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# FDA Clinical Hold on Advaxis Cancer Study
- URL: https://www.fdaweb.com/fda-clinical-hold-on-advaxis-cancer-study/
- Published: 2018-03-13T12:00:00.000Z
- Updated: 2026-09-14T23:52:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140968

FDA has placed on clinical hold an Advaxis IND for a Phase 1/2 combination study of axalimogene filolisbac with AstraZeneca’s Imfinzi (durvalumab) for treating patients with advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer. The company says the hold was in response to a recent safety report submission regarding a Grade 5 serious adverse event (patient death) on 2/27 involving respiratory failure which occurred following the sixth combination cycle in the trial. Enrollment and further dosing are on hold in the trial while the company, AstraZeneca and FDA work closely with the site investigator to review the event in detail and to resolve the hold, it says.