Evaluation of efficacy and safety of pembrolizumab in combination with lenvatinib in patients with recurrent, persistent, metastatic or locally advanced vulva cancer.
Signed written informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patients awareness and willingness to comply with the study requirements.
Female patients who are at least 18 years of age on the day signing informed consent
Histologically confirmed locally advanced, recurrent, persistent and/or metastatic VSCC not amenable for salvage surgery or definitive (chemo)radiation (additive palliative radiotherapy for symptom control is allowed)
≤2 previous lines of chemotherapy for recurrent or metastatic disease
Non squamous cell histology
Pre-existing ≥Grade 3 gastrointestinal or nongastrointestinal fistula
Radiographic evidence of major blood vessel infiltration
Bradyarrhythmia
AGO Research GmbH
Lead sponsor