Trial Outcomes & Findings for A Study to Assess BMS-986207 in Combination With Nivolumab and Ipilimumab as First-line Treatment for Participants With Stage IV Non-Small Cell Lung Cancer (NCT NCT05005273)

Last Updated: 2024-02-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

From first dose to progression or death, 2.3 months

Results posted on

2024-02-28

Participant Flow

1 participant randomized and treated

Participant milestones

Participant milestones
Measure	Treatment 1 nivolumab 360mg Q3W Ipilimumab 1mg/kg Q6W BMS-986207 600mg Q3W	Treatment 2 nivolumab 360mg Q3W Ipilimumab 1mg/kg Q6W Placebo Q3W
Overall Study STARTED	1	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment 1 nivolumab 360mg Q3W Ipilimumab 1mg/kg Q6W BMS-986207 600mg Q3W	Treatment 2 nivolumab 360mg Q3W Ipilimumab 1mg/kg Q6W Placebo Q3W
Overall Study Study Terminated	1	0

Baseline Characteristics

A Study to Assess BMS-986207 in Combination With Nivolumab and Ipilimumab as First-line Treatment for Participants With Stage IV Non-Small Cell Lung Cancer

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: From first dose to progression or death, 2.3 months

Population: BICR evaluation did not occur so 0 participants were analyzed for this endpoint.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose to progression or death, 2.3 months

Population: All Treated Participants

PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression 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.

Outcome measures

Outcome measures
Measure	Treatment 1 n=1 Participants nivolumab 360mg Q3W Ipilimumab 1mg/kg Q6W BMS-986207 600mg Q3W	Treatment 2 nivolumab 360mg Q3W Ipilimumab 1mg/kg Q6W Placebo Q3W
Progression Free Survival by Investigator	2.3 Months 1 participant analyzed. Lower limit and upper limit cannot be computed via KM methodology.	—

SECONDARY outcome

Timeframe: From first dose to progression or death, 2.3 months

Population: BICR evaluation did not occur so 0 participants were analyzed for this endpoint.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose to progression or death, 2.3 months

Population: 0 participants met the criteria for to be considered CR and PR, 0 participants were analyzed for this endpoint

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose to progression or death, 2.3 months

Population: All Treated Participants

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.

Outcome measures

Outcome measures
Measure	Treatment 1 n=1 Participants nivolumab 360mg Q3W Ipilimumab 1mg/kg Q6W BMS-986207 600mg Q3W	Treatment 2 nivolumab 360mg Q3W Ipilimumab 1mg/kg Q6W Placebo Q3W
Duration of Response (DOR) by Investigator	NA Months Participant did not meet criteria for CR or PR so could not be evaluated	—

SECONDARY outcome

Timeframe: From randomization to time of death, 2.3 months

Population: All Treated Participants

OS is defined as the time from randomization to the time of death due to any cause.

Outcome measures

Outcome measures
Measure	Treatment 1 n=1 Participants nivolumab 360mg Q3W Ipilimumab 1mg/kg Q6W BMS-986207 600mg Q3W	Treatment 2 nivolumab 360mg Q3W Ipilimumab 1mg/kg Q6W Placebo Q3W
Overall Survival (OS)	2.3 Months only 1 participant treated and analyzed, lower limit number and upper limit number cannot be calculated using KM methodology.	—

SECONDARY outcome

Timeframe: From first dose to progression or death, 2.3 months

Population: All Treated Participants

Outcome measures

Outcome measures
Measure	Treatment 1 n=1 Participants nivolumab 360mg Q3W Ipilimumab 1mg/kg Q6W BMS-986207 600mg Q3W	Treatment 2 nivolumab 360mg Q3W Ipilimumab 1mg/kg Q6W Placebo Q3W
Number of Participants Who Had AEs, SAEs, AEs Leading to Discontinuation and Deaths. Adverse Events	0 Participants	0 Participants
Number of Participants Who Had AEs, SAEs, AEs Leading to Discontinuation and Deaths. Serious Adverse Events	1 Participants	0 Participants
Number of Participants Who Had AEs, SAEs, AEs Leading to Discontinuation and Deaths. Deaths	1 Participants	0 Participants
Number of Participants Who Had AEs, SAEs, AEs Leading to Discontinuation and Deaths. AEs leading to discontinuation	0 Participants	0 Participants

Adverse Events

Nivolumab 360 mg + Ipilimumab 1 mg/kg + BMS-986207 600 mg

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Nivolumab 360 mg + Ipilimumab 1 mg/kg + Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Nivolumab 360 mg + Ipilimumab 1 mg/kg + BMS-986207 600 mg n=1 participants at risk nivolumab 360mg Q3W Ipilimumab 1mg/kg Q6W BMS-986207 600mg Q3W	Nivolumab 360 mg + Ipilimumab 1 mg/kg + Placebo nivolumab 360mg Q3W Ipilimumab 1mg/kg Q6W Placebo Q3W
Cardiac disorders Cardiac arrest	100.0% 1/1 • 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 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	— 0/0 • 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 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
Infections and infestations Sepsis	100.0% 1/1 • 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 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	— 0/0 • 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 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

Other adverse events

Other adverse events
Measure	Nivolumab 360 mg + Ipilimumab 1 mg/kg + BMS-986207 600 mg n=1 participants at risk nivolumab 360mg Q3W Ipilimumab 1mg/kg Q6W BMS-986207 600mg Q3W	Nivolumab 360 mg + Ipilimumab 1 mg/kg + Placebo nivolumab 360mg Q3W Ipilimumab 1mg/kg Q6W Placebo Q3W
Gastrointestinal disorders Nausea	100.0% 1/1 • 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 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	— 0/0 • 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 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
Infections and infestations Bronchitis	100.0% 1/1 • 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 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	— 0/0 • 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 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
Investigations Blood alkaline phosphatase increased	100.0% 1/1 • 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 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	— 0/0 • 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 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
Investigations Blood lactate dehydrogenase increased	100.0% 1/1 • 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 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	— 0/0 • 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 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
Metabolism and nutrition disorders Hypoalbuminaemia	100.0% 1/1 • 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 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	— 0/0 • 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 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
Metabolism and nutrition disorders Hypokalaemia	100.0% 1/1 • 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 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	— 0/0 • 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 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
Metabolism and nutrition disorders Hyponatraemia	100.0% 1/1 • 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 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	— 0/0 • 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 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
Skin and subcutaneous tissue disorders Eczema	100.0% 1/1 • 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 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	— 0/0 • 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 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

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please Email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER

Measure	Treatment 1 n=1 Participants nivolumab 360mg Q3W Ipilimumab 1mg/kg Q6W BMS-986207 600mg Q3W	Treatment 2 nivolumab 360mg Q3W Ipilimumab 1mg/kg Q6W Placebo Q3W	Total n=1 Participants Total of all reporting groups
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants