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

Completed · Phase 1

Conditions studied: Cancer - Solid Tumors and B-Cell Non-Hodgkin's Lymphoma

In brief

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

Key facts

Study ID: NCT01471210
Run by: Bristol-Myers Squibb
People needed: 124
Starts: 2012-02-01
Expected to finish: 2016-04-01
Last updated by the study team: 2017-04-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Signed Written Informed Consent
The signed informed consent form
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
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 minimized
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

You may not qualify if…

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
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
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
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
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:
Use of anti-cancer treatment (including investigational drugs) within 28 days
Immunosuppressive medications or immunosuppressive doses of systemic corticosteroids

Where it is running

Division Of Hematology & Oncology Ctr. For Health Sciences — Los Angeles, California, United States
Stanford University Medical Center — Stanford, California, United States
University Of Chicago — Chicago, Illinois, United States
Indiana University Cancer Center — Indianapolis, Indiana, United States
Dana Farber Cancer Institute — Boston, Massachusetts, United States
Karmanos Cancer Institute — Detroit, Michigan, United States
John Theurer Cancer Center — Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States
Providence Portland Med Ctr — Portland, Oregon, United States
Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
Hospital Of The University Of Pennsylvania — Philadelphia, Pennsylvania, United States
University Of Virginia Health System — Charlottesville, Virginia, United States
Local Institution — Créteil, France
Local Institution — Lille, France
Local Institution — Paris, France
Local Institution — Pessac, France
Local Institution — Pierre-Bénite, France
Local Institution — Rennes, France
Local Institution — Rouen, France
Local Institution — Villejuif, France
Local Institution — Essen, Germany
Hospital Universitari Vall D'Hebron — Barcelona, Spain
Fundacion Jimenez Diaz — Madrid, Spain
Local Institution — Pamplona, Spain

Full record on ClinicalTrials.gov

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