Seattle Genetics SGNTV-002 - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn about the safety and effectiveness of the investigational drug tisotumab vedotin in platinum-resistant ovarian cancer. Tisotumab vedotin is an experimental drug that is designed to stick to cancer cells, so the drug can kill them. .
What is the Condition Being Studied?
Platinum-resistant ovarian cancer

Who Can Participate in the Study?

Adult females with platinum-resistant ovarian cancer

Age Group
Adults

What is Involved?

If you agree to be in this study, you will:
- Be randomized, like the flip of a coin, to one of two study drug options:
Group A: tisotumab vedotin once every 3 weeks
Group B: tisotumab vedotin once a week for 3 weeks, followed by one week off

- Receive the study drug until your disease no longer responds to the study drug, side effects prevents further continuation of the study drug, or the study closes.

- Return for a follow-up visit 30 days after the end of the study drug treatment period.
- Long-term follow-up contact will be made every 12 weeks until the end of participation in the study.

Participation in this study is expected to last up to 3 years and will include 30 or more office visits to the clinic. The sponsor plans to close the study about 2 years after the last patient agrees to participate in the study.

Study Details

Full 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
Principal Investigator
Gynecologic Oncologist
Protocol Number
IRB: PRO00100540
NCT: NCT03657043
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698