A Phase III Study of Pomalidomide and Low Dose Dexamethasone With or Without Pembrolizumab (MK3475) in Refractory or Relapsed and Refractory Multiple Myeloma (rrMM) (KEYNOTE 183)

Trial Profile

A Phase III Study of Pomalidomide and Low Dose Dexamethasone With or Without Pembrolizumab (MK3475) in Refractory or Relapsed and Refractory Multiple Myeloma (rrMM) (KEYNOTE 183)

Suspended
Phase of Trial: Phase III

Latest Information Update: 09 Sep 2017

At a glance

  • Drugs Pembrolizumab (Primary) ; Pomalidomide (Primary) ; Dexamethasone
  • Indications Multiple myeloma
  • Focus Registrational; Therapeutic Use
  • Acronyms KEYNOTE-183
  • Sponsors Merck Sharp & Dohme
  • Most Recent Events

    • 05 Jul 2017 According to a Merck & Co. media release, this trial has been placed on full clinical hold by the US FDA due to safety concerns observed in KEYNOTE-183 and KEYNOTE-185 trials. All patients enrolled in this trial will discontinue investigational treatment with pembrolizumab.
    • 16 Jun 2017 Status changed from active, no longer recruiting to suspended.
    • 12 Jun 2017 According to a Merck & Co media release, the company has accepted the external Data Monitoring Committee recommendation to pause new enrollment in the study. The pause is to allow for additional information to be collected to better understand more reports of death in the KEYTRUDA groups. Patients currently enrolled in these two studies will continue to receive treatment.
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