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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-000039-29 | EudraCT Number | ||
| U1111-1263-4850 | Other Identifier | WHO |
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The purpose of this study is to determine the safety and efficacy of BMS-986207 in combination with nivolumab and ipilimumab as first-line treatment for participants with stage IV non-small cell lung cancer (NSCLC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental |
| |
| Arm B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival by BICR | 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. | From first dose to progression or death, 2.3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival by Investigator | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0080 | Tucson | Arizona | 85719 | United States | ||
| Local Institution - 0051 |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
| BMS Clinical Trial Patient Recruiting |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.
Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at:
https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
See Plan Description
See Plan Description
1 participant randomized and treated
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment 1 | nivolumab 360mg Q3W Ipilimumab 1mg/kg Q6W BMS-986207 600mg Q3W |
| FG001 | Treatment 2 | nivolumab 360mg Q3W Ipilimumab 1mg/kg Q6W Placebo Q3W |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 13, 2022 |
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| Ipilimumab | Drug | Specified dose on specified days |
|
|
| BMS-986207 | Drug | Specified dose on specified days |
|
| Placebo | Other | Specified dose on specified days |
|
| From first dose to progression or death, 2.3 months |
| Overall Response Rate (ORR) by BICR | 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. | From first dose to progression or death, 2.3 months |
| Overall Response Rate (ORR) by Investigator | 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. | From first dose to progression or death, 2.3 months |
| Duration of Response (DOR) by Investigator | 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. | From first dose to progression or death, 2.3 months |
| Overall Survival (OS) | OS is defined as the time from randomization to the time of death due to any cause. | From randomization to time of death, 2.3 months |
| Number of Participants Who Had AEs, SAEs, AEs Leading to Discontinuation and Deaths. | From first dose to progression or death, 2.3 months |
| Fountain Valley |
| California |
| 92708 |
| United States |
| Local Institution - 0070 | Fort Myers | Florida | 33901 | United States |
| Local Institution - 0073 | Gainesville | Florida | 32610 | United States |
| Local Institution - 0036 | Orange City | Florida | 32763 | United States |
| Local Institution - 0045 | Pensacola | Florida | 32504 | United States |
| Local Institution | Port Saint Lucie | Florida | 34952 | United States |
| Local Institution - 0068 | St. Petersburg | Florida | 33705 | United States |
| Local Institution | Tallahassee | Florida | 32308 | United States |
| Local Institution | West Palm Beach | Florida | 33401 | United States |
| Local Institution - 0081 | Boise | Idaho | 83706 | United States |
| Local Institution - 0077 | Coeur d'Alene | Idaho | 83214 | United States |
| Local Institution - 0074 | Edgewood | Kentucky | 41017 | United States |
| Local Institution - 0002 | Ann Arbor | Michigan | 48109 | United States |
| Local Institution - 0049 | Brooklyn | New York | 11220 | United States |
| Local Institution - 0012 | Charleston | South Carolina | 29414 | United States |
| Local Institution - 0053 | Milwaukee | Wisconsin | 53226 | United States |
| Local Institution - 0009 | Pergamino | Buenos Aires | 2700 | Argentina |
| Local Institution - 0054 | Rosario | Santa Fe Province | S2000DEJ | Argentina |
| Local Institution - 0062 | Buenos Aires | 1061 | Argentina |
| Local Institution - 0021 | Buenos Aires | 1125 | Argentina |
| Local Institution - 0011 | Buenos Aires | 1280 | Argentina |
| Local Institution - 0048 | Buenos Aires | C1122 | Argentina |
| Local Institution - 0057 | San Juan | 5400 | Argentina |
| Local Institution - 0063 | Orange | New South Wales | 2800 | Australia |
| Local Institution - 0056 | Wahroonga | New South Wales | 0 | Australia |
| Local Institution - 0052 | Warrnambool | Victoria | 3280 | Australia |
| Local Institution - 0034 | Mechelen | Antwerpen | 2800 | Belgium |
| Local Institution - 0040 | Charleroi | 6000 | Belgium |
| Local Institution - 0043 | Mons | 7000 | Belgium |
| Local Institution - 0019 | Sint-Niklaas | 9100 | Belgium |
| Local Institution - 0050 | Santiago | Santiago Metropolitan | 8320000 | Chile |
| Local Institution - 0035 | Viña del Mar | Valparaiso | 2520000 | Chile |
| Local Institution - 0015 | Viña del Mar | Valparaiso | 2520598 | Chile |
| Local Institution - 0037 | Limoges | 87042 | France |
| Local Institution - 0030 | Nantes | 44093 | France |
| Local Institution - 0044 | Pessac | 33604 | France |
| Local Institution - 0016 | Rouen | 76000 | France |
| Local Institution - 0031 | Saint-Priest-en-Jarez | 42271 | France |
| Local Institution - 0013 | Suresnes | 92150 | France |
| Local Institution - 0042 | Toulon | 83056 | France |
| Local Institution - 0005 | Gauting | Bavaria | 82131 | Germany |
| Local Institution - 0022 | Frankfurt am Main | Hesse | 60590 | Germany |
| Local Institution - 0017 | Gera | 7548 | Germany |
| Local Institution - 0023 | München | 81925 | Germany |
| Local Institution - 0059 | Wiesbaden | 65199 | Germany |
| Local Institution - 0064 | Haifa | 3339419 | Israel |
| Local Institution - 0061 | Jerusalem | 9103102 | Israel |
| Local Institution - 0078 | Jerusalem | 91200 | Israel |
| Local Institution - 0079 | Jerusalem | 91200 | Israel |
| Local Institution - 0039 | Monza | MB | 20900 | Italy |
| Local Institution - 0020 | Rozzano | MI | 20089 | Italy |
| Local Institution | Milan | 20133 | Italy |
| Local Institution - 0028 | Naples | 80131 | Italy |
| Local Institution - 0001 | Padova | 35128 | Italy |
| Local Institution - 0024 | Bydgoszcz | 85-796 | Poland |
| Local Institution - 0003 | Lodz | 93-338 | Poland |
| Local Institution - 0038 | Otwock | 05-400 | Poland |
| Local Institution - 0058 | Szczecin | 70-452 | Poland |
| Local Institution - 0033 | Majadahonda | Madrid | 28220 | Spain |
| Local Institution - 0041 | Alicante | 3010 | Spain |
| Local Institution - 0026 | Barcelona | 08017 | Spain |
| Local Institution - 0075 | Barcelona | 08028 | Spain |
| Local Institution - 0006 | Barcelona | 08908 | Spain |
| Local Institution - 0046 | Jaén | 23007 | Spain |
| Local Institution - 0032 | Madrid | 28040 | Spain |
| Local Institution - 0076 | Istanbul | 34010 | Turkey (Türkiye) |
| Local Institution - 0066 | Istanbul | 34098 | Turkey (Türkiye) |
| Local Institution - 0065 | Izmir | 35575 | Turkey (Türkiye) |
| Local Institution - 0067 | Samsun | 55200 | Turkey (Türkiye) |
| Local Institution - 0072 | Yüreğir | 01250 | Turkey (Türkiye) |
| COMPLETED |
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| NOT COMPLETED |
|
|
1 participant randomized and treated
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment 1 | nivolumab 360mg Q3W Ipilimumab 1mg/kg Q6W BMS-986207 600mg Q3W |
| BG001 | Treatment 2 | nivolumab 360mg Q3W Ipilimumab 1mg/kg Q6W Placebo Q3W |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival by BICR | 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. | BICR evaluation did not occur so 0 participants were analyzed for this endpoint. | Posted | From first dose to progression or death, 2.3 months |
|
| ||||||||||||||||||||||
| Secondary | Progression Free Survival by Investigator | 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. | All Treated Participants | Posted | Mean | 95% Confidence Interval | Months | From first dose to progression or death, 2.3 months |
|
| |||||||||||||||||||
| Secondary | Overall Response Rate (ORR) by BICR | 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. | BICR evaluation did not occur so 0 participants were analyzed for this endpoint. | Posted | From first dose to progression or death, 2.3 months |
|
| ||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) by Investigator | 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. | 0 participants met the criteria for to be considered CR and PR, 0 participants were analyzed for this endpoint | Posted | From first dose to progression or death, 2.3 months |
|
| ||||||||||||||||||||||
| Secondary | Duration of Response (DOR) by Investigator | 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. | All Treated Participants | Posted | Mean | 95% Confidence Interval | Months | From first dose to progression or death, 2.3 months |
|
| |||||||||||||||||||
| Secondary | Overall Survival (OS) | OS is defined as the time from randomization to the time of death due to any cause. | All Treated Participants | Posted | Mean | 95% Confidence Interval | Months | From randomization to time of death, 2.3 months |
|
| |||||||||||||||||||
| Secondary | Number of Participants Who Had AEs, SAEs, AEs Leading to Discontinuation and Deaths. | All Treated Participants | Posted | Count of Participants | Participants | From first dose to progression or death, 2.3 months |
|
|
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nivolumab 360 mg + Ipilimumab 1 mg/kg + BMS-986207 600 mg | nivolumab 360mg Q3W Ipilimumab 1mg/kg Q6W BMS-986207 600mg Q3W | 1 | 1 | 1 | 1 | 1 | 1 |
| EG001 | Nivolumab 360 mg + Ipilimumab 1 mg/kg + Placebo | nivolumab 360mg Q3W Ipilimumab 1mg/kg Q6W Placebo Q3W | 0 | 0 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | 25.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | 25.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | 25.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | 25.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 25.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 25.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | 25.1 | Systematic Assessment |
|
Due to 1 participant being randomized and treated sub group analysis were not completed for this study.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please Email | Clinical.Trials@BMS.com |
| Dec 15, 2023 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
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| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|