A Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab in Relapsed or Refractory B-Cell Malignancies

NCT ID: NCT02061761

Last Updated: 2023-03-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-13

Study Completion Date

2022-02-16

Brief Summary

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The primary objective of this study is to characterize the safety, tolerability, dose-limiting toxicities (DLTs), and maximum tolerated dose (MTD) of relatlimab administered alone or in combination with nivolumab to subjects with relapsed or refractory B-cell malignancies. Co-primary objective is to investigate the preliminary efficacy of relatlimab in combination with nivolumab in subjects with relapsed or refractory Hodgkin lymphoma (HL), and relapsed or refractory Diffused Large B Cell lymphoma (DLBCL)

Detailed Description

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Conditions

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Hematologic Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A - relatlimab (Dose escalation)

Group Type EXPERIMENTAL

BMS-986016

Intervention Type BIOLOGICAL

Specified Dose on Specified Days

Part C - relatlimab + nivolumab (Dose escalation)

Group Type EXPERIMENTAL

BMS-986016

Intervention Type BIOLOGICAL

Specified Dose on Specified Days

BMS-936558

Intervention Type BIOLOGICAL

Specified Dose on Specified Days

Part B - relatlimab (Cohort expansion)

Group Type EXPERIMENTAL

BMS-986016

Intervention Type BIOLOGICAL

Specified Dose on Specified Days

Part D - relatlimab + nivolumab (Cohort expansion)

Group Type EXPERIMENTAL

BMS-986016

Intervention Type BIOLOGICAL

Specified Dose on Specified Days

BMS-936558

Intervention Type BIOLOGICAL

Specified Dose on Specified Days

Interventions

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BMS-986016

Specified Dose on Specified Days

Intervention Type BIOLOGICAL

BMS-936558

Specified Dose on Specified Days

Intervention Type BIOLOGICAL

Other Intervention Names

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Anti-LAG-3 (Anti-Lymphocyte Activation Gene-3), relatlimab Anti-PD-1 (Anti-Programmed-Death-1), MDX-1106, nivolumab

Eligibility Criteria

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Inclusion Criteria

* Must have histologic or cytologic confirmation of chronic lymphocytic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, or Multiple Myeloma and have relapsed following prior treatment or been refractory to prior treatment
* Must have progressed or been refractory to, at least one prior standard therapy, including radiation, immunomodulatory agents (eg, lenalidomide), immunotherapy, cytotoxic chemotherapy, and select antibody (anti-CD20, alemtuzumab, or anti-CD30) therapy.
* Must be more than 100 days post autologous transplant

Exclusion Criteria

* Known or suspected central nervous system (CNS) metastases or with the CNS as the only site of active disease (controlled CNS metastases are allowed)
* Known or suspected autoimmune disease
* History of allergy to anti-PD-1 or anti-PD-L1 antibody therapy or to other monoclonal antibodies or related compounds or to any of their components
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 - 0007

Baltimore, Maryland, United States

Site Status

Local Institution - 0004

Boston, Massachusetts, United States

Site Status

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Local Institution - 0010

St Louis, Missouri, United States

Site Status

Weill Cornell Medical College

New York, New York, United States

Site Status

Local Institution - 0002

Portland, Oregon, United States

Site Status

Local Institution - 0006

Houston, Texas, United States

Site Status

Local Institution - 0001

Seattle, Washington, United States

Site Status

Local Institution - 0011

Vancouver, British Columbia, Canada

Site Status

Local Institution - 0012

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

References

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Gopal AK, Armand P, Neelapu SS, Bartlett NL, Spurgeon SE, Kuruvilla J, Savage KJ, Leonard JP, Gelb AB, Ahmed N, Dong S, Bathena SP, Suryawanshi R, Wu JQ, Wang S, Gladstone DE. Nivolumab plus relatlimab for patients with relapsed or progressed B-cell malignancies in RELATIVITY-022. Blood Adv. 2025 Jul 8;9(13):3383-3394. doi: 10.1182/bloodadvances.2024015086.

Reference Type DERIVED
PMID: 40030000 (View on PubMed)

El Halabi L, Adam J, Gravelle P, Marty V, Danu A, Lazarovici J, Ribrag V, Bosq J, Camara-Clayette V, Laurent C, Ghez D. Expression of the Immune Checkpoint Regulators LAG-3 and TIM-3 in Classical Hodgkin Lymphoma. Clin Lymphoma Myeloma Leuk. 2021 Apr;21(4):257-266.e3. doi: 10.1016/j.clml.2020.11.009. Epub 2020 Nov 12.

Reference Type DERIVED
PMID: 33277223 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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CA224-022

Identifier Type: -

Identifier Source: org_study_id

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