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)
Gynecologic Cancers
Ovarian Cancer
Primary Peritoneal Cancer
18 Years and older, Male and Female
Olvi-Vec-022 (primary)
NCI-2023-04441
GOG-3076
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.
Objectives
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 a single-cycle (2 infusions on two
consecutive days) of Olvi-Vec through an intraperitoneal catheter. The catheter is then
removed, and patients receive systemically administered platinum-doublet chemotherapy and
bevacizumab. The control arm receives the Physician's Choice of chemotherapy and
bevacizumab at the same dose and schedule. 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 as assessed by Blinded
Independent Central Review. 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.
Eligibility
- 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.
Treatment Sites in Georgia
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