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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)

Phase 1
18 Years
Open (Enrolling)
Cancer - Solid Tumors and B-Cell Non-Hodgkin's Lymphoma

Thank you

Trial Information

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)

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:

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, physical examinations, and clinical laboratory tests

Outcome Description:

The incidence of adverse events will be tabulated and reviewed for potential significance and clinical Importance.

Outcome Time Frame:

Every 3 weeks from Baseline (Day 1) for up to 2 years

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:

February 2012

Completion Date:

September 2014

Related Keywords:

  • Cancer - Solid Tumors and B-Cell Non-Hodgkin's Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Neoplasms



Memorial Sloan Kettering Cancer Center New York, New York  10021
Stanford University Medical Center Stanford, California  94305-5408
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
Hospital of the University of Pennsylvania Philadelphia, Pennsylvania  19104
Dana Farber Cancer Institute Boston, Massachusetts  02115
Providence Portland Med Ctr Portland, Oregon  97213