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

Summary

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:

Eastern Cooperative Oncology Group (ECOG) of 0 to 1

Follicular Lymphoma (FL) must have at least 1 lesion that can be biopsied at

screening and on treatment

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

Progressed or refractory to at least 1 prior line of standard therapy

Clinical diagnosis of relapsed/refractory B-cell Malignancies (B-Non-Hodgkins

Lymphoma (NHL)) per International Workshop Group (IWG)

Exclusion Criteria:

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

Active tuberculosis (TB)

Known current drug or alcohol abuse

History of grade 3-4 drug-related hepatitis

History of any hepatitis (A, B or C)

Positive test for human immunodeficiency virus (HIV) 1&2 or known Acquired immune

deficiency syndrome (AIDS)

Active or history of autoimmune disease

Other concomitant malignancies (with some exceptions per protocol)

Active or progressing brain metastases

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Bristol-Myers Squibb

    Trial Sites

    U.S.A.

    California
    Los Angeles

    UCLA / Jonsson Comprehensive Cancer Center

    John Matthew Timmerman
    Principal Investigator

    Palo Alto

    Stanford Cancer Institute

    Ronald Levy
    Principal Investigator

    Iowa
    Iowa City

    University of Iowa/Holden Comprehensive Cancer Center

    Brian K. Link
    Principal Investigator

    Massachusetts
    Boston

    Dana-Farber Cancer Institute

    Caron Alyce Jacobson
    Principal Investigator

    Dana-Farber Harvard Cancer Center

    Caron Alyce Jacobson
    Principal Investigator

    Michigan
    Ann Arbor

    University of Michigan Comprehensive Cancer Center

    Mark S. Kaminski
    Principal Investigator

    Detroit

    Wayne State University/Karmanos Cancer Institute

    Radhakrishnan Ramchandren
    Principal Investigator

    New York
    New York

    Memorial Sloan-Kettering Cancer Center

    Andrew D. Zelenetz
    Principal Investigator

    Texas
    Houston

    M D Anderson Cancer Center

    Sattva S. Neelapu
    Principal Investigator

    Virginia
    Charlottesville

    University of Virginia Cancer Center

    Craig Anthony Portell
    Principal Investigator

    Link to the current ClinicalTrials.gov record.
    NLM Identifer NCT01775631

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