Combination Therapy for Non-Hodgkin's Lymphoma
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you stop taking any standard anti-cancer treatments, including investigational therapies, within 4 weeks before starting the study treatment. If you are on corticosteroids, you must not exceed 25 milligrams per day of prednisone or its equivalent within 4 weeks before and during the study.
What data supports the effectiveness of the drug combination therapy for Non-Hodgkin's Lymphoma?
The research highlights that combining targeted therapies, like monoclonal antibodies, can be very effective in treating Non-Hodgkin's Lymphoma. Although specific data on the combination of Atezolizumab, Tecentriq, Glofitamab, COLUMVI, glofitamab-gxbm, Polatuzumab Vedotin, and Polivy is not provided, similar combinations with rituximab have shown significant effects, suggesting potential effectiveness.12345
Is the combination therapy for Non-Hodgkin's Lymphoma safe?
Polatuzumab vedotin, part of the combination therapy, has shown an acceptable safety profile in clinical trials for relapsed or refractory large B-cell lymphomas, with manageable side effects. The risk of immune reactions is low, and the treatment has been used safely in various settings, including after other therapies like CAR T-cell therapy.678910
What makes the combination therapy for Non-Hodgkin's Lymphoma unique?
This combination therapy is unique because it includes Glofitamab, a bispecific antibody that engages T-cells to target and destroy lymphoma cells, and Polatuzumab Vedotin, which delivers a toxic agent directly to cancer cells. This approach is different from traditional chemotherapy and aims to enhance the immune system's ability to fight the cancer.14111213
What is the purpose of this trial?
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.
Research Team
Clinical Trials
Principal Investigator
Hoffmann-La Roche
Eligibility Criteria
Adults with B-cell Non-Hodgkin's Lymphoma that has come back or didn't respond to treatment, and who have no other life-prolonging therapy options. Participants must have at least one measurable lesion, be in relatively good health (ECOG 0-2), and have proper organ function. They can't join if they've had certain autoimmune diseases, lung conditions, recent cancer treatments, transplants, infections or vaccinations.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Glofitamab in combination with Atezolizumab or Polatuzumab Vedotin up to the maximum tolerated dose (MTD)
Imaging Sub-study
Participants undergo PET/CT imaging to assess CD8+ T-cells at baseline and after treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Atezolizumab
- Glofitamab
- Polatuzumab Vedotin
Atezolizumab is already approved in United States, European Union for the following indications:
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University