MO29112 Biomarker Driven Maintenance Treatment of Metastatic CRC
Research type
Research Study
Full title
A MULTI-CENTRE RANDOMISED CLINICAL TRIAL OF BIOMARKER-DRIVEN MAINTENANCE TREATMENT FOR FIRST-LINE METASTATIC COLORECTAL CANCER (MODUL)
IRAS ID
162679
Contact name
Head, EU/ROW Regulatory Affairs Pharmaceutical Division
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2014-001017-61
Duration of Study in the UK
6 years, 3 months, 9 days
Research summary
Colorectal cancer (CRC) is the second most common cancer in women and third most common in men worldwide. It is also the fourth leading cause of cancer deaths worldwide. Approximately 25% of patients with CRC have the primary cancer spread to another organ or tissue elsewhere in the body (metastases) when they are initially diagnosed, 50% will go on to develop this during their disease course.
Previously untreated metastatic colorectal cancer (mCRC) patients are treated with a combination of standard first line chemotherapy and a biologic agent called bevacizumab (induction treatment). The aim of the study is to look at whether the treatment following the induction, called maintenance treatment, is more effective when given according to the specific patient’s tumour molecular characteristics (biomarkers) than the standard treatment. The study will also look at side effects and safety of the study treatment in these patients.
There are 2 groups (cohorts) of patients in this study: Cohort 1 - patients with the BRAF mutation, and Cohort 2 - patients without the BRAF mutation. All patients will first receive standard induction treatment for 16 weeks. After this is completed, and if the mCRC has not worsened, patients can start maintenance treatment where they will either receive experimental treatment or standard treatment; this will be decided by chance by a computer, not by the doctor. Subject to ethical approval, other cohorts may be included in the future.
Cohort 1: Fluoropyrimidine, cetuximab and vemurafenib, or Fluoropyrimidine and bevacizumab
Cohort 2: Fluoropyrimidine, bevacizumab and MPDL3280A , or Fluoropyrimidine and bevacizumab
Treatment is given over 2 weeks, in repeating cycles.Drug treatment will continue until the patient’s disease worsens, the patient starts a different anti- cancer treatment, there is unacceptable toxicity, or the patient or study doctor decides to stop treatment.
A total of approximately 1680 patients will take part in the study globally with approximately 150 patients recruited at 15 UK sites.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
15/NW/0004
Date of REC Opinion
6 Feb 2015
REC opinion
Further Information Favourable Opinion