A Study of VB-111 With Paclitaxel vs Paclitaxel for Treatment of Recurrent Platinum-Resistant Ovarian Cancer (OVAL)
NCT ID: NCT03398655
Last Updated: 2023-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
408 participants
INTERVENTIONAL
2017-12-19
2022-07-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1
VB-111 + Paclitaxel
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
Arm 2
Placebo + Paclitaxel
Placebo + Paclitaxel
Placebo will be administered intravenously every 2 months Paclitaxel will be administered intravenously at a dose of 80mg/m2 every week
Interventions
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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
Placebo + Paclitaxel
Placebo will be administered intravenously every 2 months Paclitaxel will be administered intravenously at a dose of 80mg/m2 every week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
FEMALE
No
Sponsors
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GOG Foundation
NETWORK
Vascular Biogenics Ltd. operating as VBL Therapeutics
INDUSTRY
Responsible Party
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Locations
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UAB Division of GYN Oncology
Birmingham, Alabama, United States
Western Regional Medical Center
Goodyear, Arizona, United States
Arizona Oncology Associates, PC - HAL - USO
Phoenix, Arizona, United States
Arizona Oncology Associates, PC - HAL - USO
Tempe, Arizona, United States
University of Arizona Cancer Center
Tucson, Arizona, United States
UCLA-JCCC-Women's Health Clinical Research Unit
Los Angeles, California, United States
The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange
Orange, California, United States
University of California, Irvine Medical Center/Chao Family Comprehensive Cancer Center
Orange, California, United States
University of California - San Francisco
San Francisco, California, United States
Sansum Clinic - USO
Santa Barbara, California, United States
Olive View UCLA Medical Center
Sylmar, California, United States
Hartford HealthCare Cancer Institute at the Hospital of Central Ct
Hartford, Connecticut, United States
Hartford Healthcare
Hartford, Connecticut, United States
UF Health
Gainesville, Florida, United States
University of Miami
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Midwestern Regional Medical Center, Inc
Zion, Illinois, United States
Parkview Cancer Institute
Fort Wayne, Indiana, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
St. Vincent Gynecologic Oncology
Indianapolis, Indiana, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
University of Maryland
Baltimore, Maryland, United States
Holy Cross Hospital
Silver Spring, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Health Hospital
Detroit, Michigan, United States
Dartmouth- Hitchcock Medical Center
Lebanon, New Hampshire, United States
Atlantic Health System/Morristown Medical Center
Morristown, New Jersey, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, United States
Women's Cancer Care Associates, LLC
Albany, New York, United States
Westchester Medical Center
Hawthorne, New York, United States
Northwell Health Cancer Institute
Lake Success, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States
Health Quest Medical Practice, Division of Gynecology/Oncology Gyno Dyson Cancer Center Vassar Brothers Medical Center
Poughkeepsie, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
UNC Chapel Hill
Chapel Hill, North Carolina, United States
Duke University-Duke Cancer Institute
Durham, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Sanford Medical Center
Fargo, North Dakota, United States
University of Cincinnati
Cincinnati, Ohio, United States
Womens Cancer Center/Kettering Cancer Care
Kettering, Ohio, United States
University of Oklahoma Health Sciences Center-Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
The University of Pennsylvania
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
West Penn Hospital
Pittsburgh, Pennsylvania, United States
GHS Cancer Institute
Greenville, South Carolina, United States
Sanford Clinical Research
Sioux Falls, South Dakota, United States
Texas Oncology, Austin Central - USO
Austin, Texas, United States
Memorial Hermann
Houston, Texas, United States
UT Health
San Antonio, Texas, United States
Universtiy of Vermont
Burlington, Vermont, United States
MultiCare Institute for Research & Innovation
Tacoma, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Marshfield Clinic Cancer Care & Research Center
Marshfield, Wisconsin, United States
Froedtert and Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Rambam Medical Center
Haifa, , Israel
Hadassah Medical Center
Jerusalem, , Israel
Shaare Tzedek Medical Center
Jerusalem, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Chaim Sheba Medical Center
Ramat Gan, , Israel
Kaplan Medical Center, Department of Oncology
Rehovot, , Israel
Aichi Cancer Center
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Ehime University Hospital
Tōon, Ehime, Japan
Kurume University Hospital
Kurume, Fukuoka, Japan
Sapporo Medical University Hospital
Sapporo, Hokkaido, Japan
Iwate Medical University Hospital
Shiwa-gun, Iwate, Japan
Tohoku University Hospital
Sendai, Myagi, Japan
National Defense Medical College Hospital
Tokorozawa, Saitama, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto, Tokyo, Japan
Niigata Cancer Center Hospital
Niigata, , Japan
Hokkaido University Hospital
Sapporo, , Japan
Centrum Badan Klinicznych Jagiellonskiego Centrum Innowacji
Krakow, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn, , Poland
MedPolonia Sp. z o.o.
Poznan, , Poland
Parc Taulí Hospital Universitari Edifici Santa Fe, Planta 0, Sala de recerca 3
Barcelona, , Spain
Institut Català d'Oncologia - Hospital Duran i Reynals
Barcelona, , Spain
Hospital Universitario de Donostia Edificio Onkologikoa- Planta baja, Sala de Ensayos Clinicos
Donostia / San Sebastian, , Spain
Hospital Gregorio Marañon Módulo prefabricado Oncología, Planta Baja
Madrid, , Spain
MD Anderson Cancer Center Madrid Unidad de ensayos Clinicos
Madrid, , Spain
Hospital Universitario Clínico San Carlos.
Madrid, , Spain
Hospital Universitario Virgen del Rocío Servicio Oncología Médica. Ensayos Clínicos. Edificio CDCA
Seville, , Spain
Instituto Valenciano de Oncología Médica (IVO
Valencia, , Spain
Consorcio Hospitalario General Universitario de Valencia Servicio de Oncología Médica - Unidad de Investigación
Valencia, , Spain
Countries
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References
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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.
Related Links
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VBL Therapeutics Company Website
Other Identifiers
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VB-111-701/GOG-3018
Identifier Type: -
Identifier Source: org_study_id
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