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
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 4 OR

⁃ A WOCBP who agrees to follow the contraception and pregnancy testing recommendations for investigational medicinal products (IMPs) with demonstrated or suspected human teratogenicity/ fetotoxicity in early pregnancy of the CTFG-guideline in Appendix 4 during the treatment period and for at least 4 months (corresponding to time needed to eliminate pembrolizumab) after the last dose of study treatment. In addition to the described highly effective oral/transdermal contraception methods a barrier method must be used.

• A WOCBP should not become pregnant during the treatment and for at least four months.

• Available archival tumor tissue sample and/or newly obtained core or excisional biopsy of a tumor lesion ideally not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides.

• Adequate organ function as defined in Table 3 of study protocol. Specimens must be collected within 10 days prior to the start of study treatment.

Locations
Other Locations
Germany
Universitätsklinikum Augsburg
NOT_YET_RECRUITING
Augsburg
Hochtaunus-Kliniken Bad Homburg
NOT_YET_RECRUITING
Bad Homburg
Universitätsklinikum Carl Gustav Carus Dresden
NOT_YET_RECRUITING
Dresden
Universitätsklinikum Düsseldorf
NOT_YET_RECRUITING
Düsseldorf
KEM Kliniken Essen-Mitte
RECRUITING
Essen
Universitätsklinikum Essen
RECRUITING
Essen
Universitätsmedizin Göttingen
NOT_YET_RECRUITING
Göttingen
University Hospital Hamburg
RECRUITING
Hamburg
Klinikum Hanau GmbH
RECRUITING
Hanau
ZAGO - Zentrum für ambulante gynäkologische Onkologie
NOT_YET_RECRUITING
Krefeld
Universitätsmedizin Mainz
NOT_YET_RECRUITING
Mainz
Universitätsklinikum Mannheim
NOT_YET_RECRUITING
Manheim
Klinikum der Universität München, LMU
NOT_YET_RECRUITING
München
Universitätsklinikum Münster
NOT_YET_RECRUITING
Münster
University Hospital
NOT_YET_RECRUITING
Tübingen
Contact Information
Primary
Yvonne Treffner, Dr.
ytreffner@ago-ovar.de
+49 201 959812-17
Backup
Office -Essen
office-essen@ago-ovar.de
+49 201 959812-20
Time Frame
Start Date: 2025-06-24
Estimated Completion Date: 2029-10-30
Participants
Target number of participants: 42
Treatments
Experimental: Treatment allocation
Administration of pembrolizumab 400 mg Q6W in combination with lenvatinib 20 mg QD
Related Therapeutic Areas
Sponsors
Leads: AGO Research GmbH

This content was sourced from clinicaltrials.gov

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