A Study to Assess Relatlimab and Nivolumab Fixed-dose Combination in Chinese Participants With Advanced Solid Tumors
- Registration Number
- NCT05134948
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- Presence of at least one lesion with measurable disease as defined by RECIST v1.1 criteria for response assessment
- Participants must have received, and then progressed, or been intolerant to at least one standard treatment regimen in the advanced or metastatic setting, if such a therapy exists
- ECOG status of 0 or 1
- Life expectancy of ≥ 12 weeks at the time of informed consent per Investigator assessment
Exclusion Criteria
- Participants with history of severe and/or life-threatening toxicity related to prior immune therapy (eg, anti-CTLA-4 or anti-PD-1/PD-L1 treatment or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways)
- Participants with an active, known or suspected autoimmune disease
- Participants with primary CNS tumors
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort A: BMS-986213 Fixed Dose Combination BMS-986213 - Cohort B: BMS-986213 Fixed Dose Combination BMS-986213 -
- Primary Outcome Measures
Name Time Method Number of Deaths Approximately 3 years 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 AEs Leading to Discontinuation Approximately 3 years Total Body Clearance (CLT) of Relatlimab Approximately 3 years Number of Participants with Serious Adverse Events (SAEs) Approximately 3 years Number of Participants with Laboratory Abnormalities 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 Maximum Observed Plasma Concentration (Cmax) 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)) Approximately 3 years Area under the concentration-time curve in one dosing interval (AUC(TAU)) of Relatlimab Approximately 3 years Observed Concentration of Relatlimab at End of Infusion (Ceoi) Approximately 3 years
- Secondary Outcome Measures
Name Time Method Disease Control Rate (DCR) 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 Best Overall Response (BOR) by RECIST v1.1 by Investigator Approximately 3 years Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator Approximately 3 years Duration of Response (DOR) by RECIST v1.1 by Investigator Approximately 3 years
Trial Locations
- Locations (2)
Local Institution - 0001
🇨🇳Beijing, Beijing, China
Local Institution - 0002
🇨🇳Fuzhou, Fujian, China