Combination Study of Urelumab and Rituximab in Patients With B-cell Non-Hodgkins Lymphoma
Trial ID or NCT#
Status
Purpose
The purpose of the study is to determine the safety, tolerability and maximum tolerated dose of Urelumab in combination with Rituximab in patients with B-cell Non-Hodgkins Lymphoma
Official Title
A Phase 1b, Open-label, Multicenter Study of Urelumab (BMS-663513) in Combination With Rituximab in Subjects With Relapsed/Refractory B-cell Malignancies
Eligibility Criteria
- - Clinical diagnosis of relapsed/refractory B-cell Malignancies (B-Non-Hodgkins Lymphoma (NHL)) per International Workshop Group (IWG) - Progressed or refractory to at least 1 prior line of standard therapy - Subjects in Expansion cohorts are restricted to relapsed/refractory diffuse large B-cell lymphoma (DLBCL) or Follicular Lymphoma (FL) subjects who are either relapsed or refractory to prior rituximab or ritxumab-containing chemotherapy regimens - Follicular Lymphoma (FL) must have at least 1 lesion that can be biopsied at screening and on treatment - Eastern Cooperative Oncology Group (ECOG) of 0 to 1
- - Active or progressing brain metastases - Other concomitant malignancies (with some exceptions per protocol) - Active or history of autoimmune disease - Positive test for human immunodeficiency virus (HIV) 1&2 or known Acquired immune deficiency syndrome (AIDS) - History of any hepatitis (A, B or C) - History of grade 3-4 drug-related hepatitis - Known current drug or alcohol abuse - Active tuberculosis (TB) - Prior therapy with any antibody/drug that targets the T cell coregulatory proteins, including but not limited to, anti-CD137, Anti Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA4) or Anti-Glucocorticoid-induced tumor necrosis factor receptor (anti-GITR). However, Anti-Programmed Death-1 (anti-PD-1), Anti-Programmed Death-Ligand1 (anti-PD-L1) are permissible as prior therapy
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Contact
CCTO
650-498-7061
View on ClinicalTrials.gov