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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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)

NCT01471210•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
•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
+3 more criteria

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
+21 more criteria

Locations (24)

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

Key Dates

Start Date

February 1, 2012

Primary Completion Date

April 1, 2016

Completion Date

April 1, 2016

Last Updated

April 19, 2017

Enrollment

124

ACTUAL participants

Conditions

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

Interventions

Urelumab (BMS-663513)

DRUG