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A Study to Evaluate Safety in Participants with Chemotherapy-naïve Stage IV or Recurrent Non-small Cell Lung Cancer Treated With Nivolumab in Combination with Ipilimumab
A Study to Evaluate Safety in Participants with Chemotherapy-naïve Stage IV or Recurrent Non-small Cell Lung Cancer Treated With Nivolumab in Combination with Ipilimumab
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flat-Dose | Experimental | Nivolumab flat dose + Ipilimumab |
|
| Weight-Based Dose | Experimental | Nivolumab weight-based dose + Ipilimumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of high grade (Grade 3-4 and Grade 5) treatment-related select adverse events | Approximately 3 months | |
| Incidence of high grade (Grade 3-4 and Grade 5) immune-mediated adverse events | Approximately 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST v1.1) | Up to 24 months | |
| Objective Response Rate (ORR) as assessed by the Investigator using tumor progression per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) |
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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 |
|---|---|---|---|---|---|---|
| Local Institution | San Francisco | California | 94115 | United States | ||
| Local Institution |
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| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
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| Ipilimumab | Drug | Specified dose on specified days |
|
|
| Up to 24 months |
| Overall survival (OS) as defined as the time from first dosing to the date of death | Up to 5 years |
| Duration of Response (DOR) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST v1.1) | Up to 24 months |
| Lincoln |
| Nebraska |
| 68506 |
| United States |
| Local Institution | Hackensack | New Jersey | 07601 | United States |
| Local Institution | Columbus | Ohio | 43210 | United States |
| Local Institution | Lancaster | Pennsylvania | 17604 | United States |
| Local Institution | Langhorne | Pennsylvania | 19047 | United States |
| Local Institution | Sayre | Pennsylvania | 18840 | United States |
| Local Institution | Charleston | South Carolina | 29414 | United States |
| Local Institution | St. George | Utah | 84770 | United States |
| Local Institution | Viedma | Río Negro Province | 8500 | Argentina |
| Local Institution | Montreal | Quebec | H1M 1B1 | Canada |
| Local Institution | Dresden | 01307 | Germany |
| Local Institution | Gauting | 82131 | Germany |
| Local Institution | Gerlingen | 70839 | Germany |
| Local Institution | Großhansdorf | 22927 | Germany |
| Local Institution | Lima | 27 | Peru |
| Local Institution | Lima | Peru |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000074324 | Ipilimumab |
| 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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