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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 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2026-03-18

No results posted yet for this 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.

Conditions

Interventions

BIOLOGICAL

olvimulogene nanivacirepvec

Olvi-Vec is an engineered oncolytic vaccinia virus

DRUG

Platinum chemotherapy: carboplatin (preferred) or cisplatin

Administered according to local practice

DRUG

Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicin

Administered according to local practice

DRUG

Bevacizumab (or biosimilar)

Administered according to local practice

Sponsors & Collaborators

  • GOG Foundation

    collaborator NETWORK

  • Genelux Corporation

    lead INDUSTRY

Principal Investigators

  • Robert W. Holloway, MD · AdventHealth Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2026-06-30
Completion
2026-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05281471 on ClinicalTrials.gov