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)

Conditions

• Endometrioid Ovarian Cancer
• Fallopian Tube Cancer
• High-grade Serous Ovarian Cancer
• Ovarian Clear Cell Carcinoma
• Platinum-refractory Ovarian Cancer
• Platinum-resistant Ovarian Cancer
• Primary Peritoneal Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• olvimulogene nanivacirepvec — BIOLOGICAL
  Olvi-Vec is an engineered oncolytic vaccinia virus
• Platinum chemotherapy: carboplatin (preferred) or cisplatin — DRUG
  Administered according to local practice
• Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicin — DRUG
  Administered according to local practice
• Bevacizumab (or biosimilar) — DRUG
  Administered according to local practice

Study Details

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.

Key Dates

Start date

Aug 31, 2022

Status verified

Mar 2026

Primary completion

Jun 30, 2026

Completion

Oct 31, 2026

Study Design

Enrollment

186 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Olvi-Vec + Platinum-doublet & bevacizumab
  Olvi-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
• Active Comparator: Physician's Choice of Chemotherapy & bevacizumab
  Physician'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).

Primary Outcome Measure

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) [ Time Frame: From date of randomization up to 12 months ]

Locations (31)

Find similar trials in Mobile, AL

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