Tisotumab Vedotin in Squamous Cell Carcinoma of the Vulva

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
GOG Foundation
Study ID
NCT07672782
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tisotumab Vedotin — DRUG
    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.

Study Details

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.

Key Dates

Start date
Nov 30, 2026
Status verified
Jun 2026
Primary completion
Mar 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tisotumab vedotin
    Tisotumab vedotin 2.0 mg/kg IV (maximum of 200 mg for patients ≥100 kg) every 3 weeks (21 days)

Primary Outcome Measure

Overall Response Rate [ Time Frame: 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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Atrium Health Levine Cancer CenterCharlotteNorth Carolina28204
Yovanni Casablanca, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Charlotte, NC

By research site
Atrium Health Levine Cancer Center· Charlotte, NC

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