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A Study to Assess Relatlimab in Combination With Nivolumab in Chinese Participants With Advanced Solid Tumors (RELATIVITY 059)

  • Clinicaltrials.gov identifier

    NCT05134948

  • Recruitment Status

    Recruiting

  • First Posted

    November 26, 2021

  • Last update posted

    December 27, 2021

Study Description

Brief summary:

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

  • Condition or Disease:Advanced Solid Tumors
  • Intervention/Treatment: Drug: BMS-986213
  • Phase: Phase 1/Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 12 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Study to Assess Relatlimab in Combination With Nivolumab in Chinese Participants With Advanced Solid Tumors
  • Actual Study Start Date: November 2021
  • Estimated Primary Completion Date: October 2024
  • Estimated Study Completion Date: October 2024

Arms and interventions

Arm Intervention/treatment
Experimental: BMS-986213 Fixed Dose Combination
Drug: BMS-986213
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Number of Participants with Adverse Events (AEs) [ Time Frame: Approximately 3 years ]
  • 2. Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Approximately 3 years ]
  • 3. Number of Deaths [ Time Frame: Approximately 3 years ]
  • 4. Number of Participants with AEs Leading to Discontinuation [ Time Frame: Approximately 3 years ]
  • 5. Number of Participants with Laboratory Abnormalities [ Time Frame: Approximately 3 years ]
  • 6. Maximum Observed Plasma Concentration (Cmax) of Relatlimab [ Time Frame: Approximately 3 years ]
  • 7. Time of Maximum Observed Plasma Concentration (Tmax) of Relatlimab [ Time Frame: Approximately 3 years ]
  • 8. Trough Observed Plasma Concentration (Ctrough) of Relatlimab [ Time Frame: Approximately 3 years ]
  • 9. Concentration of Relatlimab at the end of a dosing interval (Ctau) [ Time Frame: Approximately 3 years ]
  • 10. Average concentration of Relatlimab over a dosing interval (Cavg(TAU)) [ Time Frame: Approximately 3 years ]
  • 11. Area under the concentration-time curve in one dosing interval (AUC(TAU)) of Relatlimab [ Time Frame: Approximately 3 years ]
  • 12. Total Body Clearance (CLT) of Relatlimab [ Time Frame: Approximately 3 years ]
  • 13. Observed Concentration of Relatlimab at End of Infusion (Ceoi) [ Time Frame: Approximately 3 years ]
  • Secondary Outcome Measures: 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 ]

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com 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

Contacts and Locations

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

China, Beijing
Local Institution
Beijing

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT05134948 History of Changes
  • Other Study ID Numbers: CA224-059
  • First Posted: November 26, 2021 Key Record Dates
  • Last Update Posted: December 27, 2021
  • Last Verified: December 2021
  • 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
  • Keywords provided by Bristol-Myers Squibb: BMS-986213
  • Additional relevant MeSH terms: Neoplasms