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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)

RecruitingPhase 3

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)

Who can join

Ages 18 and older · Women

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: Genelux Corporation · Participants: 186 · Started: Aug 31, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05281471

Locations in the U.S.

AlabamaThe University of South Alabama, Mitchell Cancer Institute, Mobile
ArizonaUniversity of Arizona Cancer Center, Tucson
CaliforniaCity of Hope, Duarte
UC San Diego Health - Moores Cancer Center, La Jolla
Hoag Gynecologic Oncology, Newport Beach
UCI Health Chao Family Comprehensive Cancer Center, Orange
FloridaAdventHealth Cancer Institute, Orlando
Sarasota Memorial Healthcare System, Sarasota
Women's Cancer Associates with Women's Care Florida, St. Petersburg
GeorgiaEmory University, Atlanta
IndianaIndiana University Simon Comprehensive Cancer Center, Indianapolis
MarylandHoly Cross Hospital, Silver Spring
MichiganUniversity of Michigan, Ann Arbor
Karmanos Cancer Institute, Detroit
MissouriMercy Hospital St. Louis, St Louis
Washington University School of Medicine, St Louis
NevadaWomen's Cancer Center of Nevada, Las Vegas
Center of Hope, Reno
New YorkStony Brook Cancer Center, Stony Brook
North CarolinaLevine Cancer Institute, Charlotte
East Carolina University, Greenville
Atrium Health Wake Forest Baptist, Comprehensive Cancer Center, Winston-Salem
OhioCleveland Clinic, Cleveland
OhioHealth Research Institute, Columbus
Kettering Health, Kettering
ProMedica Flower Hospital, Sylvania
OklahomaOklahoma University Health Stephenson Cancer Center, Oklahoma City
PennsylvaniaAHN West Penn Hospital, Pittsburgh
South CarolinaHollings Cancer Center, Charleston
TennesseeErlanger Health, Inc., Chattanooga
TexasBaylor College of Medicine, Houston
University of Texas Science Center at Houston, McGovern Medical School, Houston
WashingtonProvidence Sacred Heart Medical Center & Children's Hospital, Spokane

Conditions

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.