Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)
A Randomized Phase 3 Study Assessing the Efficacy and Safety of Olvi-Vec Followed by Platinum-doublet Chemotherapy and Bevacizumab Compared With Physician's Choice of Chemotherapy and Bevacizumab in Women With Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)
2 other identifiers
interventional
186
1 country
31
Brief Summary
The OnPrime study is a multi-center, randomized open-label phase 3 study evaluating the safety and efficacy of Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab compared to the Active Comparator Arm with Physician's Choice of chemotherapy and bevacizumab in women diagnosed with platinum-resistant/refractory ovarian cancer (includes fallopian tube cancer and primary peritoneal cancer). This Phase III trial builds on the efficacy and safety data reported in the previous Phase II VIRO-15 trial with promising objective response rate and progression-free survival observed in heavily pre-treated patients with platinum-resistant/refractory ovarian cancer. The phase II results also showed that the intra-peritoneal route of delivery was efficient in generating tumor cell killing and immune activation, and led to clinical reversal of platinum-resistance or refractoriness in this difficult-to-treat patient population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2022
Typical duration for phase_3
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2022
CompletedFirst Posted
Study publicly available on registry
March 16, 2022
CompletedStudy Start
First participant enrolled
August 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
ExpectedMarch 18, 2026
March 1, 2026
3.8 years
March 7, 2022
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS) by RECIST 1.1 in the Intention-to-Treat (ITT) population (all randomized participants regardless of whether they received any dose of treatment)
To assess progression-free survival from time of randomization until first documented disease progression based on radiological assessment or death from any cause.
From date of randomization up to 12 months
Secondary Outcomes (6)
Incidence of Treatment-emergent Adverse Events in the ITT population
From date of first study treatment until death or study completion; assessed up to 36 months
Duration of Response (DOR) by RECIST 1.1 in the ITT population
From date of randomization up to 12 months
PFS by RECIST 1.1 in the modified ITT (mITT) population (participants who received at least 1 dose of treatment in either Arm)
From date of randomization up to 12 months
PFS by iRECIST in the ITT population
From date of randomization up to 12 months
Overall Response Rate (ORR) by RECIST 1.1 in the ITT population
From date of randomization up to 12 months
- +1 more secondary outcomes
Study Arms (2)
Olvi-Vec + Platinum-doublet & bevacizumab
EXPERIMENTALOlvi-Vec: A total of 2 consecutive days of intraperitoneal catheter infusions in Week 0 Platinum-doublet \& bevacizumab (or biosimilar) administered beginning in Week 4 (preferred), but no later than Week 5
Physician's Choice of Chemotherapy & bevacizumab
ACTIVE COMPARATORPhysician's Choice of chemotherapy \& bevacizumab (or biosimilar) administered beginning in Week 0. Physician's Choice of chemotherapy includes either a single agent non-platinum chemotherapy, or as platinum chemotherapy is allowed as an option, a platinum-doublet (i.e., platinum agent combined with a non-platinum agent).
Interventions
Olvi-Vec is an engineered oncolytic vaccinia virus
Administered according to local practice
Administered according to local practice
Administered according to local practice
Eligibility Criteria
You may qualify if:
- Histologically confirmed (from prior treatment) non-resectable ovarian, fallopian tube or primary peritoneal cancer.
- High-grade serous \[including malignant mixed Mullerian tumor (MMMT) with metastasis that contains high-grade epithelial carcinoma, FIGO grades 2 \& 3 allowed\], endometrioid, or clear-cell ovarian cancer.
- Performance status ECOG of 0 or 1.
- Life expectancy of at least 6 months.
- Received a minimum of 3 prior lines (including the 1st line) of systemic therapy with no maximal limit.
- Platinum-resistant or -refractory disease based on platinum-free interval (PFI) from the last dose of the most recent. platinum-based line of therapy (must have received a minimum of 2 doses of platinum in that line) to subsequent disease progression based on radiological assessment. Platinum-refractory: PFI of \< 1 month (including disease progression while on platinum-based therapy). Platinum-resistant: PFI of 1-6 months.
- Received prior bevacizumab (or biosimilar) treatment.
- No contraindication to receive carboplatin, cisplatin or bevacizumab (or biosimilar).
- Have disease progression after last prior line of therapy based on radiological assessment prior to randomization.
- At least 1 measurable target lesion per RECIST 1.1 based on abdominal/pelvis imaging scan at screening.
- Evidence by CT and/or PET scans or physical exam of abdominal/pelvis region likely having disease in the peritoneal cavity (i.e., peritoneal carcinomatosis).
- Adequate renal, hepatic, bone marrow function, adequate coagulation tests, adequate immune function by lymphocyte count.
You may not qualify if:
- Tumors of mucinous, low-grade serous, squamous cell, small cell neuroendocrine subtypes, MMMT tumors absent an epithelial component on recent biopsy, or non-epithelial ovarian cancers (e.g., germ cell tumors, Sex-cord tumors).
- Bowel obstruction within last 3 months prior to screening.
- Active urinary tract infection, pneumonia, other systemic infections.
- Active gastrointestinal bleeding.
- Known current central nervous system (CNS) metastasis.
- Inflammatory diseases of the bowel.
- History of HIV infection.
- Active hepatitis B virus or hepatitis C virus within 4 weeks prior to study.
- History of thromboembolic event within the prior 3 months.
- Contraindications for intraperitoneal (IP) catheter placement: Bowel obstruction with distended abdomen, rigid abdomen with bulky anterior wall carcinomatosis, abdominal wall hernia mesh that precludes laparoscopic entry to abdomen.
- Clinically significant cardiac disease at screening (New York Heart Association Class III/IV).
- Acute cerebrovascular event(s) such as cerebrovascular accident (CVA) or transient ischemic attack (TIA) in previous 6 months.
- Oxygen saturation \<90%.
- Received prior virus-based gene therapy or therapy with cytolytic virus of any type.
- Receiving concurrent antiviral agent.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genelux Corporationlead
- GOG Foundationcollaborator
Study Sites (31)
The University of South Alabama, Mitchell Cancer Institute
Mobile, Alabama, 36604, United States
University of Arizona Cancer Center
Tucson, Arizona, 85719, United States
City of Hope
Duarte, California, 91010, United States
UC San Diego Health - Moores Cancer Center
La Jolla, California, 92093, United States
Hoag Gynecologic Oncology
Newport Beach, California, 92663, United States
UCI Health Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
AdventHealth Cancer Institute
Orlando, Florida, 32804, United States
Sarasota Memorial Research Institute
Sarasota, Florida, 34239, United States
Emory University
Atlanta, Georgia, 30322, United States
Indiana University Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202, United States
Holy Cross Hospital
Silver Spring, Maryland, 20910, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Mercy Hospital St. Louis
St Louis, Missouri, 63141, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89106, United States
Center of Hope
Reno, Nevada, 89511, United States
Stony Brook Cancer Center
Stony Brook, New York, 11794, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
East Carolina University
Greenville, North Carolina, 27834, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
OhioHealth Research Institute
Columbus, Ohio, 43214, United States
Kettering Health
Kettering, Ohio, 45429, United States
ProMedica Flower Hospital
Sylvania, Ohio, 43560, United States
Oklahoma University Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
AHN West Penn Hospital
Pittsburgh, Pennsylvania, 15224, United States
Hollings Cancer Center
Charleston, South Carolina, 29425, United States
Erlanger Health, Inc.
Chattanooga, Tennessee, 37403, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Texas Science Center at Houston, McGovern Medical School
Houston, Texas, 77030, United States
Providence Sacred Heart Medical Center & Children's Hospital
Spokane, Washington, 99204, United States
Related Publications (5)
Mori KM, Giuliano PD, Lopez KL, King MM, Bohart R, Goldstein BH. Pronounced clinical response following the oncolytic vaccinia virus GL-ONC1 and chemotherapy in a heavily pretreated ovarian cancer patient. Anticancer Drugs. 2019 Nov;30(10):1064-1066. doi: 10.1097/CAD.0000000000000836.
PMID: 31567308BACKGROUNDManyam M, Stephens AJ, Kennard JA, LeBlanc J, Ahmad S, Kendrick JE, Holloway RW. A phase 1b study of intraperitoneal oncolytic viral immunotherapy in platinum-resistant or refractory ovarian cancer. Gynecol Oncol. 2021 Dec;163(3):481-489. doi: 10.1016/j.ygyno.2021.10.069. Epub 2021 Oct 20.
PMID: 34686353RESULTHolloway RW, Mendivil AA, Kendrick JE, Abaid LN, Brown JV, Fitzsimmons CK, Kennard JA, King M, LeBlanc J, Lopez K, Manyam M, McKenzie ND, Mori KM, Stephens AJ, Sarfraz A. 2020 International Gynecologic Cancer Society, Oral Plenary Session presentation of VIRO-15 Phase 2 Trial Data, Robert Holloway, AdventHealth Cancer Institute, Orlando, FL. International Journal of Gynecologic Cancer 2020;30:A9-A10
RESULTHolloway RW, Mendivil AA, Kendrick JE, Abaid LN, Brown JV, LeBlanc J, McKenzie ND, Mori KM, Ahmad S. Clinical Activity of Olvimulogene Nanivacirepvec-Primed Immunochemotherapy in Heavily Pretreated Patients With Platinum-Resistant or Platinum-Refractory Ovarian Cancer: The Nonrandomized Phase 2 VIRO-15 Clinical Trial. JAMA Oncol. 2023 Jul 1;9(7):903-908. doi: 10.1001/jamaoncol.2023.1007.
PMID: 37227734RESULTHolloway RW, Thaker P, Mendivil AA, Ahmad S, Al-Niaimi AN, Barter J, Beck T, Chambers SK, Coleman RL, Crafton SM, Crane E, Ramez E, Ghamande S, Graybill W, Herzog T, Indermaur MD, John VS, Landrum L, Lim PC, Lucci JA, McHale M, Monk BJ, Moore KN, Morris R, O'Malley DM, Reid TJ, Richardson D, Rose PG, Scalici JM, Silasi DA, Tewari K, Wang EW. A phase III, multicenter, randomized study of olvimulogene nanivacirepvec followed by platinum-doublet chemotherapy and bevacizumab compared with platinum-doublet chemotherapy and bevacizumab in women with platinum-resistant/refractory ovarian cancer. Int J Gynecol Cancer. 2023 Sep 4;33(9):1458-1463. doi: 10.1136/ijgc-2023-004812.
PMID: 37666539DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert W. Holloway, MD
AdventHealth Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2022
First Posted
March 16, 2022
Study Start
August 31, 2022
Primary Completion
June 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
March 18, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share