Tisotumab Vedotin in Squamous Cell Carcinoma of the Vulva (NCT07672782) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Tisotumab Vedotin in Squamous Cell Carcinoma of the Vulva
United States28 participantsStarted 2026-11
Plain-language summary
This is an open-label, single arm, phase 2 study designed to evaluate the efficacy of tisotumab vedotin in participants with recurrent or metastatic squamous cell carcinoma of the vulva by estimating the objective response rate.
Patients will receive tisotumab vedotin every 3 weeks (21 days plus or minus 3 days). Treatment will continue until either unacceptable toxicity, progression of disease, or investigator/patient request for withdrawal.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Has not received more than 2 prior systemic therapy regimens for recurrent and/or metastatic vulva cancer. Chemotherapy administered in the adjuvant or neoadjuvant setting, or in combination with radiation therapy, should not be counted as separate systemic therapy regimen.
. Is not a candidate for curative therapy, including but not limited to radiotherapy or exenterative surgery.
. A minimum of one non-nodal lesion ≥10 mm in the longest diameter from a nonirradiated area. If target lesion(s) are located within previously irradiated area only, the participant can be enrolled only if there has been demonstrated progression in the "in field" lesion and upon approval of the sponsor's medical monitor.
. Lymph node lesion ≥15 mm in the shortest diameter from a non-irradiated area.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Response Rate
Timeframe: 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.