Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Platinum-doublet + Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (OnPrime, GOG-3076)

  • STATUS
    Recruiting
  • End date
    Oct 23, 2026
  • participants needed
    186
  • sponsor
    Genelux Corporation
Updated on 7 October 2022
paclitaxel
carcinoma
doxorubicin
cavity
metastasis
carboplatin
gemcitabine
bevacizumab
docetaxel
cancer chemotherapy
ovarian cancer
taxane
peritoneal cancer
cancer of the ovary

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 platinum-doublet chemotherapy and bevacizumab in women diagnosed with platinum-resistant/refractory ovarian cancer (includes fallopian tube cancer and primary peritoneal cancer).

Description

Olvi-Vec (olvimulogene nanivacirepvec, aka GL-ONC1, laboratory name: GLV-1h68) is an oncolytic vaccinia virus-based immunotherapy. This study is to test the hypothesis that the combination of Olvi-Vec followed by further chemotherapy is particularly effective against established tumors by virus-mediated immune activation and re-sensitization of tumor cells to chemotherapy. Participant population includes histologically confirmed non-resectable platinum-resistant/refractory ovarian cancer (PRROC). Determination of progression-free survival, safety and overall survival are key objectives. Participants randomized into the Experimental Arm will receive intraperitoneal infusion of Olvi-Vec through a catheter in addition to platinum-doublet chemotherapy and bevacizumab. Treatment in the Active Comparator Arm allows the same platinum-doublet chemotherapy and bevacizumab as the Experimental Arm. Biological samples will be obtained from some Experimental Arm participants for virus-shedding testing. Assessment of response to treatment in both arms will be by RECIST 1.1 and iRECIST. Maintenance/continued treatment with non-platinum chemotherapy and bevacizumab is dependent on a participant being clinically stable until confirmed progressive disease by iRECIST or can no longer tolerate therapy.

Dr. Robert W. Holloway (AdventHealth Cancer Institute, Orlando, FL) will serve as the National Principal Investigator for this Phase 3 study in PRROC.

Details
Condition Platinum-resistant Ovarian Cancer, Platinum-refractory Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, High-grade Serous Ovarian Cancer, Endometrioid Ovarian Cancer, Ovarian Clear Cell Carcinoma
Treatment 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)
Clinical Study IdentifierNCT05281471
SponsorGenelux Corporation
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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
Time from Last Platinum of 3-15 months since the last dose of platinum in the most recent platinum-based line of therapy (excluding using platinum as a radiosensitizer) until consent into this trial
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
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