Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT07290894

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

Led by National Cancer Institute, Naples · Updated on 2026-04-02

80

Participants Needed

1

Research Sites

289 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent before any study procedure
  • Female, age 18 years or older at consent
  • Histologically or cytologically confirmed unresectable squamous cell carcinoma, adenocarcinoma, or mixed histology of vulva, meeting criteria for Cohort A, B, or C
  • At least one measurable tumor lesion by RECIST 1.1
  • Life expectancy of at least 16 weeks
  • ECOG performance status 0 or 1
  • Blood pressure controlled at or below 140/90 mmHg at screening, stable antihypertensive medications within 1 week before treatment
  • Provide formalin fixed paraffin embedded tumor samples collected before systemic treatment for quality control
  • Ability to swallow oral medications
  • Normal organ and bone marrow function as defined by specific laboratory values
  • INR or PT aPTT/PTT at or below 1.5 times upper normal limit unless on anticoagulants within therapeutic range
  • Not pregnant or breastfeeding and either not a woman of childbearing potential or using highly effective contraception or abstinent during treatment and specified post-treatment periods
  • Negative pregnancy test within 24 hours before first treatment dose if woman of childbearing potential
  • Willing and able to comply with scheduled visits, treatments, labs, and procedures
Not Eligible

You will not qualify if you...

  • Diagnosis of vulvar melanomas, sarcomas, Paget's disease, or basal cell carcinoma
  • Early-stage vulvar cancer treatable by upfront curative surgery
  • Prior systemic anticancer therapy for vulvar cancer, anti-VEGF therapy, or investigational agents as specified for cohorts
  • Received live vaccines within 30 days before treatment
  • Preexisting grade 3 or higher gastrointestinal or non-gastrointestinal fistula
  • Active infections requiring systemic treatment
  • Known HIV positive status
  • Active hepatitis B or C infection as defined
  • Immunodeficiency or recent systemic steroid/immunosuppressive therapy
  • Active autoimmune disease requiring recent systemic treatment
  • Inability to swallow oral medication
  • Recent chemotherapy or radiotherapy within 3 weeks prior to study treatment (except palliative)
  • Major surgery within 3 weeks before treatment without recovery
  • Breastfeeding women
  • Active or untreated brain metastases except stable treated cases under conditions
  • Other malignancies except certain treated cancers with no disease for 5 or more years
  • Prolonged QTcF interval or low left ventricular ejection fraction
  • Participation in another investigational study within 3 months
  • Unresolved toxicity or complications from prior treatments or surgeries
  • Significant cardiovascular impairment as defined
  • Bleeding or clotting disorders or tumor invasion into major blood vessels
  • Recent arterial thromboembolism within 12 months
  • Active hemoptysis within 3 weeks prior to treatment
  • Proteinuria over 1 g/24 hours
  • Conditions affecting absorption of Lenvatinib
  • History of organ transplant
  • History or current pneumonitis or interstitial lung disease needing steroids
  • Psychiatric or substance abuse conditions interfering with study participation
  • Prior therapy with PD-1, PD-L1, PD-L2 inhibitors or other immune checkpoint agents

AI-Screening

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Trial Site Locations

Total: 1 location

1

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

Naples, Italy, 80131

Actively Recruiting

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Research Team

C

Clorinda Schettino, MD

CONTACT

S

Sandro Pignata, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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