Pembrolizumab Combination With Lenvatinib in Pts With Recurrent,Persistent,Metastatic or Locally … (NCT05903833) | Clinical Trial Compass
RecruitingPhase 2
Pembrolizumab Combination With Lenvatinib in Pts With Recurrent,Persistent,Metastatic or Locally Advanced Vulvar Cancer Not Amenable to Curative Surgery or Radiotherapy
Germany42 participantsStarted 2025-06-24
Plain-language summary
Evaluation of efficacy and safety of pembrolizumab in combination with lenvatinib in patients with recurrent, persistent, metastatic or locally advanced vulva cancer.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. 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
✓. Measurable disease (investigator assessed RECIST 1.1). Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
✓. Have an eastern cooperative oncology group (ECOG) performance status of 0-1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.
✓. No pregnancy (as documented by a positive beta-human chorionic gonadotropin \[ß-hCG\] or human chorionic gonadotropin \[hCG\]) test with a minimum sensitivity of 25 IU/L or equivalent units of ß-hCG \[or hCG\]), no breastfeeding, and at least one of the following conditions applies:
✓. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR
Exclusion criteria
✕. Non squamous cell histology
✕. Contraindications regarding treatment with pembrolizumab: