Return to Clinical Trials Search Results

A Phase 2, Open-Label Multicenter Study to Evaluate the Safety and Clinical Activity of Durvalumab in Combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (R-CHOP) or with Lenalidomide Plus R-CHOP (R2 CHOP) in Subjects with Previously Untreated, High Risk Diffuse Large B Cell Lymphoma

Primary Objective The primary objective of the study is to explore he clinical activity of Durvalumab (MEDI4736) in combination with R-CHOP (non-ABC) or R2-CHOP (ABC) followed by Durvalumab consolidation therapy in previously untreated subjects diagnosed with high-risk DLBCL. Secondary Objectives The secondary objectives of the study are: *To evaluate the safety and tolerability of durvalumab when given in combination with R-CHOP or R2-CHOP followed by Durvalumab consolidation therapy. *To identify and develop biomarkers of the tumor microenvironment and of the host immune system which are predictive of clinical response to Durvalumab, when administered in combination with R-CHOP or R2-CHOP, followed by Durvalumab consolidation therapy that will be tested in further randomized clinical studies. Examples of defined analytical methods that will be investigated may include, but are not limited to: - PD-L1 IHC - Gene Expression Signatures Exploratory Objective The exploratory objective of the study is examine the pharmacokinetic/pharmacodynamic (PK/Pd) relationship, and the mechanistic biomarkers for Durvalumab when given in combination with R-CHOP or with R2-CHOP followed by Durvalumab consolidation therapy.

Primary Objective The primary objective of the study is to explore he clinical activity of Durvalumab (MEDI4736) in combination with R-CHOP (non-ABC) or R2-CHOP (ABC) followed by Durvalumab consolidation therapy in previously untreated subjects diagnosed with high-risk DLBCL. Secondary Objectives The secondary objectives of the study are: *To evaluate the safety and tolerability of durvalumab when given in combination with R-CHOP or R2-CHOP followed by Durvalumab consolidation therapy. *To identify and develop biomarkers of the tumor microenvironment and of the host immune system which are predictive of clinical response to Durvalumab, when administered in combination with R-CHOP or R2-CHOP, followed by Durvalumab consolidation therapy that will be tested in further randomized clinical studies. Examples of defined analytical methods that will be investigated may include, but are not limited to: - PD-L1 IHC - Gene Expression Signatures Exploratory Objective The exploratory objective of the study is examine the pharmacokinetic/pharmacodynamic (PK/Pd) relationship, and the mechanistic biomarkers for Durvalumab when given in combination with R-CHOP or with R2-CHOP followed by Durvalumab consolidation therapy.