Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100)

Official Title

A Randomized, Open-label, Multicentre, Phase 3 Study To Evaluate The Efficacy And Safety Of Avelumab (msb0010718c) In Combination With And/or Following Chemotherapy In Patients With Previously Untreated Epithelial Ovarian Cancer Javelin Ovarian 100

Summary:

This is a Phase 3, open-label, international, multi-centre, efficacy, and safety study of avelumab in combination with and/or following platinum-based chemotherapy. Eligible patients must have previously untreated, histologically confirmed Stage II-IV epithelial ovarian (EOC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) and be candidates for platinum-based chemotherapy. The primary purpose of the study is to demonstrate if avelumab given as single agent in the maintenance setting following frontline chemotherapy or in combination with carboplatin/paclitaxel is superior to platinum-based chemotherapy alone followed by observation in this population of newly diagnosed ovarian cancer patients.

Trial Description

Primary Outcome:

  • Progression-Free Survival (PFS)
Secondary Outcome:
  • Overall Survival (OS)
  • Maintenance Progression-Free Survival (PFS)
  • Duration of Response (DR)
  • Objective Response Rate - Percentage of Participants With Objective Response
  • EuroQoL5 Dimension (EQ-5D-5L)
  • FOSI-18 [FACT Ovarian Symptom Index-18]
  • ADA [Anti-Drug Antibodies]
  • Presence or absence of predictive candidate biomarkers in tumour tissue
  • Area under the Concentration-Time Curve (AUC)
  • Cmax
  • Volume of Distribution
  • Clearance (CL)
  • Progression Free Survival 2 (PFS2)
  • pathological Complete response (pCR)

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