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A Phase 1/2 Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMBD-501 in Patients With HER3-Expressing Solid Tumors
What is melanoma?
Melanoma is a cancer of the cells that make pigment. Most start in the skin, often in or near a mole. The ABCDE rule covers the warning signs: asymmetry, irregular border, uneven color, diameter over 6 millimeters, and evolution, meaning any change over time. Sun and tanning beds are the main cause, so it is most common in people with light skin. But it happens in every skin color, and in darker skin it often appears on the palms, soles, or under nails, where it gets found late.
Treatment changed fast. Until 2011 nothing reliably extended life in advanced melanoma. Then came checkpoint inhibitors, which release the brakes on the immune system, and targeted drugs for the BRAF mutation found in about half of melanomas. In 2024 the FDA approved lifileucel, the first cell therapy for a solid tumor, made from a patient's own immune cells, and personalized mRNA cancer vaccines are now in Phase 3. Most of these were tested in melanoma first, which is why its trials often offer approaches no other cancer has yet. Read more in our cancer treatment guide, and for the more common skin cancers see our skin cancer clinical trials page.
Types of melanoma clinical trials
Immunotherapy combinations. New pairings of checkpoint inhibitors, and trials adding a third drug for people whose melanoma does not respond to current immunotherapy, the largest unmet need in the field.
Cell therapy trials. Tumor infiltrating lymphocyte (TIL) therapy, in which a patient's own immune cells are harvested from the tumor, multiplied, and returned, now approved and being refined with genetic enhancements in trials.
Cancer vaccine trials. Personalized mRNA vaccines built from a patient's tumor mutations, given with immunotherapy after surgery to prevent recurrence.
Adjuvant and neoadjuvant trials. Studies of immunotherapy before or after surgery in stage II and III melanoma, where the question is how much treatment prevents recurrence and how little is enough.
Uveal and mucosal melanoma trials. Separate research for melanomas of the eye and mucous membranes, which respond poorly to standard immunotherapy and have dedicated drugs such as tebentafusp.
Detection and screening studies. AI and imaging tools for spotting melanoma earlier, liquid biopsies that track circulating tumor cells, and studies of hereditary risk genes.
New to cancer research? Our guide explain how clinical trials for cancer work and how survival reached 70 percent.
Who can participate in melanoma clinical trials?
Melanoma trials sort people by stage and by treatment history. Adjuvant and neoadjuvant trials enroll people with stage II or III disease around the time of surgery, often before any drug treatment. Metastatic trials usually want people whose melanoma has progressed after immunotherapy, since that is where new approaches are needed, though some enroll untreated stage IV disease. Many require tumor testing for BRAF and other mutations, and cell therapy trials require a tumor large enough to harvest cells from. Uveal and mucosal melanoma trials are separate and often require specific genetic markers such as HLA type. Screening studies enroll people at high risk with no diagnosis. Eligibility always varies by study.
The stages of melanoma, and why they matter for trials
Stage 0. Melanoma in situ, confined to the top layer of skin. Removed surgically and almost always cured; about 122,700 cases are expected in 2026.
Stage I and II. Invasive but confined to the skin, staged by thickness and whether the surface is broken. Surgery is the treatment, and five year survival for localized melanoma exceeds 99 percent. Higher risk stage II is where adjuvant immunotherapy trials now recruit.
Stage III. Spread to nearby lymph nodes or skin. Treated with surgery plus immunotherapy or targeted therapy, and the main setting for neoadjuvant and vaccine trials.
Stage IV. Spread to distant organs. Five year survival 35 percent, up from 15 percent, and where most new drug trials are concentrated, especially for people whose cancer has stopped responding to immunotherapy.
Study titles say "resectable," "adjuvant," "unresectable," or "metastatic," and often "anti-PD-1 refractory," meaning prior immunotherapy stopped working. Your stage and what treatments you have had tell you at a glance which studies fit.
How fast does melanoma spread?
It varies widely. Some melanomas grow slowly over years in the skin before invading; nodular melanoma can grow in weeks. Once it invades deeper layers it can reach lymph nodes and then distant organs. Thickness at diagnosis is the strongest predictor, which is why early removal matters and why staging includes measuring depth.
How to enroll in a melanoma clinical trial
Identify your trial. Use the filters. Titles name the stage, the setting (adjuvant, metastatic), and often a requirement such as "BRAF mutant" or "after anti-PD-1." Match to your pathology report and treatment history.
Select your preferred location. Enter your city or state. Cell therapy and early phase trials run at a small number of cancer centers and may require a hospital stay; adjuvant trials run more widely.
Explore study details. Click "Learn More" for eligibility, including which prior treatments are required or excluded, whether a fresh biopsy is needed, and how visits are scheduled.
Complete the health profile. Click "Get started" to begin the 5-step application. Have three things ready: your stage and melanoma type (skin, uveal, or mucosal), your BRAF and other mutation results if tested, and the list of treatments you have had and how the melanoma responded.
Submit the application. A clinical trial coordinator reviews it and contacts you. Nothing is decided until informed consent, and participation is voluntary at every step.