-Any of the following as defined by the WHO, 2016 lymphoid neoplasm classifications and
histologically confirmed:
- Diffuse large B-cell lymphoma (DLBCL), Not Otherwise Specified (NOS): Germinal center
B-cell type (GCB), Activated B-cell type (ABC)
- High-grade B-cell lymphoma (HGBCL) NOS
- HGBCL with MYC and BCL2 and/or BCL6 rearrangements
- T-cell histocyte-rich large B-cell lymphoma
- EBV+ DLBCL, NOS
- HHV8+ DLBCL, NOS
Relapsed or refractory disease following at least 2 lines (and a maximum of 4 lines) of
prior rituximab containing multi-agent chemotherapy which may include an autologous stem
cell transplantation unless patients are not considered suitable for intensive second-line
chemotherapy or autologous stem cell transplantation. Patients who are ineligible for
intensive second line chemotherapy,must have received at least one prior
rituximab-containing combination chemotherapy regimen. Patients who are ineligible for
intensive second line chemotherapy, must have received at least one prior
rituximab-containing combination chemotherapy regimen.
- Baseline measurable disease with at least 1 bi dimensional lesion with longest
diameter (LDi) >1.5cm on CT scan which is FDG avid on PET scan.
- A biopsy (archived or Screening/recent) will be collected at Screening.
- At least 18years of age (or ≥20 years in Japan).
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
- Active central nervous system (CNS) lymphoma.
- Prior organ transplantation including prior allogeneic SCT.
- Prior therapy with an anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic
T lymphocyte associated antigen 4 (CTLA 4) antibody (including ipilimumab,
tremelimumab or any other antibody, or drug specifically targeting T cell co
stimulatory or immune checkpoint pathways).