drugset / Trial / NCT02596971

A Study of Atezolizumab in Combination With Either Obinutuzumab Plus Bendamustine or Obinutuzumab Plus (+) Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Participants With Follicular Lymphoma (FL) or Rituximab + CHOP in Participants With Diffuse Large B-Cell Lymphoma (DLBCL)

NCT02596971

Phase 1/2 Completed 91 enrolled Hoffmann-La Roche
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This Phase Ib/II, open-label, multicenter, non-randomized study will evaluate the safety, efficacy, and pharmacokinetics of induction treatment consisting of atezolizumab in combination with either obinutuzumab + bendamustine (Atezo-G-benda) or obinutuzumab + CHOP (Atezo-G-CHOP) in participants with FL and atezolizumab + rituximab + chemotherapy (Atezo-R-CHOP) in participants with DLBCL, followed by post-induction treatment consisting of either atezolizumab plus obinutuzumab (Atezo-G) in participants with FL who achieve a complete response (CR) or partial response (PR) at end of induction (EOI) or atezolizumab alone in participants with DLBCL who achieve a CR at EOI.

Timeline

Start
2015-12-22
Primary completion
2018-04-11
Completion
2020-05-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody 840 mg Intravenous
Subject Atezolizumab Monoclonal antibody 1200 mg Intravenous
Subject Bendamustine Small molecule 90 mg/m2 Intravenous
Subject Cyclophosphamide Other / unclassified 750 mg/m2 Intravenous
Subject Doxorubicin Other / unclassified 50 mg/m2 Intravenous
Subject Obinutuzumab Monoclonal antibody 1000 mg Intravenous
Subject Prednisone Other / unclassified 40 mg/m2 Oral
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject Vincristine Small molecule 1.4 mg/m2 Intravenous