- Relapsed or refractory DLBCL 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 >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.
- Transformed lymphoma or Burkitt's Lymphoma.
- Active/symptomatic central nervous system (CNS) lymphoma based on clinical evaluation.
- 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).