WAKING: Wnt and checKpoint INhibition in Gastric cancer
Research type
Research Study
Full title
A multicentre phase II non-randomised trial assessing the efficacy of DKN-01 plus atezolizumab in patients with advanced mismatch repair proficient oesophagogastric cancer
IRAS ID
254810
Contact name
DAVID CUNNINGHAM
Contact email
Sponsor organisation
THE ROYAL MARSDEN NHS FOUNDATION
Eudract number
2018-004138-13
Clinicaltrials.gov Identifier
CCR 4976, CCR 4976 WAKING
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
WAKING is a phase II clinical trial, which will be carried out at The Royal Marsden Hospital and other hospitals in the U.K. The study is open to patients with metastatic cancer of the food pipe or stomach which was initially treated with chemotherapy but now has either grown or spread to another part of the body. The trial is in two parts, the first part will determine which dose of DKN-01 in combination with atezolizumab is safe and tolerable (how much any side effect can be sensibly tolerated) and the second part will assess how effective the combination of DKN-01 and atezolizumab is at shrinking down the cancer after starting treatment.
The study will be recruiting patients for a period of 24 months and it is expected that 52 patients will be included in the study.
During this study patients are required to have tissue removed from their tumour (called biopsies) either by endoscopy (a tiny camera inserted into the food pipe or stomach) or an image-guided biopsy using an ultrasound scan or CT scan depending upon where their disease is. A total of 3 biopsies will be taken; within the 4 week period before starting on the study drugs, within 2 weeks of receiving the first dose the DKN-01 treatment and after 4 weeks of the combination of DKN-01 and atezolizumab treatment. There is also an additional optional biopsy if the patient’s cancer worsens. These biopsies are critically important to help to understand the possible association between biological markers within tumour tissue and how well the study drugs work. In the future, this might help determine which people respond best to these study drugs.
REC name
London - Westminster Research Ethics Committee
REC reference
19/LO/1199
Date of REC Opinion
16 Oct 2019
REC opinion
Further Information Favourable Opinion