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Angiogenesis Inhibitor

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

Phase 3

Recruiting

Led By Robert W Holloway, MD

Research Sponsored by Genelux Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Platinum-resistant or -refractory disease based on platinum-free interval

High-grade serous, endometrioid, or clear-cell ovarian cancer

Must not have

Active urinary tract infection, pneumonia, other systemic infections

Tumors of mucinous, low-grade serous, squamous cell, small cell neuroendocrine subtypes, MMMT tumors absent an epithelial component, or non-epithelial ovarian cancers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of randomization until death or study completion; assessed up to 36 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment option for women with ovarian cancer that has stopped responding to other treatments.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions related to immune system activation (like inflammation), typical chemo side effects such as nausea, fatigue, hair loss, blood cell count changes leading to increased infection risk or bleeding problems, and potential complications from bevacizumab like high blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer did not respond to platinum-based chemotherapy.

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

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I am fully active or can carry out light work.

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

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

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

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My cancer has spread to the lining of my abdomen.

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

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

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

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I have an inflammatory bowel disease.

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

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I am currently experiencing bleeding in my stomach or intestines.

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I have a serious heart condition.

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I am currently on immunosuppressive therapy or steroids.

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I am currently taking medication for a virus.

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My cancer has spread to my brain.

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I have a history of HIV infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of randomization until death or study completion; assessed up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of randomization until death or study completion; assessed up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until death or study completion; assessed up to 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival (PFS) by RECIST 1.1 in the Intention-to-Treat (ITT) population (all randomized participants regardless of whether they received any dose of treatment)

Secondary study objectives

Duration of Response (DOR) by RECIST 1.1 in the ITT population

Incidence of Treatment-emergent Adverse Events in the ITT population

Overall Response Rate (ORR) by RECIST 1.1 in the ITT population

+3 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Olvi-Vec + Platinum-doublet & bevacizumabExperimental Treatment4 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 & bevacizumabActive Control3 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).

0 / 22Eligibility criteria met