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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

Tracking Information
First Submitted Date  ICMJE March 31, 2022
First Posted Date  ICMJE April 7, 2022
Last Update Posted Date April 28, 2023
Actual Study Start Date  ICMJE May 10, 2022
Estimated Primary Completion Date June 20, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2022)
  • 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) ]
  • 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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2022)
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • Overall Survival (OS) (Phase 2) [ Time Frame: From the time of first study treatment to death from any cause (up to approximately 4 years) ]
  • 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) ]
  • Serum Concentration of Mosunetuzumab [ Time Frame: Up to Cycle 17 (cycle length = 21 days) ]
  • Serum Concentration of Mosunetuzumab in Combination with Tiragolumab [ Time Frame: Up to Cycle 17 (cycle length = 17 days) ]
  • Serum Concentration of Mosunetuzumab in Combination with Tiragolumab and Atezolizumab [ Time Frame: Up to Cycle 17 (cycle length = 21 days) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Hodgkin Lymphoma, Follicular Lymphoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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)
    Interventions:
    • Drug: Mosunetuzumab SC
    • Drug: Tiragolumab
    • Other: Tocilizumab
  • 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)
    Interventions:
    • Drug: Mosunetuzumab SC
    • Drug: Tiragolumab
    • Drug: Atezolizumab
    • Other: Tocilizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 31, 2022)
118
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 20, 2023
Estimated Primary Completion Date June 20, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Germany,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05315713
Other Study ID Numbers  ICMJE CO43116
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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).
Current Responsible Party Hoffmann-La Roche
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hoffmann-La Roche
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date April 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP