Recruiting

Phase 3

Olvi-Vec & PlatinumEfficacy & 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)

Sponsor:

Genelux Corporation

Code:

NCT05281471

Conditions

Platinum-resistant Ovarian Cancer

Platinum-refractory Ovarian Cancer

Fallopian Tube Cancer

Primary Peritoneal Cancer

High-grade Serous Ovarian Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

olvimulogene nanivacirepvec

Platinum chemotherapy: carboplatin (preferred) or cisplatin

Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicin

Bevacizumab (or biosimilar)

Study Details

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.

Conditions

Platinum-resistant Ovarian Cancer

Platinum-refractory Ovarian Cancer

Fallopian Tube Cancer

Primary Peritoneal Cancer

High-grade Serous Ovarian Cancer

Study ID

NCT05281471

Start date

Aug 31, 2022

Status verified date

Aug, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Prior malignancy of other histology active within previous 3 years except for locally curable cancers apparently cured such as basal/squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of cervix or breast, any other stage I/II local malignancies.
Received chemotherapy, radiotherapy, other anti-cancer biologic therapies within 4 weeks prior to planned treatment.
Underwent surgery within 4 weeks, or have insufficient recovery from surgical-related trauma or wound healing, prior to first study treatment in either Arm.
Receiving immunosuppressive therapy or steroids (except acute concurrent corticosteroid of no more than 20 mg per day for medical management with prednisolone equivalent.
Symptomatic malignant ascites or pleural effusions defined as rapidly progressive ascites with abdominal distension and gastrointestinal dysfunction, pleural effusions with respiratory difficulties requiring frequent paracentesis > once every 14 days.
Known hypersensitivity to gentamicin.

Study Design

Enrollment

186 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Olvi-Vec + Platinum-doublet & bevacizumab

Olvi-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

active comparator: Physician's Choice of Chemotherapy & bevacizumab

Physician'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

olvimulogene nanivacirepvec

Olvi-Vec is an engineered oncolytic vaccinia virus

Platinum chemotherapy: carboplatin (preferred) or cisplatin

Administered according to local practice

Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicin

Administered according to local practice

Bevacizumab (or biosimilar)

Administered according to local practice

Primary outcome measure

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) [ Time Frame: From date of randomization up to 12 months ]

Central Contacts and Locations

Locations

The University of South Alabama, Mitchell Cancer Institute

Recruiting

Mobile, Alabama, United States, 36604

Contacts

Stefanie White

251-445-9834 swhite@southalabama.edu

Principal Investigator:

Jennifer Pierce, MD

University of Arizona Cancer Center

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Mitzi Miranda

520-626-0950 MMiranda@uacc.arizona.edu

Brianna Loughran

520-626-0939 bloughran@arizona.edu

Principal Investigator:

Setsuko K. Chambers, MD

City of Hope

Recruiting

Duarte, California, United States, 91010

Contacts

Edward Wang, MD, PhD

877-467-3411 edwang@coh.org

Principal Investigator:

Edward Wang, MD, PhD

UC San Diego Health - Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

Contacts

Erika Peterson

858-822-5352 espeterson@health.ucsd.edu

Principal Investigator:

Michael McHale, MD

Hoag Gynecologic Oncology

Recruiting

Newport Beach, California, United States, 92663

Contacts

Esmeralda Martinez

949-764-5827 Esmeralda.Martinez@hoag.org

Principal Investigator:

Alberto Mendivil, MD

UCI Health Chao Family Comprehensive Cancer Center

Recruiting

Orange, California, United States, 92868

Contacts

Krishnansu S. Tewari, MD

714-456-7971 ktewari@hs.uci.edu

Principal Investigator:

Krishnansu S. Tewari, MD

AdventHealth Cancer Institute

Recruiting

Orlando, Florida, United States, 32804

Contacts

Karla Hernandez-Cruz

407-609-3462 orl.gynoncologyresearch@AdventHealth.com

Principal Investigator:

Robert W Holloway, MD

Sarasota Memorial Healthcare System

Recruiting

Sarasota, Florida, United States, 34239

Contacts

Sarasota Memorial Healthcare System

941-917-2225 ResearchInstitute@smh.com

Principal Investigator:

Toni Kilts, DO

Women's Cancer Associates with Women's Care Florida

Recruiting

St. Petersburg, Florida, United States, 33713

Contacts

Rebekah Little

727-826-0795 rebekah.little@baycare.org

Megan Indermaur

727-826-0795 mindermaur@womenscarefi.com

Principal Investigator:

Megan Indermaur, MD

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Winship Referrals

404-778-1900 winship.referrals@emoryhealthcare.org

Principal Investigator:

Jennifer Scalici, MD

Indiana University Simon Comprehensive Cancer Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Cheri West, RN

317-278-3021 chawest@iu.edu

Principal Investigator:

Jessica E. Parker, MD

Holy Cross Hospital

Recruiting

Silver Spring, Maryland, United States, 20910

Contacts

Lyudmila Igorevna Kalnitskaya, MBA, MS

301-754-7552 kalnitsl@holycrosshealth.org

Principal Investigator:

Frederick D Min, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Zhen Zhou

917-912-3028 zhenniz@med.umich.edu

Munira Hussain

734-936-8349 hussain@med.umich.edu

Principal Investigator:

Jean Siedel, MD

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Elizabeth Linnik

313-576-9764 linnike@karmanos.org

Principal Investigator:

Robert Morris, MD

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Lindsey Mayer

314-287-3877 lindseymayer@wustl.edu

Principal Investigator:

Premal Thaker, MD

Mercy Hospital St. Louis

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Enguday Teshome

314-251-0742 Enguday.teshome@mercy.net

Principal Investigator:

Madhavi Manyam, MD

Women's Cancer Center of Nevada

Recruiting

Las Vegas, Nevada, United States, 89106

Contacts

Thania Escamilla

702-851-4672 tescamilla@wccenter.com

Jacky Amador

702-851-4672 Jamador@wccenter.com

Principal Investigator:

Nicola M. Spirtos, MD

Center of Hope

Recruiting

Reno, Nevada, United States, 89511

Contacts

Peter Lim, MD

775-327-4611 Plim@cohreno.com

Principal Investigator:

Peter Lim, MD

Stony Brook Cancer Center

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Latrice Tribble-Jones

631-620-1814 latrice.tribble@stonybrookmedicine.edu

Xavier Geoffroy, MSN, RN

631-649-5701 xavier.geoffroy@stonybrookmedicine.edu

Principal Investigator:

Gabrielle Gossner, MD

Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Leah Wilson

980-442-2333 Leah.J.Wilson@atriumhealth.org

Principal Investigator:

Erin K Crane, MD

East Carolina University

Recruiting

Greenville, North Carolina, United States, 27834

Contacts

Grainger Lanneau, MD

252-816-2743 Grainger.Lanneau@ecuhealth.org

Principal Investigator:

Grainger Lanneau, MD

Atrium Health Wake Forest Baptist, Comprehensive Cancer Center

Recruiting

Winston-Salem, North Carolina, United States, 27157-0001

Contacts

Laurel K Berry, MD

704-355-2000 laurel.berry@wfusm.edu

Sydney McEntire

336-713-5879 sydney.mcentire@advocatehealth.org

Principal Investigator:

Laurel K Berry, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Barbara Bittel

216-390-2456 Bittelb@ccf.org

Principal Investigator:

Peter Rose, MD

OhioHealth Research Institute

Recruiting

Columbus, Ohio, United States, 43214

Contacts

Jennifer Sexton

614-788-3860 Jennifer.Sexton@ohiohealth.com

Principal Investigator:

Aine Clements, MD

Kettering Health

Recruiting

Kettering, Ohio, United States, 45429

Contacts

Daniel Geyer

937-395-6017 daniel.geyer@ketteringhealth.org

Principal Investigator:

Thomas J. Reid, MD

ProMedica Flower Hospital

Recruiting

Sylvania, Ohio, United States, 43560

Contacts

Carissa Jock

419-824-1011 Carissa.jock@promedica.org

Julie Moon

419-824-8812 Julie.moon@promedica.org

Principal Investigator:

Adam Walter, MD

Oklahoma University Health Stephenson Cancer Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Nikolas Williams

405-271-8001 nikolas-williams@ou.edu

Debra Richardson, MD

405-271-1112 debra-richardson@ou.edu

Principal Investigator:

Debra Richardson, MD

AHN West Penn Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Sarah Crafton, MD

412-578-1116 Sarah.Crafton@ahn.org

AHN Clinical Trial

412-359-3731 clinicaltrials@ahn.org

Principal Investigator:

Sarah Crafton, MD

Hollings Cancer Center

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Crystal Knox

843-792-2803 knoxc@musc.edu

Principal Investigator:

Brian Orr, MD

Erlanger Health, Inc.

Recruiting

Chattanooga, Tennessee, United States, 37403

Contacts

Lorraine Christensen

423-778-3902 Lorraine.Christensen@erlanger.org

Kimberly Donelson

423-778-3916 Kimberly.Donelson@erlanger.org

Principal Investigator:

Stephen DePasquale, MD

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Jan Sunde, MD

832-957-6500 jan.sunde@bcm.edu

Principal Investigator:

Jan Sunde, MD

University of Texas Science Center at Houston, McGovern Medical School

Recruiting

Houston, Texas, United States, 77030

Contacts

Gabrielle Hayes

713-704-4137 gabrielle.a.hayes@uth.tmc.edu

Principal Investigator:

Joseph Lucci, III, MD

Providence Sacred Heart Medical Center & Children's Hospital

Recruiting

Spokane, Washington, United States, 99204

Contacts

Jodie Mactagone, CRC

509-474-3821 Jodie.mactagone@providence.org

Principal Investigator:

Melanie Bergman, MD

More Information

Sponsor

Genelux Corporation

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

olvimulogene nanivacirepvec
GL-ONC1
GLV-1h68
oncolytic virus
virotherapy
viral therapy
immunotherapy
immunochemotherapy
combination therapy
vaccinia virus
ovarian cancer
fallopian tube cancer
primary peritoneal cancer
platinum resistant
platinum refractory
recurrent ovarian cancer
platinum resensitization
chemoresistance
heavily pre-treated
immune activation
reversal of platinum resistance or refractoriness
resensitize

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-04. This information was provided to ClinicalTrials.gov by Genelux Corporation on 2026-08-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.