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

Completed · Phase 2

Conditions studied: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

In brief

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).

Key facts

Study ID

NCT03657043

Run by

Seagen Inc.

People needed

98

Starts

2019-03-20

Expected to finish

2022-02-08

Last updated by the study team

2023-05-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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