Study evaluating MEDI4736 + AZD9150/AZD5069 in solid tumors & RMSCCHN
Research type
Research Study
Full title
A Phase 1b/2, Open-Label, Multicentre Study Assessing the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumour Activity of MEDI4736 in Combination With AZD9150 or AZD5069 in Patients With Advanced Solid Malignancies and Subsequently Comparing AZD9150 and AZD5069 Both as Monotherapy and in Combination With MEDI4736 as Second Line Treatment in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
IRAS ID
189899
Contact name
Anthony Kong
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2015-002525-19
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 27 days
Research summary
This study is being carried out to see if the study drugs (AZD9150 or AZD5069, given with or without another study drug, MEDI4736) are effective in treating recurrent (returned after previous treatment) and/or metastatic (has spread to the other parts of the body) cancer (squamous cell carcinoma) of the head or neck. The aspects of the study that are experimental are the study drugs. The study drugs have not been studied long enough in cancer patients to be proven to be safe or effective yet. The study drugs are not approved for use in any country, except for use in research studies. The safety of the study drugs has not yet been well established, although there is some information about the safety of the drugs in humans and animals. Between 68 and 124 patients will take part at up to 40 study centres across Europe and North America. In all, 10 to 30 patients will be in each of 6 treatment groups.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
15/WM/0377
Date of REC Opinion
4 Jan 2016
REC opinion
Further Information Favourable Opinion