A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer (JAVELIN Ovarian 200)

Official Title

A Phase 3, Multicentre, Randomized, Open-label Study Of Avelumab (msb0010718c) Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum-resistant/Refractory Ovarian Cancer

Summary:

A Phase 3 global study comparing avelumab alone to avelumab plus PLD and to PLD alone to demonstrate that avelumab given alone or in combination with PLD is superior to PLD alone in prolonging Overall Survival in patients with platinum resistant/platinum refractory ovarian cancer.

Trial Description

Primary Outcome:

  • Overall Survival (OS)
  • Progression Free Survival (PFS)
Secondary Outcome:
  • OR (Objective Response)
  • PFS (Progression Free Survival)
  • DR (Duration of Response)
  • DC (Disease Control)
  • Ctrough for avelumab
  • Cmax for avelumab
  • Cmax for PLD
  • Vd (volume of distribution) for PLD
  • CL (clearance) for PLD
  • AUC (area under the concentration time curve) for PLD
  • Incidence of Anti-Drug Antibody (ADA)
  • EORTC QLQ C30
  • EORTC QLQ OV28
  • FOSI
  • EuroQoL EQ 5D
  • Tumour Tissue Biomarkers
  • Nab (neutralizing antibodies) against avelumab

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