Study of Relatlimab in Combination With Nivolumab in Chinese Participants

NCT ID: NCT05498480

Last Updated: 2024-02-20

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

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-27

Study Completion Date

2024-01-18

Brief Summary

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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.

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 1: Relatlimab Dose 1 + Nivolumab

Group Type EXPERIMENTAL

Relatlimab

Intervention Type BIOLOGICAL

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Cohort 2: Relatlimab Dose 2 + Nivolumab

Group Type EXPERIMENTAL

Relatlimab

Intervention Type BIOLOGICAL

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Interventions

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Relatlimab

Specified dose on specified days

Intervention Type BIOLOGICAL

Nivolumab

Specified dose on specified days

Intervention Type BIOLOGICAL

Other Intervention Names

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BMS-986016 BMS-936558 Opdivo

Eligibility Criteria

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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.
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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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Related Links

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Other Identifiers

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CA224-111

Identifier Type: -

Identifier Source: org_study_id

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