AstraZeneca resumes enrollment for head/neck cancer trials after hold lifted
AstraZeneca announced that the U.S. FDA has lifted the partial clinical hold on the enrollment of new patients with head and neck squamous cell carcinoma for clinical trials of durvalumab as monotherapy and in combination with tremelimumab or other potential medicines. The Phase 3 KESTREL trial has already re-opened for new patient enrollment at some clinical study sites and the EAGLE trial is expected to resume recruitment shortly, without amendments to either protocol. AstraZeneca will progressively resume enrollment for all HNSCC trials across the participating sites in the U.S. and globally, subject to national health authority and ethics committee approval where required. The status of active recruitment will be reflected on clinicaltrials.gov in the coming days. The partial clinical hold on new patient enrollment was communicated on October 27, after preliminary findings from ongoing clinical trials related specifically to head and neck cancer. The FDA lifted the partial clinical hold following a review of the comprehensive analysis provided by AstraZeneca of bleeding events that were observed as part of the routine safety monitoring of the Phase 3 KESTREL and EAGLE trials.