Study of Relatlimab in Combination With Nivolumab in Chinese Participants

Advanced Solid Tumors Clinical Trial

— RELATIVITY-111  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05498480
• Other study ID #: CA224-111
• Status: Completed
• Phase: Phase 1
• Start date: July 27, 2022
• Est. completion date: January 18, 2024

Study information

• Verified date: February 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 18, 2024
• Est. primary completion date: January 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Biological:
• Relatlimab
Specified dose on specified days
• Nivolumab
Specified dose on specified days

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

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)		Up to 123 Weeks
Primary	Number of Participants with Immune-mediated Adverse Events (IMAEs)		Up to 123 Weeks
Primary	Number of Participants with Serious Adverse Events (SAEs)		Up to 123 Weeks
Primary	Number of Deaths		Up to 123 Weeks
Primary	Number of Participants with AEs Leading to Discontinuation		Up to 123 Weeks
Primary	Number of Participants with Dose-Limiting Toxicities (DLTs)		Up to 123 Weeks
Primary	Number of Participants with Clinical Laboratory Abnormalities		Up to 123 Weeks
Primary	Maximum Observed Plasma Concentration (Cmax) of Relatlimab		Up to 123 Weeks
Primary	Time of Maximum Observed Plasma Concentration (Tmax) of Relatlimab		Up to 123 Weeks
Primary	Trough-observed serum concentration (Ctrough) of Relatlimab		Up to 123 Weeks
Secondary	Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator		Up to 123 Weeks
Secondary	Disease Control Rate (DCR) per RECIST v1.1 by Investigator		Up to 123 Weeks
Secondary	Duration of Response (DOR) per RECIST v1.1 by Investigator		Up to 123 Weeks
Secondary	Best Overall Response (BOR) per RECIST v1.1 by Investigator		Up to 123 Weeks
Secondary	Ctrough of Nivolumab		Up to 123 Weeks
Secondary	Observed Serum Concentration at End of Infusion (Ceoi) of Nivolumab		Up to 123 Weeks
Secondary	Percentage of Participants Positive for Anti-drug Antibodies (ADAs) to Relatlimab		Up to 123 Weeks
Secondary	Percentage of Participants Positive for ADAs to Nivolumab		Up to 123 Weeks

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting