Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
This is a non-randomised, open-label trial with two experimental arms. In Experimental Arm 1, participants will receive Mosunetuzumab in Combination with Tiragolumab for at least 8 and up to 17 21-day cycles. Mosunetuzumab will be administered via subcutaneous (SC) injection and Tiragolumab will be administered intravenously (via IV) every 3 weeks. In Experimental Arm 2, participants will receive Mosunetuzumab in Combination with Tiragolumab and Atezolizumab for at least 8 and up to 17 21-day cycles. Mosunetuzumab will be administered via subcutaneous (SC) injection, Tiragolumab will be administered intravenously (via IV) every 3 weeks, and Atezolizumab will be administered via IV every 3 weeks. All participants will receive tocilizumab as needed to manage cytokine release syndrome (CRS) events.
Conditions
This trial is treating people with diffuse large B-cell lymphoma or follicular lymphoma
Eligibility
Inclusion
- 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
- 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
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Hoffmann-La Roche
Scientific 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
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