A Randomized Phase 3 Study Assessing the Efficacy and Safety of Olvi-Vec followed by Platinum-doublet Chemotherapy and Bevacizumab Compared with Platinum-doublet Chemotherapy and Bevacizumab in Women with Platinum-Resistant/Refractory Ovarian Cancer (OnPrime Study)

Cancer Categories

Gynecologic

Karmanos Trial ID

GOG-3076

NCT ID

NCT05281471

Age Group

Adult

Scope

National

Phase

Phase III

Principal Investigator

Robert
Morris, M.D.
Oncology - Gynecologic, Oncology - Surgical View Profile

Objective:

Primary Objective:

The primary objective is to determine Progression-free Survival (PFS) by RECIST 1.1.

Key Secondary Objectives:

To determine Objective Response Rate (ORR) and Duration of Response (DOR) by RECIST 1.1, PFS by RECIST 1.1 (in modified population), PFS by iRECIST, Overall Survival (OS), and safety.

Key Other Objectives:

To determine ORR by the Gynecological Cancer Intergroup (GCIG) CA-125 criteria, and Clinical Benefit Rate [CBR = (CR + PR + SD ≥ 15 weeks)/total # of patients evaluated by RECIST 1.1 or iRECIST]. Additional analyses of efficacy endpoints in modified population are included.

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Eligibility

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 less than or equal to 24 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.

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