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ATHENA (A Multicenter, Randomized, Double-Blind, Placebo- Controlled Phase 3 Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy)

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Trial Profile

ATHENA (A Multicenter, Randomized, Double-Blind, Placebo- Controlled Phase 3 Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 20 Feb 2024

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At a glance

  • Drugs Nivolumab (Primary) ; Rucaparib (Primary)
  • Indications Carcinoma; Fallopian tube cancer; Ovarian cancer; Peritoneal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms ATHENA; ATHENA-COMBO; ATHENA-MONO
  • Sponsors Clovis Oncology [CEASED]; zr pharma

    • Most Recent Events

    • 09 Dec 2022 This trial has been completed in Finland according to European Clinical Trials Database record.
    • 13 Sep 2022 Results (data cutoff As of March 23, 2022 ) of subgroup analysis evaluating if all patients benefited from rucaparib 1L maintenance treatment, including those with more favourable prognostic factors at baseline, presented at the 47th European Society for Medical Oncology Congress
    • 13 Sep 2022 According to a Clovis Oncology media release, the FDA has recommended that the Company wait for more mature overall survival data from ATHENA-MONO to submit the sNDA or, if it chooses to submit the sNDA prior to receiving more mature overall survival data, then the sNDA may need to be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting. In addition, the FDA will consider overall survival data from other rucaparib clinical trials when it reviews the ATHENA-MONO dataset.
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