Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-18 @ 1:19 PM
Study NCT ID:
NCT07290894
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pembrolizumab Plus Lenvatinib in Vulvar Cancer Patients: MITO VULVA-01
Sponsor:
National Cancer Institute, Naples
Organization:
Study Overview
Official Title:
Pembrolizumab Plus Lenvatinib in Vulvar Cancer Patients: MITO VULVA-01 Study.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MITO VULVA-01
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2023-509180-24-00 | CTIS | None | View |