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A Study of Tisotumab Vedotin for Patients With Platinum-Resistant Ovarian Cancer With a Safety Run-in of a Dose-Dense Regimen (innovaTV 208)

Trial Status: Active

This trial will study tisotumab vedotin to find out what its side effects are and to see if it works for platinum-resistant ovarian cancer (PROC). It will test different doses of tisotumab vedotin that are given at different times. It will also compare the side effects and ability to treat tumors of these different doses and schedules. In this study, there will be a safety run-in group of approximately 12 patients that will look at a dose-dense treatment schedule. In a dose-dense schedule, smaller doses are given more frequently. In addition to the safety run-in patients, there will be three groups in the study. One group will get tisotumab vedotin once every 3 weeks (21-day cycles). The two other groups will get tisotumab vedotin once a week for 3 weeks followed by 1 week off (28-day cycles).

Inclusion Criteria

  • Histologic documentation of epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
  • Safety run-in only: PROC. Patients may have received more than 1 prior systemic treatment regimen in the PROC setting.
  • Part A and Part B only: Patients with PROC who have received at most 1 prior cytotoxic chemotherapy regimen in the PROC setting
  • Measurable disease according to RECIST v1.1 as assessed by the investigator
  • An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
  • Life expectancy of at least 3 months
  • Able to provide fresh or archival tissue for biomarker analysis

Exclusion Criteria

  • Primary platinum-refractory disease, defined as disease progression within 2 months of completion of first line platinum-based therapy
  • Patients with clinical symptoms or signs of gastrointestinal obstruction with the past 6 months or who currently require parenteral nutrition
  • Hematological: Known past or current coagulation defects leading to an increased risk of bleeding, diffuse alveolar hemorrhage from vasculitis, known bleeding diathesis, ongoing major bleeding, or trauma with increased risk of life-threatening bleeding within 8 weeks of trial entry
  • Cardiovascular: Clinically significant cardiac disease including uncontrolled hypertension, unstable angina, acute myocardial infarction with 6 months of screening, serious cardiac arrhythmia requiring medication, medical history of congestive heart failure, or medical history of decreased cardiac ejection fraction of <45%
  • Ophthalmological: Active ocular surface disease at baseline or prior episode of cicatricial conjunctivitis or Stevens Johnson syndrome
  • Prior treatment with MMAE-derived drugs
  • Inflammatory bowel disease including Crohn's disease and ulcerative colitis
  • Ongoing, acute, or chronic inflammatory skin disease
  • Uncontrolled tumor-related pain
  • Inflammatory lung disease requiring chronic medical therapy
  • Grade 3 or higher pulmonary disease unrelated to underlying malignancy
  • Uncontrolled pleural or pericardial effusions
  • Grade >1 peripheral neuropathy
  • Patients who are pregnant or breastfeeding

California

San Francisco
UCSF Medical Center-Mount Zion
Status: IN_REVIEW
Contact: UCSF Clinical Trials
Phone: 877-827-3222
San Jose
Stanford Cancer Center South Bay
Status: ACTIVE

Florida

Tampa
Moffitt Cancer Center
Status: ACTIVE
Contact: Thomas Stone
Phone: 813-745-3987

Kansas

Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Contact: Tina M Livingood
Phone: 913-574-0015

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: ACTIVE

New Jersey

Hackensack
Hackensack University Medical Center
Status: ACTIVE

New York

New York
Icahn School of Medicine at Mount Sinai
Status: ACTIVE
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE

North Carolina

Durham
Duke University Medical Center
Status: ACTIVE

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: ACTIVE
Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE

South Carolina

Charleston
Medical University of South Carolina
Status: IN_REVIEW

Virginia

Charlottesville
University of Virginia Cancer Center
Status: ACTIVE

The study objectives are to evaluate the safety, antitumor activity, and pharmacokinetics of tisotumab vedotin (TV) administered every 3 weeks or on Days 1, 8, and 15 of every 4-week cycle (dose-dense regimen; 3Q4W) for patients with epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that has relapsed within 6 months of the completion of platinum-based treatment and determined to be platinum resistant. All patients must have PROC and be eligible for single agent chemotherapy. The safety run-in period will evaluate the safety of a weekly schedule. The highest dose level that is considered safe will be the recommended phase 2 dose (RP2D) and will be used in Part A. In Part A, participants will be randomized in a 1:1 ratio to receive tisotumab vedotin intravenously (IV) every 3 weeks (Q3W regimen) or the safety run-in RP2D on Days 1, 8, and 15 of every 4-week cycle (weekly regimen; 3Q4W) if a RP2D has been identified. Participants who enroll in Part B will receive tisotumab vedotin on Days 1, 8, and 15 of every 4-week cycle (weekly regimen) at a pre-specified dose level, if the dose level is considered safe and tolerable in the safety run-in period.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Seattle Genetics

  • Primary ID SGNTV-002
  • Secondary IDs NCI-2018-02323
  • Clinicaltrials.gov ID NCT03657043