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A Trial of LNS8801 With or Without Pembrolizumab in Patients With Refractory Melanoma
NCT06624644 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL LNS8801
- DRUG Chemotherapy (dacarbazine or temozolomide)
- BIOLOGICAL Immunotherapy (Pembrolizumab)
- BIOLOGICAL Immunotherapy (nivolumab and relatlimab)
Study Locations (7)
California
- USC Newport Beach — Newport Beach
- UCSF — San Francisco
- Stanford — Stanford
Colorado
- University of Colorado Anschutz — Aurora
Massachusetts
- Dana Farber — Boston
New Mexico
- University of New Mexico — Albuquerque
Pennsylvania
- UPenn — Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2025-08-06 |
| Est. Completion | 2031-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06624644
The ClinicalTrials.gov registry entry for NCT06624644 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 135 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Linnaeus Therapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Cutaneous Melanoma appearing as the primary indexed condition, and to 5 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06624644 reports 7 study locations spanning 5 distinct geographic areas — top geographies include California, Colorado, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06624644 about?
NCT06624644 is a clinical study titled "A Trial of LNS8801 With or Without Pembrolizumab in Patients With Refractory Melanoma". 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 compa...
What is the current status of trial NCT06624644?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 135 participants. The study started on 2025-08-06. Estimated completion is 2031-02.
What conditions does trial NCT06624644 study?
This clinical trial studies the following conditions: Cutaneous Melanoma, Unresectable Melanoma, Melanoma (Skin Cancer), Melanoma Stage IIIB-IV. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06624644?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), LNS8801 (BIOLOGICAL), Chemotherapy (dacarbazine or temozolomide) (DRUG), Immunotherapy (Pembrolizumab) (BIOLOGICAL), Immunotherapy (nivolumab and relatlimab) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06624644?
This trial is sponsored by Linnaeus Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06624644 being conducted?
This trial has 7 study locations across California, Colorado, Massachusetts, New Mexico, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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