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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

December 31, 2025

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2028

Conditions
Penile Cancer
Interventions
DRUG

Cemiplimab

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.

Trial Locations (1)

Unknown

Hospital Israelita Albert Einstein, São Paulo

All Listed Sponsors
lead

Hospital Israelita Albert Einstein

OTHER