Tisotumab Vedotin in Squamous Cell Carcinoma of the Vulva
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorGOG Foundation
About this trial
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.
Eligibility criteria
Qualifiers
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 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.
Disqualifiers
Has primary melanoma, adenocarcinoma, sarcomatoid, or other histologies not mentioned in inclusion criterion 3
Known past or current coagulation defects leading to an increased risk of bleeding
Diffuse alveolar hemorrhage from vasculitis
Known bleeding diathesis
Trial design
Treatments tested in this trial
- Tisotumab Vedotin
Treatment groups
28 Participants
are divided into 1 treatment groupSponsors and collaborators
GOG Foundation
Lead sponsor
Pfizer
Collaborator
Source ClinicalTrials.gov