Melanoma is a skin cancer that starts in pigment-making cells. When caught early, it's usually curable with surgery. Advanced melanoma was once nearly always fatal, but immunotherapy drugs introduced in the 2010s now help many people live years longer, and some see their cancer disappear completely.
What's actually going on in research
Trials are testing combinations of checkpoint inhibitors, targeted drugs for specific mutations, cellular therapies that train immune cells to hunt melanoma, and vaccines that teach the immune system to recognize cancer. Researchers are also studying ways to prevent melanoma from returning after surgery and to reach brain metastases more effectively.
Personalized cancer vaccines
Custom vaccines made from each person's tumor are being combined with checkpoint inhibitors. Early data shows they may prevent melanoma from coming back after surgery by training the immune system to recognize leftover cancer cells.
TIL therapy
Tumor-infiltrating lymphocyte therapy takes immune cells from a person's tumor, multiplies them by the billions, and infuses them back. FDA approved lifileucel in 2024 for advanced melanoma after other treatments stop working.
Brain metastases
New combinations of immunotherapy and targeted therapy are being tested specifically for melanoma that has spread to the brain. Some trials use drugs that cross the blood-brain barrier more easily than older options.
What to know before you search
Eligibility typically depends on melanoma stage, mutation status (especially BRAF), prior treatments, and whether the cancer has spread to the brain or other organs.
What types of trials are currently open
- Immunotherapy trials — Testing checkpoint inhibitors like pembrolizumab and nivolumab, often in new combinations or earlier in treatment.
- Targeted therapy trials — Testing drugs that block specific mutations, mainly BRAF and MEK inhibitors for BRAF-mutated melanoma.
- Cell therapy trials — Studies of TIL therapy and CAR-T cells, which use a person's own immune cells to fight melanoma.
- Vaccine trials — Testing personalized vaccines made from each person's tumor, usually combined with immunotherapy.
- Prevention trials — Testing treatments after surgery to prevent melanoma from returning, especially in people at high risk of recurrence.
Recently added Melanoma trials
Thymosin Alpha 1 Combined With Anti-PD-1 Monoclonal Antibody in Elderly Patients With Advanced Melanoma
Primary Objective: To evaluate the effectiveness of Thymosin Alpha-1 combined with PD-1 monoclonal antibody in elderly patients with advanced melanoma . Secondary Objective: To evaluate the safety and tolerability of adenpeptide-α1 combined with PD-1 antibody in elderly patients with advanced melanoma . Study Design：Open-label, single-arm, non-controlled clinical trial. Primary Inclusion Criteria: 1. Age ≥60 years old; 2. Pathologically confirmed as inoperable or metastatic melanoma; 3. one or more lesions evaluable by RECIST1.1 standards. 4. The Eastern Cooperative Oncology Group (ECOG) scoring system in the United States scores from 0-2; Main exclusion criteria: 1. Received treatment with a regimen containing PD-1, PD-L1, or CTLA-4 antibodies within the past 6 months; 2. Received thymosin class drug treatment within 3 months before signing the informed consent. 3. Symptomatic, untreated central nervous system metastases. Treatment： Thymosin Alpha 1 1.6mg, sc，QD，d1-7;1.6mg, sc， three times per week, d8-21. Each 21 days is considered one cycle, for a total of 12 weeks. Anti-PD-1 monoclonal antibody (Toripalimab) 240mg per dose,ivdrip，Q3W，4 cycles. Primary study endpoints: Objective Response Rate (ORR: CR+PR) Secondary study endpoints: Progression-Free Survival (PFS), Duration of Response (DOR), Overall Survival (OS) Adverse Events (AEs)
Urinary Microbiome as a Biomarker for Melanoma Diagnosis and Response Prediction to Systemic Tumour Therapy
This study looks at whether the bacteria naturally present in urine (the "urinary microbiome") can help doctors better understand melanoma, a type of skin cancer, and predict how well patients respond to treatment. In recent years, researchers have discovered that bacteria in the body-especially in the gut-can influence cancer development and how patients respond to therapy. However, very little is known about the bacteria in urine and whether they may also play a role in cancer. In this study, patients with melanoma who are starting treatment (such as immunotherapy or targeted therapies) will be asked to provide urine samples and stool samples at several time points, as well as answer questionnaires about their health and lifestyle. A group of people without melanoma will also provide urine samples for comparison. Researchers will analyze these samples to identify the types of bacteria present and how they change over time. They will then investigate whether certain bacterial patterns are linked to better or worse treatment outcomes. The study does not change the medical treatment patients receive. Participation mainly involves providing samples and filling out questionnaires, which represents only a small additional effort. The results of this study may help to identify new, non-invasive biomarkers that could improve early diagnosis and help doctors choose the most effective treatment for melanoma patients in the future
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