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Olvi-Vec: A total of 2 consecutive days of intraperitoneal catheter infusions in Week 0

Platinum-doublet \& bevacizumab (or biosimilar) administered beginning in Week 4 (preferred), but no later than Week 5

Physician's Choice of chemotherapy \& bevacizumab (or biosimilar) administered beginning in Week 0. Physician's Choice of chemotherapy includes either a single agent non-platinum chemotherapy, or as platinum chemotherapy is allowed as an option, a platinum-doublet (i.e., platinum agent combined with a non-platinum agent).

Olvi-Vec is an engineered oncolytic vaccinia virus

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)

Stefanie White

Jennifer M Scalici, MD

Claudia Al Khairi

Setsuko K. Chambers, MD

Edward Wang, MD, PhD

Alexandrea Cronin

Michael McHale, MD

Ramez Eskander, MD

Esmeralda Martinez

Alberto Mendivil, MD

Krishnansu S. Tewari, MD

Karla Hernandez-Cruz

Robert W Holloway, MD

Monica Rengifo Pardo, MD

Matthew L. Anderson, MD, PhD

Megan Indermaur, MD

Rebekah Little, CRC

Cheri West, RN

Jessica E. Parker, MD

Lyudmila Igorevna Kalnitskaya, MBA, MS

James F Barter, MD

Robert Morris, MD

Linda Odibo

Premal Thaker, MD

Crystal Tindall, BSN, RN

Jessica Black

Dan-Arin Silasi, MD

Peter Lim, MD

Leah Wilson

Erin K Crane, MD

Jackie Ludwig

Peter Rose, MD

Daniel Geyer

Tammy Bonham

Thomas J. Reid, MD

Debra Richardson, MD

Ashma Acharya

Sarah Crafton, MD

Crystal Knox

Whitney S Graybill, MD

Stephen DePasquale, MD

Kim Donelson, LPN CCRP

Jodie Mactagone, CRC

Melanie Bergman, MD

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.

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.

Randomization (2:1) is either into the Experimental Arm which is Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab or into the Active Comparator Arm which is Physician's Choice of chemotherapy and bevacizumab.

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)

A Randomized Phase 3 Study Assessing the Efficacy and Safety of Olvi-Vec Followed by Platinum-doublet Chemotherapy and Bevacizumab Compared With Physician's Choice of Chemotherapy and Bevacizumab in Women With Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)

To assess progression-free survival from time of randomization until first documented disease progression based on radiological assessment or death from any cause.

Determine safety and tolerability of administering multiple doses of Olvi-Vec via intraperitoneal catheter in combination with platinum-doublet and bevacizumab (or biosimilar) as assessed by CTCAE v. 5.0 following initiation of study treatment until end of study participation.

Time from date of first response until the first date of progressive disease based on radiological assessment.

Time from randomization to first documented disease progression based on radiological assessment or death from any cause.

Time from randomization to first documented disease progression with confirmatory imaging scan performed 4-8 weeks after unconfirmed disease progression or death from any cause.

Ratio of the sum of CR \& PR divided by the number of ITT participants from start of treatment to confirmation of response.

Time from randomization until date of death from any cause.

GOG Foundation

Genelux Corporation

Spots Global Cancer Trial Database for platinum chemotherapy: carboplatin (preferred) or cisplatin