A Phase 1 Study of Relatlimab (Anti-LAG-3 Monoclonal Antibody) in Combination With Nivolumab (Anti-PD-1 Monoclonal Antibody) in Chinese Participants With Advanced Solid Tumors

Bristol-Myers Squibb1 site in 1 country6 target enrollmentJuly 27, 2022

Overview

Brief Summary

The purpose of this study is to evaluate the safety and drug levels of relatlimab combined with nivolumab in Chinese participants with advanced solid tumors.

Registry

clinicaltrials.gov

Start Date

July 27, 2022

End Date

January 18, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participants must have histologic or cytological confirmation of an incurable solid malignancy that is advanced (metastatic and/or unresectable) except for participants with primary central nervous system (CNS) tumors.
•Participants must have received, and then progressed or been intolerant to at least 1 standard treatment regimen in the advanced or metastatic setting (immune check inhibitor-experienced or non-experienced population may be included), if such a therapy exists. Participants who refuse or are ineligible for standard therapy will be allowed to enroll provided their refusal/ineligibility is documented in medical records.
•Eastern Cooperative Oncology Group (ECOG) 0 to 1.

Exclusion Criteria

•Participants with history of severe and/or life-threatening toxicity related to prior immune therapy (eg, anti-cytotoxic T-lymphocyte-associated protein 4 \[anti-CTLA-4\] or anti-programmed cell death protein 1 \[anti-PD-1\]/programmed death-ligand 1 \[PD-L1\] treatment or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures (eg, hormone replacement after endocrinopathy).
•Participants with an active, known, or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
•Prior treatment with LAG-3 targeted agents.
•Other protocol-defined inclusion/exclusion criteria apply

Outcomes

Primary Outcomes

Number of Participants with Immune-mediated Adverse Events (IMAEs)

Time Frame: Up to 123 Weeks

Maximum Observed Plasma Concentration (Cmax) of Relatlimab

Time Frame: Up to 123 Weeks

Number of Participants with Serious Adverse Events (SAEs)

Time Frame: Up to 123 Weeks

Number of Participants with Clinical Laboratory Abnormalities

Time Frame: Up to 123 Weeks

Number of Participants with Dose-Limiting Toxicities (DLTs)

Time Frame: Up to 123 Weeks

Time of Maximum Observed Plasma Concentration (Tmax) of Relatlimab

Time Frame: Up to 123 Weeks

Trough-observed serum concentration (Ctrough) of Relatlimab

Time Frame: Up to 123 Weeks

Number of Deaths

Time Frame: Up to 123 Weeks

Number of Participants with AEs Leading to Discontinuation

Time Frame: Up to 123 Weeks

Number of Participants with Adverse Events (AEs)

Time Frame: Up to 123 Weeks

Secondary Outcomes

Ctrough of Nivolumab(Up to 123 Weeks)
Percentage of Participants Positive for ADAs to Nivolumab(Up to 123 Weeks)
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator(Up to 123 Weeks)
Disease Control Rate (DCR) per RECIST v1.1 by Investigator(Up to 123 Weeks)
Duration of Response (DOR) per RECIST v1.1 by Investigator(Up to 123 Weeks)
Best Overall Response (BOR) per RECIST v1.1 by Investigator(Up to 123 Weeks)
Percentage of Participants Positive for Anti-drug Antibodies (ADAs) to Relatlimab(Up to 123 Weeks)
Observed Serum Concentration at End of Infusion (Ceoi) of Nivolumab(Up to 123 Weeks)