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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004283-65 | EudraCT Number |
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Business objectives have changed
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| Name | Class |
|---|---|
| Clovis Oncology, Inc. | INDUSTRY |
| Exelixis | INDUSTRY |
| Eli Lilly and Company | INDUSTRY |
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This study is for participants with Non-small Cell Lung Cancer that has spread or has reoccurred after failure of Chemotherapy and Immunotherapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: cabozantinib + nivolumab + ipilimumab | Experimental |
| |
| Arm B: cabozantinib + nivolumab | Experimental |
| |
| Arm C: nivolumab + ramucirumab + docetaxel | Experimental |
| |
| Arm D: lucitanib + nivolumab | Experimental |
| |
| Arm E: nivolumab + docetaxel | Experimental |
| |
| Arm F: docetaxel | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nivolumab | Biological | Specified dose on Specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Reponse Rate (ORR) using RECIST 1.1 per Blinded Independent Central Review (BICR) assessment | approximately 33 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Up to 5 Years | |
| Duration of Response (DOR) by BICR using RECIST 1.1 | approximately 33 months | |
| Progression-Free Survival (PFS) by BICR using RECIST 1.1 |
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For more information regarding Bristol-Myers Squibb 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 |
|---|---|---|---|---|---|---|
| Local Institution | Detroit | Michigan | 48201 | United States | ||
| Local Institution |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| FDA Safety Alerts and Recalls |
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|
| ipilimumab | Biological | Specified dose on Specified days |
|
|
| cabozantinib | Drug | Specified dose on Specified days |
|
|
| docetaxel | Biological | Specified dose on Specified days |
|
| ramucirumab | Biological | Specified dose on Specified days |
|
|
| lucitanib | Drug | Specified dose on Specified days |
|
|
| Up to 5 Years |
| Incidence of Adverse Events (AEs) | Up to 5 Years |
| Incidence of Serious Adverse Events (SAEs) | Up to 5 Years |
| Incidence of Select AEs | Up to 5 Years |
| Ciudad Autónoma de Buenos Aires |
| Buenos Aires |
| 1426 |
| Argentina |
| Local Institution | Buenos Aires | Distrito Federal | 1431 | Argentina |
| Local Institution | Buenos Aires | Distrito Federal | C1199ABB | Argentina |
| Local Institution | Caba | Distrito Federal | 1430 | Argentina |
| Local Institution | Capital | Distrito Federal | C1280 | Argentina |
| Local Institution | Charleroi | 6000 | Belgium |
| Local Institution | Gilly | 6060 | Belgium |
| Local Institution | Leuven | 3000 | Belgium |
| Local Institution | Copenhagen Ø | 2100 | Denmark |
| Local Institution | Athens | 11527 | Greece |
| Local Institution | Neo Faliro | 18547 | Greece |
| Local Institution | Torreón | Coahuila | 27010 | Mexico |
| Local Institution | Zapopan | Jalisco | 44280 | Mexico |
| Local Institution | Mexico City | Mexico City | 03240 | Mexico |
| Local Institution | Puebla City | Puebla | 72530 | Mexico |
| Local Institution | Amsterdam | 1066 CX | Netherlands |
| Local Institution | Rotterdam | 3015 GD | Netherlands |
| Local Institution | Oslo | 0379 | Norway |
| Local Institution | Warsaw | Masovian Voivodeship | 02-781 | Poland |
| Local Institution | Krakow | 30-688 | Poland |
| Local Institution | Craiova | 200347 | Romania |
| Local Institution | Timișoara | 300696 | Romania |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000074324 | Ipilimumab |
| C558660 | cabozantinib |
| D000077143 | Docetaxel |
| D000096662 | Ramucirumab |
| C000595232 | E-3810 |
| 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 |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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