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 intravenous 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. In addition, subcutaneous mosunetuzumab in combination with polatuzumab vedotin will be evaluated in participants with at least 2 prior lines of systemic therapy for the treatment of R/R mantle cell lymphoma (MCL).

Trial Description

Primary Outcome:

  • 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)
  • Best Objective Response Rate (ORR), Defined as CR or Partial Response (PR) at any Time, Based on PET-CT and/or CT Scan, as Determined by the Independent Review Committee (IRC) using Standard Criteria for NHL
Secondary Outcome:
  • Best ORR (CR or PR at any Time) Based on PET-CT and/or CT Scan, as Determined by the Investigator Using Standard Criteria for NHL
  • Best CR Rate on Study Based on PET-CT, and/or CT Scan, as Determined by the Investigator and IRC Using Standard Criteria for NHL
  • CR Rate at the Time of Primary Response Assessment (PRA) Based on PET-CT, as Determined by the Investigator and IRC Using Standard Criteria for NHL
  • ORR, Defined as CR or PR, at PRA Based on PET-CT as Determined by the Investigator and IRC Using Standard Criteria for NHL
  • Duration of Response (DOR) as Determined by the Investigator and IRC Using Standard Criteria for NHL
  • Progression-Free Survival (PFS) as Determined by the Investigator and IRC Using Standard Criteria for NHL
  • Event-Free Survival (EFS) as Determined by the Investigator and IRC Using Standard Criteria for NHL
  • Overall Survival (OS)
  • Anti-Drug Antibodies (ADAs) to Mosunetuzumab
  • ADAs to Polatuzumab Vedotin
  • Mosunetuzumab Serum Concentration

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society