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

NCT06624644 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2026-04-22

No results posted yet for this 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.

Conditions

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

Sponsors & Collaborators

  • Linnaeus Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-06
Primary Completion
2029-02-28
Completion
2031-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06624644 on ClinicalTrials.gov