Pembrolizumab Plus Lenvatinib in Vulvar Cancer Patients: MITO VULVA-01
ConditionVulva Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorNational Cancer Institute, Naples
About this trial
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
Eligibility criteria
Qualifiers
Signed informed consent prior to any study specific procedure;
Female, age ≥ 18 years at time of signing informed consent;
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
Disqualifiers
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);
Trial design
Treatments tested in this trial
- Pembrolizumab
- Lenvatinib Capsules
Treatment groups
80 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov