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New treatment option for Recurrent Vulvar Cancer
Official title Pembrolizumab Combination With Lenvatinib in Pts With Recurrent,Persistent,Metastatic or Locally Advanced Vulvar Cancer Not Amenable to Curative Surgery or Radiotherapy
ClinicalTrials.gov ID: NCT05903833
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, being studied as a potential treatment for recurrent vulvar cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Evaluation of efficacy and safety of pembrolizumab in combination with lenvatinib in patients with recurrent, persistent, metastatic or locally advanced vulva cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Signed written informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patients awareness...
- 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...
- ≤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...
You likely can't join 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
See the full eligibility criteria
Who can join
- 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...
- Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 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...
- 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.
What rules you out
- 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...
- 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...
- 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...
- 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...
- Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib.
- Active CNS metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks...
- History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Major active infection requiring systematic therapy.
- Has active hemoptysis within 3 weeks prior to the first dose of study intervention or tumor bleeding within 2 weeks prior randomization.
- Known history of Human Immunodeficiency Virus (HIV) infection
- History of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.
- Known history of active TB (Bacillus tuberculosis).
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in...
- Pregnancy
- Breastfeeding Prior/ Concomitant Therapy
- Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
- Systemic use of corticosteroids or immunosuppressive drugs within 7 days prior start of study treatment (see EC 11.)
- Systemic corticosteroids (at dose higher than 10 mg/day equivalent prednisone); if systemic corticoid use, corticoid must be stopped at least 7 days before study treatment start
- Interferons
- Interleukins
- Live vaccine Note: Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, BCG, and typhoid vaccine. Seasonal influenza vaccines for...
- Antiarrhythmics of classes Ia and III and other QT-interval prolongation drugs
- Prior systemic anti-cancer therapy including investigational agents within 4 weeks [could consider shorter interval for kinase inhibitors or other short half-life drugs] prior to allocation.
- Prior radiotherapy within 2 weeks of start of study intervention. Patients must have recovered from radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is...
- Not recovered adequately from any toxicity from other anticancer treatment regimens and/or complications from major surgery prior to starting therapy. Note: Withhold lenvatinib for at least 1 week prior to elective...
- Administration of a live, attenuated vaccine within 30 days prior first dose of study drug. Diagnostic Assessments
- Uncontrolled blood pressure (Systolic BP \>140 mmHg or diastolic BP \>90 mmHg) in spite of an optimized regimen of antihypertensive medication.
- Change of anti-HTN (hypertension) medical regimen within 1 week prior to randomization
- Prolongation of corrected QT interval (QTc interval) \>480 ms
- Left ventricular ejection fraction (LVEF) below the institutional normal range as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).
- Electrolyte abnormalities that have not been corrected.
- people having \>1+ proteinuria on urine dipstick testing unless a 24-hour urine collection for quantitative assessment indicates that the urine protein is \<1 g/24 hours. Prior/Concurrent Study Experience
- Prior enrolment on a clinical study evaluating pembrolizumab and lenvatinib for a carcinoma, regardless of treatment received.
- Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention. Note: Patients who have entered...
The study team makes the final eligibility decision.
Where it's taking place
- Augsburg, Germany
- Bad Homburg, Germany
- Dresden, Germany
- Düsseldorf, Germany
- Essen, Germany
- Göttingen, Germany
- Hamburg, Germany
- Hanau, Germany
- Krefeld, Germany
- Mainz, Germany
- Manheim, Germany
- München, Germany
- Münster, Germany
- Tübingen, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Augsburg, Germany; Bad Homburg, Germany; Dresden, Germany; Düsseldorf, Germany; Essen, Germany; Göttingen, Germany and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.