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
NCT ID: NCT01471210
Last Updated: 2017-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
124 participants
INTERVENTIONAL
2012-02-29
2016-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
CA-4948-101: Open-Label, Dose Escalation and Expansion Trial of Emavusertib (CA-4948) in Relapsed or Refractory Primary Central Nervous System Lymphoma (R/R PCNSL)
NCT03328078
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young Adults With Hodgkin and Non-Hodgkin Lymphoma
NCT05255601
UBX-303061 in Subjects With Relapsed/Refractory B-Cell Malignancies
NCT06590961
Safety and Pharmacokinetic Study of IMM0306 in Patients With Refractory or Relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL)
NCT04746131
Orelabrutinib, Sintilimab and Temozolomide in Relapsed or Refractory Central Nervous System Lymphoma
NCT04961515
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Part 1 : Urelumab (BMS-663513) Dose escalation
Urelumab (BMS-663513) solution administered intravenously on specified days
Urelumab (BMS-663513)
Part 2 : Urelumab (BMS-663513) Cohort Expansion
Urelumab (BMS-663513) solution administered intravenously on specified days
Urelumab (BMS-663513)
Part 3:Urelumab (BMS-663513) Tumor-specific Cohort Expansions
Enrollment of subjects of three specific tumor types \[(colorectal cancer (CRC), head and neck squamous cell carcinoma (SCCHN), and B-Cell non-Hodgkin's lymphoma (B-NHL)\] who will be treated at the Maximum Tolerated Dose (MTD) (or highest dose tested)
Urelumab (BMS-663513)
Part 4:Urelumab (BMS-663513) Cohort Expansion in B-NHL
Arm A and Arm B: Urelumab (BMS-663513) liquid administered intravenously on specified days exploring q3w and q6w dosing regimen
Urelumab (BMS-663513)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Urelumab (BMS-663513)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
Exclusion Criteria
* 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 days
2. Immunosuppressive medications or immunosuppressive doses of systemic corticosteroids
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 (BMS-663513)
* Prior organ allograft or allogeneic bone marrow transplantation
* Prisoners or subjects who are involuntarily incarcerated
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012-000170-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA186-011
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.