Overview

Avelumab In Combination Regimens That Include An Immune Agonist, Epigenetic Modulator, CD20 Antagonist and/or Conventional Chemotherapy in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)

Status:
Terminated
Trial end date:
2019-12-02
Target enrollment:
0
Participant gender:
All
Summary
Study B9991011 is a multi-center, international, randomized, open label, 2 component (Phase 1b followed by Phase 3), parallel-arm study of avelumab in combination with various agents for the treatment of Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Collaborator:
EMD Serono
Treatments:
Avelumab
Azacitidine
Bendamustine Hydrochloride
Gemcitabine
Oxaliplatin
Rituximab
Criteria
Key Inclusion Criteria:

-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.

Key Exclusion Criteria:

- 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).