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A RANDOMIZED, OPEN-LABEL, MULTICENTER, PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AVELUMAB IN COMBINATION WITH CHEMOTHERAPY FOLLOWED BY MAINTENANCE THERAPY OF AVELUMAB IN COMBINATION WITH THE POLY (ADENOSINE DIPHOSPHATE [ADP]-RIBOSE) POLYMERASE (PARP) INHIBITOR TALAZOPARIB IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED OVARIAN CANCER (JAVELIN OVARIAN PARP100)

Trial Profile

A RANDOMIZED, OPEN-LABEL, MULTICENTER, PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AVELUMAB IN COMBINATION WITH CHEMOTHERAPY FOLLOWED BY MAINTENANCE THERAPY OF AVELUMAB IN COMBINATION WITH THE POLY (ADENOSINE DIPHOSPHATE [ADP]-RIBOSE) POLYMERASE (PARP) INHIBITOR TALAZOPARIB IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED OVARIAN CANCER (JAVELIN OVARIAN PARP100)

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 12 Sep 2019

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At a glance

  • Drugs Avelumab (Primary) ; Talazoparib (Primary) ; Bevacizumab; Carboplatin; Paclitaxel
  • Indications Carcinoma; Fallopian tube cancer; Ovarian cancer; Peritoneal cancer; Sarcoma
  • Focus Registrational; Therapeutic Use
  • Acronyms JAVELIN OVARIAN PARP 100
  • Sponsors Pfizer
  • Most Recent Events

    • 07 Aug 2019 Planned End Date changed from 18 May 2026 to 20 Nov 2021.
    • 07 Aug 2019 Planned primary completion date changed from 9 Feb 2022 to 20 Nov 2021.
    • 19 Mar 2019 According to a Merck KGaA media release, the alliance determined that the degree of benefit observed with avelumab in ovarian cancer in that study does not support continuation of this study in an unselected patient population and emphasizes the need to better understand the role of immunotherapy in ovarian cancer. Additional factors include the rapidly changing treatment landscape and the approval of a PARP inhibitor.This decision was not made due to safety reasons.
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