A Phase II, Open-Label, Multicenter Trial to Investigate the Clinical Activity and Safety of Avelumab (MSB0010718C) in Subjects With Merkel Cell Carcinoma

Trial Profile

A Phase II, Open-Label, Multicenter Trial to Investigate the Clinical Activity and Safety of Avelumab (MSB0010718C) in Subjects With Merkel Cell Carcinoma

Recruiting
Phase of Trial: Phase II

Latest Information Update: 12 Oct 2017

At a glance

  • Drugs Avelumab (Primary)
  • Indications Merkel cell carcinoma
  • Focus Therapeutic Use
  • Acronyms JAVELIN Marker 200; JAVELIN Merkel 200
  • Sponsors EMD Serono; Merck KGaA
  • Most Recent Events

    • 12 Oct 2017 Results (n=88; data cut off: 12 months from enrolment of last subject ) assessing association between different types of adverse events and EQ-5D utility in avelumab treated patients, presented at the 20th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research.
    • 12 Oct 2017 Results (n=88) assessing association between tumour lesion size and health-related quality of life outcomes in patients with metastatic merkel cell carcinoma treated with avelumab, were presented at the 20th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research.
    • 27 Sep 2017 According to a Merck KGaA media release, based on the data from this trial, the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved BAVENCIO (avelumab, genetically recombinant Injection 200mg/mL for intravenous use) as the first and only treatment indicated for curatively unresectable Merkel cell carcinoma (MCC).
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