A Study to Assess Relatlimab and Nivolumab Fixed-dose Combination in Chinese Participants With Advanced Solid Tumors (RELATIVITY 059)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: BMS-986213

Study type: Interventional

Funder types: Industry

Identifiers

NCT05134948

CA224-059

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Cohort A: BMS-986213 Fixed Dose Combination

Experimental group

Treatment:

Drug: BMS-986213

Cohort B: BMS-986213 Fixed Dose Combination

Experimental group

Treatment:

Drug: BMS-986213