LNS8801 With or Without Pembrolizumab for Melanoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, LNS8801, to determine its effectiveness in treating melanoma, a type of skin cancer, by preventing its growth or spread. Researchers will compare LNS8801 alone to a combination of LNS8801 and pembrolizumab, a drug that aids the immune system in fighting cancer, as well as other treatments selected by doctors. The trial seeks participants with melanoma that cannot be surgically removed or has spread, who have tried other treatments like anti-PD-1 therapy but require new options. Participants must be able to swallow pills and have measurable cancer. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing access to potentially effective new therapies.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop your current medications, but you cannot have had anti-cancer or investigational treatments within 4 weeks before starting the study drug.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study found LNS8801 to be safe and easy to handle when used alone, with no serious side effects or dose-limiting issues. Another study tested LNS8801 with pembrolizumab, and this combination was also safe and well-tolerated.
These findings suggest that both treatments are generally safe for people. While individual reactions may vary, these studies indicate that the treatments do not usually cause severe problems.12345Why are researchers excited about this trial's treatments?
Researchers are excited about LNS8801 for melanoma because it offers a novel approach by targeting the AHR (aryl hydrocarbon receptor) pathway, which is different from most current treatments. Most melanoma therapies focus on inhibiting specific proteins like BRAF or leveraging the immune system with checkpoint inhibitors like pembrolizumab. However, LNS8801's unique mechanism could potentially enhance immune response and inhibit tumor growth. When combined with pembrolizumab, it may further boost the effectiveness of immunotherapy. Additionally, LNS8801 can be taken orally, which is a convenient alternative to intravenous treatments.
What evidence suggests that this trial's treatments could be effective for melanoma?
Research has shown that LNS8801 may help treat melanoma. In earlier studies, 63% of patients taking LNS8801 alone experienced no cancer growth or spread. For those with specific markers, this rate reached 100%, with no cancer progression for over six months. In this trial, some participants will receive LNS8801 as monotherapy, while others will receive a combination of LNS8801 with pembrolizumab. Previous studies demonstrated that when LNS8801 was combined with pembrolizumab, more than 75% of patients had no cancer return after two years, and over 90% experienced no disease progression. These findings suggest that LNS8801, both alone and with pembrolizumab, could effectively treat melanoma.16789
Are You a Good Fit for This Trial?
This trial is for patients with advanced melanoma that can't be surgically removed and has spread. Participants must be able to swallow pills, have a certain level of fitness (ECOG 0-1), and their cancer must have worsened despite previous anti-PD-1 therapy. They should also be eligible for one of the standard treatments chosen by their doctor.Inclusion Criteria
Timeline for a Trial Participant
Prescreening
Patients must initially consent to a prescreening blood-based genetic test only
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive LNS8801 alone, LNS8801 with pembrolizumab, or physician's choice treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- LNS8801
- Pembrolizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Linnaeus Therapeutics, Inc.
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University