An Open-Label Phase lB Study of RO7082859 and Atezolizumab in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

  • Cancer
  • Non-Hodgkin's Lymphoma
Please note that the recruitment status of the trial at your site may differ.
Trial Status:


This trial runs in
  • Barcelona
  • Gent
  • L'Hospitalet de Llobregat
  • Madrid
  • Ramat Gan
  • València
Trial Identifier:

NCT03533283 NP39488

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      Trial Summary

      This is an open-label, single arm, multicenter, dose finding, Phase Ib study in order to assess the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) for this combination treatment and to evaluate the general safety, tolerability, pharmacokinetic (PK), pharmacodynamic, and preliminary anti-tumor activity of this combination treatment in adult patients. This study includes an additional open-label imaging feasibility sub-study using a tracer in adult participants with relpased/refractory B-cell non-Hodgkin's lymphoma to image CD8+T-cells at baseline and after treatment with glofitamab, including pre-treatment with obinutuzumab.

      Hoffmann-La Roche Sponsor
      N/A Phase
      NCT03533283,NP39488 Trial Identifier
      Glofitamab, Atezolizumab, Obinutuzumab, Tocilizumab, Polatuzumab Vedotin, 89Zr-Df-IAB22M2C Treatments
      Non-Hodgkins Lymphoma Condition
      Official Title

      An Open-Label, Multi-Center, Phase IB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin (Plus a Single Pre-Treatment Dose of Obinutuzumab) in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

      Eligibility Criteria

      All Gender
      ≥ 18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Histologically-confirmed hematologic malignancy that is expected to express CD20 (Relapsed after or refractory to respond to at least one prior treatment regimen; no available treatment options that are expected to prolong survival or patients refusing chemotherapy or autologous stem cell transplant (SCT). Note: The expansion part is restricted to relapsed/refractory follicular lymphoma (r/r FL) and relapsed/refractory diffuse large B cell lymphoma (r/r DLBCL))
      • At least one measurable target lesion
      • Fresh pre-treatment biopsy, but if this cannot be taken, a previous archived biopsy from metastatic lesion can be taken as replacement if it is not older than 6 months and not confounded by major events (progression, treatment)
      • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
      • Adequate organ function (liver, hematological, renal)
      • Negative test results for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV)

      Inclusion Criteria Specific to Imaging Substudy

      • At least two measurable target lesions
      • Able to provide two fresh tumor biopsies (baseline and on-treatment)
      Exclusion Criteria
      • Participants with Chronic Lymphocytic Leukemia (CLL), acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma, Richter's transformation, CD20-positive ALL, Burkitt lymphoma, or lymphoplasmacytic lymphoma
      • Current > Grade 1 peripheral neuropathy (only for participants being treated in the polatuzumab vedotin arm)
      • Patients with known active infection, or reactivation of a latent infection within 4 weeks prior to Obinutuzumab (Gpt) infusion
      • Patient with history of confirmed progressive multifocal leukoencephalopathy (PML)
      • History of leptomeningeal disease
      • Current or past history of central nervous system (CNS) lymphoma
      • Current or past history of CNS disease
      • Major surgery or significant traumatic injury </=28 days prior to Gpt infusion
      • Significant cardiovascular disease or significant pulmonary disease
      • Active or history of autoimmune disease or immune deficiency (with exceptions, e.g. hypothyroidism and Diabetes mellitus Type 1)
      • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g. bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
      • Treatment with any other standard anti-cancer radiotherapy / chemotherapy including investigational therapy within 4 weeks prior to Gpt infusion
      • Prior solid organ transplantation
      • Prior allogenic stem cell transplant (SCT)
      • Autologous SCT within 100 days prior to Gpt infusion
      • Documented refractoriness to an obinutuzumab-monotherapy regimen
      • Prior treatment with anti-cancer/lymphoma therapies and systemic immunotherapeutic/immunostimulating agents within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to Gpt infusion
      • Any history of immune related >/= Grade 3 adverse events (AE) with the exception of endocrinopathy managed with replacement therapy
      • Ongoing corticosteroid use >25 milligrams/day of prednisone or equivalent within 4 weeks prior to and during study treatment
      • Treatment with systemic immunosuppressive medication
      • Administration of a live, attenuated vaccine within 4 weeks prior to Gpt infusion or anticipation that such a live attenuated vaccine will be required during the study or within 5 months after last dose of study treatment

      Exclusion Criteria Specific to Imaging Substudy

      • Circulating lymphoma cells, defined by out of range (high) absolute lymphocyte count and/or the presence of abnormal/malignant cells in the peripheral blood differential signifying circulating lymphoma cell
      • Participants who have had splenectomy or functional asplenia that could compromise protocol objectives

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