A Study of Glofitamab (RO7082859) and Atezolizumab or Polatuzumab Vedotin (Plus A Single Pretreatment Dose of Obinutuzumab) in Adult Patients with Relapsed/Refractory B-Cell Non-Hodgkin’s Lymphoma

Trial details

Who runs it

F. Hoffmann-La Roche AG

Trial code

EU 2023-505222-34-00

Record updated

2026. augusztus 20.

Original description

To evaluate the efficacy of glofitamab in combination with polatuzumab vedotin (including a single pretreatment dose of obinutuzumab) in patients diagnosed with R/R large B-cell lymphoma (LBCL) diffuse large B-cell lymphoma (DLBCL) NOS, high-grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL), and transformed follicular lymphoma (trFL) as measured by IRC-assessed best ORR according to standard NHL response criteriaTo determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) for glofitamab in combination with atezolizumab or polatuzumab vedotin (including a single pretreatment dose of obinutuzumab) To determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) for glofitamab in combination with atezolizumab or polatuzumab vedotin (including a single pretreatment dose of obinutuzumab)Read full original descriptionShow less

An Open-Label, Multi-Center, Phase Ib/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin (Plus A Single Pretreatment Dose of Obinutuzumab) in Adult Patients with Relapsed/Refractory B-Cell Non-Hodgkin’s Lymphoma

To evaluate the efficacy of glofitamab in combination with polatuzumab vedotin (including a single pretreatment dose of obinutuzumab) in patients diagnosed with R/R large B-cell lymphoma (LBCL) diffuse large B-cell lymphoma (DLBCL) NOS, high-grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL), and transformed follicular lymphoma (trFL) as measured by IRC-assessed best ORR according to standard NHL response criteriaTo determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) for glofitamab in combination with atezolizumab or polatuzumab vedotin (including a single pretreatment dose of obinutuzumab) To determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) for glofitamab in combination with atezolizumab or polatuzumab vedotin (including a single pretreatment dose of obinutuzumab)

Inclusion: Eastern Cooperative Oncology Group performance status of 0, 1, or 2; Life expectancy of >= 12 weeks; Adequate liver function, hematological function, renal function; Negative serologic and/or polymerase chain reaction test results for acute or chronic hepatitis B virus (HBV) infection; Negative test results for hepatitis C virus (HCV) and Human immunodeficiency virus (HIV); Negative HIV test at screening, with the following exception: - Individuals with a positive HIV test at screening are eligible provided they are stable on antiretroviral therapy for at least 4 weeks, have a CD4 count = 200/mL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months - Patients with positive HIV at screening should be monitored while receiving study treatment. HIV viral load will be performed every 3 months (± 4 weeks) in the first 6 months and subsequently every 6 months (± 4 weeks) until end of study treatment. If HIV viral load is detected (positive), the patient should be treated per local institutional standards,and the Medical Monitor should be notified. Testing may be performed at the local institution. If local laboratory assessments are not available for testing, local laboratory collections may be waived only if samples are collected for central laboratory assessments of viral infections.

Exclusion: Patients with known active infection, or reactivation of a latent infection, whether bacterial, viral, fungal, mycobacterial, or other pathogens or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks prior to obinutuzumab (Gazyva, Gazyvaro) pretreatment (Gpt) infusion. Note: Exclusion of patients with mycobacterial infections on the basis of chest X-ray or CT or on the basis of a positive Quantiferon or Mantoux test; Major surgery or significant traumatic injury <= 28 days prior to Gpt infusion or anticipation of the need for major surgery during study treatment; Patient with history of confirmed progressive multifocal leukoencephalopathy (PML); History of leptomeningeal disease, current or past history of central nervous system (CNS) lymphoma and CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease; Patients with chronic lymphocytic leukemia, acute lymphoblastic leukemia (ALL) (including CD20+ ALL), lymphoblastic lymphoma, Richter’s transformation, Burkitt lymphoma or lymphoplasmacytic lymphoma; Current Grade > 1 peripheral neuropathy (only for patients being treated in the polatuzumab vedotin arm).

EU CTIS 2023-505222-34-00