Title: A Phase 3 Randomized, Open-label, Multi-center, Global Study of MEDI4736 Alone or in Combination With Tremelimumab Versus Standard of Care in the Treatment of First-line Recurrent or Metastatic Squamous Cell Head and Neck Cancer Patients1
Principal Investigator: Tanguy Seiwert, The University of Chicago
Description: The open-label, phase 3 KESTREL trial (ClinicalTrials.gov Identifier: NCT02551159) is recruiting participants with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) to evaluate durvalumab with or without tremelimumab as first-line therapy compared with standard of care.
The study is randomly assigning patients 2:1:1 to receive durvalumab plus tremelimumab intravenously every 4 weeks, durvalumab alone every 4 weeks, or the standard of care EXTREME regimen (cetuximab, fluorouracil, cisplatin/carboplatin).
The co-primary endpoints are progression-free survival and overall survival. Investigators will also assess overall response rate, duration of response, the 12-month progression-free and overall survival rates, the 24-month overall survival rate, safety and tolerability, and health-related quality of life.
For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT02551159.
Status: This study is recruiting patients as of February 2, 2017.
Durvalumab is an engineered human IgG1 monoclonal antibody that blocks binding of programmed cell death ligand-1 (PD-L1) to PD-1 and CD80. Tremelimumab is a selective human IgG2 monoclonal antibody inhibitor of CTLA-4.
- ClinicalTrials.gov. Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer (KESTREL). NCT02551159. https://clinicaltrials.gov/ct2/show/NCT02551159. Updated November, 2016. Accessed February 2, 2017.