Vulvar Cancers

This research will determine the impact of optimizing dosage and storage conditions for indocyanine green on health outcomes and will contribute to improving treatment processes in gynecological cancers. Ultrastaging will increase the detection of micrometastases. Furthermore, the cost impact of these optimizations will be evaluated. It will help develop more effective, safe, and cost-effective methods for sentinel lymph node mapping in gynecological cancers. Furthermore, significant savings in healthcare costs could be achieved.

This is a phase II, randomized study that will include 42 participants who have received 4 to 6 cycles of first-line platinum-based chemotherapy for advanced vulvar squamous cell carcinoma (SCC) not amenable to curative surgical treatment (FIGO 2018 stages III-IV - International Federation of Gynecology and Obstetrics) / recurrent disease, and who have not progressed at the end of these 4 to 6 cycles. Participants eligible for the study will be randomized between 4 and 8 weeks after the last chemotherapy cycle to receive: - Cemiplimab maintenance plus best supportive care: cemiplimab 350 mg IV every 3 weeks until week 24, disease progression, unacceptable toxicity or consent withdrawal. Patients who continue to derive clinical benefit on the experimental arm may continue to receive treatment until week 48. - Best supportive care.