Javelin DLBCL: Phase 1B/3 study of Avelumab in patients with DLBCL
Research type
Research Study
Full title
PHASE 1B/PHASE 3 MULTICENTER STUDY OF AVELUMAB (MSB0010718C) IN COMBINATION REGIMENS THAT INCLUDE AN IMMUNE AGONIST, EPIGENETIC MODULATOR, CD20 ANTAGONIST AND/OR CONVENTIONAL CHEMOTHERAPY IN PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL) JAVELIN DLBCL
IRAS ID
220550
Contact name
Graham Collins
Contact email
Sponsor organisation
Pfizer Inc, 235 East 42nd Street, New York, NY 10017
Eudract number
2016-002904-15
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
Diffuse large B-cell lymphoma (DLBCL) is a common type of non-Hodgkin lymphoma (NHL), a cancer of the lymphatic system (part of the immune system which helps fight infection). B-lymphocytes are white blood cells that fight infection; DLBCL develops when the body makes abnormal B-lymphocytes.
The standard of care is a combination of chemotherapy drugs and a monoclonal antibody (rituximab). Most patients with DLBCL may be cured with this regimen, but patients who have treatment failure have a very poor outcome.
The purpose of this research study is to learn about the effects of avelumab when given with other investigational and approved cancer therapies to find the best treatment combination for DLBCL.
Avelumab and utomilumab are new investigational treatments. Both are antibodies (a type of protein in the blood) thought to work by helping the immune system to fight cancer cells.
The combinations of avelumab with other therapies used in this study are not approved for use outside of clinical studies. Some of the drugs may be approved in some countries without avelumab for NHL and/or other blood cancers.
Clinical safety data with single-agent avelumab in advanced solid tumour patients available to date, suggests an acceptable safety profile. The clinical safety profile of utomilumab supports its use as a single-agent and in combination with rituximab.
There are two parts to this study: Phase1b (3treatment arms with avelumab); Phase3 (will use the most promising avelumab-containing combination from phase1b and compare it with a current standard combination treatment used in relapsed DLBCL). For both parts, patients will be assigned by chance to one of the arms.
Approximately 84patients will take part in Phase1b; and 220 in Phase3. Participants will attend study visits at screening, various points during each 28day cycle, end of treatment, 30, 60 and 90 days after last dose, followed by survival follow-up every 2months (via phone is acceptable).
Sponsor:Pfizer Inc.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
17/SC/0232
Date of REC Opinion
3 Jul 2017
REC opinion
Further Information Favourable Opinion