CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 186 target
Drug / intervention
olvimulogene nanivacirepvec +3 morebiological
Likely dose
Not stated in record
Key inclusion· 12
  • ✓Histologically confirmed non-resectable ovarian, fallopian tube or primary peritoneal cancer
  • ✓High-grade serous, endometrioid, or clear-cell ovarian cancer (including MMMT with high-grade epithelial component)
  • ✓ECOG performance status 0 or 1
  • ✓Life expectancy of at least 6 months
Key exclusion· 21
  • ✕Mucinous, low-grade serous, squamous cell, small cell neuroendocrine subtypes or non-epithelial cancers
  • ✕Bowel obstruction within last 3 months
  • ✕Active urinary tract infection, pneumonia, or other systemic infections
  • ✕Active gastrointestinal bleeding

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT05281471Phase 3RecruitingMonitorUpdated 3mo ago · Completion was 1mo ago
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A Randomized Phase 3 Study Assessing the Efficacy and Safety of Olvi-Vec Followed by Platinum-doublet Chemotherapy and Bevacizumab Compared With Physician's Choice of Chemotherapy and Bevacizumab in Women With Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)

Genelux Corporation·interventional·Posted Mar 16, 2022·Updated Mar 18, 2026

In Brief

A Phase 3 clinical trial evaluating olvimulogene nanivacirepvec, Platinum chemotherapy: carboplatin (preferred) or cisplatin, and 2 other interventions for Platinum-resistant Ovarian Cancer and 6 related conditions. Currently recruiting, targeting 186 participants across 31 sites.

Signals

Enrolling slower than its timeline implies

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPlatinum-resistant Ovarian Cancer, Platinum-refractory Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, High-grade Serous Ovarian Cancer, Endometrioid Ovarian Cancer, Ovarian Clear Cell Carcinoma
CountriesUnited States
CollaboratorsGOG Foundation

Timeline

Phase 3Recruiting
2023202420252026
First PostedMar 16, 2022
Enrollment StartAug 31, 2022
Primary CompletionJun 1, 2026
Study CompletionOct 1, 2026
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 4.3 years ago

Interventions

olvimulogene nanivacirepvecbiological

Olvi-Vec is an engineered oncolytic vaccinia virus

Platinum chemotherapy: carboplatin (preferred) or cisplatindrug

Administered according to local practice

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

Administered according to local practice

Bevacizumab (or biosimilar)drug

Administered according to local practice