Combination Study of Urelumab and Rituximab in Patients With B-cell Non-Hodgkins Lymphoma

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: B-Cell Malignancies

Treatments: Biological: Urelumab; Biological: Rituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01775631

CA186-017

Details and patient eligibility

About

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

Full description

Intervention model: Dose Escalation (part 1) of study= Sequential Design; Dose Expansion (part 2) of study= Parallel Design

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion 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

Exclusion Criteria:

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

Arm -1 - Urelumab + Rituximab

Experimental group

Description:

Urelumab (BMS-663513) flat dose intravenous infusion on specified days Rituximab intravenous flat dose infusion on specified days

Treatment:

Biological: Rituximab

Biological: Urelumab

Arm 1 - Urelumab + Rituximab

Experimental group

Description:

Urelumab (BMS-663513) flat dose intravenous infusion on specified days Rituximab intravenous flat dose infusion on specified days

Treatment:

Biological: Rituximab

Biological: Urelumab