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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization until death or study completion; assessed up to 36 months
Awards & highlights
OnPrime Trial 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.Check my eligibility
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.See study design
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.
OnPrime Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
I am fully active or can carry out light work.
Select...
I have had at least 3 different treatments for my condition.
Select...
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.
Select...
My cancer has spread to the lining of my abdomen.
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I can safely receive treatments like carboplatin, cisplatin, or bevacizumab.
Select...
My cancer has worsened after my last treatment, as shown by scans.
Select...
I have at least one tumor that can be measured on a scan.
OnPrime Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreOnPrime 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: Platinum-doublet & bevacizumabActive Control3 Interventions
Platinum-doublet & bevacizumab (or biosimilar) administered beginning in Week 0
Find a Location
Who is running the clinical trial?
GOG FoundationNETWORK
42 Previous Clinical Trials
16,555 Total Patients Enrolled
8 Trials studying Ovarian Cancer
3,279 Patients Enrolled for Ovarian Cancer
Genelux CorporationLead Sponsor
6 Previous Clinical Trials
131 Total Patients Enrolled
1 Trials studying Ovarian Cancer
46 Patients Enrolled for Ovarian Cancer
Robert W Holloway, MDPrincipal InvestigatorOnPrime Study
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 have not had a bowel obstruction in the last 3 months.I am fully active or can carry out light work.I do not have an active infection like a UTI or pneumonia.I have had at least 3 different treatments for my condition.I have not had a blood clot in the last 3 months.I have previously been treated with bevacizumab or a similar medication.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.You are allergic to gentamicin.My cancer in the ovary, fallopian tube, or peritoneum cannot be surgically removed.It's been 3-15 months since my last platinum-based cancer treatment.My cancer has spread to the lining of my abdomen.I have had gene therapy or treatment with a virus that kills cancer cells.I haven't had cancer treatment like chemo or radiation in the last 4 weeks.I have not had a stroke or similar brain event in the last 6 months.Your oxygen level is less than 90%.I have an inflammatory bowel disease.I have not had any other cancer types active in the last 3 years.You are expected to live for at least 6 more months.I am currently experiencing bleeding in my stomach or intestines.You have a current hepatitis B or hepatitis C infection within the past 4 weeks.I have a serious heart condition.My kidney, liver, blood, and immune system are functioning well.I am currently on immunosuppressive therapy or steroids.I had surgery less than 4 weeks ago.I can safely receive treatments like carboplatin, cisplatin, or bevacizumab.My cancer has worsened after my last treatment, as shown by scans.I am currently taking medication for a virus.My cancer has spread to my brain.I have a history of HIV infection.I have at least one tumor that can be measured on a scan.
Research Study Groups:
This trial has the following groups:- Group 1: Olvi-Vec + Platinum-doublet & bevacizumab
- Group 2: Platinum-doublet & bevacizumab
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are allowed to enroll in this experiment?
"That is correct, the online information shows that this clinical trial is still searching for subjects. The posting date was August 31st, 2022 and there was a recent update on September 1st, 2022. They need 186 individuals from 2 locations."
Answered by AI
Are people still being signed up for this experiment?
"The latest information on clinicaltrials.gov suggests that this trial is still recruiting patients. The study, which was first announced on 8/31/2022, is looking for 186 individuals who are willing to participate at 2 different sites."
Answered by AI
Does olvimulogene nanivacirepvec have official government backing?
"There is some efficacy data and multiple rounds of safety data from Phase 3 trials, so olvimulogene nanivacirepvec received a score of 3 for safety."
Answered by AI
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