A Study of VB-111 With Paclitaxel vs Paclitaxel for Treatment of Recurrent Platinum-Resistant Ovarian Cancer (OVAL) (OVAL)
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
Doctors at 49 research centers are seeking patients with recurrent, platinum-resistant ovarian cancer to participate in a 400-patient study comparing a previously trialed drug, VB-111, against placebo when combined with paclitaxel. VB-111 is a genetic therapy which employs a virus to target the angiogenesis factors in tumor epithelial cells that indicate the tumor is growing new blood flow to feed itself. By infecting and killing those specific cells in the tumor, VB-111 starves the tumor and recruits the patient’s own immune response to further fight the cancer.
A portion of participants will be given VB-11 in combination with paclitaxel (Taxol™), while the remainder will receive a placebo and paclitaxel. You will not know which group you are assigned. If effective, the treatment is expected to improve outcomes for the patients.
- Be 18 to 65 years of age
- Have a histologically confirmed epithelial ovarian cancer and must have platinum-resistant disease
- Not have any prior radiotherapy to the pelvis or abdomen
THE STUDY INVOLVES:
- Prescreening tests to confirm eligibility of the patient to participate.
- VB-111 will be administered intravenously every 2 months
- Paclitaxel will be administered intravenously every week
- Follow up will continue for up to 5 years after the final treatment
LOCATIONS AND CONTACTS:
49 study sites are participating across the US. See the full list, along with contact information, here.
Vascular Biogenics Ltd. operating as VBL Therapeutics
GOG Foundation, Inc.
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