Melanoma

Treatments & research overview

What researchers are actively studying

Active trials explore whether T-cell receptor therapies (ACTengine IMA203) and tumour-infiltrating lymphocyte products can match or exceed checkpoint inhibitors in previously treated disease. Duration-of-therapy questions are being addressed in a phase 3 study of intermittent versus continuous PD-1 therapy, and circulating tumour DNA (ctDNA) is being tested as a guide for adding ipilimumab to nivolumab plus relatlimab. For mucosal melanoma, adjuvant radiotherapy with chemotherapyDrugs that kill rapidly dividing cells, including cancer cells.Click for full explanation → plus a PD-1 inhibitor is under study, as is nivolumab with or without cabozantinib after surgery. Brain metastasis work includes bevacizumab and atezolizumab with or without cobimetinib. Dendritic cell therapy (DOC1021), CAR-TA type of immunotherapy that reprograms a patient's own T cells to attack cancer.Click for full explanation → therapies targeting B7-H3, PRAME-directed natural killer (NK) cells, and oncolytic agents such as vusolimogene oderparepvec (RP1) are in early trials. Mitogen-activated protein kinase (MAPK) pathway drugs are being combined with pembrolizumab, and the galectin-3 inhibitor GB1211 is in phase 2 with pembrolizumab.

Where the evidence stands

Checkpoint combinations, targeted BRAF/MEK inhibitor combinations, and single-agent PD-1 therapy have phase 3 evidence in advanced melanoma. Tebentafusp and lifileucel both have phase 3 or equivalent regulatory-grade data in their niches. Phase 3 studies underway include IMA203 versus investigator choice in previously treated advanced melanoma, intermittent versus continuous PD-1 therapy, and a surgical re-excision study (NORMA 2). Many cellular, bispecific, and viral therapies remain in phase 1, and mucosal melanoma strategies have mostly small phase 2 support.

What this means for people affected

Melanoma is one of the cancers where immunotherapyTreatments that use the body's immune system to fight cancer.Click for full explanation → and targeted therapyDrugs that block specific molecules that cancer cells need to grow.Click for full explanation → have most dramatically changed outcomes. For BRAF-mutated disease there are both immunotherapyTreatments that use the body's immune system to fight cancer.Click for full explanation → and targeted options, and selecting between them is now a common and nuanced decision. Uveal melanoma and mucosal melanoma have fewer options but are finally seeing meaningful new treatments. For people whose disease has progressed on first-line checkpoint therapy, cellular therapies such as tumour-infiltrating lymphocytes and T-cell receptor therapies are beginning to offer a path forward. Early detection still matters enormously, because melanoma caught early is often highly treatable with surgery alone.

Last updated April 22, 2026

Recent research findings

Understanding evidence levels
PreclinicalLab or cell studies — no human data yet.
Animal StudyResults in animals only — may not apply to humans.
Phase 1 TrialFirst-in-human safety testing in small groups.
Phase 2 TrialEarly effectiveness testing in a larger group.
Phase 3 TrialLarge controlled trial — the strongest trial evidence.
Observational StudyPatterns observed in populations — not a controlled trial.
ReviewSummary analysis of multiple existing studies.
Meta-AnalysisStatistical pooling of results from multiple studies.
Observational StudyPatterns observed in populations over time, not a controlled experiment.Published: April 20, 2026

Men with Melanoma Lose More Years of Life Than Women

Researchers analyzed a large group of people in Sweden who were diagnosed with melanoma. They found that men with melanoma tend to lose more years of life than women. It's not clear why this is the case.

Why it matters: This finding could help researchers understand why men and women with melanoma have different outcomes.
PubMed
Phase 3 TrialLarge controlled trial comparing treatments. The strongest level of trial evidence.Est. completion: October 1, 2031

New Treatment Options for Advanced Melanoma Being Tested

This clinical trialA research study that tests a medical intervention in human volunteers.Click for full explanation → is studying a new treatment called IMA203 for people with advanced melanoma that cannot be removed or has spread. The trial is comparing IMA203 to other treatments that are already available. The trial is currently recruiting participants.

Why it matters: This trial may help doctors find better treatment options for people with advanced melanoma.

Recruiting participants

ClinicalTrials.gov
Phase 2 TrialTests early effectiveness in a larger group after phase 1 safety is established.Est. completion: December 1, 2033

Lifileucel for Advanced Melanoma: A Phase 2 Clinical TrialA research study that tests a medical intervention in human volunteers.Click for full explanation →

This trial is studying Lifileucel, a treatment made from tumor-infiltrating lymphocytes, in adults with advanced melanoma. The trial is currently active but not recruiting participants. The goal is to learn more about the safety and effectiveness of Lifileucel in this patient group.

Why it matters: This trial aims to contribute to the understanding of Lifileucel as a potential treatment option for people with advanced melanoma.

Active but not recruiting participants.

ClinicalTrials.gov
ReviewSummary and analysis of existing published studies.Published: April 17, 2026

New Treatment Approach for Advanced Melanoma Shows Promise

Researchers reviewed the use of a treatment called neoadjuvant systemic therapy (NAST) for people with stage III or IV melanoma that can be removed with surgery. They found that NAST may improve outcomes for these patients, but more research is needed. The study looked at evidence from recent clinical trialsA research study that tests a medical intervention in human volunteers.Click for full explanation →.

Why it matters: This finding could lead to better treatment options for people with advanced melanoma.
Efficacy

Recent randomised phase II and III controlled trials have demonstrated significant improvements in event-free survival (EFS) rates with NAST compared to standard adjuvant therapy alone.

PubMed
PreclinicalLab or cell studies. No human data yet.Est. completion: May 1, 2031

Testing a New Approach to Treating Advanced Melanoma

Researchers are studying whether adding a medication called ipilimumab to two other treatments, nivolumab and relatlimab, can help patients with advanced melanoma. This trial is currently recruiting participants. The goal is to see if this combination of treatments is safe and effective.

Why it matters: This trial may help doctors find a more effective treatment for patients with advanced melanoma.

Recruiting participants

ClinicalTrials.gov
Phase 2 TrialTests early effectiveness in a larger group after phase 1 safety is established.Published: April 16, 2026

Combining Radiotherapy, ChemotherapyDrugs that kill rapidly dividing cells, including cancer cells.Click for full explanation →, and a PD-1 Inhibitor for Mucosal Melanoma

Researchers are testing a new treatment for mucosal melanoma, a type of skin cancer, that combines radiotherapy, chemotherapyDrugs that kill rapidly dividing cells, including cancer cells.Click for full explanation →, and a PD-1 inhibitor. This study aims to see if this combination can improve survival rates for patients with this type of cancer. The study is still ongoing and results are not yet available.

Why it matters: This study may provide new insights into the treatment of mucosal melanoma, a type of skin cancer with a high risk of relapse.
PubMed
Lab StudyLaboratory experiments on cells or tissue. No human or animal data.Published: April 15, 2026

ChemotherapyDrugs that kill rapidly dividing cells, including cancer cells.Click for full explanation →'s Heart Damage Linked to Gene ZNF281

Researchers studied how chemotherapyDrugs that kill rapidly dividing cells, including cancer cells.Click for full explanation → affects the heart and found that a gene called ZNF281 is involved in this damage. They tested a new drug that blocks ZNF281 and found it helped prevent heart damage in lab experiments. However, more research is needed to confirm these findings.

Why it matters: This research could lead to new treatments that reduce the risk of heart damage from chemotherapyDrugs that kill rapidly dividing cells, including cancer cells.Click for full explanation →.
Efficacy

Inhibition of ZNF281 completely prevented AIC.

This study was conducted in lab experiments and animal models, and more research is needed to confirm its findings.

PubMed
Phase 1 TrialFirst-in-human trial. Focuses on safety and dosing in small groups.Est. completion: December 31, 2028

Testing a New Treatment for Advanced Solid Tumours

Researchers are studying a new treatment called HX009+IN10018 for people with advanced biliary tract cancer and melanoma. This treatment is being tested with or without standard chemotherapyDrugs that kill rapidly dividing cells, including cancer cells.Click for full explanation →. The trial is currently recruiting participants.

Why it matters: This trial may help doctors understand if HX009+IN10018 is a safe and effective treatment for these types of cancer.

Recruiting participants, early stage trial

ClinicalTrials.gov
Lab StudyLaboratory experiments on cells or tissue. No human or animal data.Published: April 15, 2026

Cancer Cells Adapt to Treatment by Changing Their Gene Expression

Researchers studied how cancer cells change their gene expression when treated with certain drugs. They found that cancer cells go through a series of changes in their gene expression, which helps them become more resistant to treatment. This process involves a protein called NF-κB, which plays a key role in changing the way genes are expressed.

Why it matters: This finding could help researchers understand how cancer cells become resistant to treatment and develop new ways to target these cells.

The study was conducted in BRAF-mutant melanoma models and patient specimens, and the findings may not be generalizable to other types of cancer.

PubMed
PreclinicalLab or cell studies. No human data yet.Est. completion: July 24, 2028

Melanoma Study Uses AI to Predict Response to Anti-PD-1 Treatment

Researchers are developing an artificial intelligence algorithm to analyze melanoma peri-scar dermatoheliosis and predict how well patients will respond to anti-PD-1 treatment. This trial is currently recruiting participants. The goal is to improve treatment outcomes for people with metastatic melanoma.

Why it matters: This study may help doctors make more informed decisions about treatment for patients with metastatic melanoma.

Recruiting status: RECRUITING

ClinicalTrials.gov
Phase 1 TrialFirst-in-human trial. Focuses on safety and dosing in small groups.Est. completion: October 5, 2029

Testing BI 3810944 in People With Advanced Cancer

This clinical trialA research study that tests a medical intervention in human volunteers.Click for full explanation → is studying the effects of different doses of BI 3810944 in people with advanced solid tumours, including melanoma. The trial is currently recruiting participants. The goal is to see if BI 3810944 helps, but it's too early to know if it will.

Why it matters: This trial aims to gather information about the safety and potential benefits of BI 3810944 in treating advanced cancer.

Recruiting participants

ClinicalTrials.gov
Phase 1 TrialFirst-in-human trial. Focuses on safety and dosing in small groups.Est. completion: April 30, 2029

Testing Aerosolized Aldesleukin for Lung Metastases

This clinical trialA research study that tests a medical intervention in human volunteers.Click for full explanation → is studying the safety and effects of aerosolized aldesleukin in patients with lung metastases from various cancers. The trial is currently active but not recruiting participants. The results of this trial are not yet available.

Why it matters: This trial may help researchers understand how aerosolized aldesleukin affects patients with lung metastases.

Active but not recruiting participants

ClinicalTrials.gov

Related clinical trials

PHASE3RECRUITING

SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma

NCT06743126
PHASE1ACTIVE_NOT_RECRUITING

Aerosolized Aldesleukin in Treating Patients With Lung Metastases

NCT01590069
PHASE4RECRUITING

ctDNA-guided Addition of Ipilimumab to Patients Receiving Nivolumab and Relatlimab

NCT07504796
PHASE2ACTIVE_NOT_RECRUITING

A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Melanoma

NCT07288203
PHASE2RECRUITING

A Phase 2 Trial for Metastatic Melanoma Using Adoptive Cell Therapy With Tumor Infiltrating Lymphocytes Plus IL-2 Either Alone or Following the Administration of Pembrolizumab

NCT02621021
PHASE1RECRUITING

HX009+ IN10018 With or Without Standard ChemotherapyDrugs that kill rapidly dividing cells, including cancer cells.Click for full explanation → for Advanced Solid Tumours

NCT06708663
RECRUITING

Generation of an Artificial Intelligence Algorithm Based on the Analysis of Melanoma Peri-scar Dermatoheliosis, as a Predictive Factor of Response to Anti-PD-1

NCT05856565
PHASE1RECRUITING

A Study in People With Advanced Cancer (Solid Tumours) to Test Different Doses of BI 3810944 and to Find Out Whether it Helps

NCT07224425
PHASE2RECRUITING

Binimetinib and Encorafenib for the Treatment of Metastatic Melanoma and Central Nervous System Metastases

NCT05026983
PHASE2RECRUITING

Stereotactic Ablative Radiotherapy (XRT) and ImmunotherapyTreatments that use the body's immune system to fight cancer.Click for full explanation → for Oligometastatic Extracranial Melanoma

NCT06767306