Phase 2 study in Patients with Recurrent or Metastatic SCCHN
Research type
Research Study
Full title
A Phase II, Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 Monotherapy, Tremelimumab Monotherapy, and MEDI4736 in Combination with Tremelimumab in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
IRAS ID
164909
Contact name
Hisham Mehanna
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2014-003717-29
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 7 months, 16 days
Research summary
The aim of this phase 2 study is to determine the efficacy and safety of MEDI4736 monotherapy, tremelimumab monotherapy, and MEDI4736 + tremelimumab combination therapy in the treatment of participants with a type of head and neck cancer called squamous cell carcinoma of the head and neck (SCCHN). SCCHN patients whose cancer is recurrent (i.e. returned) or metastatic (i.e. a cancer that has spread) and were previously treated with a platinum-based medicine but their cancer continued to progress during or after treatment will be invited to participate. Participants within this group will be invited to have their cancer analysed to see if their cancer finds to be negative to a protein called PD-L1.
Participants will be randomised in a stratified manner according to prognostic factors (human papilloma virus status, smoking status, and anatomic location of primary tumour) to achieve a balance between treatments for each of the factors. Participants will be randomised in a 1:1:2 fashion to MEDI4736 monotherapy, tremelimumab monotherapy, or MEDI4736 + tremelimumab combination therapy.
Approximately 240 participants will take part in approximately 110 clinical study sites across Europe, Canada and USA.
Treatment with MEDI4736 monotherapy, tremelimumab monotherapy, or MEDI4736 + tremelimumab combination therapy will commence on Day 0 following confirmation of eligibility and randomisation. Participants will be treated with their assigned study medication (MEDI4736 monotherapy, tremelimumab monotherapy, or MEDI4736 + tremelimumab combination therapy) for a maximum of 12 months or until confirmed disease progression (unless, in the Investigator's opinion, the participant continues to receive benefit from the treatment and after discussion with the Sponsor), initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criterion is met.
Following completion or discontinuation of treatment, participants will enter a follow-up period.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
15/NE/0149
Date of REC Opinion
27 May 2015
REC opinion
Further Information Favourable Opinion