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The purpose of this study is to evaluate the safety, tolerability, drug effects, drug levels and preliminary antitumor activity of BMS-986416 when administered alone and in combination with Nivolumab in participants with select advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1A: Monotherapy (BMS-986416) | Experimental |
| |
| Part 1B: Combination Therapy (BMS-986416 + Nivolumab) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986416 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | Up to 100 days after the last treatment of study intervention(s) | |
| Incidence of Serious Adverse Events (SAEs) | Up to 100 days after the last treatment of study intervention(s) | |
| Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria | Up to 100 days after the last treatment of study intervention(s) | |
| Incidence of AEs leading to discontinuation | Up to 100 days after the last treatment of study intervention(s) | |
| Incidence of AEs leading to death | Up to 100 days after the last treatment of study intervention(s) | |
| Protocol-defined maximum tolerated dose (MTD) or maximum administered dose (MAAD) | Up to 100 days after the last treatment of study intervention(s) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed serum concentration (Cmax) of BMS-986416 | Up to 100 days after the last treatment of study intervention(s) | |
| Time of maximum observed serum concentration (Tmax) of BMS-986416 | Up to 100 days after the last treatment of study intervention(s) |
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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 - 0006 | Atlanta | Georgia | 30322 | United States | ||
| Local Institution - 0005 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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| Nivolumab | Drug | Specified dose on specified days |
|
|
| Trough observed serum concentration (Ctrough) of BMS-986416 | Up to 100 days after the last treatment of study intervention(s) |
| Overall Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per Investigator assessment | Up to 2 years |
| Duration of Response (DOR) using RECIST 1.1 per Investigator assessment | Up to 2 years |
| Incidence of clinically significant changes in ECG parameters: QTcF | QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave | Up to 100 days after the last treatment of study intervention(s) |
| Baltimore |
| Maryland |
| 21287 |
| United States |
| Local Institution - 0002 | Hackensack | New Jersey | 07601 | United States |
| Local Institution - 0013 | Cleveland | Ohio | 44106-1716 | United States |
| Local Institution - 0003 | Pittsburgh | Pennsylvania | 15232 | United States |
| Local Institution - 0004 | Houston | Texas | 77030 | United States |
| Local Institution - 0021 | Ciudad Autónoma de Buenos Aires | Buenos Aires | C1426ANZ | Argentina |
| Local Institution - 0027 | ABB | Buenos Aires F.D. | C1199ABB | Argentina |
| Local Institution - 0022 | CABA | Buenos Aires F.D. | C1430EGF | Argentina |
| Local Institution - 0043 | Edegem | Antwerpen | 2650 | Belgium |
| Local Institution - 0016 | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| Local Institution - 0009 | Edmonton | Alberta | T6X 1E8 | Canada |
| Local Institution - 0008 | Toronto | Ontario | M5G 2M9 | Canada |
| Local Institution - 0001 | Montreal | Quebec | H2X 3H8 | Canada |
| Local Institution - 0025 | Santiago | Santiago Metropolitan | 7500921 | Chile |
| Local Institution - 0026 | Santiago | Santiago Metropolitan | 7620002 | Chile |
| Local Institution - 0024 | Santiago | Santiago Metropolitan | 8420383 | Chile |
| Local Institution - 0010 | Chuo-ku | Tokyo | 104-0045 | Japan |
| Local Institution - 0020 | Maastricht | Limburg | 6229 HX | Netherlands |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D002295 | Carcinoma, Transitional Cell |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D006528 | Carcinoma, Hepatocellular |
| 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 |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D002294 | Carcinoma, Squamous Cell |
| D006258 | Head and Neck Neoplasms |
| D000230 | Adenocarcinoma |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| 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 |
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