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
The primary objective of this 3-arm clinical trial is to compare progression-free survival (PFS) of LNS8801 + pembrolizumab arm vs Physicians’ Choice (PC) treatment using RECIST 1.1.
Why this Research Matters
This is a randomized, controlled, open-label, multicenter study to characterize the safety, tolerability, and antitumor effects of LNS8801 alone and in combination with pembrolizumab in treatment refractory, unresectable cutaneous melanoma patients who are homozygous for the consensus GPER protein–coding amino acid sequence (C/C) and have progressed on prior immune checkpoint inhibitor therapy, including an anti–PD-1 therapy
Who can Participate
Inclusion: -Has histologically confirmed unresectable and/or metastatic cutaneous melanoma (Stage IIB - Stage IV). -Has progressed on treatment with an anti–PD-1 monoclonal antibody (mAb) administered either as monotherapy or in combination with other therapies. Patients may have had intervening therapies since progression. -Has received an anti–CTLA-4 containing regimen or is not eligible for or has declined anti–CTLA-4 therapy prior to and for this study Exclusion: -Has mucosal, acral lentiginous, or uveal/ocular/choroidal melanoma. Detailed eligibility criteria is available on clinicaltrials.gov. These requirements will be discussed with your doctor and/or study representative. Click the NCT number link below to learn more about this study on ClinicalTrials.gov
Study ID
Protocol Number: 25-0336
More information available at ClinicalTrials.gov: NCT06624644
Meet the Team
Principal Investigator