PROTOCOL VB-111-701 / GOG-3018

STUDY 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

The study is conducted in collaboration with the GOG Foundation, Inc.

The GOG Foundation, Inc. is a not-for-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies. The GOG Foundation, Inc. is committed to maintaining the highest standards in clinical trials development, execution, analysis and distribution of results.  The GOG Foundation, Inc. is the only group in the United States that focuses its research on women with pelvic malignancies, such as cancer of the ovary, uterus, and cervix. The GOG Foundation, Inc. is multi-disciplinary in its approach to clinical trials, and includes gynecologic oncologists, medical oncologists, pathologists, radiation oncologists, nurses, statisticians, basic scientists, quality of life experts, data managers, and administrative personnel.

STUDY OVERVIEW

The OVAL Study – a phase 3 Research Study Recruiting Patients with Ovarian Cancer

These days, the OVAL study is enrolling women with Recurrent Platinum Resistant Ovarian Cancer. “Recurrent” means that it’s a tumor that has returned after being treated.

Just like your normal cells, cancer cells require blood flow in order to thrive and grow. The investigational medication (VB-111) being tested in this study is designed to destroy new blood vessels that nourish the tumor, which may affect the growth of cancerous tumors like Ovarian Cancer by causing tumor starvation. In addition, there is evidence that the investigational medication stimulates the immune system in the tumor area to act against the tumor cells.

VB-111 is administered by a simple intravenous infusion every 8 weeks. It is based on a virus which has been modified genetically so it cannot reproduce and remain in the body. A genetic code was inserted into the virus, causing it to intentionally damage rapidly growing blood vessels existing in the tumor environment, but does not damage normal blood vessels or other parts of the body. 

“Investigational” means that the medication is not yet approved for use by the general public. Doctors are studying this medication to better understand how it might help people with recurrent ovarian cancer.

In order to qualify for this study, you must meet the following criteria:

  • You are at least 18 years of age
  • You have a platinum resistant ovarian cancer, that has returned after being treated

Doctors will also check other requirements to confirm that you qualify.

There are two medications in this study:

  1. The investigational medication, VB-111
  2. A medication called Paclitaxel, that’s already approved to treat recurrent ovarian cancer.

It is expected that approximately 400 women who qualify for and agree to participate in this research study will be randomly assigned to one of two treatment groups. One group will receive Paclitaxel together with the investigational medication, and the other group will receive Paclitaxel together with placebo.

Treatment group 1: Investigational medication every 8 weeks and Paclitaxel on a weekly basis

Treatment group 2: Placebo every 8 weeks and Paclitaxel on a weekly basis

  1. Find a clinic participating in the OVAL study.
  1. Talk to study investigator to help you decide if the OVAL study may be right for you.
  1. Give informed consent

A study doctor will explain the study procedures and its possible benefits and risks. In addition, the study doctor will also answer any questions you may have. To join our study, you must read and sign an informed consent document, to show that you understand the study and what’s required of you.

  1. Find out if you’re eligible

The study team will ask you some health questions and perform some assessments (like blood tests), to make sure you meet the requirements for the study.

  1. Participate

If eligible, you’ll be requested to participate in a number of study visits during the study. Study visits are scheduled according to a study protocol (a written study plan). The study team will work with you to find convenient times for these visits.