Last reviewed 2026-04-20 · How we verify

Opdualag

At a glance

Approved indications

• Advanced melanoma with tumour cell PD-L1 expression below 1%
• Unresectable or metastatic melanoma

Common side effects

• Musculoskeletal pain
• Fatigue
• Rash
• Pruritus
• Diarrhea
• Decreased hemoglobin
• Decreased lymphocytes
• Increased AST
• Increased ALT
• Decreased sodium
• Nausea
• Headache

Serious adverse events

• Serious adverse reactions (overall)
• Adrenal insufficiency
• Anemia
• Colitis
• Pneumonia
• Acute myocardial infarction
• Back pain
• Myocarditis
• Pneumonitis
• Fatal adverse reactions

Key clinical trials

• Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis (PHASE1, PHASE2)
• SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma (PHASE3)
• VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs [IGNYTE-3] (PHASE3)
• Intralesional Influenza Vaccine for the Treatment of Stage I-IV Melanoma (PHASE1)
• IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301) (PHASE3)
• A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head) (PHASE3)
• A Study of IO102/IO103, Nivolumab, and Relatlimab in People With Melanoma (PHASE2)
• Neoadjuvant Nivolumab and Relatlimab in Merkel Cell Carcinoma (PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Opdualag CI brief — competitive landscape report
• Opdualag updates RSS · CI watch RSS
• Australian & New Zealand Children's Haematology/Oncology Group portfolio CI