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

Launched by LINNAEUS THERAPEUTICS, INC. · Oct 1, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new medication called LNS8801 to see if it can help treat patients with advanced melanoma, a type of skin cancer that is difficult to treat. The main goal is to find out how long patients can expect their melanoma to remain stable (not growing or spreading) after starting treatment. Participants will be divided into three groups: one group will take LNS8801 alone, another group will take LNS8801 along with another medication called pembrolizumab, and the third group will receive a treatment chosen by their doctor, which could include chemotherapy or other immunotherapy options.

To be eligible for the trial, patients should have advanced melanoma that cannot be surgically removed, have previously received certain cancer therapies, and be able to swallow tablets. Throughout the study, patients will visit the clinic regularly for treatment and check-ups to monitor their health and the effectiveness of the medication. It’s important for potential participants to know that this trial is not yet recruiting, but it aims to provide new options for those battling this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • Blue nevus subtype, mucosal, acral lentiginous, or uveal/ocular/choroidal Melanoma.
• • Previous anti-cancer or investigational drug/device treatment within 4 weeks of the first dose of study drug.
• • Radiotherapy within 2 weeks of starting study drug.
• • Allogeneic tissue/solid organ transplant.
• • Unstable autoimmune or immunodeficiency disease.
• • Other concurrent health issues that would make participation or completion of the study difficult.
• • Prior reaction to anti PD-1 therapy that would make treatment with pembrolizumab unadvisable.
• • Other protocol-defined inclusion/exclusion criteria may apply.