A Trial of LNS8801 With or Without Pembrolizumab in Patients With Refractory Melanoma (NCT06624644)
A Multicenter, Open-Label, Randomized, Controlled Study to Assess the Antitumor Activity of LNS8801 With and Without Pembrolizumab in Patients With Treatment-Refractory, Unresectable Melanoma
🩺 Plain-English Summary (8th-Grade Level)
The goal of this clinical trial is to understand if a new drug called LNS8801 can safely treat patients with melanoma. The primary question to be answered is what is the average length of time during which melanoma does not grow or spread after starting treatment with LNS8801? Researchers will compare LNS8801 taken alone or LNS8801 taken together with another drug called pembrolizumab to other therapies as decided by the treating doctor. 135 patients will be randomly (like flipping a coin) placed in 3 treatment groups. In the first group (LNS8801 only) - Patients will take 125mg tablet of LNS8801 by mouth once per day every day for up to 2 years. In the second group (LNS8801 + pembrolizumab) - Patients will take 125mg tablet of LNS8801 by mouth once per day plus 200 mg of pembrolizumab by IV infusion once every 3 weeks for up to 2 years. In the third group, called Physician's Choice (PC), patients will receive chemotherapy (dacarbazine or temozolomide) or immunotherapy (pembrolizumab, nivolumab/relatlimab or nivolumab/ipilimumab) as determined by their treating physician. How often the patient visits the clinic visits will depend on the treatment group. Besides returning to the clinic for treatment, the patient will undergo periodic safety assessments and other required study procedures such as imaging assessments.
Who can join: Review the eligibility criteria below.
Location: USC Newport Beach — Newport Beach, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (9 Sites)
- USC Newport Beach — Newport Beach, California
- UCSF — San Francisco, California
- Stanford — Stanford, California
- University of Colorado Anschutz — Aurora, Colorado
- University of Colorado — Denver, Colorado
- Moffitt Cancer Center — Tampa, Florida
- Dana Farber — Boston, Massachusetts
- University of New Mexico — Albuquerque, New Mexico
- UPenn — Philadelphia, Pennsylvania
📞 Contact the Study Coordinator
Phone: (210) 563-8441
Email: svelayutham@lumabridge.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Melanoma (Skin Cancer)
- A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Melanoma — Nashville, Tennessee
- Bright Light Therapy in Patients With Melanoma or Non-small Cell Lung Cancer (NSCLC) Who Are Receiving First-Line Immune Checkpoint Blockade — New York, New York
- NeoAdjuvant, Spare-Adjuvant (NASA) in Stage IIIB-IV (M1a) Melanoma — Chapel Hill, North Carolina
- Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors — Tucson, Arizona
- Sun Exposure and Activities After Skin Cancer: Optimization of mHealth Interventions — Chicago, Illinois
- Phase Ib Study of AlpeliSib With PEmbroLizumab in Patients With mEtastatic Breast caNcer or melanomA (SELENA) — Houston, Texas
Explore by condition: All Melanoma (Skin Cancer) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.