OncRef

Clinical Trial: NCT03671018

A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 1

Lead Sponsor:Hoffmann-La Roche
Information Provided By:Hoffmann-La Roche
Last Update Posted:2024-11-29

Study Overview

Brief Summary

This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of intravenous (IV) or subcutaneous (SC) mosunetuzumab in combination with polatuzumab vedotin in participants with diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and mantle cell lymphoma (MCL). It will consist of a dose finding portion followed by an expansion phase for second line or later (2L+) participants with relapsed or refractory (R/R) DLBCL and 2L+ R/R FL. In addition, subcutaneous mosunetuzumab in combination with polatuzumab vedotin will be evaluated in participants with at least 2 prior lines of systemic therapy (3L+) for the treatment of R/R mantle cell lymphoma (MCL) and in participants with 2L+ R/R DLBCL.

Official Title

An Open-Label, Randomized, Multicenter, Phase Ib/II Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in Patients With B-Cell Non-Hodgkin Lymphoma

Conditions

B-cell Non-Hodgkin Lymphoma

Intervention / Treatment

  • Drug: Mosunetuzumab (IV)
  • Drug: Mosunetuzumab (SC)
  • Drug: Polatuzumab vedotin
  • Drug: Tocilizumab
  • Drug: Rituximab

Other Study ID Numbers

  • GO40516
  • 2018-001141-13
  • 2018

Start Date (Actual)

2018-09-25

Primary Completion Date (Actual)

2024-01-30

Study Completion Date (Estimated)

2025-07-20

Enrollment (Estimated)

422

Study Type

Interventional

Phase

Phase 1, Phase 2