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

Official Title

A Phase 1B Study Evaluating RO7082859 in Combination With Rituximab (R) or Obinutuzumab (G) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Participants With Relapsed or Refractory Non-Hodgkin Lymphoma (R/R NHL) or in Participants With Untreated Diffuse Large B-Cell Lymphoma (DLBCL)

Summary:

This is a phase 1B, multi-centre, 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 - Part II: Dose expansion in which the maximum tolerated dose (MTD) (or optimal biologic dose [OBD]) determined in Part I will be further assessed in participants with r/r NHL and those with untreated DLBCL (>60 years old with an age-adjusted International Prognostic Index [IPI]) of 2-3), and the impact of using G in place of R in Cycle 1 on safety and tolerability will be assessed via a randomized, unblinded, two-arm design in participants with untreated DLBCL.

Trial Description

Primary Outcome:

• Part I: Percentage of Participants with Dose Limiting Toxicities (DLTs)
• Part I and II: Percentage of Participants with Adverse Events

• Parts I and II: Percentage of Participants with a Complete Response (CR) as Assessed by the Investigator using Modified Lugano 2014 Criteria
• Parts I and II: Percentage of Participants with Overall Response (Partial Response [PR] or Complete Response [CR])
• Parts I and II: Duration of Response (DOR)
• Progression-Free Survival (PFS)
• Overall Survival (OS)
• Parts I and II: Area Under the Serum Concentration Versus Time Curve (AUC) of RO7082859
• Parts I and II: Time to Maximum Serum Concentration (tmax) of RO7082859
• Parts I and II: Maximum Serum Concentration (Cmax) of RO7082859
• Parts I and II: Minimum Serum Concentration (Cmin) of RO7082859
• Change from Baseline in T-cell Activation Markers

View this trial on ClinicalTrials.gov