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
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
- 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.