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).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02951156.
The target study population of this Phase 1b/3 registrational study is patients with R/R
DLBCL who have completed at least 2 (but not more than 4) lines of prior
rituximab-containing multi-agent chemotherapy, and/or in whom autologous stem cell
transplant (ASCT) has failed, or who are not candidates for ASCT or who are not eligible
for intensive chemotherapy. Patients who are ineligible for intensive second line
chemotherapy must have received at least one prior rituximab-containing combination
chemotherapy regimen. The study will assess the safety, efficacy, pharmacokinetics (PK),
immunogenicity of the 3 avelumab-based combination regimens tested, and collect patient
reported outcome (PRO) data.
Lead OrganizationPfizer Inc