A Study to Evaluate 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
- Conditions
- Relapsed or Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (NHL)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-001060-23-BE
- Lead Sponsor
- F. Hoffman-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 118
- Age >= 18 years
- Participants who have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Participants who have a life expectancy of at least 12 weeks 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).
- Participants who have histologically documented FL or DLBCL that expresses CD20 as determined by the local laboratory.
- Participants who have at least one bi-dimensionally measurable (>1.5 cm) nodal lesion, or at least one bi-dimensionally measurable (>1.0 cm) extranodal lesion
- Participants who have confirmed availability of a tumor tissue
- Participants with FL for whom a bone marrow biopsy and aspirate can be collected
- Participants with adequate hematologic and organ function
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 118
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 118
Participants who have received any of the following treatments prior to study entry:
o Treatment with mosunetuzumab or other CD20/CD3-directed bispecific antibodies
o Treatment with tiragolumab or other anti- T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibition motif (ITIM) domains agent
o Allogeneic stem Cell Transplant (SCT)
o Solid organ transplantation
- Participants who received any of the following treatments, whether investigational or approved, within the respective time periods prior to initiation of study treatment:
o Radiotherapy within 2 weeks prior to the first dose of study treatment If participants have received radiotherapy within 4 weeks prior to the first study treatment administration, participants must have at least one measurable lesion outside of the radiation field.
o Autologous SCT within 100 days prior to first study treatment
o Chimeric antigen receptor T-cell therapy within 30 days before first study treatment
o Use of monoclonal antibodies or antibody-drug conjugates for the treatment of lymphoma, within 4 weeks prior to first study treatment
o Use of radioimmunoconjugates within 12 weeks prior to first study treatment
o Systemic immunosuppressive medications within 2 weeks prior to first dose of study treatment
o Any other anti-cancer therapy, whether investigational or approved
o The Medical Monitor should be informed of any prior cancer immunotherapy not explicitly described in this protocol
- Participants who received a live, attenuated vaccine within 4 weeks before first dose of study treatment, or in whom it is anticipated that such a live attenuated vaccine will be required during the study period or within 5 months after the final dose of study treatment
- Participants with aggressive NHL who are currently eligible for autologous SCT
- Participants with current or past history of CNS lymphoma or leptomeningeal infiltration
- Participants with a history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibody therapy
- Participants with a contraindication to atezolizumab (specific to Arm 2 of the study ) or tocilizumab
- Participants in whom clinically significant toxicities from prior treatment have not resolved to Grade <= 1 (per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v5.0) prior to the first study drug administration
- Participants with treatment-emergent immune-mediated adverse events associated with prior immunotherapeutic agents
- Participants with evidence of any significant, concomitant disease that could affect compliance with the protocol or interpretation of results
- Participants who underwent recent major surgery within 4 weeks prior to first study treatment administration
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method