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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003059-46 | EudraCT Number |
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Business objectives have changed.
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This is a study of Nivolumab in combination with experimental medication BMS-986205 compared to the standard of care EXTREME regimen in head and neck cancer that has come back after initial treatment, or is widespread when first diagnosed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nivolumab and BMS-986205 | Experimental | Nivolumab administered in combination with BMS-986205 |
|
| EXTREME study regimen | Active Comparator | Cetuximab + Cisplatin/Carboplatin + Fluorouracil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Biological | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) as determined by Blinded Independent Central Review (BICR) using RECIST 1.1 | Approximately 2 years | |
| Overall survival (OS) | Approximately 40 months | |
| Objective response rate (ORR) determined by BICR using RECIST 1.1 | Approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events (AE) | Approximately 2 years | |
| Number of serious adverse events (SAE) | Approximately 2 years | |
| Time to meaningful symptomatic deterioration (TTSD) |
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For more information regarding Bristol-Myers Squibb 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 |
|---|---|---|---|---|---|---|
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212-0000 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
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| BMS-986205 | Drug | Administered 100mg orally once daily for a maximum of 104 weeks |
|
| Cetuximab | Biological | 400 mg/m² intravenous administration once only, then 250 mg/m² weekly maintenance until disease progression, unacceptable toxicity, withdrawal of informed consent, or other reason |
|
| Cisplatin | Drug | Cisplatin (100 mg/m2) every 3 weeks (Up to 6 cycles) |
|
| Carboplatin | Drug | Carboplatin (AUC of 5 mg per milliliter per minute) every 3 weeks (Up to 6 cycles) |
|
| Fluorouracil | Drug | 1000 mg/m² per day for 4 days, every 3 weeks (Up to 6 cycles) |
|
| Approximately 2 years |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| C000630574 | linrodostat |
| D000068818 | Cetuximab |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D005472 | Fluorouracil |
| 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 |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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