NCT05903833

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
42mo left

Started Jun 2025

Typical duration for phase_2

Geographic Reach
1 country

15 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Jun 2025Oct 2029

First Submitted

Initial submission to the registry

May 11, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
2 years until next milestone

Study Start

First participant enrolled

June 24, 2025

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2029

Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

2.4 years

First QC Date

May 11, 2023

Last Update Submit

September 8, 2025

Conditions

Recurrent Vulvar CancerPersistent Vulvar CancerMetastatic Vulva CancerLocally Advanced Vulvar Cancer

Keywords

Advanced vulvar cancerRecurrent vulvar cancerPersistent vulvar canserMetastatic vulvar cancerLocally advanced vulvar cancerPembrolizumabLenvatinib

Outcome Measures

Primary Outcomes (1)

  • ORR within 24 weeks

    ORR will be defined as the proportion of patients with PR or CR within 24 weeks starting with the first study treatment. Tumor responses will be assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

    24 weeks

Secondary Outcomes (10)

  • Evaluate the efficacy of lenvatinib + pembrolizumab in terms of overall ORR

    From date of starting study treatment until the date of first documented progression or date of death from any cause, whichever occurs earlier, assessed up to 40 months

  • Evaluate the efficacy of lenvatinib + pembrolizumab in terms of disease control rate (DCR)

    For 8 weeks

  • Evaluate the efficacy of lenvatinib + pembrolizumab in terms of duration of response (DOR)

    Time from response until first progression or death, whichever occurs first, assessed up to 40 months

  • Evaluate the efficacy of lenvatinib + pembrolizumab in terms of overall survival (OS)

    Time from date of starting study treatment to death, assessed up to 40 months

  • Evaluate the efficacy of lenvatinib + pembrolizumab in terms of progression free survival (PFS)

    Time from starting study treatment to progressive disease or death, whichever occurs first, assessed up to 40 months

  • +5 more secondary outcomes

Study Arms (1)

Treatment allocation

EXPERIMENTAL

Administration of pembrolizumab 400 mg Q6W in combination with lenvatinib 20 mg QD

Drug: PembrolizumabDrug: Lenvatinib

Interventions

PembrolizumabDRUG

400 mg Q6W

Treatment allocation
LenvatinibDRUG

20 mg QD

Treatment allocation

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Non squamous cell histology
  • Contraindications regarding treatment with pembrolizumab:
  • allergy or hypersensitivity to pembrolizumab or one of the components.
  • Contraindications regarding treatment with lenvatinib: allergy or hypersensitivity to lenvatinib or one of the components or:
  • Pre-existing ≥Grade 3 gastrointestinal or nongastrointestinal fistula
  • Radiographic evidence of major blood vessel infiltration
  • Bradyarrhythmia
  • Arterial dissection/aneurysm
  • Long QT Syndrome
  • Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 12 months of the first dose of study drug, or cardiac arrhythmia requiring medical treatment at screening.
  • History or evidence of major thrombotic (e.g. symptomatic pulmonary embolism) or hemorrhagic disorders within 6 months prior to day 1, cycle 1. The degree of tumor invasion/infiltration of major blood vessels (e.g. carotid artery) should be considered because of the potential risk of severe haemorrhage associated with tumor shrinkage/necrosis following lenvatinib therapy.
  • Allogenic tissue/solid organ transplant.
  • Diagnosis of immunodeficiency
  • Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
  • History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years (time requirement does not apply for definitively treated early endometrial cancer (FIGO IA/B), in-situ carcinomas \[e.g. breast, cervix, bladder\], or basal or squamous cell carcinoma of the skin).
  • +32 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Universitätsklinikum Augsburg

Augsburg, Germany

NOT YET RECRUITING

Hochtaunus-Kliniken Bad Homburg

Bad Homburg, Germany

NOT YET RECRUITING

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, Germany

NOT YET RECRUITING

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

NOT YET RECRUITING

KEM Kliniken Essen-Mitte

Essen, Germany

RECRUITING

Universitätsklinikum Essen

Essen, Germany

RECRUITING

Universitätsmedizin Göttingen

Göttingen, Germany

NOT YET RECRUITING

University Hospital Hamburg

Hamburg, Germany

RECRUITING

Klinikum Hanau GmbH

Hanau, Germany

RECRUITING

ZAGO - Zentrum für ambulante gynäkologische Onkologie

Krefeld, Germany

NOT YET RECRUITING

Universitätsmedizin Mainz

Mainz, Germany

NOT YET RECRUITING

Universitätsklinikum Mannheim

Manheim, Germany

NOT YET RECRUITING

Klinikum der Universität München, LMU

München, Germany

NOT YET RECRUITING

Universitätsklinikum Münster

Münster, Germany

NOT YET RECRUITING

University Hospital

Tübingen, Germany

NOT YET RECRUITING

Related Links

MeSH Terms

Conditions

Vulvar Neoplasms

Interventions

pembrolizumablenvatinib

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsVulvar DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Linn Wölber, MD PhD

    UKE Hamburg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yvonne Treffner, Dr.

CONTACT

+49 201 959812-17ytreffner@ago-ovar.de

Office -Essen

CONTACT

+49 201 959812-20office-essen@ago-ovar.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2023

First Posted

June 15, 2023

Study Start

June 24, 2025

Primary Completion (Estimated)

October 30, 2027

Study Completion (Estimated)

October 30, 2029

Last Updated

September 9, 2025

Record last verified: 2025-09

Locations

DE(15)