MORPHEUS - GASTRIC CANCER
Research type
Research Study
Full title
A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED, UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE IMMUNOTHERAPY-BASED TREATMENT COMBINATIONS IN PATIENTS WITH LOCALLY ADVANCED UNRESECTABLE OR METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION CANCER (MORPHEUS-GASTRIC CANCER)
IRAS ID
230104
Contact name
Ian Chau
Contact email
Sponsor organisation
F. Hoffman-La Roche Ltd
Eudract number
2016-004529-17
Duration of Study in the UK
3 years, 1 months, 7 days
Research summary
Advanced gastric cancer remains a very deadly disease. Existing treatments improve median survival for the disease from 4 to 12 months. Because of such a poor prognosis new treatment options are required.
This study will compare the effects of various experimental treatment combinations against the standard treatments for advanced gastric cancer. During Stage 1 of the study patients will be enrolled in 2 cohorts. The First-Line cohort (1L) will consist of gastric cancer patients who have not received prior chemotherapy. The Second-Line (2L) Cohort will enrol patients who have progressed after receiving chemotherapy for gastric cancer. The standard treatment for 1L cohort will be mFOLFOX6 which will be compared to the combinations of mFOLFOX6 with Atezoizumab and Cobimetinib. In 2L cohort Ramucirumab+Paclitaxel (standard treatment) will be compared to the combinations of Atezoizumab with Cobimetinib, PEGPH20, BL-8040 and Linagliptin. Within each cohort patients will be randomly assigned to a treatment group. Both the patient and the study doctor will know the treatment assigned. The study medication will be given in 21-28 day cycles until progression of disease, loss of benefit or unacceptable toxicity. Patients who complete the study will be followed up every 3 months.
For each treatment group there will be a Preliminary phase and an Expansion phase. 15-40 patients will be enrolled in each treatment group in the Preliminary phase. Treatment regimens that display clinical activity and do not have unacceptable toxicity will be used in the Expansion Phase which will enrol additional 25 patients in each such treatment regimen group. The other treatments will be discontinued.
In total up to 148−357 patients will be enrolled during Stage 1.
Patients in 2L cohort who have progressed during Stage 1 will have an option to receive an experimental treatment during Stage 2 provided they satisfy the eligibility criteria and have not received the Stage 2 experimental treatment during Stage 1.
Study assessments include physical examinations, vital signs, ECG, ECHO or MUGA, eye examinations, blood and urine tests, tumour biopsies, CT or MRI scans.
The study will run for 3-5 years at approximately 22 sites in Asia, US and Europe with 2 UK sites.REC name
London - Westminster Research Ethics Committee
REC reference
18/LO/0500
Date of REC Opinion
26 Jun 2018
REC opinion
Further Information Favourable Opinion