End point description |
PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression by BICR or death due to any cause, whichever is earlier.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
here "99999" means NA
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End point type |
Secondary
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End point timeframe |
From first dose to progression or death, 2.3 months
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No statistical analyses for this end point |
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End point title |
Overall Response Rate (ORR) by Investigator | ||||||||
End point description |
ORR is defined as the percentage of participants with a confirmed Best overall response of Complete Response (CR) or Partial Response (PR) by RECIST v1.1.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
here "99999" means NA
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End point type |
Secondary
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End point timeframe |
From first dose to progression or death, 2.3 months
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Notes [5] - No subjects with CR or PR |
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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 |
Adverse Events and Serious Adverse Events (From first dose to last dose + 100 days) and All-Cause mortality (From randomization to end of study): 2.3 Months
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Adverse event reporting additional description |
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
MedDRA25.1
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Reporting groups
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Reporting group title |
Nivolumab 360 mg + Ipilimumab 1 mg/kg + BMS-986207 600 mg
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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 Jun 2022 |
The study design has been updated from
double-blind randomized assignment to
single-blind randomized assignment.
Investigators, site staff, and participants will
be blinded to BMS-986207 treatment
assignment. Data Monitoring Committee
(DMC) and Sponsor will be unblinded to
treatment assignment to monitor safety |
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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 |