MORPHEUS-UC
Research type
Research Study
Full title
A PHASE Ib/II, OPEN-LABEL, MULTICENTER,RANDOMIZED UMBRELLA STUDY EVALUATINGTHE EFFICACY AND SAFETY OF MULTIPLEIMMUNOTHERAPY-BASED TREATMENTS ANDCOMBINATIONS IN PATIENTS WITH UROTHELIALCARCINOMA (MORPHEUS-UC)
IRAS ID
247918
Contact name
Thomas Powles
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2017-004634-28
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
Urothelial carcinoma (UC) is the most common cancer of the urinary system and it most often affects the bladder. Current treatments for metastatic UC(mUC) improve median survival from 6 to around 15 months. The overall 5-year survival rate for mUC remains very poor at approximately 5.2% and better treatment options are needed.
Immunotherapy drugs such as atezolizumab that direct body’s own immune system to fight cancer are currently being developed for treatment of UC. Atezolizumab is approved in the EU for treatment of mUC. In this study it will be tested alone and in combination with other drugs to find out the effectiveness and safety of the combinations in patients with locally advanced or metastatic UC after failure with platinum-containing chemotherapy.
The study consists of 2 stages. During Stage 1, patients will be randomly assigned to receive atezolizumab alone (control group) or atezolizumab in combination with either niraparib, enfortumab vedotin, Hu5F9-G4, isatuximab, linagliptin, or tocilizumab (experimental groups).
The study medication will be given in 21-28 day cycles until loss of clinical benefit or unacceptable toxicity.
After treatment discontinuation patients will be followed up every 3 months.
Each treatment group will first enrol 15-40 patients in the Preliminary phase. Treatment combinations that demonstrate clinical activity and acceptable safety will be used in the Expansion Phase. Additional 25 patients will be enrolled in each such treatment regimen group. The other treatments will be discontinued. A serial biopsy cohort may be opened for each Expansion phase treatment group. Such cohorts will enrol up to 15 patients who are willing and able to undergo additional biopsies.
In total up to 130−305 patients will be enrolled during Stage 1.
Patients who experience loss of clinical benefit or unacceptable toxicity in Stage 1 may be enrolled in Stage 2 to receive a different treatment combination.
Study assessments include physical examinations, vital signs, eye examinations, ECG, blood and urine tests, tumour biopsies, CT or MRI scans.
The study will run for 3-5 years at around 25 sites in the US, Korea and Europe, with 3 sites in the UK.REC name
London - South East Research Ethics Committee
REC reference
19/LO/0085
Date of REC Opinion
25 Jan 2019
REC opinion
Favourable Opinion