A Multicenter, Open-Label, Randomized, Controlled Study to Assess the Antitumor Activity of LNS8801 With and Without Pembrolizumab in Patients With Treatment-Refractory, Unresectable Melanoma

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
USC Newport Beach
RECRUITING
Newport Beach
UCSF
RECRUITING
San Francisco
Stanford
RECRUITING
Stanford
Colorado
University of Colorado Anschutz
RECRUITING
Aurora
Massachusetts
Dana Farber
RECRUITING
Boston
New Mexico
University of New Mexico
RECRUITING
Albuquerque
Pennsylvania
UPenn
RECRUITING
Philadelphia
Contact Information
Primary
Sudha Velayutham
svelayutham@lumabridge.com
210-563-8441
Time Frame
Start Date: 2025-08-06
Estimated Completion Date: 2031-02
Participants
Target number of participants: 135
Treatments
Experimental: LNS8801 Monotherapy
125 mg LNS8801 by mouth every day
Experimental: LNS8801 + Pembrolizumab
125 mg LNS8801 by mouth every day plus 200 mg Pembrolizumab by IV infusion once every 3 weeks.
Active_comparator: Physician's Choice
patients may receive chemotherapy or immunotherapy as determined by physician.
Related Therapeutic Areas
Sponsors
Collaborators: Merck Sharp & Dohme LLC
Leads: Linnaeus Therapeutics, Inc.

This content was sourced from clinicaltrials.gov

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