A clinical trial to look at how safe and effective mosunetuzumab plus tiragolumab, with or without atezolizumab, is for the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma (NHL)

An Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab in Combination With Tiragolumab With or Without Atezolizumab in Participants With B-Cell Non-Hodgkin Lymphoma

  • Non-Hodgkin's Lymphoma
  • Follicular Lymphoma
Trial Status:

Recruiting

This trial runs in
Countries
  • Australia
  • Belgium
  • Canada
  • Germany
  • United Kingdom
  • United States
Trial Identifier:

NCT05315713 CO43116

      Show trial locations

      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial Summary

      This study will evaluate the safety, efficacy, and pharmacokinetics of mosunetuzumab in combination with tiragolumab, with or without atezolizumab, in participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) who have received at least two previous lines of systemic therapy.

      Hoffmann-La Roche Sponsor
      Phase 1/Phase 2 Phase
      NCT05315713 , CO43116 Trial Identifier
      All Gender
      ≥18 Years Age
      No Healthy Volunteers

      How does the CO43116 clinical trial work?

      This clinical trial is recruiting people who have a type of disease called B-cell non-Hodgkin lymphoma (NHL). In order to take part, patients must have ‘relapsed’ or ‘refractory’ B-cell NHL, which means that the cancer has come back after being treated or did not get better with at least two previous treatments.

      The purpose of this clinical trial is to test the safety and effectiveness of mosunetuzumab plus tiragolumab, with or without atezolizumab, and to understand the way your body processes the combination.

      How do I take part in this clinical trial?

      To be able to take part in this clinical trial, you must be at least 18 years old and have been diagnosed with relapsed or refractory B-cell NHL.

      You must not be pregnant or breastfeeding, or intending to become pregnant during the clinical trial or soon after. If you have received certain medications or have certain other medical conditions, you may not be able to take part in this clinical trial.

      If you think this clinical trial may be suitable for you and would like to take part, please talk to your doctor. If your doctor thinks that you might be able to take part in this clinical trial, he/she may refer you to the closest clinical trial doctor. They will give you all the information you need to make your decision about taking part in the clinical trial. You can also find the clinical trial locations on this page.

      You will have some further tests to make sure you will be able to take the treatments given in this clinical trial. Some of these tests or procedures may be part of your regular medical care. They may be done even if you do not take part in the clinical trial. If you have had some of the tests recently, they may not need to be done again.

      Before starting the clinical trial, you will be told about any risks and benefits of taking part in the trial. You will also be told what other treatments are available so that you may decide if you still want to take part.

      While taking part in the clinical trial, both men and women (if you are not currently pregnant but can become pregnant) will need to either not have heterosexual intercourse or take contraceptive medication for safety reasons. 

      What treatment will I be given if I join this clinical trial?

      The first part of the clinical trial (the safety run-in) aims to find the best dose of mosunetuzumab when combined with tiragolumab and atezolizumab. Depending on when you join the trial, you will be put into one of the following safety run-in treatment groups:

      • Mosunetuzumab, given as an injection under the skin (subcutaneous) on Days 1, 8 and 15 of Cycle 1, and Day 1 of each cycle after that, and tiragolumab, given as an infusion into your vein on Day 1 of each cycle, for up to 17 three-week cycles
        • If a certain number of people have side effects with this treatment regimen, it may be adapted to start tiragolumab treatment later, at Day 1 of Cycle 2
      • Mosunetuzumab, given as an injection under the skin (subcutaneous), tiragolumab given as an infusion into your vein, and atezolizumab, given as an infusion into your vein on Day 1 of each cycle, starting at Cycle 2, for up to 17 three-week cycles. The dose and timing of mosunetuzumab and tiragolumab in this group will be decided based on results from the previous treatment group

      You will have at least eight cycles of clinical trial treatment, unless your disease gets worse before then. After eight cycles, your clinical trial doctor will run tests to check how well the treatment is working. If the treatment is working well, you will continue to be treated for up to 17 cycles in total, or until your disease gets worse (whichever occurs first).

      This clinical trial is open-label, which means that both you and your clinical trial doctor will know which treatment you are receiving. Depending on the results from the safety run-in part of the clinical trial, more patients may be enrolled later (the expansion phase).

      How often will I be seen in follow-up appointments, and for how long?

      You will be given the clinical trial treatment (mosunetuzumab and tiragolumab, with or without atezolizumab) for up to 17 three-week cycles (roughly one year). You are free to stop this treatment at any time. After being given treatment for the first time, you will need to stay in hospital for 72 hours to check for any side effects. When you leave the hospital, you will still be seen regularly by the clinical trial doctor. Your clinical trial doctor will be able to give you more information on how often they will need to see you. These hospital visits will include checks to see how you are responding to the treatment and any side effects that you may be having. After you have finished treatment, your clinical trial doctor will follow up with you every three months (either by phone or clinic visit) for as long as you agree to it.

      What happens if I am unable to take part in this clinical trial?

      If this clinical trial is not suitable for you, you will not be able to take part. Your doctor will suggest other clinical trials that you may be able to take part in or other treatments that you can be given. You will not lose access to any of your regular care.

      For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT05315713  

      Trial-identifier: NCT05315713

      Trial Summary

      This study will evaluate the safety, efficacy, and pharmacokinetics of mosunetuzumab in combination with tiragolumab, with or without atezolizumab, in participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) who have received at least two previous lines of systemic therapy.

      Hoffmann-La Roche Sponsor
      Phase 1/Phase 2 Phase
      NCT05315713 , CO43116 Trial Identifier
      Mosunetuzumab SC, Tiragolumab, Atezolizumab, Tocilizumab Treatments
      Non-Hodgkin Lymphoma, Follicular Lymphoma Condition
      Official Title

      A Phase Ib/II Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab in Combination With Tiragolumab With or Without Atezolizumab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Aged >/= 18 years
      • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
      • Life expectancy of at least 12 weeks
      • Histologically documented FL or DLBCL that has relapsed or failed to respond to at least two prior systemic treatment regimens and for which no suitable therapy of curative intent or higher priority exists (e.g., standard chemotherapy, ASCT, CAR T cells)
      • At least one bi-dimensionally measurable (> 1.5 cm) nodal lesion, or at least one bi-dimensionally measurable (> 1.0 cm) extranodal lesion
      • Participants with FL (including trFL) for whom a bone marrow biopsy and aspirate can be collected
      • Adequate hematologic and organ function
      Exclusion Criteria
      • Received any of the following treatments prior to study entry: mosunetuzumab or other CD20/CD3-directed bispecific antibodies; tiragolumab or other anti-TIGIT agent; allogenic SCT; solid organ transplantation
      • Currently eligible for autologous SCT
      • Current or past history of CNS lymphoma or leptomeningeal infiltration
      • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
      • Contraindication to atezolizumab (if applicable) or tocilizumab
      • Clinically significant toxicities from prior treatment have not resolved to Grade </= 1 (per NCI CTCAE v5.0) prior to the first study drug administration with exceptions defined by the protocol
      • Treatment-emergent immune-mediated adverse events associated with prior immunotherapeutic agents as defined by the protocol
      • Evidence of any significant, concomitant disease as defined by the protocol
      • Major surgery within 4 weeks prior to first study treatment administration, with the exception of protocol-mandated procedures (e.g., tumor biopsies and bone marrow biopsies)
      • Significant cardiac, pulmonary, CNS, or liver disease, or known active infections
      • History of other malignancy that could affect compliance with the protocol or interpretation of results
      • History of autoimmune disease with exceptions as defined in the protocol

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