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)

Launched by GENELUX CORPORATION · Mar 7, 2022

Keywords

ClinConnect Summary

The OnPrime study is a clinical trial that is investigating a new treatment approach for women with certain types of ovarian cancer that have not responded well to standard chemotherapy, known as platinum-resistant or platinum-refractory ovarian cancer. This trial is comparing a new treatment called Olvi-Vec, followed by standard chemotherapy and a drug called bevacizumab, to the usual choice of chemotherapy and bevacizumab determined by doctors. The goal is to see if the new treatment can help patients feel better and live longer compared to the current standard treatment.

To participate, women must have a confirmed diagnosis of non-resectable ovarian, fallopian tube, or primary peritoneal cancer and must have received at least three prior treatments. Participants should also have measurable disease, meaning there are clear signs of cancer that can be monitored. The study is currently recruiting women aged 65 to 74 who meet these criteria. If you join the trial, you will receive close monitoring and care throughout the process, and the study aims to gather important information to potentially improve treatment options for future patients.

Gender

FEMALE

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.