NCT06624644 · Linnaeus Therapeutics, Inc.
A Trial of LNS8801 With or Without Pembrolizumab in Patients With Refractory Melanoma
What this study is about
The goal of this clinical trial is to understand if a new drug called LNS8801 can safely treat patients with melanoma.
View original scientific description
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.
Interventions
BIOLOGICAL
LNS8801
G protein-coupled estrogen receptor (GPER) agonist
BIOLOGICAL
Pembrolizumab
Recombinant monoclonal antibody (anti-PD1)
DRUG
Chemotherapy (dacarbazine or temozolomide)
chemotherapy (dacarbazine, temozolomide)
BIOLOGICAL
Immunotherapy (Pembrolizumab)
pembrolizumab
BIOLOGICAL
Immunotherapy (nivolumab and relatlimab)
nivolumab and relatlimab
BIOLOGICAL
Immunotherapy (ipilimumab and nivolumab)
ipilimumab and nivolumab
Primary outcome measures
Compare progression-free survival (PFS) of LNS8801 + pembrolizumab vs PC arms as assessed by RECIST v1.1.
Time frame: up to 2 years.
Compare PFS between each of the 3 arms
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 autoim
Where
- Newport Beach, California
- San Francisco, California
- Stanford, California
- Aurora, Colorado
- Denver, Colorado
- Tampa, Florida
- Boston, Massachusetts
- Albuquerque, New Mexico
- Philadelphia, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 22, 2026 · Source of record for eligibility and locations