Durvalumab With or Without Tremelimumab in Resectable Locally Advanced Squamous Cell Carcinoma of the Oral Cavity
Status:
Recruiting
Trial end date:
2022-03-31
Target enrollment:
Participant gender:
Summary
This is a randomized, open-label, prospective, pilot phase I/II study with focus on
translational research and on the evaluation of the biological changes that are observed in
sequential tumor tissue acquisition in patients with newly diagnosed advanced (stage IV) oral
cavity SCC. Patients are treated with Durvalumab (arm A) or Durvalumab + Tremelimumab (arm B)
after biopsy-confirmed diagnosis of locally advanced resectable SCCHN of the oral cavity.
After surgery, the standard of care treatment is radiotherapy, and, depending on risk
assessment concurrent cisplatin. Patients will be treated with Durvalumab (arm A) or
Durvalumab and Tremelimumab (arm B) during six additional cycles, starting from day one of
the postoperative radiotherapy.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Universitaire Ziekenhuizen Leuven
Collaborators:
AstraZeneca European Organisation for Research and Treatment of Cancer - EORTC Vlaams Instituut voor Biotechnologie (VIB)