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)

Active:	Yes
Cancer Type:	Gynecologic Cancers Ovarian Cancer Primary Peritoneal Cancer	NCT ID:	NCT05281471
Trial Phases:	Phase III	Protocol IDs:	Olvi-Vec-022 (primary) NCI-2023-04441 GOG-3076
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Genelux Corporation
NCI Full Details:	http://clinicaltrials.gov/show/NCT05281471

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.

Treatment Sites in Georgia

Emory University Hospital - Midtown
550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.