RecruitingRecurrent Vulvar CancerPersistent Vulvar CancerMetastatic Vulva Cancer
Pembrolizumab Combination With Lenvatinib in Pts With Recurrent,Persistent,Metastatic or Locally Advanced Vulvar Cancer Not Amenable to Curative Surgery or Radiotherapy
Eligible age
18+ yrs
Accepts
Women
Locations
0 states
Healthy volunteers
No
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About this study
Evaluation of efficacy and safety of pembrolizumab in combination with lenvatinib in patients with recurrent, persistent, metastatic or locally advanced vulva cancer.
Sponsor: AGO Research GmbH
You may qualify if…
- ✓ 1. 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.
- ✓ 2. Female patients who are at least 18 years of age on the day signing informed consent
- ✓ 3. 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)
- ✓ 4. ≤2 previous lines of chemotherapy for recurrent or metastatic disease
- ✓ 5. 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.
- ✓ 6. 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.
- ✓ 7. 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:
- ✓ 1. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR
You may not qualify if…
- ✕ 1. Non squamous cell histology
- ✕ 2. Contraindications regarding treatment with pembrolizumab:
- ✕ allergy or hypersensitivity to pembrolizumab or one of the components.
- ✕ 3. Contraindications regarding treatment with lenvatinib: allergy or hypersensitivity to lenvatinib or one of the components or:
- ✕ 1. Pre-existing ≥Grade 3 gastrointestinal or nongastrointestinal fistula
- ✕ 2. Radiographic evidence of major blood vessel infiltration
- ✕ 4. Bradyarrhythmia
- ✕ 5. Arterial dissection/aneurysm
Source: ClinicalTrials.gov · NCT05903833 · last updated 2026-05-11