Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT07290894
Brief 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).
Study:
NCT07290894
Study Brief:
Protocol Section:
NCT07290894