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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000170-28 | EudraCT Number |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 : Urelumab (BMS-663513) Dose escalation | Experimental | Urelumab (BMS-663513) solution administered intravenously on specified days |
|
| Part 2 : Urelumab (BMS-663513) Cohort Expansion | Experimental | Urelumab (BMS-663513) solution administered intravenously on specified days |
|
| Part 3:Urelumab (BMS-663513) Tumor-specific Cohort Expansions | Experimental | 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) |
|
| Part 4:Urelumab (BMS-663513) Cohort Expansion in B-NHL | Experimental | Arm A and Arm B: Urelumab (BMS-663513) liquid administered intravenously on specified days exploring q3w and q6w dosing regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urelumab (BMS-663513) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | The incidence of adverse events will be tabulated and reviewed for potential significance and clinical Importance. | Every 3 weeks from Baseline (Day 1) for up to 2 years |
| Dose-limiting toxicity and maximum tolerated dose of Urelumab (BMS-663513) as determined by the incidence of dose-limiting toxicities | Every 3 weeks from Baseline (Day 1) for up to 9 weeks of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed serum concentrations (Cmax) of Urelumab (BMS-663513) | Cycle 1 Day 1 | |
| Minimum observed serum concentrations (Cmin) of Urelumab (BMS-663513) | Cycle 2 Day 1, Cycle 3 Day 1, every 12 weeks thereafter up to 2 years |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
Signed Written Informed Consent
Target Population
Age and Reproductive Status
Exclusion Criteria:
Target Disease Exceptions
Medical History and Concurrent Diseases
Physical and Laboratory Test Findings
Allergies and Adverse Drug Reaction
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:
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
Other Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division Of Hematology & Oncology Ctr. For Health Sciences | Los Angeles | California | 90095 | United States | ||
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| Time of maximum observed serum concentration (Tmax) of Urelumab (BMS-663513) | Cycle 1 Day 1 |
| Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] of Urelumab (BMS-663513) | Cycle 1 Day 1 - Day 4, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 8, Cycle 3 Day 1 and every 12 weeks thereafter up to 2 years |
| Plasma half-life (T-HALF) of Urelumab (BMS-663513) | Cycle 1 Day 1 - Day 4, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 8, Cycle 3 Day 1 and every 12 weeks thereafter up to 2 years |
| Total body clearance (CLT) of Urelumab (BMS-663513) | Cycle 1 Day 1 - Day 4, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 8, Cycle 3 Day 1 and every 12 weeks thereafter up to 2 years |
| Volume of distribution at steady-state (Vss) of Urelumab (BMS-663513) | Cycle 1 Day 1 - Day 4, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 8, Cycle 3 Day 1 and every 12 weeks thereafter up to 2 years |
| Human Anti-human Antibodies | Immunogenicity of Urelumab (BMS-663513), as determined by blood sample measurements of human antihuman antibodies (HAHA) | Cycle 1 Day 1 - Day 4, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 8, Cycle 3 Day 1 and every 12 weeks thereafter up to 2 years |
| Tumor response and progression as determined by proportion of patients with best overall response (BOR), progression-free survival (PFS), objective response rate (ORR), time to response, and duration of response | 9 weeks from Baseline (Day 1) and every 9 weeks until disease progression, death or last tumor assessment (Approximately up to 2 years) |
| Stanford University Medical Center |
| Stanford |
| California |
| 94305 |
| United States |
| University Of Chicago | Chicago | Illinois | 60637 | United States |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| John Theurer Cancer Center | Hackensack | New Jersey | 07601 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Providence Portland Med Ctr | Portland | Oregon | 97213 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Hospital Of The University Of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University Of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
| Local Institution | Créteil | 94010 | France |
| Local Institution | Lille | 59037 | France |
| Local Institution | Paris | 75475 | France |
| Local Institution | Pessac | 33604 | France |
| Local Institution | Pierre-Bénite | 69495 | France |
| Local Institution | Rennes | 35033 | France |
| Local Institution | Rouen | F-76038 | France |
| Local Institution | Villejuif | 94805 | France |
| Local Institution | Essen | 45147 | Germany |
| Hospital Universitari Vall D'Hebron | Barcelona | 08035 | Spain |
| Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Local Institution | Pamplona | 31192 | Spain |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000620833 | urelumab |
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