Melanoma Clinical Trials Intelligence
Monthly Update Report for Trials Started in August 2026
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1: Summary data from new trials identified for Melanoma.
Overview
Number of Trials: 3
Three trials focus on advanced melanoma, exploring oncolytic virus therapy, adoptive T cell therapy for leptomeningeal disease, and neoadjuvant immune checkpoint inhibition. All target immune or viral mechanisms to improve outcomes in metastatic or resectable melanoma.
Common Criteria Across Trials
Common Inclusion
- Age 18 years or older
- Histologically confirmed melanoma diagnosis
- Adequate performance status (ECOG 0-2)
- Adequate hematologic, renal, and hepatic function
- Willingness to provide informed consent
- Use of adequate contraception for reproductive-age participants
Common Exclusion
- Active uncontrolled infections or unstable medical conditions
- Active autoimmune disease requiring systemic immunosuppression
- Pregnant or breastfeeding women
- Unresolved toxicity from prior cancer therapy
- Contraindications to required imaging or procedures
Outcomes Summary
Primary Outcomes
- Safety and tolerability (dose-limiting toxicity) (2 trials)
- Feasibility and safety of cellular therapy administration (1 trials)
- Pathologic response rate (1 trials)
Secondary Outcomes
- Overall survival (2 trials)
- Progression-free survival (2 trials)
- Immune response biomarkers (1 trials)
2: Extracted Trials with New Information
Trials with Special Criteria
Genomic / Biomarker Trials
- NCT07414979 — Requires HLA-A2 or HLA-A24 expression for T cell antigen specificity.
Unique or Unusual Criteria
- NCT07444606 — Requires stereotactic intracranial biopsy for viral administration and tumor confirmation before each dose.
- NCT07414979 — Intrathecal delivery of autologous antigen-specific CD8+ T cells for leptomeningeal disease.
- NCT07740941 — Excludes patients with prior PD-1/CTLA-4 therapy, focusing on treatment-naive checkpoint inhibitor use.
Trials with Emerging Treatments
- NCT07444606 — Dose Ranging, Toxicity Seeking, Phase 1 Trial of Oncolytic Adenoviral Therapy for Melanoma Intracranial and Extracranial Metastases
Items: DNX-2401
Note: Investigational oncolytic adenovirus without FDA approval, tested for direct intracranial and extracranial melanoma injection. - NCT07414979 — Phase 1 Study Of Intrathecal Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cells For Patients With Leptomeningeal Melanoma
Items: Autologous CD8+ antigen-specific T cells
Note: Novel personalized cellular immunotherapy delivered intrathecally, not yet FDA approved. - NCT07740941 — NeoAdjuvant, Spare-Adjuvant (NASA) in Stage IIIB- IV (M1a) Melanoma
Items: Ipilimumab plus nivolumab
Note: Combination immune checkpoint inhibition explored in neoadjuvant setting to potentially spare adjuvant therapy.
3: Individual Trial Overviews
NCT07444606
Dose Ranging, Toxicity Seeking, Phase 1 Trial of Oncolytic Adenoviral Therapy for Melanoma Intracranial and Extracranial Metastases
Organization/Sponsor: M.D. Anderson Cancer Center
Example patient: A 55-year-old man with stage IV cutaneous melanoma progressing on nivolumab, with three untreated brain metastases (1.5cm largest) and good organ function, meets criteria for Group A enrollment.
Phase 1
NCT07444606
Dose Ranging, Toxicity Seeking, Phase 1 Trial of Oncolytic Adenoviral Therapy for Melanoma Intracranial and Extracranial Metastases
Organization/Sponsor: M.D. Anderson Cancer Center
Example patient: A 55-year-old man with stage IV cutaneous melanoma progressing on nivolumab, with three untreated brain metastases (1.5cm largest) and good organ function, meets criteria for Group A enrollment.
Interventions
-
Oncolytic Virus: DNX-2401
Summary: DNX-2401 is an oncolytic adenovirus engineered to selectively infect and lyse tumor cells via direct viral replication, studied for safety/efficacy in melanoma brain and extracranial metastases. Source: Summary of Web Search.
Key Inclusion
- Stage IV melanoma, age 18+
- ECOG performance status 0-1
- Relapsed/refractory on FDA-approved checkpoint inhibitor (ipilimumab, nivolumab, pembrolizumab, relatlimab)
- Group A: 1-5 brain metastases with untreated measurable lesion for biopsy/injection
- Group B: injectable extracranial cutaneous/subcutaneous/nodal lesion ≥5mm
- Adequate hematologic, renal, and liver function
- Able to undergo contrast MRI of brain
- Willing to use effective contraception
Key Exclusion
- >5 intracranial metastases
- Symptomatic brain metastases or leptomeningeal disease
- Recent WBRT/SRT within 2 days of treatment
- High-dose corticosteroid use
- Checkpoint inhibitor naive
- Active uncontrolled infection, HIV, HBV, or HCV
- Immunosuppressive disorders or autoimmune disease
- Primary uveal or mucosal melanoma
NCT07414979
Phase 1 Study Of Intrathecal Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cells For Patients With Leptomeningeal Melanoma Genomic-based
Organization/Sponsor: M.D. Anderson Cancer Center
Example patient: A 45-year-old HLA-A2-positive woman with metastatic cutaneous melanoma and confirmed leptomeningeal disease, ECOG 1, on low-dose dexamethasone, with no active infections or unresolved prior treatment toxicities.
Phase 1
NCT07414979
Phase 1 Study Of Intrathecal Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cells For Patients With Leptomeningeal Melanoma Genomic-based
Organization/Sponsor: M.D. Anderson Cancer Center
Example patient: A 45-year-old HLA-A2-positive woman with metastatic cutaneous melanoma and confirmed leptomeningeal disease, ECOG 1, on low-dose dexamethasone, with no active infections or unresolved prior treatment toxicities.
Interventions
-
Biological/Cellular Therapy: CD8+ T cells
Summary: Autologous CD8+ antigen-specific T cells (cytotoxic T lymphocytes) administered intrathecally to target melanoma cells via MHC Class I-restricted antigen recognition, inducing apoptosis through perforin and granzyme release; investigational adoptive cell therapy for leptomeningeal melanoma. Source: Summary of Web Search.
Key Inclusion
- Radiographic and/or CSF cytological evidence of leptomeningeal disease
- Confirmed primary CNS melanoma or metastatic melanoma diagnosis
- Age ≥18 years
- HLA-A2 or HLA-A24 expression
- ECOG/Zubrod performance status ≤1
- Steroid dose ≤4 mg/24hr dexamethasone equivalent with neurologic stability
- Adequate washout from prior radiation, chemo, IT therapy, or investigational agents
- Willing to use contraception and provide informed consent
Key Exclusion
- Underlying medical/psychiatric condition making treatment hazardous
- Unresolved toxicities from prior therapy (>grade 1)
- Pregnant or breastfeeding
- Concurrent intrathecal therapy with another agent not allowed
NCT07740941
NeoAdjuvant, Spare-Adjuvant (NASA) in Stage IIIB- IV (M1a) Melanoma
Organization/Sponsor: UNC Lineberger Comprehensive Cancer Center
Example patient: A 55-year-old with newly diagnosed resectable stage IIIB cutaneous melanoma, ECOG status 1, normal organ function, no prior immunotherapy, and no autoimmune disease, eligible for neoadjuvant checkpoint inhibitor therapy.
Phase N/A
NCT07740941
NeoAdjuvant, Spare-Adjuvant (NASA) in Stage IIIB- IV (M1a) Melanoma
Organization/Sponsor: UNC Lineberger Comprehensive Cancer Center
Example patient: A 55-year-old with newly diagnosed resectable stage IIIB cutaneous melanoma, ECOG status 1, normal organ function, no prior immunotherapy, and no autoimmune disease, eligible for neoadjuvant checkpoint inhibitor therapy.
Interventions
-
Combination Immunotherapy: Ipilimumab plus nivolumab
Summary: Combines CTLA-4 blockade (ipilimumab) and PD-1 blockade (nivolumab) to enhance anti-tumor immune response in melanoma; used as neoadjuvant therapy. Source: Summary of Web Search. -
Monoclonal Antibody (Immune Checkpoint Inhibitor): Pembrolizumab
Summary: PD-1 blocking humanized IgG4 antibody that enhances T-cell mediated anti-tumor immunity; FDA-approved for melanoma and other cancers, used here as spare-adjuvant therapy. Source: FDA label, NCI Thesaurus.
Key Inclusion
- Age ≥18 years
- ECOG Performance Status 0-2
- Histologically confirmed cutaneous melanoma or melanoma of unknown primary
- AJCC stage IIIB/IVa resectable disease measurable by iRECIST
- Adequate hematologic, renal, hepatic, and heart function
- Willing to comply with study procedures including randomization
- Informed consent and HIPAA authorization obtained
Key Exclusion
- Prior treatment with PD-1 and CTLA-4 inhibitors
- Active autoimmune disease requiring systemic immunosuppressive treatment
- Serious medical or psychiatric conditions interfering with participation
- Laboratory abnormalities posing unacceptable risk