Safety and Efficacy of Nivolumab and Imiquimod Combination in Vulvar Squamous Cell Carcinoma Patients

COLOMBE is a multicenter, single arm, phase 1/2 trial designed to evaluate the safety and efficacy of imiquimod cream with IV low dose nivolumab in primary resectable vulvar squamous cell carcinoma patients prior to surgery, leveraging the preoperative "window of opportunity" period, an unavoidable interval due to surgical scheduling.

NCT Number	NCT07679841
Lead Sponsor	Centre Leon Berard
Conditions	Vulvar Squamous Cell Carcinoma
Enrollment	50 participants
Start Date	2026-09
Primary Completion	2029-09 (estimated)
Study Completion	2029-09 (estimated)
Updated on ClinicalTrials.gov	2026-07-01