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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)

ConditionsPlatinum-resistant Ovarian CancerPlatinum-refractory Ovarian CancerFallopian Tube CancerPrimary Peritoneal CancerHigh-grade Serous Ovarian CancerEndometrioid Ovarian CancerOvarian Clear Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorGenelux Corporation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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], endometrioid, or clear-cell ovarian cancer.

Performance status ECOG of 0 or 1.

Life expectancy of at least 6 months.

Disqualifiers

Tumors of mucinous, low-grade serous, squamous cell, small cell neuroendocrine subtypes, MMMT tumors absent an epithelial component on recent biopsy, or non-epithelial ovarian cancers (e.g., germ cell tumors, Sex-cord tumors).

Bowel obstruction within last 3 months prior to screening.

Active urinary tract infection, pneumonia, other systemic infections.

Active gastrointestinal bleeding.

Trial design

Design model

Parallel

Treatments tested in this trial

  • olvimulogene nanivacirepvec

    Biological/Vaccine

    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

Treatment groups

186 Participants
are divided into 2 treatment groups
Group A: Olvi-Vec + Platinum-doublet & bevacizumabExperimental treatment 4 interventions
Group B: Physician's Choice of Chemotherapy & bevacizumabActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

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)

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

Time frame
From date of randomization up to 12 months

Secondary outcomes

1

Incidence of Treatment-emergent Adverse Events in the ITT population

Determine safety and tolerability of administering multiple doses of Olvi-Vec via intraperitoneal catheter in combination with platinum-doublet and bevacizumab (or biosimilar) as assessed by CTCAE v. 5.0 following initiation of study treatment until end of study participation.

Time frame
From date of first study treatment until death or study completion; assessed up to 36 months
2

Duration of Response (DOR) by RECIST 1.1 in the ITT population

Time from date of first response until the first date of progressive disease based on radiological assessment.

Time frame
From date of randomization up to 12 months
3

PFS by RECIST 1.1 in the modified ITT (mITT) population (participants who received at least 1 dose of treatment in either Arm)

Time from randomization to first documented disease progression based on radiological assessment or death from any cause.

Time frame
From date of randomization up to 12 months
4

PFS by iRECIST in the ITT population

Time from randomization to first documented disease progression with confirmatory imaging scan performed 4-8 weeks after unconfirmed disease progression or death from any cause.

Time frame
From date of randomization up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Genelux Corporation

Lead sponsor

GOG Foundation

Collaborator

Source ClinicalTrials.gov
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