Actively Recruiting
Study to Assess the Antitumor Activity of LNS8801 With and Without Pembrolizumab in Treatment-Refractory Unresectable Melanoma
Led by Linnaeus Therapeutics, Inc. · Updated on 2026-04-22
135
Participants Needed
9
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a new drug called LNS8801 for treating patients with melanoma that cannot be removed by surgery and has not responded to previous immune checkpoint inhibitor therapy. The study focuses on patients who have a specific genetic makeup (two copies of the functional GPER protein-coding sequence) and have melanoma that has progressed despite prior treatments. The main goal is to measure the average time during which melanoma does not grow or spread after starting treatment with LNS8801, either alone or combined with pembrolizumab, compared to other treatments chosen by the doctor. Participants will be randomly assigned to one of three groups. The first group will take 125 mg of LNS8801 by mouth daily for up to two years. The second group will take the same dose of LNS8801 daily plus 200 mg of pembrolizumab through an IV infusion every three weeks, also for up to two years. The third group will receive chemotherapy or immunotherapy as decided by their physician. The pembrolizumab dose may be adjusted after six months if appropriate. Patients in the combination group may stop one medication if needed due to side effects but continue the other. Treatment may continue beyond disease progression if clinically beneficial. During the study, participants will have clinic visits at intervals depending on their treatment group, including safety checks and imaging scans to monitor tumor response every eight weeks during the first year, every twelve weeks in the second year, and every six months afterward. Researchers will also track overall survival, hospitalization days, response duration, disease control, and any side effects. Safety assessments will continue up to 90 days after the last dose for those receiving immune checkpoint inhibitors and 30 days for others. Long-term follow-up for survival and anti-cancer treatments will continue for up to five years after treatment ends.
CONDITIONS
Brief Title
A Trial of LNS8801 With or Without Pembrolizumab in Patients With Refractory Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed unresectable and/or metastatic cutaneous melanoma.
- Have two copies of the fully functional GPER protein-coding sequence.
- Eligible for and willing to receive one or more physician's choice therapies.
- Able to swallow tablets.
- Progressed on treatment with an anti-PD-1 monoclonal antibody.
- Received or declined anti-CTLA-4 and/or BRAF therapy prior to this study.
- Measurable disease.
- Eastern Cooperative Oncology Group Performance Status of 0 to 1.
You will not qualify if you...
- Blue nevus subtype, mucosal, acral lentiginous, or uveal/ocular/choroidal melanoma.
- Anti-cancer or investigational treatment within 4 weeks before starting study drug.
- Radiotherapy within 2 weeks before starting study drug.
- Allogeneic tissue or solid organ transplant.
- Unstable autoimmune or immunodeficiency disease.
- Other health issues that would interfere with study participation.
- Prior reaction to anti PD-1 therapy making pembrolizumab unadvisable.
- Other protocol-defined inclusion/exclusion criteria may apply.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) including genetic testing and tumor imaging
Duration - Up to 2 years
Participants receive assigned treatments: LNS8801 alone, LNS8801 with pembrolizumab, or physician's choice chemotherapy or immunotherapy. Treatment continues until disease progression, unacceptable side effects, or up to approximately 2 years.
Daily oral dosing of LNS8801; pembrolizumab IV infusion every 3 weeks (with possible modification to every 6 weeks after 6 months); tumor imaging every 8 weeks for the first year, then every 12 weeks during the second year
Duration - Up to 2 years after treatment ends
Participants are monitored after treatment ends for safety and overall survival, including regular assessments every 6 months for the first year and annually thereafter up to 2 years.
Visits every 6 months for the first year, then annually
Trial Site Locations
Total: 9 locations
1
USC Newport Beach
Newport Beach, California, United States, 92663
Actively Recruiting
2
UCSF
San Francisco, California, United States, 94143
Actively Recruiting
3
Stanford
Stanford, California, United States, 94305
Actively Recruiting
4
University of Colorado Anschutz
Aurora, Colorado, United States, 80045
Actively Recruiting
5
University of Colorado
Denver, Colorado, United States, 80204
Actively Recruiting
6
Moffitt Cancer Center
Tampa, Florida, United States, 87535
Actively Recruiting
7
Dana Farber
Boston, Massachusetts, United States, 02215
Actively Recruiting
8
University of New Mexico
Albuquerque, New Mexico, United States, 87106
Actively Recruiting
9
UPenn
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
Research Team
S
Sudha Velayutham
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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