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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003058-18 | EudraCT Number |
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Business objectives have changed.
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This is a study of experimental medication BMS-986205 given with Nivolumab with or without chemotherapy compared to chemotherapy in participants with previously untreated stage IV or recurrent non-small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | BMS-986205 and Nivolumab administered in combination |
|
| Arm B | Experimental | BMS-986205 and Nivolumab administered in combination with chemotherapy |
|
| Arm C | Active Comparator | Chemotherapy administered alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986205 | Drug | Administered orally daily, 100 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) measured by number of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group | 24 months | |
| Progression free survival (PFS) measured by the time between the date of randomization and the first date of documented progression, as determined by the Blinded Independent Central Review, or death, due to any cause, whichever occurs first | 34 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) measured by the time between the date of randomization and the date of death due to any cause | Approximately 5 years | |
| Number of treatment-related adverse events (AE) | Approximately 5 years |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could 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 | San Diego | California | 92123 | United States | ||
| Local Institution |
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| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
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| Nivolumab |
| Biological |
Specified dose on specified days |
|
|
| Chemotherapy | Drug | Platinum-based doublet chemotherapy |
|
| Number of treatment-related serious adverse events | Approximately 5 years |
| Fort Myers |
| Florida |
| 33916 |
| United States |
| Local Institution | Jacksonville | Florida | 32256 | United States |
| Local Institution | St. Petersburg | Florida | 33705 | United States |
| Local Institution | Tallahassee | Florida | 32308 | United States |
| Local Institution | West Palm Beach | Florida | 33401 | United States |
| Local Institution | Decatur | Georgia | 30033 | United States |
| Local Institution | Marietta | Georgia | 30060 | United States |
| Local Institution | Wichita | Kansas | 67214 | United States |
| Local Institution | Louisville | Kentucky | 40202 | United States |
| Local Institution | Boston | Massachusetts | 02114 | United States |
| Local Institution | Bridgeton | Missouri | 63044 | United States |
| Local Institution | Lincoln | Nebraska | 68510 | United States |
| Local Institution | Cleveland | Ohio | 44106 | United States |
| Local Institution | Gettysburg | Pennsylvania | 17325 | United States |
| Local Institution | Greenville | South Carolina | 29607 | United States |
| Local Institution | Lebanon | Tennessee | 37087 | United States |
| Local Institution | Fort Worth | Texas | 76104 | United States |
| Local Institution | Lubbock | Texas | 79430-0002 | United States |
| Local Institution | Darlinghurst | New South Wales | 2010 | Australia |
| Local Institution | Brisbane | Queensland | 4102 | Australia |
| Local Institution | Melbourne | Victoria | 3004 | Australia |
| Local Institution | Murdoch | Western Australia | 6150 | Australia |
| Local Institution | North Tamworth | 2340 | Australia |
| Local Institution | Vienna | 1090 | Austria |
| Local Institution | Wels | 4600 | Austria |
| Local Institution | Ipatinga | Minas Gerais | 35160-158 | Brazil |
| Local Institution | Jd. Petropolis-Londrina | Paraná | 86015-520 | Brazil |
| Local Institution | Centro-porto Alegre | Rio Grande do Sul | 90050-170 | Brazil |
| Local Institution | Ijuí | Rio Grande do Sul | 98700-000 | Brazil |
| Local Institution | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Local Institution | Barretos | São Paulo | 14780-070 | Brazil |
| Local Institution | Morumbi | São Paulo | 05652-900 | Brazil |
| Local Institution | Rio de Janeiro | 22793-080 | Brazil |
| Local Institution | Québec | Quebec | G1R 2J6 | Canada |
| Local Institution | Prague | 128 08 | Czechia |
| Local Institution | Besançon | 25030 | France |
| Local Institution | La Tronche | 38700 | France |
| Local Institution | Paris | 75248 | France |
| Local Institution | Pessac | 33604 | France |
| Local Institution | Pringy | 74374 | France |
| Local Institution | Rennes | 35033 | France |
| Local Institution | Saint-Herblain | 44805 | France |
| Local Institution | Toulon | 83000 | France |
| Local Institution | Berlin | 14165 | Germany |
| Local Institution | Gauting | 82131 | Germany |
| Local Institution | Gera | 07548 | Germany |
| Local Institution | Göttingen | 37075 | Germany |
| Local Institution | Großhansdorf | 22927 | Germany |
| Local Institution | Hamburg | 21075 | Germany |
| Local Institution | Heidelberg | 69126 | Germany |
| Local Institution | Oldenburg | 26121 | Germany |
| Local Institution | Paderborn | 33098 | Germany |
| Local Institution | Wiesbaden | 65199 | Germany |
| Local Institution | Athens | 11527 | Greece |
| Local Institution | Athens | 18547 | Greece |
| Local Institution | Thessaloniki | 54 622 | Greece |
| Local Institution | Modena | 41100 | Italy |
| Local Institution | Monza (MB) | 20900 | Italy |
| Local Institution | Naples | 80131 | Italy |
| Local Institution | Perugia | 06132 | Italy |
| Local Institution | Ravenna | 48121 | Italy |
| Local Institution | Reggio Emilia | 42100 | Italy |
| Local Institution | Fukushima | Fukushima | 9601295 | Japan |
| Local Institution | Morioka | Iwate | 0208505 | Japan |
| Local Institution | Osaka-sayama-shi | Osaka | 5898511 | Japan |
| Local Institution | Kitaadachi-gun | Saitama | 362-0806 | Japan |
| Local Institution | Mérida | Yucatán | 97070 | Mexico |
| Local Institution | Seoul | 03080 | South Korea |
| Local Institution | Seoul | 135-710 | South Korea |
| Local Institution | A Coruña | Galicia | 15006 | Spain |
| Local Institution | Barcelona | 08035 | Spain |
| Local Institution | Madrid | 28041 | Spain |
| Local Institution | Majadahonda - Madrid | 28222 | Spain |
| Local Institution | Málaga | 29010 | Spain |
| Local Institution | Valencia | 46026 | Spain |
| Local Institution | Basel | 4031 | Switzerland |
| Local Institution | Taipei | 11217 | Taiwan |
| Local Institution | Taipei | Taiwan |
| Local Institution | ?stanbul | 34890 | Turkey (Türkiye) |
| Local Institution | Adana | 01250 | Turkey (Türkiye) |
| Local Institution | Antalya | 07070 | Turkey (Türkiye) |
| Local Institution | Istanbul | 34098 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| C000630574 | linrodostat |
| D000077594 | Nivolumab |
| D004358 | Drug Therapy |
| 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 |
| D013812 | Therapeutics |
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