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

Official Title

An Open-Label, Randomized, Multicentre, 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

Summary:

This study will evaluate the safety, tolerability, pharmacokinetics, and efficacy of mosunetuzumab in combination with polatuzumab vedotin in participants with diffuse large B-cell lymphoma (DLBCL) and in participants with follicular lymphoma (FL). 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.

Trial Description

Primary Outcome:

• Complete Response (CR) Rate Based on Positron Emission Tomography-Computed Tomography (PET-CT), as Assessed Using Standard Criteria for non-Hodgkin Lymphoma (NHL)
• Maximum Tolerated Dose (MTD) of Mosunetuzumab in Combination with Polatuzumab Vedotin
• Recommended Phase II Dose of Mosunetuzumab in Combination with Polatuzumab Vedotin
• Percentage of Participants with Adverse Events (AE)

• CR Rate Based on PET-CT, as Assessed Using Standard Criteria for NHL
• CR Rate Based on CT Only, as Assessed Using Standard Criteria for NHL
• Objective Response Rate (ORR), Defined as CR or PR, Based on PET-CT as Assessed Using Standard Criteria for NHL
• Best ORR (CR or PR at any Time) Based on PET-CT or CT Only, as Assessed Using Standard Criteria for NHL
• Duration of Response (DOR) as Assessed Using Standard Criteria for NHL
• Progression-Free Survival (PFS) as Assessed Using Standard Criteria for NHL
• Event-Free Survival (EFS) as Assessed Using Standard Criteria for NHL
• Overall Survival (OS)
• Time to Deterioration in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning and Fatigue
• Time to Deterioration in Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Subscale
• Anti-Drug Antibodies (ADAs) to Mosunetuzumab
• ADAs to Polatuzumab Vedotin
• Mosunetuzumab Serum Concentration

View this trial on ClinicalTrials.gov