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

Advanced Solid Tumors Clinical Trial

— RELATIVITY 059  

Official title:

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05134948
• Other study ID #: CA224-059
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: November 30, 2021
• Est. completion date: October 22, 2025

Study information

• Verified date: May 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: October 22, 2025
• Est. primary completion date: October 22, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• BMS-986213
Specified dose on specified days

Locations

Country	Name	City	State
China	Local Institution - 0001	Beijing	Beijing
China	Local Institution - 0002	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events (AEs)		Approximately 3 years
Primary	Number of Participants with Immune-mediated Adverse Events (IMAEs)		Approximately 3 years
Primary	Number of Participants with Serious Adverse Events (SAEs)		Approximately 3 years
Primary	Number of Deaths		Approximately 3 years
Primary	Number of Participants with AEs Leading to Discontinuation		Approximately 3 years
Primary	Number of Participants with Laboratory Abnormalities		Approximately 3 years
Primary	Maximum Observed Plasma Concentration (Cmax) of Relatlimab		Approximately 3 years
Primary	Time of Maximum Observed Plasma Concentration (Tmax) of Relatlimab		Approximately 3 years
Primary	Trough Observed Plasma Concentration (Ctrough) of Relatlimab		Approximately 3 years
Primary	Concentration of Relatlimab at the end of a dosing interval (Ctau)		Approximately 3 years
Primary	Average concentration of Relatlimab over a dosing interval (Cavg(TAU))		Approximately 3 years
Primary	Area under the concentration-time curve in one dosing interval (AUC(TAU)) of Relatlimab		Approximately 3 years
Primary	Total Body Clearance (CLT) of Relatlimab		Approximately 3 years
Primary	Observed Concentration of Relatlimab at End of Infusion (Ceoi)		Approximately 3 years
Secondary	Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator		Approximately 3 years
Secondary	Disease Control Rate (DCR) by RECIST v1.1 by Investigator		Approximately 3 years
Secondary	Duration of Response (DOR) by RECIST v1.1 by Investigator		Approximately 3 years
Secondary	Best Overall Response (BOR) by RECIST v1.1 by Investigator		Approximately 3 years
Secondary	Ctrough of Nivolumab		Approximately 3 years
Secondary	Ceoi of Nivolumab		Approximately 3 years
Secondary	Number of Anti-drug Antibodies (ADAs) to Relatlimab		Approximately 3 years
Secondary	Number of ADAs to Nivolumab		Approximately 3 years

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls