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Completed

NCT Number: NCT05134948

A Study to Assess Relatlimab and Nivolumab Fixed-dose Combination in Chinese Participants With Advanced Solid Tumors

The purpose of this study is to assess the safety, drug levels, immunogenicity and preliminary efficacy of BMS-986213 (nivolumab-relatlimab fixed-dose combination) in Chinese participants with advanced solid tumors.

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Local Institution - 0001, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Presence of at least one lesion with measurable disease as defined by RECIST v1.1 criteria for response assessment
  • Participants must have received, and then progressed, or been intolerant to at least one standard treatment regimen in the advanced or metastatic setting, if such a therapy exists
  • ECOG status of 0 or 1
  • Life expectancy of ≥ 12 weeks at the time of informed consent per Investigator assessment

Exclusion criteria

  • Participants with history of severe and/or life-threatening toxicity related to prior immune therapy (eg, anti-CTLA-4 or anti-PD-1/PD-L1 treatment or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways)
  • Participants with an active, known or suspected autoimmune disease
  • Participants with primary CNS tumors

Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

BMS-986213

Drug

Specified dose on specified days

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: Approximately 3 years

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

    Time frame: Approximately 3 years

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

    Time frame: Approximately 3 years

  4. Number of Deaths

    Time frame: Approximately 3 years

  5. Number of Participants with AEs Leading to Discontinuation

    Time frame: Approximately 3 years

  6. Number of Participants with Laboratory Abnormalities

    Time frame: Approximately 3 years

  7. Maximum Observed Plasma Concentration (Cmax) of Relatlimab

    Time frame: Approximately 3 years

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

    Time frame: Approximately 3 years

  9. Trough Observed Plasma Concentration (Ctrough) of Relatlimab

    Time frame: Approximately 3 years

  10. Concentration of Relatlimab at the end of a dosing interval (Ctau)

    Time frame: Approximately 3 years

  11. Average concentration of Relatlimab over a dosing interval (Cavg(TAU))

    Time frame: Approximately 3 years

  12. Area under the concentration-time curve in one dosing interval (AUC(TAU)) of Relatlimab

    Time frame: Approximately 3 years

  13. Total Body Clearance (CLT) of Relatlimab

    Time frame: Approximately 3 years

  14. Observed Concentration of Relatlimab at End of Infusion (Ceoi)

    Time frame: Approximately 3 years

Secondary outcomes

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

    Time frame: Approximately 3 years

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

    Time frame: Approximately 3 years

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

    Time frame: Approximately 3 years

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

    Time frame: Approximately 3 years

  5. Ctrough of Nivolumab

    Time frame: Approximately 3 years

  6. Ceoi of Nivolumab

    Time frame: Approximately 3 years

  7. Number of Anti-drug Antibodies (ADAs) to Relatlimab

    Time frame: Approximately 3 years

  8. Number of ADAs to Nivolumab

    Time frame: Approximately 3 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1/2 Study of Relatlimab (Anti-LAG-3 Monoclonal Antibody) and Nivolumab (Anti-PD-1 Monoclonal Antibody) Fixed-dose Combination in Chinese Participants With Advanced Solid Tumors (RELATIVITY 059)

Acronym: RELATIVITY 059

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Nov 26, 2021
Registry last updated
Dec 3, 2025

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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