Phase II Study Tisotumab Vedotin in Metastatic or Recurrent Squamous Cell Carcinoma of the Vulva
GOG Foundation
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.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * 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: 1. 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 co…
Interventions
- DrugTisotumab Vedotin
Tisotumab vedotin is an antibody-drug conjugate (ADC) directed against tissue factor (TF) and is composed of an IgG1 human monoclonal antibody chemically conjugated via a protease cleavable valine citrulline linker to the drug MMAE.
Location
- Atrium Health Levine Cancer CenterCharlotte, North Carolina