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New treatment option for Vulva Cancer
Official title Pembrolizumab Plus Lenvatinib in Vulvar Cancer Patients: MITO VULVA-01
ClinicalTrials.gov ID: NCT07290894
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for vulva 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
- MITO VULVA-1 is a prospective, single arm, multi-cohorts, phase II trial that aims to assess the activity and the safety of Lenvatinib plus Pembrolizumab in patients with vulvar cancer. 80 patients will be overall enrolled in the study.Three cohorts are planned
- 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
- Target subject population 1. Signed informed consent prior to any study specific procedure;
- Female, age ≥ 18 years at time of signing informed consent;
- Patients with histologically or cytologically confirmed unresectable squamous cell carcinoma, adenocarcinoma and mixed histology (adenosquamous) of...
- T2 or T3 primary tumors (N0-3, M0) not amenable to surgical resection by standard radical vulvectomy (Cohort A) OR
- recurrent or de novo metastatic chemotherapy-naive vulvar squamous cell carcinoma, adenocarcinoma and mixed histology (adenosquamous) of the vulva...
You likely can't join if
- Patients with vulvar melanomas, sarcomas, vulvar Paget's disease, or basal cell carcinoma;
- Patients diagnosed with early-stage vulvar cancer that, according to the Investigator, can be treated with upfront curative surgery;
- Patients who have received any systemic anticancer therapy for vulvar cancer, anti-VEGF therapy, or any systemic investigational anticancer agent...
- Received a live vaccine or live attenuated within 30 days of planned start of study treatment (Cycle 1/Day 1). Note: The killed virus vaccines (ie...
- Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula;
- Active infection (any infection requiring systemic treatment);
See the full eligibility criteria
Who can join
- Target subject population 1. Signed informed consent prior to any study specific procedure;
- Female, age ≥ 18 years at time of signing informed consent;
- Patients with histologically or cytologically confirmed unresectable squamous cell carcinoma, adenocarcinoma and mixed histology (adenosquamous) of the vulva, defined as:
- T2 or T3 primary tumors (N0-3, M0) not amenable to surgical resection by standard radical vulvectomy (Cohort A) OR
- recurrent or de novo metastatic chemotherapy-naive vulvar squamous cell carcinoma, adenocarcinoma and mixed histology (adenosquamous) of the vulva, (Cohort B) OR
- recurrent squamous cell carcinoma of the vulva after primary chemoradiation or patients with metastatic squamous cell carcinoma, adenocarcinoma and mixed histology (adenosquamous) of the vulva in progression to a...
- At least 1 measurable target lesion according to RECIST 1.1;
- Patients must have a life expectancy ≥ 16 weeks;
- ECOG performance status of 0 to 1;
- Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤140/90 mmHg at Screening and no change in antihypertensive medications within 1 week before the Cycle 1/Day 1;
- Patient must provide formalin fixed paraffin embedded (FFPE), archival tumor samples, from primary tumor surgery or biopsy of primary tumor or metastases. The samples must be collected before any systemic treatment...
- Patient must be able to take oral medications;
- Patients must have normal organ and bone marrow function measured as defined below:
- Haemoglobin ≥ 10.0 g/dL with no blood transfusion in the past 28 days
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x institutional upper limit of normal unless liver...
- Patients must have creatinine clearance estimated of ≥51 mL/min using the Cockcroft-Gault equation or based on a 24 hour urine test: Estimated creatinine clearance = (140-age [years]) x weight (kg)(x F)a serum...
- INR or PT aPTT/PTT ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants;
- Patient is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- Is not a Women of Childbearing Potential (WOCBP) or
- Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle...
- A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention; Note: If a urine test cannot be confirmed as...
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
What rules you out
- Patients with vulvar melanomas, sarcomas, vulvar Paget's disease, or basal cell carcinoma;
- Patients diagnosed with early-stage vulvar cancer that, according to the Investigator, can be treated with upfront curative surgery;
- Patients who have received any systemic anticancer therapy for vulvar cancer, anti-VEGF therapy, or any systemic investigational anticancer agent including radiotherapy (Cohort A and B); patients who have received any...
- Received a live vaccine or live attenuated within 30 days of planned start of study treatment (Cycle 1/Day 1). Note: The killed virus vaccines (ie seasonal influenza vaccines for injection are allowed);
- Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula;
- Active infection (any infection requiring systemic treatment);
- people known to be positive for Human Immunodeficiency Virus (HIV);
- Patients with known active hepatitis (i.e. Hepatitis B or C)
- Active hepatitis B virus (HBV) is defined by a known positive HBV surface antigen (HBsAg) result. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of...
- Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA;
- people with a diagnosis of immunodeficiency or who are receiving systemic steroid therapy (dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the...
- Active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or...
- Patients unable to swallow orally administered medication;
- Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment;
- Major surgery within 3 weeks of starting study treatment and patients must have recovered from any effects of major surgery;
- Breast feeding women;
- Known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression) for at...
- Other malignancy unless curatively treated with no evidence of disease for ≥5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS)...
- Prolongation of QTcF interval to ≥480 msec;
- LVEF below of the institutional (or local laboratory), normal range, as determinated, by MUGA or ECHO;
- Participation in another clinical study with an investigational product during the last 3 months;
- people who have not recovered adequately from any toxicity from other anti- cancer treatment regimens and/or complications from major surgery prior to starting therapy. Note: Withhold lenvatinib for at least 1 week...
- Significant cardiovascular impairment including: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction, cerebro vascular accident/stroke...
- Bleeding or thrombotic disorders or people at risk for severe hemorrhage. Radiographic evidence of tumor invasion/infiltration of major blood vessels (e.g. carotid artery) or intratumoral cavitation. Note: The degree of...
- Radiographic evidence of tumor invasion/infiltration of major blood vessels (e.g. carotid artery) or intratumoral cavitation. Note: The degree of major blood vessel should be considered because of the potential risk of...
- History of arterial tromboembolism within 12 months of start the study;
- Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug;
- Urine protein ≥1 g/24 hours. Note: Participants with proteinuria ≥2+ (≥100 mg/dL) on urine dipstick testing (urinalysis) will undergo 24-hour urine collection for quantitative assessment of proteinuria;
- GI malabsorption or any other condition that might affect the absorption of Lenvatinib;
- An allogenic tissue/solid organ transplant;
- History of (noninfectious) pneumonitis/interstizial lung disease (ILD) that require steroids or current pneumonitis/ interstitial lung disease;
- Known psychiatric disorder or substance abuse that would interfere with participant ability to cooperate with the requirement of the study.
- Has received prior therapy with an anti-PD1, anti PD-L1 or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
The study team makes the final eligibility decision.
Where it's taking place
- Naples, Italy
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 Naples, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.