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

Sponsor
Hospital Israelita Albert Einstein
Study ID
NCT07101848
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Vulvar Cancers

Eligibility Criteria

Sex
FEMALE
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 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.

Key Dates

Start date
Nov 1, 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