Last updated on February 2020

A Study of RO7082859 in Combination With Rituximab or Obinutuzumab Plus Cyclophosphamide Doxorubicin Vincristine and Prednisone (CHOP) in Participants With Non-Hodgkin Lymphomas and Participants With DLBCL

Brief description of study

This is a phase 1B, multi-center, dose-finding study of RO7082859 administered in combination with obinutuzumab (Gazyva; [G]), rituximab (R) and standard doses of CHOP (G/R-CHOP or R-CHOP) in participants with r/r NHL and untreated diffuse large B-cell lymphoma (DLBCL). Evaluating the safety, preliminary activity, pharmacokinetic (PK), and pharmacodynamic effects of this combination will be the main objectives of this study. The study is divided in two parts:

  • Part I: Dose finding in participants with r/r NHL; test use of G vs R in Cycle 1
  • Part II: Dose Expansion. The maximum tolerated dose or optimal biological dose (MTD or OBD) will be further assessed in participants with r/r NHL and those with untreated DLBCL (>60 years of age with an age-adjusted International Prognostic Index (IPI) of 2-3). Particularly, the impact of using RO7082859 plus G/R-CHOP (i.e., add-on arm) versus RO7082859 plus CHOP (i.e., replacement arm) will be assessed in untreated DLBCL participants.

Clinical Study Identifier: NCT03467373

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