Safety, Tolerability, Pharmacokinetics, and Immunoregulatory Study of Urelumab (BMS-663513) in Subjects With Advanced and/or Metastatic Solid Tumors and Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma

Not Recruiting

Trial ID: NCT01471210


The purpose of the study is to assess the safety, tolerability, pharmacokinetics and immunoregulatory activity of urelumab (BMS-663513) in cancer subjects with advanced and/or metastatic tumors and relapsed/refractory B-Cell Non-Hodgkin's Lymphoma

Official Title

A Phase 1 Study of the Safety, Tolerability, Pharmacokinetics and Immunoregulatory Activity of Urelumab (BMS-663513) in Subjects With Advanced and/or Metastatic Solid Tumors and Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)

Stanford Investigator(s)

A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD

Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)


For more information regarding BMS clinical trial participation, please visit

Inclusion Criteria:

   1. Signed Written Informed Consent

      - The signed informed consent form

   2. Target Population

      - Subjects with advanced and/or metastatic solid tumors or B-NHL who are either
      refractory to or have relapsed from standard therapies, or for whom a standard
      therapy does not exist with measurable disease per Response Evaluation Criteria
      in Solid Tumors (RECIST) 1.1 criteria

      - Life expectancy of 12 weeks or greater

      - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

      - Adequate organ and marrow function

      - For certain subjects, willing and able to provide pre- and post-treatment fresh
      tumor biopsies

   3. Age and Reproductive Status

      - Women of childbearing potential (WOCBP) and men must be using an acceptable
      method of contraception to avoid pregnancy throughout the study and for at least
      4 weeks prior to initiation of dosing, and for at least 60 days after the last
      dose of investigational product in such a manner that the risk of pregnancy is

      - WOCBP must have a negative serum or urine pregnancy test [minimum sensitivity 25
      UI/L or equivalent units of human chorionic gonadotrophin (HCG)] within 24 hours
      prior to the start of investigational product

      - Women must not be breastfeeding

Exclusion Criteria:

   1. Target Disease Exceptions

      - Subjects with known or suspected brain metastasis unless previously treated and
      without evidence of progression

      - Subjects with a history of prior malignancy active within the previous 2 years
      except for locally curable cancers that have been apparently cured

      - Subjects with hepatocellular carcinoma

   2. Medical History and Concurrent Diseases

      - Any active autoimmune disease or documented history of autoimmune disease, or
      history of syndrome that required systemic steroids or immunosuppressive
      medications, except for subjects with vitiligo, psoriasis inactive within past 2
      years, resolved childhood asthma/atopy, or thyroid disease controlled by
      replacement therapy without the need for immunosuppression

      - Known or suspected human immunodeficiency virus (HIV) or hepatitis A(acute), B or
      C infection

      - History of any hepatitis (e.g., alcohol or non-alcohol steatohepatitis (NASH),
      drug-related, auto-immune)

      - Evidence of active infection, requiring parenteral anti-bacterial, anti-viral or
      anti-fungal therapy < 7 days prior to administration of study medication

      - History of clinically significant cardiac disease, including but not limited to a
      history (personal or family) of congenital long QT syndrome

      - Grade > 1 QTc prolongation at baseline (> 450 msec by Bazett formula) confirmed
      by a repeat electrocardiogram (ECG)

      - History of myocardial infarction or uncontrolled angina within 12 months prior to
      administration of study drug

   3. Physical and Laboratory Test Findings

      - WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy
      for the entire study period and for up to 12 weeks after the last dose of
      investigational product

      - Women who are pregnant or breastfeeding

      - Women with a positive pregnancy test on enrollment or prior to investigational
      product administration

      - Sexually active fertile men not using effective birth control if their partners
      are WOCBP

      - Positive blood screen for hepatitis A IgM, hepatitis C antibody, hepatitis B
      surface antigen, or HIV-1, -2 antibody

   4. Allergies and Adverse Drug Reaction

      - History of allergy to Urelumab (BMS-663513) or related compounds

      - History of significant drug allergy (such as anaphylaxis or hepatotoxicity) to a
      prior biologic therapy

   5. Prohibited Treatments and/or Therapies

      - The systemic use of the following therapies are prohibited within 28 days of
      first dose of study medication, or longer where indicated:

         1. Use of anti-cancer treatment (including investigational drugs) within 28

         2. Immunosuppressive medications or immunosuppressive doses of systemic

         3. Surgery (except minor surgeries,e.g., biopsies) or radiotherapy

         4. Any non-oncology live viral vaccine therapies used for the prevention of
         infectious diseases.

      - Prior treatment with anti-programmed death 1 (anti-PD-1)/Programmed cell death 1
      ligand 1 (PD-L1) or anti-CD137

      - Any subject with the following reported drug-related adverse events on anti-
      Cytotoxic T-Lymphocyte Antigen 4 (anti-CTLA4) will not be permitted on study:
      hepatic, diarrhea/colitis or endocrine adverse events (AE)s Grade ≥ 2, any other
      non-laboratory immune-related AE ≥ Grade 3. Subjects must have minimum 9 week
      washout period between the last dose of anti-CTLA4 and the first dose Urelumab

      - Prior organ allograft or allogeneic bone marrow transplantation

   6. Other Exclusion Criteria

      - Prisoners or subjects who are involuntarily incarcerated


drug: Urelumab (BMS-663513)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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