MPDL3280A-Early phase study in patients with solid tumours
Research type
Research Study
Full title
AN EARLY-PHASE, MULTICENTER, OPEN-LABEL STUDY OF THE SAFETY AND PHARMACOKINETICS OF ANTI−PD-L1 ANTIBODY (MPDL3280A) IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH PREVIOUSLY TREATED SOLID TUMORS
IRAS ID
174561
Contact name
Head, EU / International Pharmaceuticals Division, PDR
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2014-004697-41
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
MPDL3280A is a new PD-L1 antibody (immunotherapy medication) designed to enable the body’s immune system to better recognise and kill cancer cells. The purpose of this study is to assess the proposed dose of MPDL3280A in children, adolescents and young adult patients, to test its safety and to establish what effects (good or bad), it may have on young patients and their cancers.
Paediatric/adolescent/young adult cancer that is refractory (unresponsive) to initial treatment) or which relapses (recurs) following previous treatment represents an area of high unmet medical need. Despite the progress made over 40 years of clinical research using combinations of chemotherapy, radiotherapy, and surgery, survival rates have not significantly improved for children and young adults with refractory or recurrent solid tumours.
Patients who pass all screening tests will receive the MPDL3280A study medication at their treating hospital/clinic, on Day 1 of each 3 week cycle. The medication is given intravenously (through a vein), over 60 minutes at first and, if tolerated well, over 30 minutes for each additional dose of MPDL3280A. All patients receive the active study medication ie there is no placebo ('dummy') drug.
The treatment with the study medication may last for up to 8 months, as long as the patient's cancer has not worsened, the study treatment has not become intolerable eg due to severe side effects (determined by the Study Doctor in discussions with the patient/legal guardian), the patient/legal guardian or their Study Doctor decide it is in their best interest to stop the treatment or the study is ended by the study sponsor.
Approximately 40-100 children, adolescents, and young adult patients will take part in this study in approximately 50 sites in North America and Europe. This study is open to male and female participants up to 30 years of age, who meet the study requirements.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
15/SC/0456
Date of REC Opinion
28 Aug 2015
REC opinion
Favourable Opinion