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

NCT ID: NCT05134948

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-30

Study Completion Date

2025-10-24

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort A: BMS-986213 Fixed Dose Combination

Group Type EXPERIMENTAL

BMS-986213

Intervention Type DRUG

Specified dose on specified days

Cohort B: BMS-986213 Fixed Dose Combination

Group Type EXPERIMENTAL

BMS-986213

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986213

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0001

Beijing, Beijing Municipality, China

Site Status

Local Institution - 0002

Fuzhou, Fujian, China

Site Status

Countries

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China

Related Links

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Other Identifiers

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CA224-059

Identifier Type: -

Identifier Source: org_study_id

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