Pembrolizumab plus Lenvatinib in vulvar cancer patients: The prospective, multi-cohorts and multicentre, phase 2 MITO VULVA-01 study.

2023-509180-24-00 · tracked via the Priya Life Science EU tracker

Sponsor

IRCCS Istituto Nazionale Tumori Fondazione Pascale

Sponsor type

Hospital/Clinic/Other health care facility

Therapeutic area

Female Urogenital Diseases and Pregnancy Complications

Decision date

12/09/2025

Enrollment target

Sites

Italy

Condition studied

vulvar cancer

Investigational medicinal product(s)

KEYTRUDA 25 mg/mL concentrate for solution for infusion.LenvatinibLenvatinib

Eligibility

Age group

18-64 years, 65+ years

Sex

Female

Primary endpoint

Objective response rate (ORR) defined as a complete response (CR) or partial response (PR) by the Investigator using RECIST 1.1 criteria, in each single cohort (ORR will be evaluated after 4 cycles in Cohort A patients and on the whole treatment period in Cohort B and C patients), Safety profile of Pembrolizumab plus Lenvatinib according to CTCAE (version 5.0) and PRO-CTCAE questionnaire in the overall study population

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

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