AzTrials
AzTrials

Recurrent Platinum Resistant Ovarian CancerPhase 3OVALNCT03398655

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

A Phase 3 study testing VB-111 + Paclitaxel in people with Recurrent Platinum Resistant Ovarian Cancer, run by Vascular Biogenics Ltd. operating as VBL Therapeutics at 94 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
VB-111 + Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
408 participants
Where
94 sitesin 5 countries
Study dates
19 Dec 2017to 19 Jul 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients ≥18 years of age
  • Histologically confirmed epithelial ovarian cancer and documented disease.
  • Patients must have platinum-resistant disease
  • Patients must have disease that is measurable according to RECIST 1.1 and require chemotherapy treatment.
  • ECOG PS 0-1.
  • Adequate hematological functions:
Show all 10Show fewer
  • 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.
  • 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).

Who cannot join

  • Non-epithelial tumors (Carcino-sarcomas are excluded)
  • Ovarian tumors with low malignant potential (i.e. borderline tumors) clear cell carcinomas, grade 1 serous tumors or mucinous tumors.
  • 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.
  • Previous ovarian cancer treatment with >5 anticancer regimens.
  • Any prior radiotherapy to the pelvis or whole abdomen.
  • Inadequate liver function, defined as serum creatinine > ULN, unless calculated creatinine clearance > 50ml/min (by Cockroft \& Gault formula):
Show all 22Show fewer
  • 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).
  • Inadequate renal function, defined as:
  • Serum creatinine > ULN OR
  • Calculated creatinine clearance < 50ml/min (by Cockroft \& Gault formula)
  • New York Heart Association (NYHA) Grade II or greater congestive heart failure
  • History of myocardial infarction or unstable angina within 6 months prior to day of randomization.
  • History of stroke or transient ischemic attack within 6 months prior to day of randomization.
  • Patient with proliferative and/or vascular retinopathy
  • Known brain metastases
  • History of hemoptysis or active GI bleeding within 6 month prior to day of randomization
  • Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
  • History of abdominal fistula or gastrointestinal perforation.
  • Current signs and symptoms of bowel obstruction
  • Uncontrolled active infection
  • 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

Trial locations and contacts

94 sites in 5 countries.

94 sites in 5 countries

United States64 sites

  • Women's Cancer Care Associates, LLC

    Albany, New York, 12208

  • New Mexico Cancer Care Alliance

    Albuquerque, New Mexico, 87106

  • University of Michigan

    Ann Arbor, Michigan, 04801

  • Emory University

    Atlanta, Georgia, 30322

  • Texas Oncology, Austin Central - USO

    Austin, Texas, 78731

  • University of Maryland

    Baltimore, Maryland, 21201

  • St. Luke's University Health Network

    Bethlehem, Pennsylvania, 18015

  • UAB Division of GYN Oncology

    Birmingham, Alabama, 35344

  • Massachusetts General Hospital

    Boston, Massachusetts, 20114

  • Universtiy of Vermont

    Burlington, Vermont, 05405

  • UNC Chapel Hill

    Chapel Hill, North Carolina, 27707

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Health Hospital

    Detroit, Michigan, 48202

  • Duke University-Duke Cancer Institute

    Durham, North Carolina, 27710

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401

  • Sanford Medical Center

    Fargo, North Dakota, 58122

  • Parkview Cancer Institute

    Fort Wayne, Indiana, 46845

  • UF Health

    Gainesville, Florida, 32610

  • Western Regional Medical Center

    Goodyear, Arizona, 85338

  • GHS Cancer Institute

    Greenville, South Carolina, 29605

  • Hartford HealthCare Cancer Institute at the Hospital of Central Ct

    Hartford, Connecticut, 06053

  • Hartford Healthcare

    Hartford, Connecticut, 06106

  • Westchester Medical Center

    Hawthorne, New York, 10532

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Memorial Hermann

    Houston, Texas, 77030

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46131

  • St. Vincent Gynecologic Oncology

    Indianapolis, Indiana, 46260

  • Womens Cancer Center/Kettering Cancer Care

    Kettering, Ohio, 45429

  • Northwell Health Cancer Institute

    Lake Success, New York, 11042

  • Dartmouth- Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • University of Kentucky

    Lexington, Kentucky, 40536

  • UCLA-JCCC-Women's Health Clinical Research Unit

    Los Angeles, California, 90095

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Marshfield Clinic Cancer Care & Research Center

    Marshfield, Wisconsin, 54449

  • University of Miami

    Miami, Florida, 33136

  • Froedtert and Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Atlantic Health System/Morristown Medical Center

    Morristown, New Jersey, 07928

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07103

  • University of Oklahoma Health Sciences Center-Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange

    Orange, California, 92868

  • University of California, Irvine Medical Center/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • The University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Arizona Oncology Associates, PC - HAL - USO

    Phoenix, Arizona, 85016

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

  • Health Quest Medical Practice, Division of Gynecology/Oncology Gyno Dyson Cancer Center Vassar Brothers Medical Center

    Poughkeepsie, New York, 12601

  • UT Health

    San Antonio, Texas, 78229

  • University of California - San Francisco

    San Francisco, California, 94158

  • Sansum Clinic - USO

    Santa Barbara, California, 93105

  • Holy Cross Hospital

    Silver Spring, Maryland, 20902

  • Sanford Clinical Research

    Sioux Falls, South Dakota, 57104

  • Olive View UCLA Medical Center

    Sylmar, California, 91342

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • MultiCare Institute for Research & Innovation

    Tacoma, Washington, 98405

  • Arizona Oncology Associates, PC - HAL - USO

    Tempe, Arizona, 85284

  • University of Arizona Cancer Center

    Tucson, Arizona, 85719

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

  • Midwestern Regional Medical Center, Inc

    Zion, Illinois, 60099

Other trials in United States

Japan12 sites

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

  • Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Koto, Tokyo, 135-8550

  • Kurume University Hospital

    Kurume, Fukuoka

  • Aichi Cancer Center

    Nagoya, Aichi-ken

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Sapporo Medical University Hospital

    Sapporo, Hokkaido

  • Hokkaido University Hospital

    Sapporo, 060-8648

  • Tohoku University Hospital

    Sendai, Myagi

  • Iwate Medical University Hospital

    Shiwa-gun, Iwate, 028-3695

  • National Defense Medical College Hospital

    Tokorozawa, Saitama, 359-8513

  • Ehime University Hospital

    Tōon, Ehime, 791-0295

Other trials in Japan

Spain9 sites

  • Parc Taulí Hospital Universitari Edifici Santa Fe, Planta 0, Sala de recerca 3

    Barcelona, 08208

  • Institut Català d'Oncologia - Hospital Duran i Reynals

    Barcelona, 08908

  • Hospital Universitario de Donostia Edificio Onkologikoa- Planta baja, Sala de Ensayos Clinicos

    Donostia / San Sebastian, 20014

  • Hospital Gregorio Marañon Módulo prefabricado Oncología, Planta Baja

    Madrid, 28009

  • MD Anderson Cancer Center Madrid Unidad de ensayos Clinicos

    Madrid, 28033

  • Hospital Universitario Clínico San Carlos.

    Madrid, 28040

  • Hospital Universitario Virgen del Rocío Servicio Oncología Médica. Ensayos Clínicos. Edificio CDCA

    Seville, 41013

  • Instituto Valenciano de Oncología Médica (IVO

    Valencia, 46009

  • Consorcio Hospitalario General Universitario de Valencia Servicio de Oncología Médica - Unidad de Investigación

    Valencia, 46014

Other trials in Spain

Israel6 sites

  • Rambam Medical Center

    Haifa

  • Hadassah Medical Center

    Jerusalem, 91120

  • Shaare Tzedek Medical Center

    Jerusalem

  • Rabin Medical Center

    Petah Tikva, 49100

  • Chaim Sheba Medical Center

    Ramat Gan

  • Kaplan Medical Center, Department of Oncology

    Rehovot

Other trials in Israel

Poland3 sites

  • Centrum Badan Klinicznych Jagiellonskiego Centrum Innowacji

    Krakow, 30-348

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie

    Olsztyn, 10-228

  • MedPolonia Sp. z o.o.

    Poznan, 60-375

Other trials in Poland

About this study

Official title: 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.

Being tested
VB-111 + Paclitaxel, Placebo + Paclitaxel
Keywords
Recurrent Ovarian cancer, Platinum resistant ovarian cancer, Ovarian cancer, Ovarian carcinoma, Epithelial ovarian cancer, paclitaxel
Medical subject headings
Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VB-111 + PaclitaxelDrug

    Also called Ofranergene Obadenovec

    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

  • Placebo + PaclitaxelDrug

    Placebo will be administered intravenously every 2 months Paclitaxel will be administered intravenously at a dose of 80mg/m2 every week

Study groups in NCT03398655
Study groupRoleWhat they receive
Arm 1ExperimentalVB-111 + Paclitaxel
Receives: Drug: VB-111 + Paclitaxel
Arm 2Active comparatorPlacebo + Paclitaxel
Receives: Drug: Placebo + Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Measured: From randomization until death from any cause (up to 5 years after last study treatment)

  2. Progression Free Survival (PFS) by RECIST 1.1

    Measured: From randomization until progression defined according to RECIST 1.1 or death, whichever occurs first (up to 5 years after last study treatment)

Secondary outcomes (4)

  1. Combined CA-125 and RECIST 1.1 response (GCIG)

    Measured: From date of study entry until the date of death from any cause, or up to 5 years after last study treatment

  2. CA-125 Response (GCIG)

    Measured: From date of study entry until the date of death from any cause, or up to 5 years after last study treatment

  3. Objective response rate (ORR) by RECIST 1.1

    Measured: From date of study entry until the date of death from any cause, or up to 5 years after last study treatment

  4. OS100 for a sensitivity analysis of OS

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2018
  2. Study start19 Dec 2017
  3. Primary completion19 Jul 2022
  4. Study completion19 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
408 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03398655
Sponsor's protocol ID
VB-111-701/GOG-3018
Acronym
OVAL
Status last verified
Jun 2021
First submitted
7 Jan 2018
Last updated
10 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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.

    PubMed 37906726

  • 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.

    PubMed 33637348

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing VB-111 + Paclitaxel in people with Recurrent Platinum Resistant Ovarian Cancer, run by Vascular Biogenics Ltd. operating as VBL Therapeutics at 94 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in United States, Japan, Spain, Israel, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: From randomization until death from any cause (up to 5 years after last study treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03398655, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in