drugset / Trial / NCT07679841
Safety and Efficacy of Nivolumab and Imiquimod Combination in Vulvar Squamous Cell Carcinoma Patients
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2026-09
- Primary completion
- 2029-09
- Completion
- 2029-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Imiquimod | Other / unclassified | 5 % | — |
| Subject | Nivolumab | Monoclonal antibody | 40 mg | Intravenous |