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Completed

NCT Number: NCT05498480

Study of Relatlimab in Combination With Nivolumab in Chinese Participants

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 201315, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Relatlimab

Biological

Specified dose on specified days

Other names: BMS-986016

Nivolumab

Biological

Specified dose on specified days

Other names: BMS-936558, Opdivo

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: Up to 123 Weeks

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

    Time frame: Up to 123 Weeks

  3. Number of Participants with Serious Adverse Events (SAEs)

    Time frame: Up to 123 Weeks

  4. Number of Deaths

    Time frame: Up to 123 Weeks

  5. Number of Participants with AEs Leading to Discontinuation

    Time frame: Up to 123 Weeks

  6. Number of Participants with Dose-Limiting Toxicities (DLTs)

    Time frame: Up to 123 Weeks

  7. Number of Participants with Clinical Laboratory Abnormalities

    Time frame: Up to 123 Weeks

  8. Maximum Observed Plasma Concentration (Cmax) of Relatlimab

    Time frame: Up to 123 Weeks

  9. Time of Maximum Observed Plasma Concentration (Tmax) of Relatlimab

    Time frame: Up to 123 Weeks

  10. Trough-observed serum concentration (Ctrough) of Relatlimab

    Time frame: Up to 123 Weeks

Secondary outcomes

  1. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator

    Time frame: Up to 123 Weeks

  2. Disease Control Rate (DCR) per RECIST v1.1 by Investigator

    Time frame: Up to 123 Weeks

  3. Duration of Response (DOR) per RECIST v1.1 by Investigator

    Time frame: Up to 123 Weeks

  4. Best Overall Response (BOR) per RECIST v1.1 by Investigator

    Time frame: Up to 123 Weeks

  5. Ctrough of Nivolumab

    Time frame: Up to 123 Weeks

  6. Observed Serum Concentration at End of Infusion (Ceoi) of Nivolumab

    Time frame: Up to 123 Weeks

  7. Percentage of Participants Positive for Anti-drug Antibodies (ADAs) to Relatlimab

    Time frame: Up to 123 Weeks

  8. Percentage of Participants Positive for ADAs to Nivolumab

    Time frame: Up to 123 Weeks

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Acronym: RELATIVITY-111

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 12, 2022
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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