A Phase 2/3 (Adaptive Design) Study of the Concomitant Administration of Indoximod or Placebo Plus Pembrolizumab or Nivolumab in Adult Patients With Unresectable Stage III or Stage IV Malignant Melanoma

Trial Profile

A Phase 2/3 (Adaptive Design) Study of the Concomitant Administration of Indoximod or Placebo Plus Pembrolizumab or Nivolumab in Adult Patients With Unresectable Stage III or Stage IV Malignant Melanoma

Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 30 May 2018

At a glance

  • Drugs Indoximod (Primary) ; Nivolumab (Primary) ; Pembrolizumab (Primary)
  • Indications Malignant melanoma
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms Indigo301
  • Sponsors NewLink Genetics Corporation
  • Most Recent Events

    • 15 Apr 2018 According to a NewLink Genetics Corporation media release, Company has determined that it will not initiate the randomization portion of this study, will evaluate the design, trial size and feasibility of an alternative randomized evaluation of indoximod in melanoma in the context of the failure of a competitors trial of its enzymatic IDO inhibitor in a similar clinical setting.
    • 01 Mar 2018 According to a NewLink Genetics Corporation media release, the company initiated dose determination portion in 2017 and anticipates initiating randomization portion in Q2-Q3 2018.
    • 28 Dec 2017 Status changed from not yet recruiting to recruiting.
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