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)
Phase 3
186
about 4.2 years
18+
Female only
31 sites in AL, AZ, CA +16
What this study is about
This trial is testing a new treatment called Olvi-Vec combined with platinum chemotherapy and bevacizumab compared to standard chemotherapy and bevacizumab for women with ovarian cancer that has not responded to platinum drugs. The goal is to see if the new treatment improves outcomes in these patients.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Receive olvimulogene nanivacirepvec
- 2.Take Bevacizumab (or biosimilar)
- 3.Take Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicin
- +1 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You are randomly assigned, but you will know your treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
bevacizumab, cisplatin (Platinum chemotherapy; crosslinks DNA to stop replication), docetaxel, paclitaxel (Taxane chemotherapy; stabilizes microtubules), chemotherapy (Taxane chemotherapy; stabilizes microtubules), chemotherapy (Anthracycline chemotherapy; intercalates DNA and inhibits topoisomerase II)
infusion, injection, intravenous
Primary: 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: 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, Overall Survival in the ITT population, PFS by RECIST 1.1 in the modified ITT (mITT) population (participants who received at least 1 dose of treatment in either Arm), PFS by iRECIST in the ITT population
Oncology