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

NCT07290894 | Recruiting Phase 2

• 2 other identifiers: MITO VULVA-01 2023-50918024002023-509180-24-00
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Vulva Cancer

Keywords

vulvar cancer; pambrolizumab; lenvatinib; Phase II trial

Outcome Measures

Primary Outcomes (2)

• Objective Tumor Response Rate (ORR)

  Objective Tumor Response Rate (ORR) as defined by recist1.1 calculated as the proportion of patients achieving complete or partial response relative to total patients enrolled

  every 12 weeks from enrollment until disease progression (up to 72 months)

• Toxicity in the overall study population (all the three cohorts together).

  Toxicity rate is defined as the proportion of patients experiencing any grade AE accordingly to the NCI Common Terminology Criteria of Adverse Events (NCI CTC-AE) Version 5, relative to the total of patients receiving at least one cycle of treatment Toxicity will be evaluated also using Patient Reported Outcome Common Terminology Criteria of Adverse Events ( PRO-CTCAE) questionnaire.

  At baseline during screening period (within 7 days prior to Cycle 1 Day 1), at day 1 of the first 4 cycles for patients in all cohorts. Cycle is defined as 21 days

Secondary Outcomes (3)

• Progression free survival (PFS)

  until progression of disease (up to 72 months)

• Overall Survival (OS)

  up to 72 months

• Toxicity

  At the end of Cycle 5 day 1 ( each cycle is 21 days), until progression disease. (Up to 72 months)

Study Arms (1)

Pembrolizumab+lenvatinib

EXPERIMENTAL

Pembrolizumab 200 mg + Lenvatinib 20 mg. Pembrolizumab will be administered up to 35 Cycles. Lenvatinib until disease progression or unaccetable toxicity

Drug: Pembrolizumab; Drug: Lenvatinib Capsules

Interventions

Pembrolizumab DRUG

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.

Pembrolizumab+lenvatinib

Lenvatinib Capsules DRUG

.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.

Pembrolizumab+lenvatinib

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent prior to any study specific procedure;
• Female, age ≥ 18 years at time of signing informed consent;
• Patients with histologically or cytologically confirmed unresectable squamous cell carcinoma, adenocarcinoma and mixed histology (adenosquamous) of the vulva, defined as:
• T2 or T3 primary tumors (N0-3, M0) not amenable to surgical resection by standard radical vulvectomy (Cohort A) OR
• recurrent or de novo metastatic chemotherapy-naive vulvar squamous cell carcinoma, adenocarcinoma and mixed histology (adenosquamous) of the vulva, (Cohort B) OR
• recurrent squamous cell carcinoma of the vulva after primary chemoradiation or patients with metastatic squamous cell carcinoma, adenocarcinoma and mixed histology (adenosquamous) of the vulva in progression to a chemotherapy-based treatment (Cohort C)
• At least 1 measurable target lesion according to RECIST 1.1;
• Patients must have a life expectancy ≥ 16 weeks;
• ECOG performance status of 0 to 1;
• Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤140/90 mmHg at Screening and no change in antihypertensive medications within 1 week before the Cycle 1/Day 1;
• Patient must provide formalin fixed paraffin embedded (FFPE), archival tumor samples, from primary tumor surgery or biopsy of primary tumor or metastases. The samples must be collected before any systemic treatment. (chemotherapy-naïve patients). A quality control analysis of samples will be performed before patient's enrollment. Only patients with adequate tumor samples will be enrolled.
• Patient must be able to take oral medications;
• Patients must have normal organ and bone marrow function measured as defined below:
• Haemoglobin ≥ 10.0 g/dL with no blood transfusion in the past 28 days
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L

You may not qualify if:

• Patients with vulvar melanomas, sarcomas, vulvar Paget's disease, or basal cell carcinoma;
• Patients diagnosed with early-stage vulvar cancer that, according to the Investigator, can be treated with upfront curative surgery;
• Patients who have received any systemic anticancer therapy for vulvar cancer, anti-VEGF therapy, or any systemic investigational anticancer agent including radiotherapy (Cohort A and B); patients who have received any further systemic therapy for advanced disease after progression to a first-line platinum-based chemotherapy (Cohort C);
• Received a live vaccine or live attenuated within 30 days of planned start of study treatment (Cycle 1/Day 1). Note: The killed virus vaccines (ie seasonal influenza vaccines for injection are allowed);
• Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula;
• Active infection (any infection requiring systemic treatment);
• Subjects known to be positive for Human Immunodeficiency Virus (HIV);
• Patients with known active hepatitis (i.e. Hepatitis B or C)
• Active hepatitis B virus (HBV) is defined by a known positive HBV surface antigen (HBsAg) result. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HBsAg) are eligible;
• Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA;
• Subjects with a diagnosis of immunodeficiency or who are receiving systemic steroid therapy (dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medications;
• Active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment;
• Patients unable to swallow orally administered medication;
• Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment;
• Major surgery within 3 weeks of starting study treatment and patients must have recovered from any effects of major surgery;

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (1)

Nation Cancer Institute of Naples, Division of Medical Oncology - Uro-Gynecology Department, Naples

Naples, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Vulvar Neoplasms

Interventions

pembrolizumab; lenvatinib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Sandro Pignata, MD, PhD

  National Cancer Institute,IRCCS, Fondazione G. Pascale, Naples , Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clorinda Schettino, MD

CONTACT

+39 081 - 17770276; c.schettino@istitutotumori.na.it

Sandro Pignata, MD, PhD

CONTACT

39 081-17770755; s.pignata@istitutotumori.na.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: pembrolizuma plus lenvatinib

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 18, 2025
• Study Start: March 12, 2026
• Primary Completion (Estimated): October 1, 2031
• Study Completion (Estimated): October 1, 2031
• Last Updated: April 2, 2026

Record last verified: 2026-04

Locations

IT (1)