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| Name | Class |
|---|---|
| GOG Foundation | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | VB-111 + Paclitaxel |
|
| Arm 2 | Active Comparator | Placebo + Paclitaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VB-111 + Paclitaxel | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | From randomization until death from any cause (up to 5 years after last study treatment) | |
| Progression Free Survival (PFS) by RECIST 1.1 | From randomization until progression defined according to RECIST 1.1 or death, whichever occurs first (up to 5 years after last study treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Combined CA-125 and RECIST 1.1 response (GCIG) | 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) | From date of study entry until the date of death from any cause, or up to 5 years after last study treatment |
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Inclusion Criteria:
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:
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:
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):
Inadequate renal function, defined as:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Division of GYN Oncology | Birmingham | Alabama | 35344 | United States | ||
| Western Regional Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37906726 | Derived | 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. | |
| 33637348 |
| Label | URL |
|---|---|
| VBL Therapeutics Company Website | View source |
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|
| Placebo + Paclitaxel | Drug | Placebo will be administered intravenously every 2 months Paclitaxel will be administered intravenously at a dose of 80mg/m2 every week |
|
| Objective response rate (ORR) by RECIST 1.1 | 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 | 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 |
| Goodyear |
| Arizona |
| 85338 |
| United States |
| Arizona Oncology Associates, PC - HAL - USO | Phoenix | Arizona | 85016 | United States |
| Arizona Oncology Associates, PC - HAL - USO | Tempe | Arizona | 85284 | United States |
| University of Arizona Cancer Center | Tucson | Arizona | 85719 | United States |
| UCLA-JCCC-Women's Health Clinical Research Unit | Los Angeles | California | 90095 | United States |
| The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange | Orange | California | 92868 | United States |
| University of California, Irvine Medical Center/Chao Family Comprehensive Cancer Center | Orange | California | 92868 | United States |
| University of California - San Francisco | San Francisco | California | 94158 | United States |
| Sansum Clinic - USO | Santa Barbara | California | 93105 | United States |
| Olive View UCLA Medical Center | Sylmar | California | 91342 | United States |
| Hartford HealthCare Cancer Institute at the Hospital of Central Ct | Hartford | Connecticut | 06053 | United States |
| Hartford Healthcare | Hartford | Connecticut | 06106 | United States |
| UF Health | Gainesville | Florida | 32610 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| Midwestern Regional Medical Center, Inc | Zion | Illinois | 60099 | United States |
| Parkview Cancer Institute | Fort Wayne | Indiana | 46845 | United States |
| Indiana University School of Medicine | Indianapolis | Indiana | 46131 | United States |
| St. Vincent Gynecologic Oncology | Indianapolis | Indiana | 46260 | United States |
| University of Kansas Cancer Center | Westwood | Kansas | 66205 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Holy Cross Hospital | Silver Spring | Maryland | 20902 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 20114 | United States |
| University of Michigan | Ann Arbor | Michigan | 04801 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Henry Ford Health Hospital | Detroit | Michigan | 48202 | United States |
| Dartmouth- Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Atlantic Health System/Morristown Medical Center | Morristown | New Jersey | 07928 | United States |
| Rutgers New Jersey Medical School | Newark | New Jersey | 07103 | United States |
| New Mexico Cancer Care Alliance | Albuquerque | New Mexico | 87106 | United States |
| Women's Cancer Care Associates, LLC | Albany | New York | 12208 | United States |
| Westchester Medical Center | Hawthorne | New York | 10532 | United States |
| Northwell Health Cancer Institute | Lake Success | New York | 11042 | United States |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | 10016 | United States |
| Health Quest Medical Practice, Division of Gynecology/Oncology Gyno Dyson Cancer Center Vassar Brothers Medical Center | Poughkeepsie | New York | 12601 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| UNC Chapel Hill | Chapel Hill | North Carolina | 27707 | United States |
| Duke University-Duke Cancer Institute | Durham | North Carolina | 27710 | United States |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| Sanford Medical Center | Fargo | North Dakota | 58122 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Womens Cancer Center/Kettering Cancer Care | Kettering | Ohio | 45429 | United States |
| University of Oklahoma Health Sciences Center-Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
| Willamette Valley Cancer Institute and Research Center | Eugene | Oregon | 97401 | United States |
| St. Luke's University Health Network | Bethlehem | Pennsylvania | 18015 | United States |
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| The University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| West Penn Hospital | Pittsburgh | Pennsylvania | 15224 | United States |
| GHS Cancer Institute | Greenville | South Carolina | 29605 | United States |
| Sanford Clinical Research | Sioux Falls | South Dakota | 57104 | United States |
| Texas Oncology, Austin Central - USO | Austin | Texas | 78731 | United States |
| Memorial Hermann | Houston | Texas | 77030 | United States |
| UT Health | San Antonio | Texas | 78229 | United States |
| Universtiy of Vermont | Burlington | Vermont | 05405 | United States |
| MultiCare Institute for Research & Innovation | Tacoma | Washington | 98405 | United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| Marshfield Clinic Cancer Care & Research Center | Marshfield | Wisconsin | 54449 | United States |
| Froedtert and Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Rambam Medical Center | Haifa | Israel |
| Hadassah Medical Center | Jerusalem | 91120 | Israel |
| Shaare Tzedek Medical Center | Jerusalem | Israel |
| Rabin Medical Center | Petah Tikva | 49100 | 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 | 277-8577 | Japan |
| Ehime University Hospital | Tōon | Ehime | 791-0295 | Japan |
| Kurume University Hospital | Kurume | Fukuoka | Japan |
| Sapporo Medical University Hospital | Sapporo | Hokkaido | Japan |
| Iwate Medical University Hospital | Shiwa-gun | Iwate | 028-3695 | Japan |
| Tohoku University Hospital | Sendai | Myagi | Japan |
| National Defense Medical College Hospital | Tokorozawa | Saitama | 359-8513 | Japan |
| National Cancer Center Hospital | Chuo-ku | Tokyo | 104-0045 | Japan |
| Cancer Institute Hospital of Japanese Foundation for Cancer Research | Koto | Tokyo | 135-8550 | Japan |
| Niigata Cancer Center Hospital | Niigata | 951-8566 | Japan |
| Hokkaido University Hospital | Sapporo | 060-8648 | Japan |
| Centrum Badan Klinicznych Jagiellonskiego Centrum Innowacji | Krakow | 30-348 | Poland |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie | Olsztyn | 10-228 | Poland |
| MedPolonia Sp. z o.o. | Poznan | 60-375 | Poland |
| Parc Taulí Hospital Universitari Edifici Santa Fe, Planta 0, Sala de recerca 3 | Barcelona | 08208 | Spain |
| Institut Català d'Oncologia - Hospital Duran i Reynals | Barcelona | 08908 | Spain |
| Hospital Universitario de Donostia Edificio Onkologikoa- Planta baja, Sala de Ensayos Clinicos | Donostia / San Sebastian | 20014 | Spain |
| Hospital Gregorio Marañon Módulo prefabricado Oncología, Planta Baja | Madrid | 28009 | Spain |
| MD Anderson Cancer Center Madrid Unidad de ensayos Clinicos | Madrid | 28033 | Spain |
| Hospital Universitario Clínico San Carlos. | Madrid | 28040 | Spain |
| Hospital Universitario Virgen del Rocío Servicio Oncología Médica. Ensayos Clínicos. Edificio CDCA | Seville | 41013 | Spain |
| Instituto Valenciano de Oncología Médica (IVO | Valencia | 46009 | Spain |
| Consorcio Hospitalario General Universitario de Valencia Servicio de Oncología Médica - Unidad de Investigación | Valencia | 46014 | Spain |
| Derived |
| 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 1, 2023 | May 26, 2023 | 36 |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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