Last updated on November 2019

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


Brief description of study

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). We will be testing different doses of tisotumab vedotin that are given at different times. We will 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 up to 12 patients that will look at a dose-dense treatment schedule. In a dose-dense schedule, smaller doses are given more frequently. After the run-in period is over, there will be two groups in the study. One group will get tisotumab vedotin once every 3 weeks (21 day cycles). The other group will get tisotumab vedotin once a week for 3 weeks followed by 1 week off (28-day cycles).

Detailed Study 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 (dose-dense regimen) 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. All patients must have PROC and be eligible for single agent chemotherapy. Additionally, patients must have previously received a bevacizumab-containing treatment regimen for ovarian cancer, if eligible.

Clinical Study Identifier: NCT03657043

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