NCT06624644 A Trial of LNS8801 With or Without Pembrolizumab in Patients With Refractory Melanoma
| NCT ID | NCT06624644 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Linnaeus Therapeutics, Inc. |
| Condition | Melanoma (Skin Cancer) |
| Study Type | INTERVENTIONAL |
| Enrollment | 135 participants |
| Start Date | 2025-08-06 |
| Primary Completion | 2029-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 135 participants in total. It began in 2025-08-06 with a primary completion date of 2029-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06624644 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Melanoma (Skin Cancer). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06624644 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06624644 currently recruiting?
Yes, NCT06624644 is actively recruiting participants. Contact the research team at svelayutham@lumabridge.com for enrollment information.
Where is the NCT06624644 trial being conducted?
This trial is being conducted at Newport Beach, United States, San Francisco, United States, Stanford, United States, Aurora, United States and 5 additional locations.
Who is sponsoring the NCT06624644 clinical trial?
NCT06624644 is sponsored by Linnaeus Therapeutics, Inc.. The trial plans to enroll 135 participants.
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