Spots Global Cancer Trial Database for A Study of Weekly Tisotumab Vedotin for Patients With Platinum-Resistant Ovarian Cancer With Safety Run-in (innovaTV 208)
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Trial Identification
Brief Title: A Study of Weekly Tisotumab Vedotin for Patients With Platinum-Resistant Ovarian Cancer With Safety Run-in (innovaTV 208)
Official Title: Open Label Phase 2 Study of Tisotumab Vedotin for Patients With Platinum-Resistant Ovarian Cancer With a Safety Run-in of a Dose-Dense Regimen
Study ID: NCT03657043
Interventions
Study Description
Brief Summary: 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).
Detailed Description: 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 (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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Stanford Cancer Center South Bay, San Jose, California, United States
Poudre Valley Health System (PVHS), Fort Collins, Colorado, United States
Miami Cancer Institute at Baptist Health, Inc., Miami, Florida, United States
Miami Cancer Institute- Plantation (MCIP), Miami, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Augusta University, Augusta, Georgia, United States
University of Kansas Cancer Center, Westwood, Kansas, United States
Karmanos Cancer Institute / Wayne State University, Detroit, Michigan, United States
University of Missouri Healthcare / Ellis Fischel Cancer Center, Columbia, Missouri, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Mount Sinai Chelsea, New York, New York, United States
Mount Sinai Medical Center, New York, New York, United States
Columbia University Medical Center, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Cleveland Clinic Fairview Hospital, Cleveland, Ohio, United States
Cleveland Clinic, The, Cleveland, Ohio, United States
Ohio State University Clinical Trials Management Office, Columbus, Ohio, United States
Cleveland Clinic Hillcrest Hospital, Mayfield Heights, Ohio, United States
Texas Oncology - Fort Worth, Dallas, Texas, United States
Renovatio Clinical, The Woodlands, Texas, United States
University of Virginia, Charlottesville, Virginia, United States
Algemeen Ziekenhuis Maria Middelares, Ghent, Other, Belgium
Universitair Ziekenhuis Leuven, Lueven, Other, Belgium
Aalborg Universite Hospital, Aalborg, Other, Denmark
Mater Private, Dublin, Other, Ireland
Cork University Hospital, Wilton, Other, Ireland
Ospedale Ramazzini di Carpi, Carpi, Other, Italy
IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.l, Meldola, Other, Italy
Istituto Europeo di Oncologia, Milano, Other, Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli, Other, Italy
Fondazione Policlinico Universitario Agostino, Rome, Other, Italy
Hospital Universitario Vall d'Hebron, Barcelona, Other, Spain
L'Institut Catala d'Oncologia, L'Hospitalet de Llobregat, Other, Spain
Hospital Universitario Ramon y Cajal, Madrid, Other, Spain
HM Centro Integral Oncologico Clara Campal, Madrid, Other, Spain
Clinica Universidad de Navarra, Pamplona, Other, Spain
Hospital Universitario Quironsalud Madrid, Pozuelo de Alarcón, Other, Spain
Contact Details
Name: Kristi Schmidt, MD
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR
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