Relatlimab

Relatlimab is a human IgG4 monoclonal antibody that binds to the LAG-3 receptor, blocks interaction with its ligands, including MHC II, and reduces LAG-3 pathway-mediated inhibition of the immune response. Antagonism of this pathway promotes T cell proliferation and cytokine secretion.

• 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.ICD-10: C43.9

• None. • None.contraindicated

• Adult patients and pediatric patients 12 years of age or older who weigh at least 40 kg: 480 mg nivolumab and 160 mg relatlimab intravenously every 4 weeks. (2) • Administer OPDUALAG as an intravenous infusion over 30 minutes. (2) • See full Prescribing Information for dosage modifications for adverse reactions (2.2) and preparation and administration instructions for the injection (2.3) . 2.1 Recommended Dosage The recommended dosage of OPDUALAG for adult patients and pediatric patients 12 years of age or older who weigh at least 40 kg is 480 mg nivolumab and 160 mg relatlimab administered intravenously every 4 weeks until disease progression or unacceptable toxicity occurs. The recommended dosage for pediatric patients 12 years of age or older who weigh less than 40 kg has not been established [see Use in Specific Populations (8.4) ] . 2.2 Dosage Modifications No dose reduction for OPDUALAG is recommended. In general, withhold OPDUALAG for severe (Grade 3) immune-mediated adverse reactions (IMARs). Permanently discontinue OPDUALAG for life-threatening (Grade 4) IMARs, recurrent severe (Grade 3) IMARs that require systemic immunosuppressive treatment, or an inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks of initiating steroids. Dosage modifications for adverse reactions that require management different from these general guidelines are summarized in Table 1.

• Immune-Mediated Adverse Reactions : (5.1) o Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis with renal dysfunction, and immune-mediated myocarditis. o Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. o Withhold or permanently discontinue based on severity and type of reaction. (2.2) • Infusion-related reactions : Interrupt, slow the rate of infusion, or permanently discontinue OPDUALAG based on severity of reaction. ( 2.2 , 5.2 ) • Complications of allogeneic HSCT : Fatal and other serious complications can occur in patient who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody. (5.3) • Embryo-fetal toxicity : Can cause fetal harm. Advise females of reproductive potential of potential risk to a fetus and to use effective contraception. ( 5.4 , 8.1 , 8.3 ) 5.1 Severe and Fatal Immune-Mediated Adverse Reactions OPDUALAG potentially breaks peripheral tolerance and induces immune-mediated adverse reactions (IMARs) [see Clinical Pharmacology (12.1) ] . Important IMARs listed under Warnings and Precautions may not include all possible severe and fatal IMARs. IMARs, which may be severe or fatal, can occur in any organ system or tissue.

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling. • Severe and Fatal IMARs [see Warnings and Precautions (5.1) ] • Infusion-Related Reactions [see Warnings and Precautions (5.2) ] • Complications of Allogeneic HSCT [see Warnings and Precautions (5.3) ] The most common adverse reactions (≥20%) are musculoskeletal pain, fatigue, rash, pruritus, and diarrhea. (6.1) The most common laboratory abnormalities (≥20%) are decreased hemoglobin, decreased lymphocytes, increased AST, increased ALT, and decreased sodium. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of OPDUALAG was evaluated in RELATIVITY-047, a randomized (1:1), double-blinded trial in 714 patients with previously untreated metastatic or unresectable melanoma [see Clinical Studies (14) ] . Patients received intravenous OPDUALAG (nivolumab 480 mg and relatlimab 160 mg) every 4 weeks (n=355) or nivolumab 480 mg by intravenous infusion every 4 weeks (n=359). Patients were treated with OPDUALAG or nivolumab until disease progression or unacceptable toxicity.

• Lactation: Advise not to breastfeed. (8.2) 8.1 Pregnancy Risk Summary Based on findings in animals and mechanism of action, OPDUALAG can cause fetal harm when administered to a pregnant woman. Administration of nivolumab to cynomolgus monkeys from the onset of organogenesis through delivery resulted in increased abortion and premature infant death ( see Data ). Human IgG4 is known to cross the placenta; therefore, nivolumab and relatlimab have the potential to be transmitted from the mother to the developing fetus. The effects of OPDUALAG are likely to be greater during the second and third trimesters of pregnancy. There are no available data on OPDUALAG in pregnant women to evaluate a drug-associated risk. Advise the patient of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data OPDUALAG injection for intravenous use contains nivolumab and relatlimab [see Description (11) ] . Nivolumab: One function of the PD-1/PD-L1 pathway is to preserve pregnancy by maintaining immune tolerance to the fetus.

Metabolism

The pharmacokinetics (PK) of relatlimab following the administration of OPDUALAG were characterized in patients with cancer who received relatlimab 20 to 800 mg every 2 weeks (0.25 to 10 times the approved recommended dosage) or 160 to 1440 mg every 4 weeks (1 to 9 times the approved recommended dosage) either as a monotherapy or in combination with nivolumab dosages of 80 or 240 mg every 2 weeks or 480 mg every 4 weeks. Steady-state concentrations of relatlimab were reached by 16 weeks with an every 4-week regimen and the systemic accumulation was 1.9-fold.

• Mar 18, 2022BLABLA761234Bristol Myers Squibb

1. 1Death6515%
2. 2Off Label Use5212%
3. 3Malignant Neoplasm Progression317.1%
4. 4Myocarditis184.1%
5. 5Product Storage Error184.1%
6. 6Fatigue153.4%
7. 7Adverse Event133.0%
8. 8Rash133.0%
9. 9Diarrhoea122.7%
10. 10Myasthenia Gravis122.7%
11. 11Colitis112.5%
12. 12Product Dose Omission Issue92.1%
13. 13Acute Kidney Injury81.8%
14. 14Infusion Related Reaction81.8%
15. 15Weight Decreased81.8%

The 10 most recently updated of 107 ClinicalTrials.gov registrations naming Relatlimab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Study of Relatlimab and Nivolumab (Opdualag) in Replication Repair Deficient HGG and DIPG
  Not yet recruiting · Phase 2 · Interventional · 12 enrolled · Nationwide Children's Hospital
  NCT07644312updated 2026-06-12
• Neoadjuvant Nivolumab Combination Treatment in Resectable Non-small Cell Lung Cancer Patients
  Completed · Phase 2 · Interventional · 90 enrolled · University Hospital, Essen
  NCT04205552updated 2026-06-11
• Feasibility and Efficacy of Perioperative Nivolumab With or Without Relatlimab for Patients With Potentially Resectable Hepatocellular Carcinoma (HCC)
  Active not recruiting · Phase 1 · Interventional · 31 enrolled · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  NCT04658147updated 2026-06-11
• Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
  Recruiting · Phase 2 · Interventional · 156 enrolled · National Cancer Institute (NCI)
  NCT06029270updated 2026-06-11
• Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
  Recruiting · Phase 2 · Phase 3 · Interventional · 992 enrolled · National Cancer Institute (NCI)
  NCT05987241updated 2026-06-11
• SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma
  Recruiting · Phase 3 · Interventional · 360 enrolled · Immatics US, Inc.
  NCT06743126updated 2026-06-10
• IL-17 Blockade to Decrease irAEs (REPLAY)
  Recruiting · Phase 1 · Interventional · 4 enrolled · Duke University
  NCT07237594updated 2026-06-04
• Pan Tumor Rollover Study
  Recruiting · Phase 2 · Interventional · 1,500 enrolled · Bristol-Myers Squibb
  NCT03899155updated 2026-06-03
• Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
  Active not recruiting · Phase 2 · Interventional · 6,452 enrolled · National Cancer Institute (NCI)
  NCT02465060updated 2026-06-03
• Anti-Lag-3 (Relatlimab) and Anti-PD-1 Blockade (Nivolumab) Versus Standard of Care (Lomustine) for the Treatment of Patients With Recurrent Glioblastoma
  Suspended · Phase 2 · Interventional · 184 enrolled · National Cancer Institute (NCI)
  NCT06325683updated 2026-06-03

Frequently asked questions

How does Relatlimab work?

Relatlimab is a human IgG4 monoclonal antibody that binds to the LAG-3 receptor, blocks interaction with its ligands, including MHC II, and reduces LAG-3 pathway-mediated inhibition of the immune response. Antagonism of this pathway promotes T cell proliferation and cytokine secretion.

What is Relatlimab used for?

According to FDA labeling, Relatlimab carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Relatlimab?

Relatlimab is classified as Lymphocyte Activation Gene-3 Blocker, Antibody-Receptor Interactions, Lymphocyte Activation Gene-3 Antagonists, Increased Cytokine Production, Increased T Lymphocyte Activation.

What are the brand names for Relatlimab?

Relatlimab is marketed under brand names including Opdualag.

What are the contraindications for Relatlimab?

Relatlimab labeling lists contraindications including: None. • None.. Always consult the full prescribing information and a clinician.