Phase 1-2 Study of ADXS11-001 or MEDI4736 Alone or Combination In Previously Treated Locally Advanced or Metastatic Cervical or HPV+ Head & Neck Cancer

Trial Profile

Phase 1-2 Study of ADXS11-001 or MEDI4736 Alone or Combination In Previously Treated Locally Advanced or Metastatic Cervical or HPV+ Head & Neck Cancer

Suspended
Phase of Trial: Phase I/II

Latest Information Update: 16 Mar 2018

At a glance

  • Drugs Axalimogene filolisbac (Primary) ; Durvalumab (Primary)
  • Indications Cervical cancer; Head and neck cancer
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Advaxis
  • Most Recent Events

    • 12 Mar 2018 According to an Advaxis, Inc. media release, The US FDA has placed IND for this trial on clinical hold as of 9 March 2018. The clinical hold pertains to a submission of a safety report to the FDA regarding a patient death involving respiratory failure which occurred following the sixth combination cycle. Enrollment and further dosing are on hold in this trial.
    • 12 Mar 2018 According to an Advaxis, Inc. media release, status changed from recruiting to suspended.
    • 13 Jun 2017 According to an Advaxis media release, case study data from this trial presented at annual Investor & Analyst Day.
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