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The purpose of the study is to determine the safety, tolerability and maximum tolerated dose of Urelumab in combination with Cetuximab in patients with Advanced/Metastatic Colorectal Cancer or Advanced/Metastatic Squamous Cell Carcinoma of the Head and Neck.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Urelumab + Cetuximab | Experimental | Urelumab every 3 weeks with Cetuximab weekly through Intravenous infusion |
|
| Cohort 2: Urelumab + Cetuximab | Experimental | Urelumab every 3 weeks with Cetuximab weekly through Intravenous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urelumab | Biological |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| The primary safety endpoint is the incidence, potential significance, and clinical importance of adverse events | As determined by medical review of adverse event reports, vital sign measurements, electrocardiograms (ECGs), and results of physical examination and laboratory tests During a 3 week cycle, safety labs are done on Days 1, 2, 3, 5, 8, and 15. Starting on Cycle 3, Day 1, Chemistry (excluding Liver function test (LFTs)) are to be performed on Day 1 and Day 15 of each cycle thereafter. Physical exams are done on Day 1 of each cycle. Vital signs are done on Days 1, 2, 8, and 15 at Cycle 1 and then on Days 1 and 2 of each cycle thereafter. Adverse events are collected from screening to 60 days after last dose of Urelumab | Approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Up to 2 years | |
| Duration of Objective Response (DOR) | Up to 2 years | |
| Progression Free Survival (PFS) |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States | ||
| University Of Chicago |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38458639 | Derived | Khushalani NI, Ott PA, Ferris RL, Cascone T, Schadendorf D, Le DT, Sharma MR, Barlesi F, Sharfman W, Luke JJ, Melero I, Lathers D, Neely J, Suryawanshi S, Sanyal A, Holloway JL, Suryawanshi R, Ely S, Segal NH. Final results of urelumab, an anti-CD137 agonist monoclonal antibody, in combination with cetuximab or nivolumab in patients with advanced solid tumors. J Immunother Cancer. 2024 Mar 7;12(3):e007364. doi: 10.1136/jitc-2023-007364. |
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| Cetuximab |
| Biological |
|
| Up to 2 years |
| Immunogenicity measured by the occurrence of anti-drug antibody after the administration of BMS-663513 | Up to 2 years |
| Maximum observed serum concentration (Cmax) of BMS-663513 in combination with Cetuximab | Up to 2 years |
| Time of maximum observed serum concentration (Tmax) of BMS-663513 in combination with Cetuximab | Up to 2 years |
| Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-663513 in combination with Cetuximab | Up to 2 years |
| Area under the serum concentration-time curve from time zero to the time of last quantifiable serum concentration (AUC(0-T)) of BMS-663513 in combination with Cetuximab | Up to 2 years |
| Elimination half-life (T-HALF) of BMS-663513 in combination with Cetuximab | Up to 2 years |
| Total body clearance (CLT) of BMS-663513 in combination with Cetuximab | Up to 2 years |
| Volume of distribution at steady-state (Vss) of BMS-663513 in combination with Cetuximab | Up to 2 years |
| Trough observed concentration (Cmin) of BMS-663513 in combination with Cetuximab | Up to 2 years |
| Chicago |
| Illinois |
| 60637 |
| United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Providence Oncology & Hematology Care Eastside | Portland | Oregon | 97213 | United States |
| Upmc Cancer Center | Pittsburgh | Pennsylvania | 15213 | United States |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| C000620833 | urelumab |
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| 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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