Non Hodgkin Lymphoma Clinical Trial

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

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.

View Eligibility Criteria

Eligibility 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 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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

118

Study ID:

NCT05315713

Recruitment Status:

Recruiting

Sponsor:

Hoffmann-La Roche

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There are 15 Locations for this study

See Locations Near You

USC Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Lifespan Cancer Institute
Providence Rhode Island, 02905, United States
St Vincent's Hospital Sydney
Darlinghurst New South Wales, 2010, Australia
Eastern Health
Box Hill Victoria, , Australia
St Vincent's Hospital Melbourne
Fitzroy Victoria, 3065, Australia
AZ Sint Jan Brugge Oostende AV
Brugge , 8000, Belgium
Institut Jules Bordet
Bruxelles , 1000, Belgium
AZ Groeninge
Kortrijk , 8500, Belgium
CHU UCL Namur - Mont-Godinne
Yvoir , 5530, Belgium
Tom Baker Cancer Centre-Calgary
Calgary Alberta, T2N 4, Canada
Princess Margaret Cancer Centre
Toronto Ontario, M5G 1, Canada
Universitaet Duisburg-Essen
Essen , 45122, Germany
Beatson West of Scotland Cancer Centre
Glasgow , G12 0, United Kingdom
Royal Marsden Hospital - Institute of Cancer Research - Chelsea
London , SE3 6, United Kingdom
Plymouth Hospitals NHS Trust - Derriford Hospital
Plymouth , , United Kingdom
Royal Marsden Hospital - Institute of Cancer Research - Sutton
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

118

Study ID:

NCT05315713

Recruitment Status:

Recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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