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

Study acronym: BRAVA PENILE
StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
This is a phase II, randomized study which will enroll participants given 4 to 6 cycles of first-line platinum-based chemotherapy treatment for advanced penile SCC not amenable by curative surgical treatment (stages III-IV as per American Joint Committeeon Cancer - AJCC - 8th) recurrent and who did not progress 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 NCT07101822
Lead Sponsor Hospital Israelita Albert Einstein
Conditions
(from sponsor)		 Penile Cancer
Related terms Penile Neoplasms
Enrollment 42 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov