Ovarian Cancer > Bevacizumab

Olvi-Vec + Chemotherapy for Ovarian Cancer (OnPrime Trial)

Recruiting in Palo Alto (17 mi)

+33 other locations

Overseen By Robert W Holloway, MD

Age: 18+

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Genelux Corporation

Must not be taking: Antivirals, Immunosuppressants, Steroids

Disqualifiers: CNS metastasis, HIV, Hepatitis, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you have received chemotherapy, radiotherapy, or other anti-cancer biologic therapies within 4 weeks prior to the planned treatment, or if you are receiving immunosuppressive therapy or steroids above a certain dose.

What data supports the effectiveness of the drug Olvi-Vec + Chemotherapy for Ovarian Cancer?

Research shows that adding bevacizumab (a drug that stops the growth of new blood vessels) to standard chemotherapy can improve the time patients live without their cancer getting worse, although it doesn't increase overall survival. This suggests that combining bevacizumab with chemotherapy might help control ovarian cancer for a longer period.

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Is the combination of Olvi-Vec and chemotherapy safe for treating ovarian cancer?

Bevacizumab, a component of the treatment, has been studied extensively and is generally considered safe for ovarian cancer, though it can cause side effects like high blood pressure, bleeding, and delayed wound healing. These side effects are usually manageable by doctors. The safety of Olvi-Vec specifically is not detailed in the provided research.

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What makes the Olvi-Vec + Chemotherapy treatment for ovarian cancer unique?

The Olvi-Vec + Chemotherapy treatment is unique because it combines a novel oncolytic virus therapy (Olvimulogene Nanivacirepvec) with standard chemotherapy and bevacizumab, potentially offering a new mechanism of action by using a virus to target cancer cells, which is different from traditional chemotherapy or bevacizumab alone.

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Eligibility Criteria

This trial is for women with ovarian cancer that's resistant to platinum-based treatments. They should have had at least three prior systemic therapies, a life expectancy of over six months, and no major health issues that would interfere with the treatment. Participants must not have had recent surgeries or other cancers in the last three years, among other criteria.

Inclusion Criteria

My cancer did not respond to platinum-based chemotherapy.

My ovarian cancer is of a specific type: high-grade serous, endometrioid, or clear-cell.

I am fully active or can carry out light work.

I have had at least 3 different treatments for my condition.

I have previously been treated with bevacizumab or a similar medication.

My cancer in the ovary, fallopian tube, or peritoneum cannot be surgically removed.

My cancer has spread to the lining of my abdomen.

I can safely receive treatments like carboplatin, cisplatin, or bevacizumab.

My cancer has worsened after my last treatment, as shown by scans.

I have at least one tumor that can be measured on a scan.

Exclusion Criteria

I do not have an active infection like a UTI or pneumonia.

My ovarian cancer is not of the mucinous, low-grade serous, squamous cell, small cell neuroendocrine, MMMT without epithelial component, or non-epithelial type.

I have fluid buildup due to cancer in my abdomen or chest.

I have had gene therapy or treatment with a virus that kills cancer cells.

I have an inflammatory bowel disease.

I have not had any other cancer types active in the last 3 years.

I am currently experiencing bleeding in my stomach or intestines.

I have a serious heart condition.

I am currently on immunosuppressive therapy or steroids.

I am currently taking medication for a virus.

My cancer has spread to my brain.

I have a history of HIV infection.

Participant Groups

The OnPrime study compares Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab against just platinum-doublet chemotherapy and bevacizumab. It aims to see if adding Olvi-Vec improves outcomes for those with tough-to-treat ovarian cancer.

Group I: Olvi-Vec + Platinum-doublet & bevacizumab Experimental Treatment 4 Interventions

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

Group II: Physician's Choice of Chemotherapy & bevacizumab Active Control 3 Interventions

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).

Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:

🇪🇺 Approved in European Union as Avastin for:

• Colorectal cancer
• Breast cancer
• Non-small cell lung cancer
• Renal cell carcinoma
• Ovarian cancer

🇺🇸 Approved in United States as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Glioblastoma
• Renal cell carcinoma
• Cervical cancer
• Ovarian cancer

🇯🇵 Approved in Japan as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

🇨🇦 Approved in Canada as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

Find A Clinic Near You

Research locations nearby Select from list below to view details:

AdventHealth Cancer Institute Orlando, FL

Holy Cross Hospital Silver Spring, MD

Providence Sacred Heart Medical Center & Children's Hospital Spokane, WA

City of Hope Duarte, CA

More Trial Locations

Who is running the clinical trial?

Genelux Corporation Lead Sponsor

GOG Foundation Collaborator

References

1. United States pubmed.ncbi.nlm.nih.gov

Phase III trials of standard chemotherapy with or without bevacizumab for ovarian cancer: a meta-analysis. [2021] Platinum-based standard chemotherapy improves survival of ovarian cancer (OC), but the five-year survival rate remains below 50%. Antiangiogenic agents (7.5 or 15 mg/kg Bevacizumab, Bev) plus to standard chemotherapy improve progression-free survival (PFS) not overall survival (OS) in completed randomized controlled trials (RCTs). The efficacy and safety of two doses of Bev + standard chemotherapy remain controversial.

2. United States pubmed.ncbi.nlm.nih.gov

OCEANS: a randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. [2022] This randomized, multicenter, blinded, placebo-controlled phase III trial tested the efficacy and safety of bevacizumab (BV) with gemcitabine and carboplatin (GC) compared with GC in platinum-sensitive recurrent ovarian, primary peritoneal, or fallopian tube cancer (ROC).

3. United States pubmed.ncbi.nlm.nih.gov

Comparison of bevacizumab alone or with chemotherapy in recurrent ovarian cancer patients. [2022] To compare the efficacy of chemotherapy (C) combined with bevacizumab (Bev) versus Bev alone in recurrent, heavily pretreated epithelial ovarian cancer (EOC).

4. Japan pubmed.ncbi.nlm.nih.gov

Heterogeneous effects of cytotoxic chemotherapies for platinum-resistant ovarian cancer. [2023] Single-agent chemotherapy with or without bevacizumab (Bev) is a standard therapy for platinum-resistant ovarian cancer (PR-OC). However, there is a lack of literature on chemotherapy agent selection in heterogenous PR-OC. Therefore, we aimed to clarify the heterogeneous treatment effects of each chemotherapy agent.

5. United States pubmed.ncbi.nlm.nih.gov

Combination gemcitabine, platinum, and bevacizumab for the treatment of recurrent ovarian cancer. [2022] To describe the response rate (RR), progression-free survival (PFS), and toxicity profile of combination gemcitabine, platinum, and bevacizumab (GPB) for the treatment of recurrent epithelial ovarian cancer (EOC).

6. Greece pubmed.ncbi.nlm.nih.gov

Adverse Events Associated With Long-term Treatment of Epithelial Ovarian Cancer With Bevacizumab and Chemotherapy. [2022] Adverse events associated with long-term bevacizumab administration for ovarian cancer have been poorly documented in Japan. This study aimed to evaluate the adverse events of bevacizumab combined with chemotherapy for treating primary and recurrent epithelial ovarian cancer in Japan.

7. New Zealand pubmed.ncbi.nlm.nih.gov

Critical appraisal of bevacizumab in the treatment of ovarian cancer. [2018] Bevacizumab is the first molecular-targeted agent to be used for the treatment of ovarian cancer. Bevacizumab is a humanized monoclonal antibody targeting vascular endothelial growth factor. Two randomized Phase III trials evaluated the combination of bevacizumab plus standard cytotoxic chemotherapy for first-line treatment of advanced ovarian cancer. Additional Phase III trials evaluated bevacizumab combined with cytotoxic chemotherapy in platinum-sensitive and platinum-resistant recurrent ovarian cancer. All these trials reported a statistically significant improvement in progression-free survival but not in overall survival. Furthermore, bevacizumab effectively improved the quality of life with regard to abdominal symptoms in recurrent ovarian cancer patients. Bevacizumab is associated with adverse events not commonly observed with cytotoxic agents used to treat gynecological cancers, such as hypertension, bleeding, thromboembolism, proteinuria, delayed wound healing, and gastrointestinal events. However, most of these events can be adequately managed by gynecologists. The clinical trial results with bevacizumab have supported its recent approval in Europe and the United States as a treatment for ovarian cancer. This review presents the latest evidence for bevacizumab therapy of ovarian cancer and describes selection of patients for personalized treatment.

8. Greece pubmed.ncbi.nlm.nih.gov

Bevacizumab in heavily pre-treated and platinum resistant ovarian cancer: a retrospective study of the North-Eastern German Society of Gynaecologic Oncology (NOGGO) Ovarian Cancer Study Group. [2022] Bevacizumab is an agent with a tolerable safety profile which was described to be effective in recurrent ovarian cancer in recent phase I and phase II trials. But it remains unclear if these characteristics can translate to the very special collective of heavily pre-treated ovarian cancer patients. The present analysis was conducted to answer questions regarding safety and efficacy for the use of bevacizumab in these patients.

9. New Zealand pubmed.ncbi.nlm.nih.gov

Retreatment with bevacizumab in patients with gynecologic malignancy is associated with clinical response and does not increase morbidity. [2021] Bevacizumab (Bev) is associated with improved progression-free survival in advanced epithelial ovarian cancer. The use of Bev in patients with gynecologic malignancy is increasing; however, little is known about cumulative toxicity and response in patients retreated with Bev. Our goal was to determine cumulative side effects and response in patients retreated with Bev.

10. United States pubmed.ncbi.nlm.nih.gov

Atezolizumab Combined With Bevacizumab and Platinum-Based Therapy for Platinum-Sensitive Ovarian Cancer: Placebo-Controlled Randomized Phase III ATALANTE/ENGOT-ov29 Trial. [2023] Platinum-based doublets with concurrent and maintenance bevacizumab are standard therapy for ovarian cancer (OC) relapsing after a platinum-free interval (PFI) >6 months. Immunotherapy may be synergistic with bevacizumab and chemotherapy.

11. United States pubmed.ncbi.nlm.nih.gov

Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: The AURELIA open-label randomized phase III trial. [2022] In platinum-resistant ovarian cancer (OC), single-agent chemotherapy is standard. Bevacizumab is active alone and in combination. AURELIA is the first randomized phase III trial to our knowledge combining bevacizumab with chemotherapy in platinum-resistant OC.

12. New Zealand pubmed.ncbi.nlm.nih.gov

Profile of bevacizumab in the treatment of platinum-resistant ovarian cancer: current perspectives. [2022] Patients with platinum-resistant ovarian cancer have progression of disease within 6 months of completing platinum-based chemotherapy. While several chemotherapeutic options exist for the treatment of platinum-resistant ovarian cancer, the overall response to any of these therapies is ~10%, with a median progression-free survival of 3-4 months and a median overall survival of 9-12 months. Bevacizumab (Avastin), a humanized, monoclonal antivascular endothelial growth factor antibody, has demonstrated antitumor activity in the platinum-resistant setting and was recently approved by US Food and Drug Administration for combination therapy with weekly paclitaxel, pegylated liposomal doxorubicin, or topotecan. This review summarizes key clinical trials investigating bevacizumab for recurrent, platinum-resistant ovarian cancer and provides an overview of efficacy, safety, and quality of life data relevant in this setting. While bevacizumab is currently the most studied and clinically available antiangiogenic therapy, we summarize recent studies highlighting novel alternatives, including vascular endothelial growth factor-trap, tyrosine kinase inhibitors, and angiopoietin inhibitor trebananib, and discuss their application for the treatment of platinum-resistant ovarian cancer.