MORPHEUS-TNBC
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 TRIPLE-NEGATIVE BREAST CANCER (MORPHEUS-TNBC)
IRAS ID
237296
Contact name
Peter Schmid
Contact email
Sponsor organisation
F. Hoffman-La Roche Ltd.
Eudract number
2017-002038-21
Duration of Study in the UK
3 years, 0 months, 23 days
Research summary
The purpose of this study is to compare the effects of different cancer immunotherapy (CIT) combinations versus standard treatment (chemotherapy) in patients with triple-negative breast cancer which has spread to other part of the body, to find out which is better. The number of available combinations may increase or decrease over the course of the study.
Patients will be randomised into treatment arms based on eligibility criteria and the stage of the study. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the patient population (e.g., with regard to prior anti-cancer treatment or biomarker status). If a patient’s disease gets worse while receiving Stage 1 treatment, they may be eligible to receive treatment with a different CIT combination during Stage 2.
A number of assessments will be performed, differing depending on which treatment arm a patient is on during the study. Assessments may include physical examinations, blood samples, ECOG performance status review, ophthalmologic examination, electrocardiograms, Multigated Acquisition (MUGA) scans, Computed Tomography (CT) scans, echocardiography (ECHO), Magnetic Resonance Imaging (MRI) scans, and/or biopsies. These assessments will help to determine if the study drugs are effective and safe.
The study will run at 2 centres in the UK and is sponsored by F. Hoffmann-La Roche Ltd.
REC name
London - South East Research Ethics Committee
REC reference
18/LO/0397
Date of REC Opinion
1 May 2018
REC opinion
Further Information Favourable Opinion