Encourage Your Patients to Participate! US-Based Clinical Trials That Are Actively Recruiting in Melanoma

Clinical trial recruitment and retention remain challenges in the quest to bring innovative therapies to all patients in need. In oncology, therapies continue to evolve, yet researchers are frequently faced with low trial participation, particularly among minority groups. Oncology Practice Management (OPM) is dedicated to providing comprehensive information aimed at eliminating health disparities and improving access to therapies for people from all populations, including racial and ethnic minorities; people with limited access to healthcare due to lack of financial resources; and people living in rural communities.

This new feature in OPM aims to provide ongoing lists of US-based trials that are actively recruiting. This issue is focused on melanoma, the most serious type of skin cancer, since May is the month when Skin Cancer Awareness Month is observed. Occurring every May, Skin Cancer Awareness Month is devoted to shining the spotlight on the most common cancer in the United States—skin cancer. According to the American Academy of Dermatology (AAD), every day approximately 9500 people in the United States are diagnosed with this type of cancer.

The AAD began Melanoma Monday on Monday, May 1, 1995, and has observed it every year since. This year, Melanoma Monday is Monday, May 5, 2025. In 2024, it was estimated that more than 200,340 melanomas would be diagnosed and about 8290 people would die of melanoma.¹ As such, encouraging participation in clinical trials on this serious form of skin cancer is key.

Healthcare practitioners may use this listing in discussions with their patients to encourage enrollment. As the National Comprehensive Cancer Network has stated, “The best management of any cancer patient is in a clinical trial.”

These clinical trial listings can be found at www.ClinicalTrials.gov.

A Study With Combinations of Anti–LAG-3 and Anti–PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma
• ClinicalTrials.gov Identifier: NCT06246916
• Condition: Melanoma
• Locations: 56 locations
A Study to Evaluate ABP 206 Compared With Opdivo (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma
• ClinicalTrials.gov Identifier: NCT06054555
• Condition: Melanoma
• Locations: 168 locations
A Trial to Learn If Fianlimab and Cemiplimab Are Safe and Work Better Than Anti–PD-1 Alone in Adult Participants With Resectable Stage III or IV Melanoma
• ClinicalTrials.gov Identifier: NCT06190951
• Condition: Melanoma
• Locations: 31 locations
A Trial to See If the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After It Has Been Removed With Surgery
• ClinicalTrials.gov Identifier: NCT05608291
• Condition: Melanoma
• Locations: 213 locations
Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma
• ClinicalTrials.gov Identifier: NCT05352672
• Condition: Melanoma
• Locations: 219 locations
A Phase 2/3 Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma
• ClinicalTrials.gov Identifier: NCT02339571
• Conditions:
  • Stage III Cutaneous Melanoma AJCC v7
  • Stage IV Cutaneous Melanoma AJCC v6 and v7
• Locations: 744 locations
A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma
• ClinicalTrials.gov Identifier: NCT06007690
• Conditions:
  • Choroidal Melanoma
  • Indeterminate Lesions
  • Ocular Melanoma
  • Uveal Melanoma
• Locations: 51 locations
Tebentafusp Regimen Versus Investigator’s Choice in Previously Treated Advanced Melanoma (TEBE-AM)
• ClinicalTrials.gov Identifier: NCT05549297
• Condition: Advanced Melanoma
• Locations: 66 locations
IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)
• ClinicalTrials.gov Identifier: NCT06112314
• Condition: Advanced Melanoma
• Locations: 97 locations
VO and Nivolumab Versus Physician’s Choice in Advanced Melanoma That Progressed on Anti–PD-1 and Anti–CTLA-4 Drugs (IGNYTE-3)
• ClinicalTrials.gov Identifier: NCT06264180
• Condition: Advanced Melanoma
• Locations: 30 locations
Efficacy of Daromun Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C Melanoma
• ClinicalTrials.gov Identifier: NCT03567889
• Condition: Melanoma Stage IIIB/C
• Locations: 34 locations
Safety and Efficacy of EIK1001-006 in Combo With Pembro Versus Placebo and Pembro as First-Line Therapy in Patients With Advanced Melanoma
• ClinicalTrials.gov Identifier: NCT06697301
• Condition: Advanced Melanoma
• Locations:
  • Chandler, AZ
  • Colorado Springs, CO
  • Pittsburgh, PA
SUPRAME-ACTengine^® IMA203 Versus Investigator’s Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma
• ClinicalTrials.gov Identifier: NCT06743126
• Condition: Melanoma, Cutaneous Malignant
• Locations: 6 locations
IDE196 (Darovasertib) in Combination With Crizotinib As First-Line Therapy in Metastatic Uveal Melanoma
• ClinicalTrials.gov Identifier: NCT05987332
• Condition: Metastatic Uveal Melanoma
• Locations: 66 locations
A Randomized, Phase 2/3 Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab in Immune Checkpoint Inhibitor–Naïve Adult Patients With Metastatic Uveal Melanoma
• ClinicalTrials.gov Identifier: NCT06581406
• Condition: Metastatic Uveal Melanoma
• Locations: 12 locations
A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With NRAS-Mutant Melanoma (SEACRAFT-2)
• ClinicalTrials.gov Identifier: NCT06346067
• Conditions: Advanced or Metastatic NRAS-Mutant Melanoma
• Locations: 59 locations

Reference

1. American Cancer Society. Key statistics for melanoma skin cancer. Last updated January 17, 2024. Accessed April 1, 2025. www.cancer.org/cancer/types/melanoma-skin-cancer/about/key-statistics.html