MEDI4736 and Tremelimumab for 1st line head and neck cancer
Research type
Research Study
Full title
A Phase III Randomized, Open-label, Multi-center, Global Study of MEDI4736 in Combination with Tremelimumab versus Standard of Care in the Treatment of First-line Recurrent or Metastatic Squamous Cell Head and Neck Cancer Patients (KESTREL)
IRAS ID
194511
Contact name
Darron Green
Contact email
Sponsor organisation
AstraZeneca UK
Eudract number
2015-003589-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 10 months, 14 days
Research summary
This a phase III, Randomized, Open-label, Multi-centre, Global Study of MEDI4736 (1500 mg (IV) infusion every 4 weeks) alone or in combination with Tremelimumab (75 mg (IV) infusion 4 weekly versus standard of care in the treatment of first-line recurrent or metastatic squamous cell head and neck cancer patients (SCCHN).
A mandatory biopsy (fresh or archival within <3 years) will be needed for central testing of the PD-L1 expression status. Patients with positive and negative PD-L1 expression will be recruited into the study, but a result must be determined from the tumour biopsy.
The co-primary objective of the study is to assess the efficacy of MEDI4736 + tremelimumab combination therapy compared to standard of care (SOC) in terms of progression free survival (PFS) according to RECIST v1.1 and overall survival (OS).
Approximately 628 patients will be evaluated and will be randomised in a 2:1:1 (50%,25% and 25%) to the following treatments:
• MEDI4736 in combination with tremelimumab
• MEDI4736 monotherapy
• Standard of Care (SOC)There is no maximum duration of treatment as patients should continue on their randomized treatment until a treatment discontinuation criterion is met or until confirmed disease progression according to RECIST v1.1 for confirmation of progression. They may also receive treatment beyond progression if the treatment shows clinical benefit, as judged by the Investigator. Following disease progression and treatment discontinuation, patients will be followed for survival.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
15/EM/0546
Date of REC Opinion
12 Jan 2016
REC opinion
Further Information Favourable Opinion