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olvimulogene nanivacirepvec

Phase 3

Platinum-resistant Ovarian Cancer | Monoclonal antibody | Oncology |Genelux Corporation|Last Updated: Mar 18, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment186
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05281471Efficacy & 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)PHASE3 RECRUITING 186Aug 31, 2022Oct 1, 2026Mar 18, 202631 United States
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Study Endpoints
Primary Endpoints
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)
From date of randomization up to 12 months

To assess progression-free survival from time of randomization until first documented disease progression based on radiological assessment or death from any cause.

Secondary Endpoints
Incidence of Treatment-emergent Adverse Events in the ITT population
From date of first study treatment until death or study completion; assessed up to 36 months
Duration of Response (DOR) by RECIST 1.1 in the ITT population
From date of randomization up to 12 months
PFS by RECIST 1.1 in the modified ITT (mITT) population (participants who received at least 1 dose of treatment in either Arm)
From date of randomization up to 12 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Olvi-Vec + Platinum-doublet & bevacizumabEXPERIMENTALOlvi-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
Physician's Choice of Chemotherapy & bevacizumabACTIVE_COMPARATORPhysician'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).
Interventions
NameTypeDescription
olvimulogene nanivacirepvecBIOLOGICALOlvi-Vec is an engineered oncolytic vaccinia virus
Platinum chemotherapy: carboplatin (preferred) or cisplatinDRUGAdministered according to local practice
Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicinDRUGAdministered according to local practice
Bevacizumab (or biosimilar)DRUGAdministered according to local practice
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites31

Inclusion Criteria: * Histologically confirmed (from prior treatment) non-resectable ovarian, fallopian tube or primary peritoneal cancer. * High-grade serous \[including malignant mixed Mullerian tumor (MMMT) with metastasis that contains high-grade epithelial carcinoma, FIGO grades 2 \& 3 allowed...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05281471primaryCompletionDate: changed
LOWMay 24, 2026NCT05281471studyFirstPostDate: changed