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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
EU CTIS ID: 2023-505222-34-00
What this study is testing
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)
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Patients with chronic lymphocytic leukemia, acute lymphoblastic leukemia (ALL) (including CD20+ ALL), lymphoblastic lymphoma, Richter’s transformation, Burkitt lymphoma or lymphoplasmacytic lymphoma
- 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
- Current Grade > 1 peripheral neuropathy (only for patients being treated in the polatuzumab vedotin arm)
- 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
- Major surgery or significant traumatic injury <= 28 days prior to Gpt infusion or anticipation of the need for major surgery during study treatment
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
- Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States; Israel. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.