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Phase 3 registrational study of Nelipepimut S in combination with trastuzumab in the patients with Triple-negative breast cancer (TNBC)

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Trial Profile

Phase 3 registrational study of Nelipepimut S in combination with trastuzumab in the patients with Triple-negative breast cancer (TNBC)

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 19 Feb 2020

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At a glance

  • Drugs Nelipepimut-S (Primary) ; Trastuzumab (Primary) ; Granulocyte macrophage colony stimulating factor
  • Indications Breast cancer; Triple negative breast cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Sellas Life Sciences Group

Most Recent Events

  • 14 Feb 2020 According to a Sellas Life Sciences Group media release, Elizabeth A. Mittendorf, is the Principal Investigator of this study.
  • 14 Feb 2020 According to a Sellas Life Sciences Group media release, company recieved feedback from a Type C review with the U.S. Food and Drug Administration (FDA).Based on written feedback from the FDA and on the totality of clinical, safety and translational NPS data presented to date, the Company has finalized the design and plan for this study.If successful, this study may be considered as the basis for a Biologics License Application (BLA) submission to the FDA.
  • 04 Mar 2019 New trial record

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