Study of Relatlimab in Combination With Nivolumab in Chinese Participants

NCT05498480 | Completed Phase 1 FDA Drug

• 1 other identifier: CA224-111
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumors

Keywords

Advanced Solid Tumors; Relatlimab; Nivolumab

Outcome Measures

Primary Outcomes (10)

• Number of Participants with Adverse Events (AEs)

  Up to 123 Weeks

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

  Up to 123 Weeks

• Number of Participants with Serious Adverse Events (SAEs)

  Up to 123 Weeks

• Number of Deaths

  Up to 123 Weeks

• Number of Participants with AEs Leading to Discontinuation

  Up to 123 Weeks

• Number of Participants with Dose-Limiting Toxicities (DLTs)

  Up to 123 Weeks

• Number of Participants with Clinical Laboratory Abnormalities

  Up to 123 Weeks

• Maximum Observed Plasma Concentration (Cmax) of Relatlimab

  Up to 123 Weeks

• Time of Maximum Observed Plasma Concentration (Tmax) of Relatlimab

  Up to 123 Weeks

• Trough-observed serum concentration (Ctrough) of Relatlimab

  Up to 123 Weeks

Secondary Outcomes (8)

• 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

• Ctrough of Nivolumab

  Up to 123 Weeks

Study Arms (2)

Cohort 1: Relatlimab Dose 1 + Nivolumab

EXPERIMENTAL

Biological: Relatlimab; Biological: Nivolumab

Cohort 2: Relatlimab Dose 2 + Nivolumab

EXPERIMENTAL

Biological: Relatlimab; Biological: Nivolumab

Interventions

Relatlimab BIOLOGICAL

Specified dose on specified days

Also known as: BMS-986016

Cohort 1: Relatlimab Dose 1 + Nivolumab; Cohort 2: Relatlimab Dose 2 + Nivolumab

Nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: BMS-936558, Opdivo

Cohort 1: Relatlimab Dose 1 + Nivolumab; Cohort 2: Relatlimab Dose 2 + Nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 201315, China

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

relatlimab; Nivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 12, 2022
• Study Start: July 27, 2022
• Primary Completion: January 18, 2024
• Study Completion: January 18, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)