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

Official Title

A Phase 1B Study Evaluating Glofitamab 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 glofitamab 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 glofitamab plus G/R-CHOP (i.e., add-on arm) versus glofitamab plus CHOP (i.e., replacement arm) will be assessed in untreated DLBCL participants.

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)
• Time to First Complete Response (TFCR)
• Time to First Response (TFOR)
• Parts I and II: Area Under the Serum Concentration Versus Time Curve (AUC) of Glofitamab
• Parts I and II: Time to Maximum Serum Concentration (tmax) of Glofitamab
• Parts I and II: Maximum Serum Concentration (Cmax) of Glofitamab
• Parts I and II: Minimum Serum Concentration (Cmin) of Glofitamab
• Change from Baseline in T-cell Activation Markers

View this trial on ClinicalTrials.gov