Clinical Trial

A PHASE II, RANDOMIZED TRIAL TO ASSESS MAINTENANCE THERAPY WITH CEMIPLIMAB VERSUS BEST SUPPORTIVE CARE AFTER 1ST LINE PLATINUM-BASED CHEMOTHERAPY IN ADVANCED/RECURRENT VULVAR CANCER

Study acronym: BRAVA VULVAR
Not Yet Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
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.
Trial Details
NCT Number NCT07101848
Lead Sponsor Hospital Israelita Albert Einstein
Conditions Vulvar Cancers
Enrollment 42 participants
Start Date 2025-11-01
Primary Completion 2028-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2025-08-03