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

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IBiomarker/Laboratory analysis, Treatment18 and overCA186-017
NCI-2013-01647, NCT01775631

Trial Description



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

Further Study Information

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

(part 2) of study= Parallel Design

Eligibility Criteria

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 Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Bristol-Myers Squibb

    Trial Sites


    Los Angeles

    UCLA / Jonsson Comprehensive Cancer Center

    John Matthew Timmerman
    Principal Investigator

    Iowa City

    University of Iowa/Holden Comprehensive Cancer Center

    Brian K. Link
    Principal Investigator


    Dana-Farber Cancer Institute

    Caron Alyce Jacobson
    Principal Investigator

    Dana-Farber Harvard Cancer Center

    Caron Alyce Jacobson
    Principal Investigator

    New York
    New York

    Memorial Sloan-Kettering Cancer Center

    Andrew D. Zelenetz
    Principal Investigator


    M D Anderson Cancer Center

    Sattva S. Neelapu
    Principal Investigator


    University of Virginia Cancer Center

    Craig Anthony Portell
    Principal Investigator

    Link to the current record.
    NLM Identifer NCT01775631

    Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the record via the link above for more information about participating sites.