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| ID | Type | Description | Link |
|---|---|---|---|
| EU 2024-513696-40 | Registry Identifier | EU Trial Number |
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The purpose of this study is to assess the safety and tolerability of BMS-986484 administered alone, in combination with nivolumab in participants with advanced/metastatic solid tumors including non-small cell lung cancer (NSCLC), microsatellite stable (MSS) colorectal carcinoma (CRC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction adenocarcinoma (G/GEJC), and squamous cell carcinoma of the head and neck (SCCHN).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1A: BMS-986484 Dose Escalation | Experimental |
| |
| Part 1B: BMS-986484 + Nivolumab Dose Escalation | Experimental |
| |
| Part 2A: BMS-986484 Dose Expansion | Experimental |
| |
| Part 2B: BMS-986484 + Nivolumab Dose Expansion | Experimental |
| |
| Part 1C: BMS-986484 + Nivolumab + Chemotherapy Dose Escalation | Experimental |
| |
| Part 1 Co-Admin: BMS-986484 + Nivolumab | Experimental |
| |
| Part 1SC: BMS-986484 Monotherapy Subcutaneous Dose Escalation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986484 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Up to approximately 2 years | |
| Incidence of serious adverse events (SAEs) | Up to approximately 2 years | |
| Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria | Up to approximately 28 days | |
| Incidence of AEs leading to discontinuation | Up to approximately 2 years | |
| Incidence of AEs leading to death | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) | Up to approximately 2 years | |
| Time of maximum observed concentration (Tmax) | Up to approximately 2 years | |
| Area under the concentration-time curve (AUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0003 | Tucson | Arizona | 85719 | United States | ||
| Local Institution - 0007 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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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.html
See Plan Description
See Plan Description
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| Experimental |
|
| Part 2C: BMS-986484 + Nivolumab + Chemotherapy Dose Expansion | Experimental |
|
| Nivolumab | Biological | Specified dose on specified days |
|
|
| Oxaliplatin | Drug | Specified dose on specified days |
|
| Capecitabine | Drug | Specified dose on specified days |
|
| Fluorouracil | Drug | Specified dose on specified days |
|
| Calcium folinate | Drug | Specified dose on specified days |
|
| Up to approximately 2 years |
| Incidence of anti-drug antibodies (ADAs) | Up to approximately 2 years |
| Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) | Up to approximately 2 years |
| Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) | Up to approximately 2 years |
| Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) | Up to approximately 2 years |
| Los Angeles |
| California |
| 90033 |
| United States |
| Local Institution - 0011 | Grand Rapids | Michigan | 49546 | United States |
| Local Institution - 0004 | Sioux Falls | South Dakota | 57104 | United States |
| Local Institution - 0013 | San Antonio | Texas | 78229 | United States |
| Local Institution - 0021 | Darlinghurst | New South Wales | 2010 | Australia |
| Local Institution - 0019 | Elizabeth Vale | South Australia | 5112 | Australia |
| Local Institution - 0017 | Toronto | Ontario | M5G 2M9 | Canada |
| Local Institution - 0016 | Montreal | Quebec | H2X 0A9 | Canada |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D013132 | Spinocerebellar Degenerations |
| D015179 | Colorectal Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| 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 |
| D002526 | Cerebellar Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| 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 |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
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