A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy

Official Title

ATHENA (A Multicentre, 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)

Summary:

This is a Phase 3, randomized, multinational, double-blind, dual placebo-controlled, 4-arm study evaluating rucaparib and nivolumab as maintenance treatment following response to front-line treatment in newly diagnosed ovarian cancer patients. Response to treatment will be analyzed based on homologous recombination (HR) status of tumour samples.

Trial Description

Primary Outcome:

  • Investigator assessed Progression-free survival (PFS)
Secondary Outcome:
  • Blinded independent central review (BICR) PFS
  • Overall Survival (OS)
  • Objective response rate (ORR)
  • Duration of response (DOR)
  • Number of participants with treatment-emergent Adverse Events (AEs) as assessed by CTCAE v4 (or higher) as a measure of safety and tolerability
  • Number of participants with serious AEs as a measure of safety and tolerability
  • Number of participants with laboratory abnormalities as a measure of safety and tolerability

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society