Tisotumab Vedotin for Vulvar Squamous Cell Carcinoma
This study is testing a drug called Tisotumab Vedotin for women with vulvar squamous cell carcinoma (a type of skin cancer in the vulva) that has come back or spread. Tisotumab Vedotin is an antibody-drug conjugate (ADC), which means it's a targeted treatment. The study aims to see how many patients respond to the treatment. You may be able to join if you are an adult woman with this type of cancer. Treatment will continue as long as it is helping and well-tolerated. The study plans to enroll 28 participants.
- Study design
- This is an open-label, single-arm, Phase 2 study, meaning all participants will receive Tisotumab Vedotin, and everyone involved will know what treatment is being given. It plans to enroll 28 participants.
- What's involved
- You will receive Tisotumab Vedotin intravenously (through a vein) every 3 weeks. Treatment will continue until the disease worsens, side effects are too severe, or you or your doctor decide to stop.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your response to treatment will be assessed every 9 weeks for the first 36 weeks, then every 12 weeks after that, for up to 5 years or until the study closes.
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NCT07672782
Tisotumab Vedotin in Squamous Cell Carcinoma of the Vulva
Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatmentGOG FoundationGovernment-funded
~28 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:Tisotumab Vedotin
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Response Rate
Measured over Measured from study enrollment then every 9 weeks for the first 36 weeks and then every 12 weeks thereafter through disease progression or completion of treatment assessed up to 5 years or study closure.
Conditions
Where it's being run
1 sites across 1 statesNorth Carolina1
Study leadership
- Yovanni Casablanca, MD · STUDY_CHAIR · Atrium Levine Cancer - Carolinas Medical Center
- Brian Slomovitz, MD · STUDY_CHAIR · GOG Foundation
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Age ≥18 years, or considered an adult by local regulations, at time of consent.
Must sign an informed consent form (ICF) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study prior to any other study-related assessments or procedures.
Has recurrent or metastatic vulva cancer with squamous cell histology, and:
Measurable disease according to RECIST v1.1 as assessed by the investigator, defined as:
Must demonstrate acceptable screening laboratory values:
Has ECOG performance status of 0 or 1 within 28 days prior to registration.
Has a negative serum pregnancy test for participants of reproductive potential. Participants that are postmenopausal, permanently sterilized or previously subjected to bilateral oophorectomy, bilateral salpingectomy and/or hysterectomy can be considered as not having reproductive potential.
Participants of reproductive potential must agree to use adequate contraception during and for 6 months after the last study treatment administration. Adequate contraception is defined as highly effective methods of contraception. Two highly effective methods of contraception must be used in countries where this is required.
Must agree not to breastfeed or donate ova, starting at the time of informed consent and continuing through 6 months after receiving the last dose of study drug administration.
If required by local health authorities, has negative serology for hepatitis B surface antigen (HBsAg)/HBV DNA, or hepatitis C antibody (HCVAb) or RNA. Active hepatitis C is defined by a known positive HCVAb result and known quantitative HCV RNA results greater than the lower limits of detection of the assay.
Must be willing and able to adhere to the prohibitions and restrictions specified in the protocol.
Exclusion
Has primary melanoma, adenocarcinoma, sarcomatoid, or other histologies not mentioned in inclusion criterion 3
Has clinically significant bleeding issues or risks:
Has cardiovascular issues or risks:
Central nervous system (CNS): any history of intracerebral arteriovenous malformation, cerebral aneurysm, or stroke (transient ischemic attack \>28 days prior to screening is allowed).
Ophthalmological: Active ocular surface disease or a history of cicatricial conjunctivitis or inflammatory conditions that predispose to cicatrizing conjunctivitis (eg, Wagner syndrome, atopic keratoconjunctivitis, autoimmune disease affecting the eyes), ocular Stevens-Johnson syndrome or toxic epidermal necrolysis, mucus pemphigoid, and participants with penetrating ocular transplants are ineligible. Cataracts alone is not an exclusion criterion.
Other cancer: known past or current malignancy other than inclusion diagnosis. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%) such as non-invasive basal cell carcinoma, non-invasive superficial bladder cancer, and ductal carcinoma in situ.
Brain metastases are allowed if the following criteria are met: definitive therapy (eg, surgery or stereotactic brain radiotherapy) has been completed \>8 weeks before the first dose of study treatment; no evidence of clinical or radiologic progression of the brain metastases; participant has completed perioperative corticosteroid therapy or steroid taper. NOTE: Chronic steroid therapy is acceptable provided that the dose is stable for 28 days prior to study enrollment.
Surgery/procedures: major surgery within 4 weeks (28 days) or minor surgery within 7 days prior to the first study treatment administration. Participants must have recovered adequately from the toxicity or complications from the intervention prior to starting study treatment. Participants who have planned major surgery during the treatment period must be excluded from the study.
Peripheral neuropathy ≥grade 2.
Prior anti-cancer therapy:
Other:
Has known seropositivity of human immunodeficiency virus (HIV); known medical history of hepatitis B or C infection. Note: No testing for HIV, hepatitis B, or hepatitis C is required, unless mandated by local health authorities. Exceptions include latent or controlled HIV infection.
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (dose exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of tisotumab vedotin.
Is pregnant or intends to conceive children within 6 months of ending study treatment.
Is breast feeding and cannot discontinue breast feeding for the duration of the study and ≥6 months after the last study treatment administration.
Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments.
Known allergies, hypersensitivity, or intolerance to study treatment or its excipients (refer to the Investigator's Brochure for further information on tisotumab vedotin).
Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study.
What this trial measures
- Overall Response RateMeasured from study enrollment then every 9 weeks for the first 36 weeks and then every 12 weeks thereafter through disease progression or completion of treatment assessed up to 5 years or study closure.
Complete or partial objective tumor response as measured by CT scan, PET-CT or MRI and assessed by RECIST v. 1.1 criteria