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The purpose of the study is to determine the safety, tolerability and maximum tolerated dose of Urelumab in combination with Rituximab in patients with B-cell Non-Hodgkins Lymphoma
Intervention model: Dose Escalation (part 1) of study= Sequential Design; Dose Expansion (part 2) of study= Parallel Design
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm -1 - Urelumab + Rituximab | Experimental | Urelumab (BMS-663513) flat dose intravenous infusion on specified days Rituximab intravenous flat dose infusion on specified days |
|
| Arm 1 - Urelumab + Rituximab | Experimental | Urelumab (BMS-663513) flat dose intravenous infusion on specified days Rituximab intravenous flat dose infusion on specified days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urelumab | Biological |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of Urelumab in combination with Rituximab as measured by incidence of adverse events (AEs), serious AEs, death, vital sign changes, electrocardiograms (ECGs), physical examination results, and laboratory test abnormalities | Up to 60 days after last dose of Urelumab | |
| Safety and tolerability of Urelumab in combination with Rituximab as measured by incidence of adverse events (AEs), serious AEs, death, vital sign changes, electrocardiograms (ECGs), physical examination results, and laboratory test abnormalities | Up to 110 days after last dose of Rituximab |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy-Antitumor Activity of Urelumab in combination with Rituximab as measured by best overall response, progression-free survival, time to response, and duration of response | Up to approximately 3 years | |
| Maximum observed serum concentration (Cmax) of Urelumab and Rituximab |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ucla Department Of Medicine | Los Angeles | California | 90095 | United States | ||
| Stanford University Medical Center |
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| Rituximab |
| Biological |
|
| 12 time points up to Day 60 of Follow-up |
| Time of maximum observed serum concentration (Tmax) of Urelumab | 12 time points up to Day 60 of Follow-up |
| Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of Urelumab | 12 time points up to Day 60 of Follow-up |
| Trough observed serum concentration (Cmin) of Urelumab and Rituximab | 12 + 9 time points up to Day 60 of Follow-up |
| Area under the concentration-time curve (AUC) in one dosing interval (AUC(TAU)) of Urelumab | 12 time points up to Day 60 of Follow-up |
| Immunogenicity of Urelumab in combination with Rituximab as determined by blood sample measurements of anti-drug antibodies (ADA) | Up to approximately 110 days post study drug |
| Stanford |
| California |
| 94305 |
| United States |
| University Of Miami Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
| Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida | 33140 | United States |
| University Of Iowa Hospitals And Clinics | Iowa City | Iowa | 52242 | United States |
| Dana Faber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| University Of Michigan Health System | Ann Arbor | Michigan | 48109 | 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 | 11065 | United States |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
| Providence Cancer Center Oncology And Hematology Care- Eastside | Portland | Oregon | 97213 | United States |
| Hospital Of The University Of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| The University Of Texas Md Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University Of Virginia School Of Medicine | Charlottesville | Virginia | 22908 | United States |
| ID | Term |
|---|---|
| C000620833 | urelumab |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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