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A Phase 1b, Open-label, Multicenter Study of Urelumab (BMS-663513) in Combination With Rituximab in Subjects With Relapsed/Refractory B-cell Malignancies

Phase 1
18 Years
Open (Enrolling)
B-Cell Malignancies

Thank you

Trial Information

A Phase 1b, Open-label, Multicenter Study of Urelumab (BMS-663513) in Combination With Rituximab in Subjects With Relapsed/Refractory B-cell Malignancies

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

For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email Please visit for more information on clinical trial participation.

Inclusion Criteria:

- Clinical diagnosis of relapsed/refractory B-cell Malignancies per International
Workshop Group (IWG) 2007 criteria or 2008 International Workshop on CLL (IWCLL)

- Follicular Lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) patients must have
at least 1 lesion that can be biopsied at screening and on treatment

- Men and women 18 and older

- Women of childbearing potential (WOCBP) and men must use highly effective methods of

- Eastern Cooperative Oncology Group (ECOG) of 0 to 1

- Progressed or refractory to at least 1 prior line of standard therapy; for dose
expansion cohort a maximum of 4 lines of cytotoxic chemotherapy-containing regimens

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 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-Programmed Death-1 (anti-PD-1), Anti-Programmed
Death-Ligand1 (anti-PD-L1), anti-CD137, Anti Cytotoxic T lymphocyte-associated
antigen 4 (anti-CTLA4), Anti-Glucocorticoid-induced tumor necrosis factor receptor

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability of Urelumab in combination with Rituximab as measured by incidence of adverse events (AEs), serious AEs, death, vital sign changes, electrocardiograms (ECGs), physical examination results, and laboratory test abnormalities

Outcome Time Frame:

Up to 60 days after last dose of Urelumab

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

March 2013

Completion Date:

May 2016

Related Keywords:

  • B-cell Malignancies
  • Neoplasms
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell



University of Miami Sylvester Comprehensive Cancer Center Miami, Florida  33136
Local Institution Bronx, New York  
Local Institution Corona, California  
Local Institution Fort Lauderdale, Florida  
Local Institution Arlington, Virginia  
Local Institution Iowa City, Iowa  
Local Institution Detroit, Michigan  
Portland Providence Medical Center Portland, Oregon  97213