A Study of VB-111 With Paclitaxel vs Paclitaxel for Treatment of Recurrent Platinum-Resistant Ovarian Cancer (OVAL)

Phase 3 Completed 408 enrolled Vascular Biogenics Ltd. operating as VBL Therapeutics GOG Foundation · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this phase 3, randomized, multicenter study is to compare VB-111 and paclitaxel to placebo and paclitaxel in adult patients with Recurrent Platinum-Resistant Ovarian Cancer.

Timeline

Start: 2017-12-19
Primary completion: 2022-07-19
Completion: 2022-07-19

Publications

Arend RC, Monk BJ, Shapira-Frommer R, Haggerty AF, Alvarez EA, Amit A, Alvarez Secord A, Muller C, Casado Herraez A, Herzog TJ, Tewari KS, Cohen JG, Huang M, Yachnin A, Holeman LL, Ledermann JA, Rachmilewitz Minei T, Buyse M, Fain Shmueli S, Lavi M, Harats D, Penson RT; OVAL/GOG-3018 Investigators. Ofranergene Obadenovec (Ofra-Vec, VB-111) With Weekly Paclitaxel for Platinum-Resistant Ovarian Cancer: Randomized Controlled Phase III Trial (OVAL Study/GOG 3018). J Clin Oncol. 2024 Jan 10;42(2):170-179. doi: 10.1200/JCO.22.02915. Epub 2023 Oct 31.
Arend RC, Monk BJ, Herzog TJ, Moore KN, Shapira-Frommer R, Ledermann JA, Tewari KS, Secord AA, Rachmilewitz Minei T, Freedman LS, Miller A, Shmueli SF, Lavi M, Penson RT. Utilizing an interim futility analysis of the OVAL study (VB-111-701/GOG 3018) for potential reduction of risk: A phase III, double blind, randomized controlled trial of ofranergene obadenovec (VB-111) and weekly paclitaxel in patients with platinum resistant ovarian cancer. Gynecol Oncol. 2021 May;161(2):496-501. doi: 10.1016/j.ygyno.2021.02.014. Epub 2021 Feb 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	VB-111	Other / unclassified	1e+13 unknown	Intravenous
Comparator	Paclitaxel	Small molecule	80 mg/m2	Intravenous

Indications

No indication recorded.