RecruitingPhase 2NCT05903833

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


Sponsor

AGO Research GmbH

Enrollment

42 participants

Start Date

Jun 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Evaluation of efficacy and safety of pembrolizumab in combination with lenvatinib in patients with recurrent, persistent, metastatic or locally advanced vulva cancer.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the combination of pembrolizumab (an immunotherapy drug) and lenvatinib (a targeted therapy) for women with advanced, recurrent, or metastatic vulvar squamous cell carcinoma — a type of cancer affecting the external female genitalia — that cannot be removed with surgery or treated with curative radiation. **You may be eligible if...** - You are a woman 18 or older - You have confirmed locally advanced, recurrent, persistent, or metastatic vulvar squamous cell carcinoma - Surgery or curative radiation is not an option - You have had no more than 2 prior lines of chemotherapy for recurrent or metastatic disease - You have measurable disease on imaging - Your general health is good (ECOG status 0–1) **You may NOT be eligible if...** - You have had more than 2 prior chemotherapy regimens for advanced disease - You have poorly controlled heart disease or other serious conditions - You are pregnant or breastfeeding - You have significant side effects still ongoing from previous treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

400 mg Q6W

DRUGLenvatinib

20 mg QD


Locations(15)

Universitätsklinikum Augsburg

Augsburg, Germany

Hochtaunus-Kliniken Bad Homburg

Bad Homburg, Germany

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, Germany

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

KEM Kliniken Essen-Mitte

Essen, Germany

Universitätsklinikum Essen

Essen, Germany

Universitätsmedizin Göttingen

Göttingen, Germany

University Hospital Hamburg

Hamburg, Germany

Klinikum Hanau GmbH

Hanau, Germany

ZAGO - Zentrum für ambulante gynäkologische Onkologie

Krefeld, Germany

Universitätsmedizin Mainz

Mainz, Germany

Universitätsklinikum Mannheim

Manheim, Germany

Klinikum der Universität München, LMU

München, Germany

Universitätsklinikum Münster

Münster, Germany

University Hospital

Tübingen, Germany

View Full Details on ClinicalTrials.gov

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NCT05903833


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