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Tisotumab Vedotin in Squamous Cell Carcinoma of the Vulva

NCT07672782 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-06-29

No results posted yet for this study

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.

Conditions

  • Vulvar Carcinoma
  • Recurrent or Metastatic Vulvar Cancer
  • Squamous Cell Carcinoma Vulva

Interventions

DRUG

Tisotumab 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.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • GOG Foundation

    lead NETWORK

Principal Investigators

  • Yovanni Casablanca, MD · Atrium Levine Cancer - Carolinas Medical Center

  • Brian Slomovitz, MD · GOG Foundation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-30
Primary Completion
2029-03-31
Completion
2029-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07672782 on ClinicalTrials.gov