A Phase II, Open-label, 1:1 Randomized, Controlled Trial Exploring the Efficacy of EMD 1201081 in Combination With Cetuximab in Second-Line Cetuximab-Naive Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN).

Trial Profile

A Phase II, Open-label, 1:1 Randomized, Controlled Trial Exploring the Efficacy of EMD 1201081 in Combination With Cetuximab in Second-Line Cetuximab-Naive Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN).

Completed
Phase of Trial: Phase II

Latest Information Update: 21 Oct 2014

At a glance

  • Drugs IMO 2055 (Primary) ; Cetuximab
  • Indications Head and neck cancer
  • Focus Therapeutic Use
  • Acronyms EMD 1201081
  • Sponsors EMD Serono
  • Most Recent Events

    • 07 Jun 2012 Planned number of patients changed from 105 to 107 and additional location (Netherlands) added as reported by European Clinical Trials Database record.
    • 03 May 2012 Primary endpoint 'Progression-free-survival-duration' has not been met.
    • 03 May 2012 Actual patient numbers amended from 104 to 106 as reported by Idera Pharmaceuticals.
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