NCT07290894

Pembrolizumab Plus Lenvatinib in Vulvar Cancer Patients: MITO VULVA-01

Pembrolizumab Plus Lenvatinib in Vulvar Cancer Patients: MITO VULVA-01 Study.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

MITO VULVA-1 is a prospective, single arm, multi-cohorts, phase II trial that aims to assess the activity and the safety of Lenvatinib plus Pembrolizumab in patients with vulvar cancer. 80 patients will be overall enrolled in the study.Three cohorts are planned

Detailed description

In this study three cohorts are planned: COHORT A: Locally advanced unresectable, treatments naïve, vulva carcinoma. Lenvatinib plus Pembrolizumab for 4 cycles. Then, in case of complete/partial clinical and/or pathological response Pembrolizumab monotherapy maintenance will be administered for a maximum of 35 cycles. COHORT B: recurrent or de novo metastatic chemotherapy naïve, vulva carcinoma. These patients will receive Lenvatinib plus Pembrolizumab. Pembrolizumab will be administered for a maximum of 35 cycles and lenvatinb until PD, unacceptable toxicity, withdraw of consent. COHORT C: recurrent or metastatic vulva carcinoma, in progression to a chemotherapy-based treatment or primary chemoradiation. These patients will receive Lenvatinib plus Pembrolizumab. Pembrolizumab will be administered for a maximum of 35 cycles, lenvatinb until PD, unacceptable toxicity, withdraw of consent. Primary objectives To determine the activity (as assessed by objective response rate) and safety of Pembrolizumab plus Lenvatinib in vulvar cancer patients for each study cohorts. Outcome Measures * Objective response rate (ORR) defined as a complete response (CR) or partial response (PR) by the Investigator using Response Evaluation Criteria in Solid Tumors (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) * To evaluate the safety of 4 cycles of Pembrolizumab and Lenvatinib in vulvar cancer patients according to CTCAE (version 5.0) and PRO-CTCAE questionnaire in the overall study population (all the three cohorts together).

Conditions

• Vulva Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab 200 mg IV infusion (30 minute) is administered at Day 1 of each 21-days cycle.Pembrolizumab will be administered up to 35 cycles.
DRUG	Lenvatinib Capsules	.Lenvatinib 20 mg (two 10-mg capsules) QD will be taken orally with water (with or without food) in 21-day cycles at approximately the same time each day. On Day 1 of each Pembrolizumab cycle, Lenvatinib will be administered within 1 hour after Pembrolizumab.

Timeline

• Start date: 2026-03-12
• Primary completion: 2031-10-01
• Completion: 2031-10-01
• First posted: 2025-12-18
• Last updated: 2026-04-02

Locations

1 site across 1 country: Italy