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RECRUITING Phase 3

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)

NCT05281471 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • BIOLOGICAL olvimulogene nanivacirepvec
  • DRUG Platinum chemotherapy: carboplatin (preferred) or cisplatin
  • DRUG Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicin
  • DRUG Bevacizumab (or biosimilar)

Study Locations (20)

California

  • City of Hope — Duarte
  • UC San Diego Health - Moores Cancer Center — La Jolla
  • Hoag Gynecologic Oncology — Newport Beach
  • UCI Health Chao Family Comprehensive Cancer Center — Orange

Florida

  • AdventHealth Cancer Institute — Orlando
  • Sarasota Memorial Research Institute — Sarasota

Michigan

  • University of Michigan — Ann Arbor
  • Karmanos Cancer Institute — Detroit

Missouri

  • Washington University School of Medicine — St Louis
  • Mercy Hospital St. Louis — St Louis

Nevada

  • Women's Cancer Center of Nevada — Las Vegas
  • Center of Hope — Reno

North Carolina

  • Levine Cancer Institute — Charlotte
  • East Carolina University — Greenville

Alabama

  • The University of South Alabama, Mitchell Cancer Institute — Mobile

Arizona

  • University of Arizona Cancer Center — Tucson

Trial Details

FieldValue
Enrollment Target 186 participants
Start Date 2022-08-31
Est. Completion 2026-10
Phase Phase 3

Sponsor

Genelux Corporation

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05281471

The ClinicalTrials.gov registry entry for NCT05281471 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 186 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genelux Corporation, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 7 conditions, with Fallopian Tube Cancer appearing as the primary indexed condition, and to 4 interventions — of which olvimulogene nanivacirepvec is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05281471 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05281471 about?

NCT05281471 is a clinical study titled "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)". 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 plat...

What is the current status of trial NCT05281471?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 186 participants. The study started on 2022-08-31. Estimated completion is 2026-10.

What conditions does trial NCT05281471 study?

This clinical trial studies the following conditions: Fallopian Tube Cancer, Primary Peritoneal Cancer, Platinum-resistant Ovarian Cancer, Ovarian Clear Cell Carcinoma, Endometrioid Ovarian Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05281471?

The interventions under investigation include: olvimulogene nanivacirepvec (BIOLOGICAL), Platinum chemotherapy: carboplatin (preferred) or cisplatin (DRUG), Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicin (DRUG), Bevacizumab (or biosimilar) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05281471?

This trial is sponsored by Genelux Corporation, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05281471 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial