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The purpose of this study is to evaluate the safety and drug levels of relatlimab combined with nivolumab in Chinese participants with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Relatlimab Dose 1 + Nivolumab | Experimental |
| |
| Cohort 2: Relatlimab Dose 2 + Nivolumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relatlimab | Biological | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | Up to 123 Weeks | |
| Number of Participants with Immune-mediated Adverse Events (IMAEs) | Up to 123 Weeks | |
| Number of Participants with Serious Adverse Events (SAEs) | Up to 123 Weeks | |
| Number of Deaths | Up to 123 Weeks | |
| Number of Participants with AEs Leading to Discontinuation | Up to 123 Weeks | |
| Number of Participants with Dose-Limiting Toxicities (DLTs) | Up to 123 Weeks | |
| Number of Participants with Clinical Laboratory Abnormalities | Up to 123 Weeks | |
| Maximum Observed Plasma Concentration (Cmax) of Relatlimab | Up to 123 Weeks | |
| Time of Maximum Observed Plasma Concentration (Tmax) of Relatlimab | Up to 123 Weeks | |
| Trough-observed serum concentration (Ctrough) of Relatlimab | Up to 123 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator | Up to 123 Weeks | |
| Disease Control Rate (DCR) per RECIST v1.1 by Investigator | Up to 123 Weeks |
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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 |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 201315 | China |
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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 Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
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| ID | Term |
|---|---|
| C000721227 | relatlimab |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Nivolumab | Biological | Specified dose on specified days |
|
|
| Duration of Response (DOR) per RECIST v1.1 by Investigator | Up to 123 Weeks |
| Best Overall Response (BOR) per RECIST v1.1 by Investigator | Up to 123 Weeks |
| Ctrough of Nivolumab | Up to 123 Weeks |
| Observed Serum Concentration at End of Infusion (Ceoi) of Nivolumab | Up to 123 Weeks |
| Percentage of Participants Positive for Anti-drug Antibodies (ADAs) to Relatlimab | Up to 123 Weeks |
| Percentage of Participants Positive for ADAs to Nivolumab | Up to 123 Weeks |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |