LNS8801 with or without Pembrolizumab for Melanoma

This study is testing a new drug, LNS8801, for patients with advanced melanoma (skin cancer that has spread or cannot be removed by surgery). Researchers want to see if LNS8801, either alone or combined with pembrolizumab (an immunotherapy), can help stop the melanoma from growing or spreading. You might be eligible if you have unresectable or metastatic melanoma, have a specific genetic marker (two copies of the fully functional GPER protein-coding sequence), and your melanoma has progressed after prior anti-PD-1 immunotherapy. The main goal is to compare how long patients live without their cancer getting worse when treated with LNS8801 combinations versus other standard therapies chosen by your doctor. About 135 patients will participate.

Study design
This is a randomized, controlled, open-label study involving 135 participants, who will be assigned to one of three treatment groups by chance.
What's involved
You will take LNS8801 tablets by mouth once daily for up to two years. If in the combination arm, you will also receive pembrolizumab infusions every three or six weeks for up to two years.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how long your cancer does not grow or spread for up to two years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06624644

A Trial of LNS8801 With or Without Pembrolizumab in Patients With Refractory Melanoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
Linnaeus Therapeutics, Inc.
~135 participants
Updated 2026-04-22 on ClinicalTrials.gov
What's tested:LNS8801PembrolizumabChemotherapy (dacarbazine or temozolomide)Immunotherapy (Pembrolizumab)Immunotherapy (nivolumab and relatlimab)Immunotherapy (ipilimumab and nivolumab)

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Compare progression-free survival (PFS) of LNS8801 + pembrolizumab vs PC arms as assessed by RECIST v1.1.
Measured over up to 2 years.
Melanoma (Skin Cancer)
Melanoma Stage IIIB-IV
Cutaneous Melanoma
Unresectable Melanoma
9 sites across 6 states
California3
Colorado2
Florida1
Massachusetts1
New Mexico1
Pennsylvania1

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.
  • Compare progression-free survival (PFS) of LNS8801 + pembrolizumab vs PC arms as assessed by RECIST v1.1.up to 2 years.

    Compare PFS between each of the 3 arms