A Trial of LNS8801 With or Without Pembrolizumab in Patients With Refractory Melanoma (NCT06624644) | Clinical Trial Compass
RecruitingPhase 2/3
A Trial of LNS8801 With or Without Pembrolizumab in Patients With Refractory Melanoma
United States135 participantsStarted 2025-08-06
Plain-language summary
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 participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Confirmed unresectable and/or metastatic cutaneous melanoma.
* 2 copies of the fully functional form of GPER protein-coding sequence.
* Eligible for and willing to receive 1 or more of the physician's choice (PC) therapies.
* Able to swallow tablets.
* Progressed on treatment with an anti-PD-1 monoclonal antibody (mAb) administered either as monotherapy or in combination with other therapies.
* Received an anti-CTLA-4 and/or BRAF containing regimen or is not eligible for or has declined anti-CTLA-4 and/or BRAF therapy prior to and for this study.
* Measurable disease.
* Eastern Cooperative Oncology Group Performance Status of 0 to 1.
Exclusion Criteria:
* Blue nevus subtype, mucosal, acral lentiginous, or uveal/ocular/choroidal Melanoma.
* Previous anti-cancer or investigational drug/device treatment within 4 weeks of the first dose of study drug.
* Radiotherapy within 2 weeks of starting study drug.
* Allogeneic tissue/solid organ transplant.
* Unstable autoimmune or immunodeficiency disease.
* Other concurrent health issues that would make participation or completion of the study difficult.
* Prior reaction to anti PD-1 therapy that would make treatment with pembrolizumab unadvisable.
* Other protocol-defined inclusion/exclusion criteria may apply.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Compare progression-free survival (PFS) of LNS8801 + pembrolizumab vs PC arms as assessed by RECIST v1.1.