DYNAMIC (1741-GITCG)
Research type
Research Study
Full title
DKN-01/atezolizumab as second line treatment of biliarY tract cancer and in combiNAtion or not with paclitaxel as second line treatMent of esophagogastrIC cancer: a multi-center Phase II Trial
IRAS ID
265836
Contact name
Elizabeth Smyth
Contact email
Sponsor organisation
European Organisation for Research and Treatment of Cancer
Eudract number
2017-002887-42
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 30 days
Research summary
This study is for adults who have an oesophagogastric cancer (cancer of the gullet or stomach) or cancer of the biliary tract (bile ducts) that cannot be treated by surgery and where the disease has progressed or failed to respond after initial therapy.
Different types of treatments are currently available for patients with an oesophagogastric cancer or biliary tract cancer. The purpose of this study is to find out if giving a combination of new immunotherapy treatments called atezolizumab (Tecentriq) and DKN-01 is effective when given alone or together with paclitaxel chemotherapy in controlling oesophagogastric cancer. Patients with biliary tract cancer will be treated with atezolizumab and DKN01 without chemotherapy. The main aim of the study is to see if these combinations could shrink tumours more than currently available treatments. The safety of these combinations and whether there are any side effects in this study population will also be assessed.
Atezolizumab is already used to treat other types of cancer like bladder cancer. DKN-01 is an experimental treatment which is currently being studied as a therapy to treat patients with oesophagogastric cancer and other cancer types. The information from this study will help doctors learn more about atezolizumab combined with DKN-01 and paclitaxal as a treatment for an oesophagogastric cancer and the same combination without paclitaxal in biliary tract cancer.
The study will compare the effects of treatments using clinical examinations, regular scans and blood tests. The study has a translational research part where blood samples will also be analysed to understand the effects of the drugs.
This study will take place in NHS sites in the UK as part of a wider international study. The study is sponsored and coordinated by the EORTC (European Organisation for Research and Treatment of Cancer), a non-profit organisation based in Brussels.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
19/NW/0511
Date of REC Opinion
23 Sep 2019
REC opinion
Further Information Favourable Opinion