Relatlimab

Generic Name: Relatlimab

Brand Names: Opdualag

Drug Type: Biotech

CAS Number: 1673516-98-7

Unique Ingredient Identifier: AF75XOF6W3

Background: Relatlimab is a human IgG4 monoclonal antibody and novel immune checkpoint inhibitor that targets lymphocyte activation gene-3 (LAG-3). It was the first commercially developed anti-LAG-3 antibody, entering clinical trials in 2013, and has garnered interest in the treatment of a variety of cancers, including leukemia and melanoma. As immune checkpoint inhibitors have limited efficacy when used alone, drugs like relatlimab have been trialed in combination with other checkpoint inhibitors - for example, PD-1 inhibitors like nivolumab or CTLA-4 inhibitors like ipilimumab - to enhance their efficacy.

Relatlimab received FDA approval in March 2022, alongside the PD-1 inhibitor nivolumab in the combination product Opdualag (Bristol-Myers Squibb), for the treatment of unresectable or metastatic melanoma. It was the first anti-LAG-3 antibody demonstrate benefit in a Phase 3 study, as well as the first to receive FDA approval.

Indication: Relatlimab is indicated in combination with nivolumab, in the combination product Opdualag, for the treatment of adult and pediatric patients ≥12 years old with unresectable or metastatic melanoma.

Associated Conditions: Metastatic Melanoma, Unresectable Melanoma

Clinical Trials

Pan Tumor Rollover Study

Phase 2

Recruiting

Conditions: Cancer

Interventions: Drug: Nivolumab
Drug: Leucovorin
Drug: Nivolumab + Relatlimab
Drug: Regorafinib
Drug: Capecitabine
Drug: Pemetrexed
Drug: Enzalutamide
Drug: Sunitinib
Drug: Pembrolizumab
Drug: Relatlimab
Drug: Temozolomide
Drug: Rucaparib
Drug: Ipilimumab
Drug: Daratumumab
Drug: Fluorouracil
Drug: Cabozantinib
Drug: Trametinib
Drug: Bevacizumab
Drug: Oxaliplatin

First Posted Date: 2019-04-02

Last Posted Date: 2025-05-06

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 1500

Registration Number: NCT03899155

Locations: 🇨🇳
Local Institution - 0245, Harbin, Heilongjiang, China
🇺🇸
Local Institution - 0110, Pittsburgh, Pennsylvania, United States
🇮🇹
Local Institution - 0327, Modena, Italy

and more 345 locations

Nivolumab, BMS-936558 in Combination With Relatlimab, BMS-986016 in Patients With Metastatic Melanoma Naïve to Prior Immunotherapy in the Metastatic Setting

Phase 2

Active, not recruiting

Conditions: Melanoma

Interventions: Drug: Relatlimab + Nivolumab
Drug: Nivolumab
Drug: Relatlimab

First Posted Date: 2018-11-16

Last Posted Date: 2023-09-07

Lead Sponsor: John Kirkwood

Target Recruit Count: 42

Registration Number: NCT03743766

Locations: 🇺🇸
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

Nivolumab Plus Relatlimab or Ipilimumab in Metastatic Melanoma Stratified by MHC-II Expression

Phase 2

Terminated

Conditions: Metastatic Melanoma
Advanced Melanoma
Metastatic Melanoma Stratified by MHC-II Expression

Interventions: Drug: Nivolumab
Drug: Relatlimab
Drug: Ipilimumab

First Posted Date: 2018-10-30

Last Posted Date: 2021-04-20

Lead Sponsor: Elizabeth Davis

Target Recruit Count: 2

Registration Number: NCT03724968

Locations: 🇺🇸
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

Study of Nivolumab and Relatlimab in Patients With Microsatellite Stable (MSS) Advanced Colorectal Cancer

Phase 2

Completed

Conditions: Microsatellite Stable (MSS) Colorectal Adenocarcinomas
Colorectal Adenocarcinoma

Interventions: Drug: Nivolumab
Drug: Relatlimab

First Posted Date: 2018-08-22

Last Posted Date: 2025-01-28

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 59

Registration Number: NCT03642067

Locations: 🇺🇸
Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States

REACTION (Radiation Enhanced Assessment of Combination Therapies in Immuno-ONcology) - Nivolumab or Nivolumab in Combination With Other Immuno-oncology (IO) Agents After Targeted Systemic Radiation in Patients With Advanced Esophagogastric Cancer

Phase 1

Active, not recruiting

Conditions: Immune Checkpoint Inhibition
Gastroesophageal Cancer

Interventions: Drug: Nivolumab
Drug: Relatlimab

First Posted Date: 2018-08-01

Last Posted Date: 2024-12-11

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 21

Registration Number: NCT03610711

Locations: 🇺🇸
Alleghany Health Network, Pittsburgh, Pennsylvania, United States
🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States
🇺🇸
Baylor University, Dallas, Texas, United States

Study of Nivolumab and Relatlimab in Advanced Mismatch Repair Deficient Cancers Resistant to Prior PD-(L)1 Inhibitor

Phase 2

Recruiting

Conditions: MSI-H Tumors
Refractory MSI - H Solid Tumors Prior of PD-(L) 1 Therapy

Interventions: Drug: Nivolumab
Drug: Relatlimab

First Posted Date: 2018-07-31

Last Posted Date: 2024-10-23

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 42

Registration Number: NCT03607890

Locations: 🇺🇸
Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
🇺🇸
Cedars Sinai Medical Center, Los Angeles, California, United States

Nivolumab Alone or Plus Relatlimab or Ipilimumab for Patients With Locally-Advanced Unresectable or Metastatic Basal Cell Carcinoma

Phase 2

Recruiting

Conditions: Basal Cell Carcinoma

Interventions: Drug: Nivolumab
Drug: Ipilimumab
Drug: Relatlimab

First Posted Date: 2018-05-11

Last Posted Date: 2025-03-14

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 57

Registration Number: NCT03521830

Locations: 🇺🇸
Johns Hopkins Hospital, Baltimore, Maryland, United States

Cytokine Microdialysis for Real-Time Immune Monitoring in Glioblastoma Patients Undergoing Checkpoint Blockade

Phase 1

Completed

Conditions: Glioblastoma

Interventions: Drug: Nivolumab
Drug: BMS-986016

First Posted Date: 2018-04-11

Last Posted Date: 2024-07-24

Lead Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

Target Recruit Count: 21

Registration Number: NCT03493932

Locations: 🇺🇸
Emory University, Atlanta, Georgia, United States
🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma

Phase 2

Active, not recruiting

Conditions: Melanoma

Interventions: Biological: Relatlimab
Biological: Nivolumab

First Posted Date: 2018-03-20

Last Posted Date: 2025-03-17

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 714

Registration Number: NCT03470922

Locations: 🇨🇦
Local Institution - 0124, Halifax, Nova Scotia, Canada
🇨🇦
Local Institution - 0068, Ottawa, Ontario, Canada
🇨🇦
Local Institution - 0128, Toronto, Ontario, Canada

and more 124 locations

An Investigational Study of Immunotherapy Combinations in Participants With Solid Cancers That Are Advanced or Have Spread

Phase 1

Completed

Conditions: Advanced Cancer

Interventions: Biological: Relatlimab
Biological: Nivolumab
Drug: BMS-986205
Biological: Ipilimumab

First Posted Date: 2018-03-08

Last Posted Date: 2025-04-02

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 229

Registration Number: NCT03459222

Locations: 🇦🇺
Local Institution - 0011, Nedlands, Western Australia, Australia
🇺🇸
Local Institution - 0003, Aurora, Colorado, United States
🇮🇹
Local Institution - 0023, Rome, Italy

and more 19 locations

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