Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Urelumab · 4 trials · 5 indications
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
The incidence of adverse events will be tabulated and reviewed for potential significance and clinical Importance.
| Arm | Type | Description |
|---|---|---|
| Urelumab (+ Nivolumab) intravenous (IV) infusion | EXPERIMENTAL | - |
| 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 |
| 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 |
| 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 |
|---|---|---|
| Urelumab | DRUG | - |
| Nivolumab | DRUG | - |
| Cetuximab | BIOLOGICAL | - |
| Rituximab | BIOLOGICAL | - |
| Urelumab (BMS-663513) | DRUG | - |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Subjects with previously treated advanced malignant solid tumor * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 * For certain subjects, willing and able to...
Urelumab is an investigational monoclonal antibody being developed for oncology indications, including advanced or metastatic solid tumors, B-cell non-Hodgkin's lymphoma, B-cell malignancies, colorectal cancer, and head and neck cancer. It is currently in Phase 1 clinical trials and is not yet approved.
Urelumab is being developed by Bristol-Myers Squibb Company, which is listed on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the safety and efficacy of Urelumab in various cancer types.
Urelumab is in Phase 1 clinical development. Multiple Phase 1 trials have been completed, including studies in solid tumors, B-cell non-Hodgkin's lymphoma, colorectal cancer, and head and neck cancer. It remains an investigational drug and has not received FDA approval.
Urelumab has been studied in several completed Phase 1 trials. NCT01471210 evaluated Urelumab in advanced solid tumors and B-cell non-Hodgkin's lymphoma. NCT01775631 tested Urelumab with rituximab in B-cell non-Hodgkin's lymphoma. NCT02110082 combined Urelumab with cetuximab in colorectal and head and neck cancers. NCT02534506 studied Urelumab in advanced malignant tumors in Japan.
Yes, Urelumab is also known as BMS-663513. In clinical trial NCT01471210, the study title refers to Urelumab (BMS-663513), indicating that these names are used interchangeably for the same investigational drug.