Study of Relatlimab in Combination With Nivolumab in Chinese Participants (RELATIVITY-111)

February 16, 2024 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201315
        • Fudan University Shanghai Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1: Relatlimab Dose 1 + Nivolumab
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Biological: Relatlimab
Specified dose on specified days
Other Names:
  • BMS-986016
Experimental: Cohort 2: Relatlimab Dose 2 + Nivolumab
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Biological: Relatlimab
Specified dose on specified days
Other Names:
  • BMS-986016

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Adverse Events (AEs)
Time Frame: Up to 123 Weeks
Up to 123 Weeks
Number of Participants with Immune-mediated Adverse Events (IMAEs)
Time Frame: Up to 123 Weeks
Up to 123 Weeks
Number of Participants with Serious Adverse Events (SAEs)
Time Frame: Up to 123 Weeks
Up to 123 Weeks
Number of Deaths
Time Frame: Up to 123 Weeks
Up to 123 Weeks
Number of Participants with AEs Leading to Discontinuation
Time Frame: Up to 123 Weeks
Up to 123 Weeks
Number of Participants with Dose-Limiting Toxicities (DLTs)
Time Frame: Up to 123 Weeks
Up to 123 Weeks
Number of Participants with Clinical Laboratory Abnormalities
Time Frame: Up to 123 Weeks
Up to 123 Weeks
Maximum Observed Plasma Concentration (Cmax) of Relatlimab
Time Frame: Up to 123 Weeks
Up to 123 Weeks
Time of Maximum Observed Plasma Concentration (Tmax) of Relatlimab
Time Frame: Up to 123 Weeks
Up to 123 Weeks
Trough-observed serum concentration (Ctrough) of Relatlimab
Time Frame: Up to 123 Weeks
Up to 123 Weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2022

Primary Completion (Actual)

January 18, 2024

Study Completion (Actual)

January 18, 2024

Study Registration Dates

First Submitted

August 10, 2022

First Submitted That Met QC Criteria

August 10, 2022

First Posted (Actual)

August 12, 2022

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA224-111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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