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

  • STATUS
    Recruiting
  • End date
    Nov 30, 2024
  • participants needed
    280
  • sponsor
    Hoffmann-La Roche
Updated on 24 October 2022
cancer
hematologic malignancy
hodgkin's disease
follicular lymphoma
diffuse large b-cell lymphoma
b-cell lymphoma
obinutuzumab

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.

Details
Condition Non-Hodgkins Lymphoma
Treatment Tocilizumab, Obinutuzumab, Atezolizumab, Polatuzumab Vedotin, RO7082859, Glofitamab, ⁸⁹Zr-Df-IAB22M2C
Clinical Study IdentifierNCT03533283
SponsorHoffmann-La Roche
Last Modified on24 October 2022

Eligibility

Yes No Not Sure

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
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
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
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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