A Phase 1/2 Study of Relatlimab (Anti-LAG-3 Monoclonal Antibody) and Nivolumab (Anti-PD-1 Monoclonal Antibody) Fixed-dose Combination in Chinese Participants With Advanced Solid Tumors (RELATIVITY 059)
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Number of Deaths
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Cohort A: BMS-986213 Fixed Dose Combination
Intervention: BMS-986213 (Drug)
Cohort B: BMS-986213 Fixed Dose Combination
Intervention: BMS-986213 (Drug)
Outcomes
Primary Outcomes
Number of Deaths
Time Frame: Approximately 3 years
Number of Participants with Adverse Events (AEs)
Time Frame: Approximately 3 years
Number of Participants with Immune-mediated Adverse Events (IMAEs)
Time Frame: Approximately 3 years
Number of Participants with AEs Leading to Discontinuation
Time Frame: Approximately 3 years
Total Body Clearance (CLT) of Relatlimab
Time Frame: Approximately 3 years
Number of Participants with Serious Adverse Events (SAEs)
Time Frame: Approximately 3 years
Number of Participants with Laboratory Abnormalities
Time Frame: Approximately 3 years
Time of Maximum Observed Plasma Concentration (Tmax) of Relatlimab
Time Frame: Approximately 3 years
Trough Observed Plasma Concentration (Ctrough) of Relatlimab
Time Frame: Approximately 3 years
Maximum Observed Plasma Concentration (Cmax) of Relatlimab
Time Frame: Approximately 3 years
Concentration of Relatlimab at the end of a dosing interval (Ctau)
Time Frame: Approximately 3 years
Average concentration of Relatlimab over a dosing interval (Cavg(TAU))
Time Frame: Approximately 3 years
Area under the concentration-time curve in one dosing interval (AUC(TAU)) of Relatlimab
Time Frame: Approximately 3 years
Observed Concentration of Relatlimab at End of Infusion (Ceoi)
Time Frame: Approximately 3 years
Secondary Outcomes
- 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)