Study on LNS8801 With or Without Pembrolizumab for Patients with Hard-to-Treat Melanoma

Sponsor: Linnaeus Therapeutics, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT06624644

This clinical trial is testing a new drug, LNS8801, to see if it can safely treat melanoma that hasn't responded to other treatments. The study will compare LNS8801 alone and with another drug, pembrolizumab, to other treatments chosen by doctors.

Patient Parameters

Parameter	Options

Program Overview

The purpose of this study is to find out if LNS8801, a new drug, can help control melanoma that is difficult to treat. Researchers want to know how long the melanoma can be kept from growing or spreading when treated with LNS8801 alone or with pembrolizumab, compared to other treatments chosen by doctors. 135 patients will be randomly assigned to one of three groups: LNS8801 only, LNS8801 with pembrolizumab, or a treatment chosen by their doctor. Patients will take LNS8801 as a daily pill, and those in the combination group will also receive pembrolizumab through an IV every three weeks. The study will last up to two years, with regular clinic visits and health checks.

Description

This study is designed to test the safety and effectiveness of LNS8801, alone and with pembrolizumab, in patients with melanoma that cannot be removed by surgery and has not responded to previous treatments. Patients will first have a genetic test to see if they have a specific protein that makes them eligible for the study. If eligible, they will be randomly placed into one of three groups: LNS8801 alone, LNS8801 with pembrolizumab, or a treatment chosen by their doctor. The study will monitor how well the treatments work and their safety. Patients will have regular check-ups, imaging tests to track the cancer, and will be followed for up to two years to see how they respond to the treatment. If patients experience side effects, they may stop one of the drugs and continue with the other. The study aims to provide new insights into treating melanoma that is hard to manage with existing therapies.

Eligibility Criteria

Inclusion Criteria

Have melanoma that cannot be surgically removed or has spread to other parts of the body.
Have two copies of a specific protein sequence needed for the study.
Be willing to receive one or more treatments chosen by their doctor.
Be able to swallow pills.
Have previously been treated with an anti-PD-1 therapy but the cancer has progressed.
Have received or are not eligible for certain other cancer treatments.
Have measurable cancer that can be tracked.
Be in good overall health, able to carry out daily activities with minimal restrictions.

Exclusion Criteria

Have a specific type of melanoma, such as blue nevus, mucosal, acral lentiginous, or eye-related melanoma.
Have received other cancer treatments or experimental drugs within four weeks before starting the study.
Have had radiation therapy within two weeks before starting the study.
Have had a tissue or organ transplant.
Have an unstable autoimmune or immune deficiency condition.
Have other health issues that would make it hard to participate in the study.
Have had a bad reaction to anti-PD-1 therapy that would make pembrolizumab unsafe.
Other specific criteria may apply.

Locations

FACILITY	ZIP	CITY	STATE
USC Newport Beach	92663	Newport Beach	California
UCSF	94143	San Francisco	California
Stanford	94305	Stanford	California
University of Colorado Anschutz	80045	Aurora	Colorado
Dana Farber	02215	Boston	Massachusetts
University of New Mexico	87106	Albuquerque	New Mexico
UPenn	19107	Philadelphia	Pennsylvania

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.