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NCT06624644 · ClinicalTrials.gov registry record · Phase 2
A Trial of LNS8801 With or Without Pembrolizumab in Patients With Refractory Melanoma
A Phase 2 study of Cutaneous Melanoma and Unresectable Melanoma, sponsored by Linnaeus Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 135
- Enrollment target
- 7
- Study locations
NCT06624644: Recruiting Phase 2 study of Cutaneous Melanoma and Unresectable Melanoma, sponsored by Linnaeus Therapeutics.
NCT06624644 is a Phase 2 study of Cutaneous Melanoma and Unresectable Melanoma that is actively recruiting participants, run by Linnaeus Therapeutics. The registered enrollment target is 135 participants, below the 363-participant average among 30 other Cutaneous Melanoma trials with a reported enrollment target (63% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06624644, a Phase 2 study of Cutaneous Melanoma and Unresectable Melanoma, is actively recruiting participants, sponsored by Linnaeus Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 135 participants
- Enrollment target
- 7
- Study locations
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.
Primary Outcome
Compare PFS between each of the 3 arms
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 |
What NCT06624644 shows while recruiting
NCT06624644 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, below the 363-participant average among 30 other Cutaneous Melanoma trials with a reported enrollment target (63% lower).
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.
NCT06624644 lists 7 locations in 5 states (California, Colorado, Massachusetts).
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.
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).
Who is sponsoring clinical trial NCT06624644?
This trial is sponsored by Linnaeus Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Cutaneous Melanoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06624644's enrollment target sits among peer trials
135 14th of 30 higher than 17 of 30 other Cutaneous Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cutaneous Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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