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The purpose of this study is to assess the safety, drug levels, immunogenicity and preliminary efficacy of BMS-986213 (nivolumab-relatlimab fixed-dose combination) in Chinese participants with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: BMS-986213 Fixed Dose Combination | Experimental |
| |
| Cohort B: BMS-986213 Fixed Dose Combination | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986213 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | Approximately 3 years | |
| Number of Participants with Immune-mediated Adverse Events (IMAEs) | Approximately 3 years | |
| Number of Participants with Serious Adverse Events (SAEs) | Approximately 3 years | |
| Number of Deaths | Approximately 3 years | |
| Number of Participants with AEs Leading to Discontinuation | Approximately 3 years | |
| Number of Participants with Laboratory Abnormalities | Approximately 3 years | |
| Maximum Observed Plasma Concentration (Cmax) of Relatlimab | Approximately 3 years | |
| Time of Maximum Observed Plasma Concentration (Tmax) of Relatlimab | Approximately 3 years | |
| Trough Observed Plasma Concentration (Ctrough) of Relatlimab | Approximately 3 years | |
| Concentration of Relatlimab at the end of a dosing interval (Ctau) | Approximately 3 years | |
| Average concentration of Relatlimab over a dosing interval (Cavg(TAU)) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator | Approximately 3 years | |
| Disease Control Rate (DCR) by RECIST v1.1 by Investigator | Approximately 3 years |
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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 - 0001 | Beijing | Beijing Municipality | 100142 | China | ||
| Local Institution - 0002 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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| Approximately 3 years |
| Area under the concentration-time curve in one dosing interval (AUC(TAU)) of Relatlimab | Approximately 3 years |
| Total Body Clearance (CLT) of Relatlimab | Approximately 3 years |
| Observed Concentration of Relatlimab at End of Infusion (Ceoi) | Approximately 3 years |
| Duration of Response (DOR) by RECIST v1.1 by Investigator | Approximately 3 years |
| Best Overall Response (BOR) by RECIST v1.1 by Investigator | Approximately 3 years |
| Ctrough of Nivolumab | Approximately 3 years |
| Ceoi of Nivolumab | Approximately 3 years |
| Number of Anti-drug Antibodies (ADAs) to Relatlimab | Approximately 3 years |
| Number of ADAs to Nivolumab | Approximately 3 years |
| Fuzhou |
| Fujian |
| 350014 |
| China |