The US Food and Drug Administration (FDA) has now lifted the partial clinical hold preventing enrolment of new patients with head and neck squamous cell carcinoma (HNSCC) in clinical trials evaluating durvalumab as monotherapy and in combination with tremelimumab or other potential medicines.
The drugmaker has resumed the Phase III Kestrel trial by enrolling new patients at select clinical study locations.
The Eagle trial is likely to resume patient recruitment in the coming days, without changes to any of the protocols.
Subject to approvals from the national health authority and ethics committee, AstraZeneca will gradually continue patient enrollment for all HNSCC trials in the participating clinical sites in the US and other countries.
Last month, the FDA imposed a partial clinical hold on new patient enrolment in the HNSCC trials after observing bleeding in some patients.
The bleeding events were part of the standard safety monitoring of the Phase III Kestrel and Eagle trials, said the pharma company.
It added that bleeding is a common complication in head and neck cancer treatments, because of the nature of the underlying disease, the proximity of tumours to major blood vessels and use of prior cancer therapies, which could involve surgery and radiation.