MORPHEUS CRC
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 METASTATIC COLORECTAL CANCER (MORPHEUS-CRC)
IRAS ID
275619
Contact name
Naureen Starling
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2017-004566-99
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 1 months, 24 days
Research summary
This is a phase Ib/II, open-label, multicentre, randomised, umbrella study in patients with metastatic colorectal cancer (mCRC). Globally, colorectal cancer is the third most commonly diagnosed cancer in males and second in females. The current management of mCRC involves various active drugs that are used either in combination or as single agents. Once patients have exhausted first- and second-line treatment options, their survival is typically less than 6 months. Recently new drugs have been approved to treat mCRC patients, however they are known to have high levels of side-effects in the patients who take them. Therefore a high unmet need remains in this patient population for more efficacious treatment options with better safety profiles and for the development of combination treatments that will bring the benefit of cancer immunotherapies with their often long-lasting responses to patients with mCRC.
This study is designed to accelerate the development of CIT combinations by identifying early signals and establishing proof-of-concept clinical data in patients with mCRC. The study is designed with the flexibility to open new treatment arms as new treatment combinations become available and close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity. Patients will be randomly assigned to a treatment arm in Stage 1 after screening, and if patients experience disease progression, loss of clinical benefit, or unacceptable toxicity, they may be eligible to receive a different treatment combination in Stage 2.
A number of assessments will be performed, differing depending on which treatment arm and stage a patient is at during the study. Assessments may include physical examinations, blood and urine samples, ECOG performance status, echocardiograms, electrocardiograms, biopsies, Computed Tomography Scans (CT Scans) and/or Magnetic Resonance Imaging Scans (MRI Scans). These assessments will help to determine if the study drugs are effective and safe.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
22/SC/0229
Date of REC Opinion
27 Mar 2020
REC opinion
Further Information Favourable Opinion