Melanoma Research

Melanoma research focuses on checkpoint inhibition, adjuvant therapy strategies, resistance biology, and biomarker-driven treatment sequencing.

Our Melanoma Analysis

• August 11, 2026Journal of Clinical OncologyPIVOTAL (Phase III, randomized, open-label)

  Neoadjuvant Intralesional Daromun Improves Recurrence-Free Survival at 36.8 Months in Resectable Locally Advanced Melanoma, with Overall Survival Data Still Immature

  PIVOTAL is a randomized, open-label phase III trial of neoadjuvant intralesional daromun (L19IL2/L19TNF) followed by surgery versus up-front surgery in 256 adults with resectable locally advanced melanoma and at least one injectable skin or nodal lesion. This report is an updated analysis with a median follow-up of 36.8 months from random assignment (data cutoff November 28, 2025).

• September 22, 2026Nature MedicinePATHFINDER 2 (NCT05155605)

  Multi-Cancer Blood Test Reaches 60% Positive Predictive Value and 99.6% Specificity in Largest Prospective Screening Study to Date

  PATHFINDER 2, a prospective, interventional cohort study of 35,878 adults aged 50 and older with no clinical suspicion of cancer, evaluated the performance and safety of a blood-based multi-cancer early detection (MCED) test that analyzes cell-free DNA methylation patterns to detect a shared cancer signal and predict its tissue of origin.

• September 10, 2026Journal of Clinical OncologyCOMBI-I

  COMBI-I: Adding Spartalizumab to Dabrafenib and Trametinib Shows a Survival Trend in Melanoma After the Trial Missed Its Primary Endpoint

  The phase 3 COMBI-I trial's final long-term follow-up analysis reports a numerically longer overall survival with the anti-PD-1 antibody spartalizumab added to dabrafenib and trametinib, versus dabrafenib and trametinib alone, in 532 patients with BRAF V600-mutant advanced melanoma.

• September 1, 2026Cancer DiscoveryNCT02706353

  Intratumoral CD40 Agonist Plus Pembrolizumab Yields 50% ORR in Melanoma

  A first-in-human, open-label, single-arm phase I/II trial tested whether an intratumoral CD40 agonist (sotigalimab) added to systemic pembrolizumab could turn immunologically "cold" tumors "hot" in patients with immune-checkpoint-blockade-naive metastatic melanoma.

• August 20, 2026JAMA Oncology

  Industry Now Outpaces Federal Cancer Trial Sponsorship Nearly 5 to 1 — And the Gap Is Widening

  A registry-based analysis of 11,681 US interventional cancer trials registered on ClinicalTrials.gov between 2008 and 2024 found that industry sponsors now outnumber federal sponsors nearly 5 to 1 (4.53-to-1 overall), with the ratio widening from 2.72-to-1 in 2008–2012 to 6.44-to-1 in 2019–2024.

• July 13, 2026Nature MedicineDYP688 First-in-Human Study (NCT05415072)

  First-in-Human ADC Shows Early Activity in GNAQ/GNA11-Mutant Uveal Melanoma

  Phase 1, first-in-human dose-escalation trial of DYP688 — an antibody-drug conjugate that targets the melanocyte antigen PMEL and delivers a Gq/11 signaling inhibitor payload — in 66 patients with metastatic uveal melanoma and other GNAQ/GNA11-mutant melanomas, a population largely excluded from the only approved therapy for this disease.

• July 22, 2026Clinical Cancer ResearchMONETTE (NCT05061134)

  MONETTE Phase II Trial: Ceralasertib Combinations Fall Short in PD-(L)1-Resistant Melanoma

  Randomized (2:1), open-label, international phase II trial of ceralasertib (an oral ATR inhibitor) plus durvalumab versus ceralasertib monotherapy in 151 patients with advanced melanoma that had progressed on prior anti-PD-(L)1 therapy

• February 13, 2026Lancet OncologyKEYVIBE-010 (NCT05665595)

  KEYVIBE-010: Adding Vibostolimab to Pembrolizumab Does Not Improve Outcomes in Resected High-Risk Melanoma

  Randomised, double-blind, phase 3 study of 1,402 patients with surgically resected stage IIB–IV cutaneous melanoma across 205 global sites