GOG3018 OVAL (Ovarian Cancer) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn about any good or bad effects of an experimental drug called VB-111 used in combination with paclitaxel, a standard chemotherapy drug.
What is the Condition Being Studied?
Platinum-resistant ovarian cancer

Who Can Participate in the Study?

Adult females with platinum resistant ovarian cancer who are willing to have biopsies as needed per study protocol.

Age Group
Adults

What is Involved?

If you agree to be in this study, you will:
-Be randomized, like drawing numbers out of a hat, to one of two different drug options:
--- Group A will receive VB-111 infusion once every 2 months
--- Group B will receive a placebo (salt water solution with no active drug) once every two months

- Everyone will:
- Receive weekly IV infusions of pacltaxel
- Have biopsies one month after the first dose of the study drug and two weeks after the third dose of study drug
- Visit the clinic every 56 days for a physical and blood work
- Continue on the study as long as your cancer does not get worse and you do not have bad effects
- Long-term follow up will continue every 3 months for up to 5 years

Study Details

Full Title
The OVAL Study: A Randomized, Controlled, Double-Arm, Double-Blind, Multi-Center Study of Ofranergene Obadenovec (VB-111) Combined with Paclitaxel vs. Paclitaxel Combined with Placebo for the Treatment of Recurrent Platinum-Resistant Ovarian Cancer
Principal Investigator
Gynecologic Oncologist
Protocol Number
IRB: PRO00100743
NCT: NCT03398655
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698