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

January 8, 2023 updated by: Vascular Biogenics Ltd. operating as VBL Therapeutics

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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

408

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Rambam Medical Center
      • Jerusalem, Israel, 91120
        • Hadassah Medical Center
      • Jerusalem, Israel
        • Shaare Tzedek Medical Center
      • Petach Tikva, Israel, 49100
        • Rabin Medical Center
      • Ramat Gan, Israel
        • Chaim Sheba Medical Center
      • Rehovot, Israel
        • Kaplan Medical Center, Department of Oncology
  • Japan
      • Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital
      • Sapporo, Japan, 060-8648
        • Hokkaido University Hospital
    • Aichi
      • Nagoya, Aichi, Japan
        • Aichi Cancer Center
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
    • Ehime
      • Tōon, Ehime, Japan, 791-0295
        • Ehime University Hospital
    • Fukuoka
      • Kurume, Fukuoka, Japan
        • Kurume University Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan
        • Sapporo Medical University Hospital
    • Iwate
      • Shiwa-gun, Iwate, Japan, 028-3695
        • Iwate Medical University Hospital
    • Myagi
      • Sendai, Myagi, Japan
        • Tohoku University Hospital
    • Saitama
      • Tokorozawa, Saitama, Japan, 359-8513
        • National Defense Medical College hospital
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
      • Koto, Tokyo, Japan, 135-8550
        • Cancer Institute Hospital of Japanese Foundation for Cancer Research
  • Poland
      • Kraków, Poland, 30-348
        • Centrum Badan Klinicznych Jagiellonskiego Centrum Innowacji
      • Olsztyn, Poland, 10-228
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
      • Poznań, Poland, 60-375
        • Medpolonia Sp. z o.o.
  • Spain
      • Barcelona, Spain, 08208
        • Parc Taulí Hospital Universitari Edifici Santa Fe, Planta 0, Sala de recerca 3
      • Barcelona, Spain, 08908
        • Institut Català d'Oncologia - Hospital Duran i Reynals
      • Donostia, Spain, 20014
        • Hospital Universitario de Donostia Edificio Onkologikoa- Planta baja, Sala de Ensayos Clinicos
      • Madrid, Spain, 28009
        • Hospital Gregorio Marañon Módulo prefabricado Oncología, Planta Baja
      • Madrid, Spain, 28033
        • MD Anderson Cancer Center Madrid Unidad de ensayos Clinicos
      • Madrid, Spain, 28040
        • Hospital Universitario Clínico San Carlos.
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocío Servicio Oncología Médica. Ensayos Clínicos. Edificio CDCA
      • Valencia, Spain, 46009
        • Instituto Valenciano de Oncología Médica (IVO
      • Valencia, Spain, 46014
        • Consorcio Hospitalario General Universitario de Valencia Servicio de Oncología Médica - Unidad de Investigación
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35344
        • UAB Division of GYN Oncology
    • Arizona
      • Goodyear, Arizona, United States, 85338
        • Western Regional Medical Center
      • Phoenix, Arizona, United States, 85016
        • Arizona Oncology Associates, PC - HAL - USO
      • Tempe, Arizona, United States, 85284
        • Arizona Oncology Associates, PC - HAL - USO
      • Tucson, Arizona, United States, 85719
        • University of Arizona Cancer Center
    • California
      • Los Angeles, California, United States, 90095
        • UCLA-JCCC-Women's Health Clinical Research Unit
      • Orange, California, United States, 92868
        • The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange
      • Orange, California, United States, 92868
        • University of California, Irvine Medical Center/Chao Family Comprehensive Cancer Center
      • San Francisco, California, United States, 94158
        • University of California - San Francisco
      • Santa Barbara, California, United States, 93105
        • Sansum Clinic - USO
      • Sylmar, California, United States, 91342
        • Olive View UCLA Medical Center
    • Connecticut
      • Hartford, Connecticut, United States, 06053
        • Hartford HealthCare Cancer Institute at the Hospital of Central Ct
      • Hartford, Connecticut, United States, 06106
        • Hartford HealthCare
    • Florida
      • Gainesville, Florida, United States, 32610
        • UF Health
      • Miami, Florida, United States, 33136
        • University of Miami
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
      • Zion, Illinois, United States, 60099
        • Midwestern Regional Medical Center, Inc
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Parkview Cancer Institute
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Gynecologic Oncology
      • Indianapolis, Indiana, United States, 46131
        • Indiana University School of Medicine
    • Kansas
      • Westwood, Kansas, United States, 66205
        • University of Kansas Cancer Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
      • Silver Spring, Maryland, United States, 20902
        • Holy Cross Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 20114
        • Massachusetts General Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 04801
        • University of Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health Hospital
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth- Hitchcock Medical Center
    • New Jersey
      • Morristown, New Jersey, United States, 07928
        • Atlantic Health System/Morristown Medical Center
      • Newark, New Jersey, United States, 07103
        • Rutgers New Jersey Medical School
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • New Mexico Cancer Care Alliance
    • New York
      • Albany, New York, United States, 12208
        • Women's Cancer Care Associates, LLC
      • Hawthorne, New York, United States, 10532
        • Westchester Medical Center
      • Lake Success, New York, United States, 11042
        • Northwell Health Cancer Institute
      • New York, New York, United States, 10016
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
      • Poughkeepsie, New York, United States, 12601
        • Health Quest Medical Practice, Division of Gynecology/Oncology Gyno Dyson Cancer Center Vassar Brothers Medical Center
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27707
        • UNC Chapel Hill
      • Durham, North Carolina, United States, 27710
        • Duke University-Duke Cancer Institute
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Medical Center
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • Sanford Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
      • Kettering, Ohio, United States, 45429
        • Womens Cancer Center/Kettering Cancer Care
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center-Stephenson Cancer Center
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Willamette Valley Cancer Institute and Research Center
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • St. Luke's University Health Network
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19104
        • The University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • West Penn Hospital
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • GHS Cancer Institute
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Clinical Research
    • Texas
      • Austin, Texas, United States, 78731
        • Texas Oncology, Austin Central - USO
      • Houston, Texas, United States, 77030
        • Memorial Hermann
      • San Antonio, Texas, United States, 78229
        • UT Health
    • Vermont
      • Burlington, Vermont, United States, 05405
        • Universtiy of Vermont
    • Washington
      • Tacoma, Washington, United States, 98405
        • MultiCare Institute for Research & Innovation
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic Cancer Care & Research Center
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert and Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Female patients ≥18 years of age
  2. Histologically confirmed epithelial ovarian cancer and documented disease.
  3. Patients must have platinum-resistant disease
  4. Patients must have disease that is measurable according to RECIST 1.1 and require chemotherapy treatment.
  5. ECOG PS 0-1.

  6. Adequate hematological functions:

    • ANC ≥ 1000/mm3
    • PLT ≥ 100,000/mm3
    • PT and PTT (seconds) < 1.2 X ULN. Patients who are anticoagulated do not need to meet criteria for PT and PTT.
  7. Patients who are known to carry a BRCA mutation may be enrolled only after (following PARP inhibitor treatment failure, or being intolerant of, or ineligible for PARP inhibitor treatment).

Exclusion Criteria:

  1. Non-epithelial tumors (Carcino-sarcomas are excluded)
  2. Ovarian tumors with low malignant potential (i.e. borderline tumors) clear cell carcinomas, grade 1 serous tumors or mucinous tumors.
  3. History of other clinically active malignancy within 5 years of enrollment, except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal-cell carcinoma, adequately controlled, non-metastatic squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast.
  4. Previous ovarian cancer treatment with >5 anticancer regimens.
  5. Any prior radiotherapy to the pelvis or whole abdomen.

  6. Inadequate liver function, defined as serum creatinine > ULN, unless calculated creatinine clearance > 50ml/min (by Cockroft & Gault formula):

    • Serum (total) bilirubin > ULN (Exception: documented Gilbert's disease patients can be enrolled)
    • Alkaline phosphatase, AST/SGOT or ALT/SGPT ≥2.5 x ULN (or ≥ 5 x ULN in the presence of liver metastases).

  7. Inadequate renal function, defined as:

    • Serum creatinine > ULN OR
    • Calculated creatinine clearance < 50ml/min (by Cockroft & Gault formula)
  8. New York Heart Association (NYHA) Grade II or greater congestive heart failure
  9. History of myocardial infarction or unstable angina within 6 months prior to day of randomization.
  10. History of stroke or transient ischemic attack within 6 months prior to day of randomization.
  11. Patient with proliferative and/or vascular retinopathy
  12. Known brain metastases
  13. History of hemoptysis or active GI bleeding within 6 month prior to day of randomization
  14. Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
  15. History of abdominal fistula or gastrointestinal perforation.
  16. Current signs and symptoms of bowel obstruction
  17. Uncontrolled active infection
  18. Patients who had evidence of disease progression during or up to 90 days from the last dose of the first line of platinum based therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
VB-111 + Paclitaxel
Drug: VB-111 + Paclitaxel
VB-111 will be administered intravenously at a dose of 1x10e13 VPs every 2 months Paclitaxel will be administered intravenously at a dose of 80mg/m2 every week
Other Names:
  • Ofranergene Obadenovec
Active Comparator: Arm 2
Placebo + Paclitaxel
Drug: Placebo + Paclitaxel
Placebo will be administered intravenously every 2 months Paclitaxel will be administered intravenously at a dose of 80mg/m2 every week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: From randomization until death from any cause (up to 5 years after last study treatment)
From randomization until death from any cause (up to 5 years after last study treatment)
Progression Free Survival (PFS) by RECIST 1.1
Time Frame: From randomization until progression defined according to RECIST 1.1 or death, whichever occurs first (up to 5 years after last study treatment)
From randomization until progression defined according to RECIST 1.1 or death, whichever occurs first (up to 5 years after last study treatment)

Secondary Outcome Measures

Outcome Measure
Time Frame
Combined CA-125 and RECIST 1.1 response (GCIG)
Time Frame: From date of study entry until the date of death from any cause, or up to 5 years after last study treatment
From date of study entry until the date of death from any cause, or up to 5 years after last study treatment
CA-125 Response (GCIG)
Time Frame: From date of study entry until the date of death from any cause, or up to 5 years after last study treatment
From date of study entry until the date of death from any cause, or up to 5 years after last study treatment
Objective response rate (ORR) by RECIST 1.1
Time Frame: From date of study entry until the date of death from any cause, or up to 5 years after last study treatment
From date of study entry until the date of death from any cause, or up to 5 years after last study treatment
OS100 for a sensitivity analysis of OS
Time Frame: From 100 days after date of study entry until the date of death from any cause, or up to 5 years after last study treatment
From 100 days after date of study entry until the date of death from any cause, or up to 5 years after last study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vascular Biogenics Ltd. operating as VBL Therapeutics

Collaborators

GOG Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2017

Primary Completion (Actual)

July 19, 2022

Study Completion (Actual)

July 19, 2022

Study Registration Dates

First Submitted

January 7, 2018

First Submitted That Met QC Criteria

January 7, 2018

First Posted (Actual)

January 12, 2018

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

January 8, 2023

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VB-111-701/GOG-3018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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