Trials / Recruiting
RecruitingNCT05903833
Pembrolizumab Combination With Lenvatinib in Pts With Recurrent,Persistent,Metastatic or Locally Advanced Vulvar Cancer Not Amenable to Curative Surgery or Radiotherapy
Pembrolizumab in Combination With Lenvatinib in Pts With Recurrent, Persistent, Metastatic or Locally Advanced Vulvar Cancer Not Amenable to Curative Surgery or Radiotherapy
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- Sponsor
- AGO Research GmbH · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Evaluation of efficacy and safety of pembrolizumab in combination with lenvatinib in patients with recurrent, persistent, metastatic or locally advanced vulva cancer.
Detailed description
A multicenter, single-arm phase II, open-label study, to evaluate the efficacy and safety of pembrolizumab 400 mg Q6W in combination with lenvatinib 20 mg QD in patients with recurrent, persistent, metastatic or locally advanced VSCC not amenable to salvage surgery or definitive (chemo)radiation.
Conditions
- Recurrent Vulvar Cancer
- Persistent Vulvar Cancer
- Metastatic Vulva Cancer
- Locally Advanced Vulvar Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pembrolizumab | 400 mg Q6W |
| DRUG | Lenvatinib | 20 mg QD |
Timeline
- Start date
- 2025-06-24
- Primary completion
- 2027-10-30
- Completion
- 2029-10-30
- First posted
- 2023-06-15
- Last updated
- 2025-09-09
Locations
15 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT05903833. Inclusion in this directory is not an endorsement.