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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)

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Trial Profile

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)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 17 May 2025

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At a glance

  • Drugs Olvimulogene nanivacirepvec (Primary) ; Bevacizumab; Carboplatin; Cisplatin; Docetaxel; Doxorubicin liposomal; Gemcitabine; Paclitaxel
  • Indications Carcinoma; Fallopian tube cancer; Ovarian cancer; Peritoneal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms OnPrime
  • Sponsors Genelux Corporation

Most Recent Events

  • 28 Mar 2025 According to a Genelux Corporation media release, The Company anticipates reporting topline data in the first half of 2026.
  • 25 Mar 2025 According to a Genelux Corporation media release, an interim analysis of overall survival (OS) is planned at the time of the primary PFS analysis. The FDA further recommended Genelux request a pre-BLA meeting with FDA with topline safety and efficacy data following completion of the study to discuss next steps. Company looks forward to reporting topline safety and efficacy data in the first half of 2026.
  • 25 Mar 2025 According to a Genelux Corporation media release, company today announced that is has concluded a productive Type D meeting with the U.S. Food and Drug Administration (FDA) for Olvi-Vec in the treatment of platinum resistant/refractory ovarian cancer (PRROC), to discuss the FDA's expectations with respect to the requirements necessary for the granting of traditional approval of Olvi-Vec.

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