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

Sponsor
Hospital Israelita Albert Einstein
Study ID
NCT07101822
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Penile Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cemiplimab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Dec 31, 2025
Status verified
Jul 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    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.
  • No Intervention: No intervention
    Best supportive care.

Primary Outcome Measure

Progression free survival [ Time Frame: From enrollment to 24 weeks ]

Central Contacts

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