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

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IBiomarker/Laboratory analysis, TreatmentActive18 and overPharmaceutical / IndustryCA186-017
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

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 Contact Information

Trial Lead Organizations/Sponsors

Bristol-Myers Squibb Company - New York

    Bristol-Myers Squibb, Study Director
    Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:

    Email: Clinical.Trials@bms.com

    Trial Sites

    U.S.A.

    California
    Los Angeles

    Jonsson Comprehensive Cancer Center at UCLA

    John Timmerman, Site 0011
    Ph: 310-582-4060

    Stanford

    Stanford Cancer Center

    Ronald Levy, Site 0001
    Ph: 650-725-6452

    Florida
    Miami

    University of Miami Sylvester Comprehensive Cancer Center - Miami

    Izidore Lossos, Site 0012
    Ph: 305-243-4785

    Miami Beach

    Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center

    Jose Lutzky, Site 0025
    Ph: 305-535-3300

    Iowa
    Iowa City

    Holden Comprehensive Cancer Center at University of Iowa

    Brian Link, Site 0004
    Ph: 319-353-8504

    Massachusetts
    Boston

    Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

    Caron Jacobson, Site 0020
    Ph: 617-632-5847

    Michigan
    Detroit

    Barbara Ann Karmanos Cancer Institute

    Radhakrishnan Ramchandren, Site 0023
    Ph: 313-576-8722

    New Jersey
    Hackensack

    Hackensack University Medical Center Cancer Center

    Martin Gutierrez, Site 0015
    Ph: 551-996-5499

    New York
    New York

    Memorial Sloan-Kettering Cancer Center

    Andrew Zelenetz, Site 0010
    Ph: 212-639-2656

    North Carolina
    Charlotte

    Levine Cancer Institute at Carolinas Medical Center

    Nilanjan Ghosh, Site 0022
    Ph: 980-442-4363

    Oregon
    Portland

    Providence Cancer Center at Providence Portland Medical Center

    John Godwin, Site 0002

    Pennsylvania
    Philadelphia

    Hospital of the University of Pennsylvania

    Sunita Nasta, Site 0024
    Ph: 215-662-6933

    Texas
    Houston

    M. D. Anderson Cancer Center at University of Texas

    Sattva Neelapu, Site 0018
    Ph: 713-563-3429

    Virginia
    Charlottesville

    University of Virginia Cancer Center

    Craig Portell, Site 0009
    Ph: 434-924-9637

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT01775631
    ClinicalTrials.gov processed this data on May 07, 2015

    Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.