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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Pembrolizumab
DrugPembrolizumab 200 mg IV infusion (30 minute) is administered at Day 1 of each 21-days cycle.Pembrolizumab will be administered up to 35 cycles.
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.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Pembrolizumab+lenvatinibExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
every 12 weeks from enrollment until disease progression (up to 72 months)2
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.
Time frame
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 daysSecondary outcomes
1
Progression free survival (PFS)
PFS is defined as the time elapsed from the date of randomization to the date of progression, as defined by investigators, or the date of death, whichever comes first. PFS will be evaluated in each single cohort
Time frame
until progression of disease (up to 72 months)2
Overall Survival (OS)
OS is defined as the time elapsed from randomization to death due to any cause. OS will be evaluated in each single cohort. Patients alive at end of the study will censored at the date of the last follow-up contact
Time frame
up to 72 months3
Toxicity
Description of overall safety of Pembrolizumab and Lenvatinib in patients who receive more than 4 cycles of treatment 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 Toxicity will be evaluated also using Patient Reported Outcome Common Terminology Criteria of Adverse Events ( PRO-CTCAE) questionnaire.
Time frame
At the end of Cycle 5 day 1 ( each cycle is 21 days), until progression disease. (Up to 72 months)Sponsors and contacts
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Source ClinicalTrials.gov