Ovarian Cancer Clinical Trial
A Study of Weekly Tisotumab Vedotin for Patients With Platinum-Resistant Ovarian Cancer With Safety Run-in (innovaTV 208)
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).
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.
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 1 to 3 anticancer lines of therapy overall, including at least 1 line of therapy containing bevacizumab or biosimilar.
Adjuvant ± neoadjuvant are considered 1 line of therapy.
Patients may have received a PARP inhibitor or an immuno-oncology (IO) agent; any of these regimens are to be considered a line of therapy for the purposes of this study if not used as maintenance therapy.
Maintenance therapy (including bevacizumab, PARP inhibitors and IOs) will be considered part of the preceding line of therapy and not to be counted as a new line of therapy.
Any chemotherapy regimen change due to toxicity in the absence of disease progression is considered as part of the same line of therapy.
Hormonal therapy will be not be counted towards the lines of therapy.
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
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
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There are 36 Locations for this study
San Jose California, 95124, United States
Fort Collins Colorado, 80524, United States
Miami Florida, 33176, United States
Miami Florida, 33176, United States
Tampa Florida, 33612, United States
Augusta Georgia, 30912, United States
Westwood Kansas, 66205, United States
Detroit Michigan, 48201, United States
Columbia Missouri, 65212, United States
Hackensack New Jersey, 07601, United States
New York New York, 10011, United States
New York New York, 10029, United States
New York New York, 10032, United States
Durham North Carolina, 27710, United States
Cleveland Ohio, 44111, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Mayfield Heights Ohio, 44124, United States
Dallas Texas, 75246, United States
The Woodlands Texas, 77380, United States
Charlottesville Virginia, 22903, United States
Ghent Other, 9000, Belgium
Lueven Other, 3000, Belgium
Aalborg Other, 9100, Denmark
Dublin Other, D07 W, Ireland
Wilton Other, T12 E, Ireland
Carpi Other, 41012, Italy
Meldola Other, 47014, Italy
Milano Other, 20141, Italy
Napoli Other, 80131, Italy
Rome Other, 00168, Italy
Barcelona Other, 08035, Spain
L'Hospitalet de Llobregat Other, 08907, Spain
Madrid Other, 28034, Spain
Madrid Other, 28050, Spain
Pamplona Other, 31008, Spain
Pozuelo de Alarcón Other, 28223, Spain
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