Actively Recruiting
Pembrolizumab Combination With Lenvatinib in Pts With Recurrent,Persistent,Metastatic or Locally Advanced Vulvar Cancer Not Amenable to Curative Surgery or Radiotherapy
Led by AGO Research GmbH · Updated on 2026-05-11
42
Participants Needed
15
Research Sites
227 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluation of efficacy and safety of pembrolizumab in combination with lenvatinib in patients with recurrent, persistent, metastatic or locally advanced vulva cancer.
CONDITIONS
Official Title
Pembrolizumab Combination With Lenvatinib in Pts With Recurrent,Persistent,Metastatic or Locally Advanced Vulvar Cancer Not Amenable to Curative Surgery or Radiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before any study procedures or treatment
- Female patients at least 18 years old at consent
- Histologically confirmed locally advanced, recurrent, persistent, or metastatic vulvar squamous cell carcinoma not suitable for salvage surgery or definitive chemoradiation
- Up to 2 prior chemotherapy lines for recurrent or metastatic disease
- Measurable disease by RECIST 1.1 criteria
- ECOG performance status of 0 or 1 evaluated within 7 days before first study dose
- Not pregnant, not breastfeeding, and either not a woman of childbearing potential or agrees to contraception and pregnancy testing during and for 4 months after treatment
- Available archival or new tumor tissue sample, preferably formalin-fixed paraffin embedded blocks
- Adequate organ function as defined in protocol with specimens collected within 10 days before treatment start
You will not qualify if you...
- Non-squamous cell histology
- Allergy or hypersensitivity to pembrolizumab or lenvatinib or their components
- Pre-existing grade 3 or higher gastrointestinal or non-gastrointestinal fistula
- Radiographic evidence of major blood vessel infiltration
- Bradyarrhythmia or significant cardiovascular impairment including congestive heart failure NYHA class greater than II, unstable angina, recent myocardial infarction or stroke within 12 months, or arrhythmia requiring treatment
- History of major thrombotic or hemorrhagic disorders within 6 months
- Allogenic tissue or solid organ transplant
- Immunodeficiency diagnosis
- Active autoimmune disease needing systemic treatment in past 2 years (except replacement therapy)
- History of second malignancy unless cured and no evidence for 2 years (exceptions apply)
- Gastrointestinal conditions affecting lenvatinib absorption
- Active central nervous system metastases or carcinomatous meningitis unless stable and off steroids
- History or current pneumonitis/interstitial lung disease requiring steroids
- Major active infection requiring therapy
- Recent hemoptysis or tumor bleeding
- Known HIV, active Hepatitis B or C, or active tuberculosis
- Psychiatric or substance abuse disorders interfering with trial participation
- Any condition or therapy that could affect study results or participant safety
- Pregnancy or breastfeeding
- Prior therapy with anti-PD-1, PD-L1, PD-L2 or similar immune checkpoint agents
- Systemic corticosteroids or immunosuppressive drugs within 7 days before treatment
- Use of antiarrhythmic drugs of classes Ia and III or other QT prolongation drugs
- Recent anti-cancer therapy within 4 weeks or recent radiotherapy within 2 weeks
- Not recovered from toxicities or complications from prior treatments or surgery
- Live attenuated vaccine within 30 days before first dose
- Uncontrolled blood pressure despite medication
- Recent changes in antihypertensive medication
- QTc interval above 480 ms
- Reduced left ventricular ejection fraction below normal institutional range
- Electrolyte abnormalities not corrected
- Significant proteinuria unless quantified below 1 g/24 hours
- Prior enrollment in pembrolizumab and lenvatinib clinical study
- Participation in other investigational studies or devices within 4 weeks before treatment start
AI-Screening
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Trial Site Locations
Total: 15 locations
1
Universitätsklinikum Augsburg
Augsburg, Germany
Actively Recruiting
2
Hochtaunus-Kliniken Bad Homburg
Bad Homburg, Germany
Actively Recruiting
3
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany
Actively Recruiting
4
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Actively Recruiting
5
KEM Kliniken Essen-Mitte
Essen, Germany
Actively Recruiting
6
Universitätsklinikum Essen
Essen, Germany
Actively Recruiting
7
Universitätsmedizin Göttingen
Göttingen, Germany
Actively Recruiting
8
University Hospital Hamburg
Hamburg, Germany
Actively Recruiting
9
Klinikum Hanau GmbH
Hanau, Germany
Actively Recruiting
10
ZAGO - Zentrum für ambulante gynäkologische Onkologie
Krefeld, Germany
Not Yet Recruiting
11
Universitätsmedizin Mainz
Mainz, Germany
Actively Recruiting
12
Universitätsklinikum Mannheim
Manheim, Germany
Actively Recruiting
13
Klinikum der Universität München, LMU
München, Germany
Actively Recruiting
14
Universitätsklinikum Münster
Münster, Germany
Actively Recruiting
15
University Hospital
Tübingen, Germany
Actively Recruiting
Research Team
Y
Yvonne Treffner, Dr.
CONTACT
O
Office -Essen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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