A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Activity of Tiragolumab in Participants With Relapsed or Refractory Multiple Myeloma or With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Multiple Myeloma, Non-Hodgkin Lymphoma, B-Cell Lymphoma
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
General Inclusion Criteria (All Participants):
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy of >/= 12 weeks
Inclusion Criteria Specific to Arms A, C and E (R/R MM):
- Arm A only: Must have R/R MM for which no established therapy for MM is appropriate and available or be intolerant to those established therapies
- Arms C and E only: Participants with R/R MM who have received at least 3 prior lines of therapy.
- Measurable disease defined by laboratory test results.
Inclusion Criteria Specific to Arms B and D (R/R NHL):
- Participants with histologically confirmed B-cell NHL who have 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.
- Must have at least one bi-dimensionally measurable lesion.
Exclusion Criteria:
General Exclusion Criteria (All Participants):
- Any anti-cancer therapy, whether investigational or approved, including chemotherapy, monoclonal antibody, radioimmunoconjugate, antibody-drug conjugate, hormonal therapy, and/or radiotherapy, within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to initiation of study treatment
- Prior treatment with any anti-TIGIT agent
- Prior treatment with chimeric antigen receptor-T (CAR-T) therapy within 12 weeks before first study drug administration
- Autologous Stem-Cell Transplantation (ASCT) within 100 days prior to first study drug administration
- Active or history of autoimmune disease or immune deficiency
- Known active bacterial, viral (including SARS-CoV-2), fungal, mycobacterial, parasitic, or other infection at study enrollment, or any major episode of infection within 4 weeks prior to first study drug administration
Exclusion Criteria Specific to Arms A, C and E (R/R MM):
- Primary or secondary plasma cell leukemia
- Current or history of CNS involvement by MM
Exclusion Criteria Specific to Arms B and D (R/R NHL):
- Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
- Current or history of CNS lymphoma
- Current eligibility for ASCT
Other protocol defined inclusion/exclusion criteria could apply
Sites / Locations
- Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center
- Emory Clinic
- University of Maryland
- Washington University
- Clinical Research Alliance
- Oncology Hematology Care, Inc.
- University of Pennsylvania; School of Medicine
- SCRI
- Virginia Cancer Specialists (Fairfax) - USOR
- Samsung Medical Center; Nephrology Department
- Seoul National University Hospital
- Yonsei Cancer Center; Yonsei Uni Coll. Med.
- Seoul St.Mary's Hospital; Medical Oncology
- Asan Medical Center; Internal Dept / Gastorenterology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
Arm A: Tiragolumab R/R MM
Arm B: Tiragolumab R/R NHL
Arm C: Tiragolumab + Daratumumab R/R MM
Arm D: Tiragolumab + Rituximab R/R NHL
Arm E: Tiragolumab + Atezolizumab + Daratumumab R/R MM
Participants with relapsed or refractory (R/R) Multiple Myeloma (MM) will receive a single dose of 600 mg tiragolumab by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W).
Participants with relapsed or refractory (R/R) non-Hodgkin Lymphoma (NHL) will receive a single dose of 600 mg tiragolumab by IV infusion Q3W.
Participants with R/R MM will receive 600 mg tiragolumab Q3W + daratumumab by subcutaneous (SC) injection.
Participants with R/R NHL will receive 600 mg tiragolumab Q3W + rituximab by IV infusion and SC injection (optional).
Participants with R/R MM will receive 600 mg tiragolumab Q3W + atezolizumab by IV infusion Q3W + daratumumab by SC injection.