drugset / Trial / NCT02580058

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)

NCT02580058

Phase 3 Completed 566 enrolled Pfizer
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2015-12-21
Primary completion
2018-09-19
Completion
2022-07-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Avelumab Monoclonal antibody 10 mg/kg Intravenous
Subject Doxorubicin Other / unclassified 40 mg/m2 Intravenous

Indications