Advanced melanoma generally refers to unresectable stage III disease or stage IV disease with distant spread. Management commonly includes systemic therapies such as immune checkpoint inhibitors and targeted therapy in biomarker-selected patients.
Tumour-infiltrating lymphocyte therapy has shown durable responses in refractory melanoma, including a 31.4% objective response rate in phase II data. The 2024 FDA approval of Lifileucel marked a milestone as regulators in other markets continue reviews.
Intravenous and subcutaneous nivolumab in advanced melanoma had similar safety profiles, with no major differences in systemic side effects. The main distinction was mild, manageable injection site reactions with subcutaneous administration.
Iovance reported real-world data suggesting Amtagvi may have a best in class profile in advanced melanoma. The company posted $263.5 million in annual sales after 2024 approval, while pursuing broader use and facing regulatory and logistics risks.
Replimune said the FDA issued a complete response letter for its RP1 plus nivolumab application in advanced melanoma. The company disputed the agency’s assessment and said it will cut jobs and scale back U.S. manufacturing.
The FDA accepted Replimune’s BLA resubmission for RP1 plus nivolumab in advanced melanoma. The agency set an April 10, 2026 PDUFA date under a Class II resubmission timeline.
Decreases in circulating tumor DNA within 3-4 weeks of immune checkpoint inhibitor therapy were strongly associated with higher response rates and longer survival in patients with unresectable stage III/IV melanoma, according to a multi-institutional retrospective analysis.
Study finds advanced melanoma patients with sufficient vitamin D levels showed better response rates and longer survival when receiving anti-PD-1 immunotherapy compared to those with low vitamin D status.
Neoadjuvant pembrolizumab achieved 71% pathologic complete response in desmoplastic melanoma patients, while lower-dose ipilimumab combination therapy showed improved survival and fewer side effects in advanced melanoma treatment.
Lynch syndrome patients gain access to prevention vaccines in clinical trials, while immunotherapy advances depend on universal tumor testing for microsatellite instability. Cancer vaccines are moving from research to clinical reality.
Iovance Biotherapeutics reported Q4 2025 revenue of $87 million, beating estimates, while receiving FDA fast-track designation for lifileucel in non-small cell lung cancer and reporting strong sarcoma trial data.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07574047 |
MELCHRONO: A Prospective Randomized Study Investigating Chrono-immunotherapy for Advanced Melanoma. |
NOT_YET_RECRUITING | PHASE4 |
| NCT07562841 |
Au-TMP and Radiotherapy for Advanced Melanoma With Anti-PD-1 Therapy |
RECRUITING | PHASE1 |
| NCT07504796 |
ctDNA-guided Addition of Ipilimumab to Patients Receiving Nivolumab and Relatlimab |
RECRUITING | PHASE4 |
| NCT07405086 |
Morning Versus Afternoon Administration of Immunotherapy for the Treatment of Advanced or Metastatic Solid Tumors, The Knight SHIFT Study |
RECRUITING | PHASE4 |
| NCT07310784 |
A Phase II Trial of LM103 in Advanced Melanoma |
RECRUITING | PHASE2 |
| NCT07107178 |
A Clinical Study of BT02 for the Treatment of Patients With Advanced Malignant Melanoma |
NOT_YET_RECRUITING | PHASE1 |
| NCT07099430 |
A Trial of LBL-024 Monotherapy, LBL-024 Combined With LBL-007 or Toripalimab in Patients With Advanced Melanoma |
RECRUITING | PHASE1/PHASE2 |
| NCT07079644 |
Outcomes of Nivolumab in Combination With Relatlimab in Patients With Advanced Melanoma in the Flatiron Database |
COMPLETED | |
| NCT07040436 |
Assessment of Safety and Efficacy of OPM-101 Combined With Anti-PD-1 in Patients With Advanced Melanoma Showing Resistance to Anti-PD-1 |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07027488 |
AB821 in Adult Participants With Locally Advanced or Metastatic Solid Tumors |
RECRUITING | PHASE1 |
