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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-006872-17 | EudraCT Number | ||
| U1111-1270-3670 | Registry Identifier | WHO |
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The purpose of this study is to assess the safety and tolerability of BMS-986406 administered alone, in combination with nivolumab, or in combination with nivolumab and platinum-doublet chemotherapy (PDCT) in participants with advanced tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1A: BMS-986406 (Monotherapy Dose Escalation) | Experimental |
| |
| Part 1B: BMS-986406 + Nivolumab (Combination Dose Escalation) | Experimental |
| |
| Part 1C: BMS-986406 + Nivolumab (Indication-Specific Dose Expansion) | Experimental |
| |
| Part 2: BMS-986406 + Nivolumab (Expansion Cohorts) | Experimental |
| |
| Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or Paclitaxel | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986406 | Biological | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to 100 days | |
| Number of participants with serious adverse events (SAEs) | Up to 100 days | |
| Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria | Up to 28 days | |
| Number of participants with AEs leading to discontinuation | Up to 100 days | |
| Number of participants with death | Up to 100 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to 14 days | |
| Time of maximum observed plasma concentration (Tmax) | Up to 14 days | |
| Trough observed plasma concentration (Ctrough) |
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Inclusion Criteria:
Parts 1A, 1B, 1C:
Part 1D:
All Parts:
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 - 0021 | Birmingham | Alabama | 35213 | United States | ||
| University California San Diego Moores Cancer Center |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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| Nivolumab | Biological | Specified dose on specified days |
|
|
| Carboplatin | Drug | Specified dose on specified days |
|
| Pemetrexed | Drug | Specified dose on specified days |
|
| Paclitaxel | Drug | Specified dose on specified days |
|
| Up to 14 days |
| Incidence of anti-drug antibody (ADAs) | Up to 14 days |
| Objective response rate (ORR) | Up to 24 months |
| Disease control rate (DCR) | Up to 24 months |
| Duration of response (DOR) per tumor appropriate criteria: Modified Response Evaluation Criteria in Solid Tumors (mRECIST) for mesothelioma | Up to 24 months |
| DOR per tumor appropriate criteria: Prostate Cancer Working Group 3 (PCWG3) for prostate cancer | Up to 24 months |
| DOR per tumor appropriate criteria: Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) for other solid tumor types | Up to 24 months |
| La Jolla |
| California |
| 92093 |
| United States |
| The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate | Los Angeles | California | 90025 | United States |
| UCLA Health | Los Angeles | California | 90404 | United States |
| Local Institution - 0001 | Hackensack | New Jersey | 07601 | United States |
| Carolina BioOncology Institute, PLLC | Huntersville | North Carolina | 28078 | United States |
| Sanford Cancer Center | Sioux Falls | South Dakota | 57104 | United States |
| Mary Crowley Cancer Research - Medical City Hospital | Dallas | Texas | 75230 | United States |
| Local Institution - 0006 | Richmond | Virginia | 23298 | United States |
| Local Institution - 0029 | Viedma | Río Negro Province | 8500 | Argentina |
| Local Institution - 0023 | Rosario | Santa Fe Province | 2000 | Argentina |
| Local Institution - 0028 | Buenos Aires | C1280 | Argentina |
| Local Institution - 0032 | Córdoba | 5002 | Argentina |
| Local Institution - 0018 | Jette | Brussels Capital | 1090 | Belgium |
| Local Institution - 0015 | Edegem | MA | 2650 | Belgium |
| Local Institution - 0012 | Brussels | 1200 | Belgium |
| Local Institution - 0031 | Kashiwa-shi | Chiba | 2778577 | Japan |
| Local Institution - 0026 | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| Local Institution - 0024 | Seoul | 3080 | South Korea |
| Local Institution - 0027 | Seoul | 3722 | South Korea |
| Local Institution - 0025 | Seoul | 6351 | South Korea |
| Local Institution - 0008 | Málaga | Andaluca | 29010 | Spain |
| Local Institution - 0030 | Barcelona | 08023 | Spain |
| Local Institution - 0017 | Barcelona | 08035 | Spain |
| Institut Catala dOncologia ICO - Hospital Duran i Reynals Location | Barcelona | 08908 | Spain |
| Local Institution - 0014 | Madrid | 28027 | Spain |
| Local Institution - 0009 | Madrid | 28041 | Spain |
| Local Institution - 0016 | Madrid | 28050 | Spain |
| Local Institution - 0033 | Pamplona | 31008 | Spain |
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D016190 | Carboplatin |
| D000068437 | Pemetrexed |
| D017239 | Paclitaxel |
| 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 |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000600 | Amino Acids, Dicarboxylic |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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