Tisotumab Vedotin in Squamous Cell Carcinoma of the Vulva

NCT07672782 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: GOG-3150
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Metastatic; Recurrent; Squamous Cell Carcinoma; Vulva; Advanced; Vulvar Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Complete or partial objective tumor response as measured by CT scan, PET-CT or MRI and assessed by RECIST v. 1.1 criteria

  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.

Secondary Outcomes (3)

• Nature and Degree of Adverse Events (Safety and Toxicity)

  Measured from the time of the first dose of study treatment until 30 days after the last dose of study treatment.

• Progression Free Survival

  Measured from study enrollment then every 9 weeks for the first 36 weeks and then every 12 weeks thereafter until time of documented disease progression or death, whichever occurs first assessed up to 5 years or study closure.

• Overall Survival

  Measured from study enrollment to time of death or the date of last contact assessed up to 5 years or study closure.

Study Arms (1)

Tisotumab vedotin

EXPERIMENTAL

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

Drug: Tisotumab Vedotin

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.

Also known as: Tisotumab vedotin-tftv, Tivdak

Tisotumab vedotin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.
• Measurable disease according to RECIST v1.1 as assessed by the investigator, defined as:
• 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.
• Must demonstrate acceptable screening laboratory values:
• Calculated eGFR (MDRD formula): ≥50 mL/min/1.73m\^2
• Alanine aminotransferase (ALT): ≤3× upper limit of normal (ULN) (if liver tumor/metastases are present, then ≤5×ULN is allowed)
• Aspartate aminotransferase (AST): ≤3×ULN (if liver tumor/metastases are present, then ≤5×ULN is allowed)
• Bilirubin: ≤1.5×ULN (except in participants diagnosed with Gilbert's syndrome, direct bilirubin ≤2×ULN)
• Hemoglobin: ≥5.6 mmol/L (9.0 g/dL)
• Absolute Neutrophil Count (ANC): ≥1500/μL (1.5x10\^9/L)

You may not qualify if:

• Has clinically significant bleeding issues or risks:
• Known past or current coagulation defects leading to an increased risk of bleeding
• Diffuse alveolar hemorrhage from vasculitis
• Known bleeding diathesis
• Ongoing major bleeding (ie, participant requires a transfusion of \>2 platelet concentrates within 14 days of the first dose of study treatment)
• Trauma with increased risk of life-threatening bleeding
• History of severe head trauma or intracranial surgery within 8 weeks of study entry
• Has cardiovascular issues or risks:
• Clinically significant cardiac disease, including unstable angina or acute myocardial infarction, 6 months prior to screening
• Any medical history of congestive heart failure (grade III or IV as classified by the New York Heart Association)
• Any medical history of decreased cardiac ejection fraction of \<45%
• A marked baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTc interval \>450 msec)
• A complete left bundle branch block (defined as a QRS interval ≥120 msec in left bundle branch block form) or an incomplete left bundle branch block
• Central nervous system (CNS): any history of intracerebral arteriovenous malformation, cerebral aneurysm, or stroke (transient ischemic attack \>28 days prior to screening is allowed).
• Brain metastases are allowed if the following criteria are met: definitive therapy (eg, surgery or stereotactic brain radiotherapy) has been completed \>8 weeks before the first dose of study treatment; no evidence of clinical or radiologic progression of the brain metastases; participant has completed perioperative corticosteroid therapy or steroid taper. NOTE: Chronic steroid therapy is acceptable provided that the dose is stable for 28 days prior to study enrollment.

Sponsors & Collaborators

• GOG Foundation: lead
• Pfizer: collaborator

Study Sites (1)

Atrium Health Levine Cancer Center

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Vulvar Neoplasms; Recurrence; Neoplasm Metastasis; Carcinoma, Squamous Cell

Interventions

tisotumab vedotin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Study Officials

• Yovanni Casablanca, MD

  Atrium Levine Cancer - Carolinas Medical Center

  STUDY CHAIR

• Brian Slomovitz, MD

  GOG Foundation

  STUDY CHAIR

Central Study Contacts

Sarin Chhab

CONTACT

215-854-0770; schhab@gog.org

Shanon Matkin

CONTACT

smatkin@gog.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 29, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: June 29, 2026

Record last verified: 2026-06

Locations

US (1)