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

  • Non-Hodgkin's Lymphoma
Trial Status:

Recruiting

This trial runs in
Cities
  • Ann Arbor
  • Aurora
  • Birmingham
  • Cambridge
  • Charlotte
  • Cáceres
  • Detroit
  • Duarte
  • Hamilton
  • Hershey
  • Houston
  • Jette
  • L'Hospitalet de Llobregat
  • La Louvière
  • Madrid
  • Miami
  • Montréal
  • New York
  • ottignies-louvain-la-neuve
  • Philadelphia
  • Pittsburgh
  • Plymouth
  • Providence
  • Saskatoon
  • Seattle
  • Sevilla
  • Tampa
  • Wauwatosa
Trial Identifier:

NCT03671018 2018-001141-13 GO40516

      Show trial locations

      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial 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).

      Hoffmann-La Roche Sponsor
      Phase 1/Phase 2 Phase
      NCT03671018 , GO40516 , 2018-001141-13 Trial Identifier
      Mosunetuzumab (IV), Mosunetuzumab (SC), Polatuzumab vedotin, Tocilizumab Treatments
      B-cell Non-Hodgkin Lymphoma Condition
      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

      Eligibility Criteria

      All Gender
      ≥ 18 Years Age
      No Healthy Volunteers
      Inclusion Criteria

      Key Inclusion Criteria:

      • ECOG PS of 0, 1, or 2
      • Histologically confirmed FL, DLBCL, or MCL
      • Must have received at least one prior systemic treatment regimen containing an anti-CD20-directed therapy for DLBCL or FL
      • For MCL, participants must have received at least two prior systemic treatment regiments, which include 1) anti-CD20-directed therapy, 2) BTK inhibitor, and 3) anthracycline or bendamustine
      • Relapsed to prior regimen(s) after having a documented history of response (complete response [CR], CR unconfirmed [CRu], or partial response [PR]) of >/= 6 months in duration from completion of regimen(s); or, refractory to any prior regimen, defined as no response to the prior therapy, or progression within 6 months of completion of the last dose of therapy
      • Measurable disease, defined as at least one bi-dimensionally measurable nodal lesion, defined as > 1.5 cm in its longest dimension, or at least one bi-dimensionally measurable extranodal lesion, defined as > 1.0 cm in its longest dimension
      • Adequate hematologic, renal, and hepatic function
      Exclusion Criteria

      Key Exclusion Criteria:

      • Prior treatment with mosunetuzumab or other CD20-directed bispecific antibodies
      • Prior treatment with polatuzumab vedotin
      • Current > Grade 1 peripheral neuropathy
      • Prior use of any monoclonal antibody, radioimmunoconjugate or antibody-drug conjugate (ADC) within 4 weeks before first dose of study treatment
      • Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first dose of study treatment
      • Treatment with radiotherapy within 2 weeks prior to the first dose of study treatment
      • Autologous stem-cell transplantation (SCT) within 100 days prior to first study treatment administration
      • Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days before first study treatment administration
      • Prior allogeneic SCT
      • Prior solid organ transplantation
      • Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
      • Patients with history of confirmed progressive multifocal leukoencephalopathy (PML)
      • Current or past history of central nervous system (CNS) lymphoma or CNS disease
      • History of autoimmune disease

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