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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05315713
Recruitment Status : Active, not recruiting
First Posted : April 7, 2022
Last Update Posted : April 28, 2023
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Non-Hodgkin Lymphoma, Follicular Lymphoma Drug: Mosunetuzumab SC Drug: Tiragolumab Drug: Atezolizumab Other: Tocilizumab Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 10, 2022
Estimated Primary Completion Date : June 20, 2023
Estimated Study Completion Date : June 20, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Subcutaneous (SC) Mosunetuzumab in Combination with Intravenous (IV) Tiragolumab
Participants will receive at least 8 and up to 17 cycles of treatment (cycle length = 21 days)
 Drug: Mosunetuzumab SC
Participants will receive SC mosunetuzumab for up to 17 treatment cycles (cycle length = 21 days)

Drug: Tiragolumab
Participants will receive IV tiragolumab every 3 weeks (Q3W) for up to 17 treatment cycles (cycle length = 21 days)

Other: Tocilizumab
Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) events
Experimental: Mosunetuzumab SC in Combination with Tiragolumab IV and Atezolizumab IV
Participants will receive at least 8 and up to 17 cycles of treatment (cycle length = 21 days)
 Drug: Mosunetuzumab SC
Participants will receive SC mosunetuzumab for up to 17 treatment cycles (cycle length = 21 days)

Drug: Tiragolumab
Participants will receive IV tiragolumab every 3 weeks (Q3W) for up to 17 treatment cycles (cycle length = 21 days)

Drug: Atezolizumab
Participants will receive IV atezolizumab Q3W for up to 17 treatment cycles (cycle length = 21 days)

Other: Tocilizumab
Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) events


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events (Phase 1b) [ Time Frame: Up to 90 days after the final dose of study treatment (up to Cycle 17; cycle length = 21 days) ]
  2. Best Objective Response Rate (ORR) as Determined by the Investigator Using Lugano 2014 Criteria (Phase 2) [ Time Frame: Up to Cycle 17 (cycle length = 21 days) ]

Secondary Outcome Measures :
  1. Best ORR as Determined by the Investigator Using Lugano 2014 Criteria (Phase 1b) [ Time Frame: Baseline up to approximately 4 years (assessed at screening, and then ever 3-6 months until disease progression, start of new anti-cancer therapy, or withdrawal) ]
  2. Best Complete Response (CR) Rate as Determined by the Investigator Using Lugano 2014 Criteria (Phase 1b and Phase 2) [ Time Frame: Baseline up to approximately 4 years (assessed at screening, and then ever 3-6 months until disease progression, start of new anti-cancer therapy, or withdrawal) ]
  3. Duration of Response (DOR) as Determined by the Investigator Using Lugano 2014 Criteria (Phase 1b and Phase 2) [ Time Frame: From the first occurrence of a documented response (CR or partial response (PR)) to disease progression or relapse, or death from any cause, whichever occurs first (up to approximately 4 years) ]
  4. Progression-Free Survival (PFS) as Determined by the Investigator Using Lugano 2014 Criteria (Phase 2) [ Time Frame: From the first study treatment to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs first (up to approximately 4 years) ]
  5. Event-Free Survival (EFS) as Determined by the Investigator Using Lugano 2014 Criteria (Phase 2) [ Time Frame: From the first study treatment to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs first (up to approximately 4 years) ]
  6. Overall Survival (OS) (Phase 2) [ Time Frame: From the time of first study treatment to death from any cause (up to approximately 4 years) ]
  7. Percentage of Participants with Adverse Events (Phase 2) [ Time Frame: Up to 90 days after the final dose of study treatment (up to Cycle 17; cycle length = 21 days) ]
  8. Serum Concentration of Mosunetuzumab [ Time Frame: Up to Cycle 17 (cycle length = 21 days) ]
  9. Serum Concentration of Mosunetuzumab in Combination with Tiragolumab [ Time Frame: Up to Cycle 17 (cycle length = 17 days) ]
  10. Serum Concentration of Mosunetuzumab in Combination with Tiragolumab and Atezolizumab [ Time Frame: Up to Cycle 17 (cycle length = 21 days) ]

Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05315713


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT05315713    
Other Study ID Numbers: CO43116
First Posted: April 7, 2022    Key Record Dates
Last Update Posted: April 28, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hoffmann-La Roche:
B-Cell Non-Hodgkin Lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Atezolizumab
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Antineoplastic Agents