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

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)

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 Overview

• Status: Completed
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: BMS-986213

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Local Institution - 0001
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Local Institution - 0002

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A: BMS-986213 Fixed Dose Combination	Drug: BMS-986213; Specified dose on specified days
Experimental: Cohort B: BMS-986213 Fixed Dose Combination	Drug: BMS-986213; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Adverse Events (AEs)	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))	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
Number of Participants with Immune-mediated Adverse Events (IMAEs)	Approximately 3 years

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2021
• Primary Completion (Actual): September 1, 2025
• Study Completion (Actual): October 24, 2025

Study Registration Dates

• First Submitted: November 16, 2021
• First Submitted That Met QC Criteria: November 16, 2021
• First Posted (Actual): November 26, 2021

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: BMS-986213
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CA224-059

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes