How many clinical trials are studying Relatlimab?

4 recruiting trials in our tracked data involve Relatlimab.

What conditions is Relatlimab being studied for?

In our tracked recruiting trials, Relatlimab is being studied in trials for Melanoma, Advanced Melanoma, Lung cancer.

Relatlimab: clinical trials recruiting now

Q: Is Relatlimab FDA-approved?

Yes. According to the FDA drug label available through openFDA, Relatlimab is an FDA-approved drug.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Relatlimab appears in the FDA drug-label database. Marketed as OPDUALAG.
Drug class: Programmed Death Receptor-1 Blocking Antibody; Lymphocyte Activation Gene-3 Blocker (FDA established pharmacologic class)
Mechanism of action: Programmed Death Receptor-1-directed Antibody Interactions; Lymphocyte Activation Gene-3 Antagonists (as stated on the FDA label)

FDA-approved use

OPDUALAG™ is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. OPDUALAG is a combination of nivolumab, a programmed death receptor-1 (PD-1) blocking antibody, and relatlimab, a lymphocyte activation gene-3 (LAG-3) blocking antibody, indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. (1)

FDA recalls / enforcement

Reason (FDA)	Classification	Status	Initiated
Lack of Assurance of Sterility. — Bristol-Myers Squibb Company	Class II (FDA: may cause temporary or reversible harm)	Ongoing	2025-10-21

FDA label via openFDA

Phase breakdown

Phase 1 1 Phase 2 3 Phase 3 1

Conditions being studied

Condition	Trials
Melanoma · Relatlimab for Melanoma	3
Advanced Melanoma	1
Lung cancer	1
Melanoma (Skin)	1
Metastatic Melanoma	1
Non-small Cell Lung Cancer	1

Recruiting trials involving Relatlimab

A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 Expression ≥ 1%
NCT06561386 · Phase: Phase 3 · Ages: 18 Years and older · Sex: All (male and female) · 322 locations
Phase I/IIa Dose Finding Study of Triplet Regimen of Relatlimab Ipilimumab and NIvolumab in First Line Therapy of Metastatic Melanoma (TRINITY)
NCT06683755 · Phase: Phase 1, Phase 2 · Ages: 18 Years and older · Sex: All (male and female) · 1 location
Phase II Study of Nivolumab in Combination With Relatlimab in Patients With Active Melanoma Brain Metastases
NCT05704647 · Phase: Phase 2 · Ages: 18 Years and older · Sex: All (male and female) · 1 location
ctDNA-guided Addition of Ipilimumab to Patients Receiving Nivolumab and Relatlimab
NCT07504796 · Phase: Phase 2 · Ages: 18 Years and older · Sex: All (male and female) · 1 location

Common questions

Is Relatlimab FDA-approved?

Yes, marketed as OPDUALAG.

How many recruiting trials involve Relatlimab?

4 recruiting trials across 6 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.