• No cap on the number of prior lines of therapy
• Primary & secondary platinum-refractory diseases also allowed
• No limitation on BRCA, HR or MMR status
• No requirement for specific tumor cell surface receptor or ligand
• Temporary catheter only in place for 1-2 weeks
• 2:1 chance of randomization into Experimental Arm

The OnPrime trial is a Phase 3 registrational trial.  The purpose of this research study is to determine how women diagnosed with platinum-resistant or platinum-refractory ovarian cancer will best respond to receiving Olvi-Vec followed by platinum- doublet chemotherapy (platinum-based chemotherapy such as carboplatin or cisplatin are given with a non-platinum based chemotherapy, including gemcitabine, paclitaxel, docetaxel, nab-paclitaxel, or pegylated liposomal doxorubicin [PLD]) along with bevacizumab, known as the Experimental Arm.  If successful, the study is expected to support FDA approval.

As a phase 3 trial, this study is the last phase of testing to be completed before the drug is submitted for regulatory approval and as such a randomized design is required. The study is designed to confirm the tested drug effectiveness, safety and also compare it to standard treatment.

Olvi-Vec is a type of experimental treatment using a modified Vaccinia virus, designed to target and kill cancer cells without harming normal tissues. Vaccinia virus naturally does not cause disease in humans. Olvi-Vec works by entering cancer cells, breaking them down, and releasing new virus particles that help further attack the cancer. This process can also boost the body’s immune response against the tumor and generate other favorable anti-tumor effects.

Platinum is known to be the most effective therapy available for ovarian cancer patients, however most patients will eventually become resistant or refractory to treatment.  In an earlier phase 2 trial (Holloway et al. JAMA Oncology, 2023; Holloway et al. Int J Gynecol Cancer, 2023), Olvi-Vec showed evidence of clinical reversal of platinum resistance or refractoriness in exemplary patients leading to potentially better outcomes then has been previously reported for this patient population.

Olvi-Vec is an experimental biologic and has not been approved by the U.S. Food and Drug Administration (FDA) and is not yet available for use outside of a clinical trial.

If you are eligible and consent to participating in this study, you will be randomly assigned to receive one of two treatment arms. The experimental arm will have twice as many patients as the active comparator arm (2:1 ratio):

• Experimental Arm:
  • Olvi-Vec – A total of 2 consecutive days of intraperitoneal catheter infusions in Week 0.
  • A catheter is surgically placed into the abdominal cavity (also known as the peritoneal cavity) 2-7 days before the first Olvi-Vec infusion and removed within 2-7 days after the last Olvi-Vec infusion.
  • Following catheter removal, you will receive platinum-doublet & bevacizumab (or biosimilar) administered as an intravenous infusion (IV) beginning in Week 4 or 5.
• Active Comparator Arm:
  • Study treatment either with one of the non-platinum drugs and bevacizumab or with the platinum-doublet chemotherapy and bevacizumab (or biosimilar) beginning in the first week (Week 0).

If your condition is clinically stable, your disease does not significantly progress and you are tolerating the study treatment, you may continue to receive either the platinum doublet therapy plus bevacizumab or one of the non-platinum chemotherapy drugs and bevacizumab (or biosimilar).

After completing treatment and long-term follow-up, the total time on study is approximately 3 years.

The following are the most commonly seen side effects from Olvi-Vec which usually are well managed with supportive care: gastrointestinal upsets such as nausea, vomiting and diarrhea; flu-like symptoms including fever, chills, cough, runny nose, sweating muscular aches, and pains; feeling tired/weak and headaches. Some women have also experienced abdominal pain and abdominal distension.

The experimental drug and any research-related procedures will be provided to you free of charge. You, or your insurance company, will be billed for those medications and treatments you would receive as the usual care for your disease. Please discuss expected costs with your study doctor.

You may be reimbursed for certain costs you acquire as a result of participating in this study. Your study team will provide you with the details, including amounts and any other requirements.