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The purpose of part 1 of this study is to determine the objective response rate (ORR) in stage IV NSCLC subjects treated with nivolumab in combination with ipilimumab as first line therapy.
The purpose of part 2 of this study is to determine the safety and tolerability of nivolumab and ipilimumab combined with a short course of chemotherapy in first line stage IV NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nivolumab+Ipilimumab | Experimental | Part 1 Specified Dose on Specified Days |
|
| Nivolumab+Ipilimumab + 2 cycles Platinum Doublet Chemotherapy | Experimental | Part 2 Specified Dose on Specified Days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Biological | Specified Dose on Specified Days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) by PD-L1 Positive and Negative Levels - Part 1 | Objective response rate (ORR) in PD-L1 positive (PD-L1 ≥1%) and PD-L1 negative (PD-L1 <1%) participants was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on Blinded Independent Central Review (BICR) assessment. | From first dose to database lock (Up to 18 months) |
| Number of Participants With Dose Limiting Toxicities (DLTs) - Part 2 | Dose limiting toxicities (DLTs) were defined as any of the items listed below.
| 9 weeks after first dose |
| Number of Participants With Adverse Events (AEs) - Part 2 | Number of participants with adverse events (AEs) including serious adverse events (SAEs) and deaths graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Ipilimumab combined with chemotherapy. | Deaths are from first dose to database lock (Up to 24 months). AEs and SAEs are from first dose to 30 days post last dose |
| Number of Participants With Laboratory Abnormalities in Hepatic Tests - Part 2 | Number of participant with specific liver laboratory abnormalities graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Ipilimumab combined with chemotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) - Part 1 | Overall survival (OS) was defined as the time from date of first treatment to the date of death due to any cause. A participant who has not died will be censored at the last known date alive. | From the date of first treatment to the date of death due to any cause (Up to approximately 72 months) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sharp Memorial Hospital | San Diego | California | 92123 | United States | ||
| Cancer Center Of Central Connecticut |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30785829 | Derived | Ready N, Hellmann MD, Awad MM, Otterson GA, Gutierrez M, Gainor JF, Borghaei H, Jolivet J, Horn L, Mates M, Brahmer J, Rabinowitz I, Reddy PS, Chesney J, Orcutt J, Spigel DR, Reck M, O'Byrne KJ, Paz-Ares L, Hu W, Zerba K, Li X, Lestini B, Geese WJ, Szustakowski JD, Green G, Chang H, Ramalingam SS. First-Line Nivolumab Plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer (CheckMate 568): Outcomes by Programmed Death Ligand 1 and Tumor Mutational Burden as Biomarkers. J Clin Oncol. 2019 Apr 20;37(12):992-1000. doi: 10.1200/JCO.18.01042. Epub 2019 Feb 20. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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324 participants treated
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| ID | Title | Description |
|---|---|---|
| FG000 | Nivolumab+Ipilimumab | Part 1 Nivolumab IV 3 mg/kg Q2W + Ipilimumab IV 1 mg/kg Q6W |
| FG001 | Nivolumab+Ipilimumab+Chemotherapy | Part 2 Nivolumab IV 360mg Q3W + Ipilimumab IV 1 mg/kg Q6W + 2 cycles Platinum Doublet Chemotherapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 11, 2018 | Jun 10, 2021 |
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| Ipilimumab | Biological | Specified Dose on Specified Days |
|
|
| Platinum Doublet Chemotherapy | Drug |
|
|
| From first dose to 30 days post last dose |
| Number of Participants With Laboratory Abnormalities in Thyroid Tests - Part 2 | Number of participants with specific thyroid laboratory abnormalities graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Ipilimumab combined with chemotherapy. | From first dose to 30 days post last dose |
| Overall Survival (OS) - Part 2 |
Overall survival (OS) was defined as the time from date of first treatment to the date of death due to any cause. A participant who has not died will be censored at the last known date alive. |
| From the date of first treatment to the date of death due to any cause (Up to approximately 59 months) |
| Progression Free Survival (PFS) - Part 1 | Progression Free Survival (PFS) was defined as the time between the date of first dose and the first date of documented progression, as determined by blinded independent central review (BICR), or death due to any cause, whichever occurred first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | From first dose to the first date of documented progression, or death due to any cause, whichever occurred first (Up to approximately 72 months) |
| Progression Free Survival (PFS) - Part 2 | Progression Free Survival (PFS) was defined as the time between the date of first dose and the first date of documented progression, as determined by investigator (per RECIST 1.1), or death due to any cause, whichever occurred first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | From first dose to the first date of documented progression, or death due to any cause, whichever occurred first (Up to approximately 59 months) |
| Objective Response Rate (ORR) - Part 1 | Objective response rate (ORR) was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on Blinded Independent Central Review (BICR) assessment. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | From first dose up to approximately 72 months |
| Objective Response Rate (ORR) - Part 2 | Objective response rate (ORR) was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on investigator assessment. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | From first dose up to approximately 59 months |
| Overall Survival (OS) by PD-L1 Expression Levels - Part 1 | Overall survival (OS) by PD-L1 expression levels was defined as the time from date of first treatment to the date of death due to any cause. A participant who has not died will be censored at the last known date alive. PD-L1 ≥1% = PD-L1 positive (membranous staining in ≥ 1% tumor cells) PD-L1 <1% = PD-L1 negative (membranous staining in <1% tumor cells) | From the date of first treatment to the date of death due to any cause (Up to approximately 72 months) |
| Progression Free Survival (PFS) by PD-L1 Expression Levels - Part 1 | Progression Free Survival (PFS) by PD-L1 expression levels was defined as the time between the date of first dose and the first date of documented progression, as determined by blinded independent central review (BICR), or death due to any cause, whichever occurred first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PD-L1 ≥1% = PD-L1 positive (membranous staining in ≥ 1% tumor cells) PD-L1 <1% = PD-L1 negative (membranous staining in <1% tumor cells) | From first dose to the first date of documented progression, or death due to any cause, whichever occurred first (Up to approximately 72 months) |
| Objective Response Rate (ORR) by PD-L1 Expression Levels-Part 1 | Objective response rate (ORR) by PD-L1 expression levels was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on Blinded Independent Central Review (BICR) assessment. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD-L1 ≥1% = PD-L1 positive (membranous staining in ≥ 1% tumor cells) PD-L1 <1% = PD-L1 negative (membranous staining in <1% tumor cells) | From first dose up to approximately 72 months |
| Overall Survival (OS) by Tumor Mutation Burden (TMB) Levels - Part 1 | Overall survival (OS) by tumor mutational burden (TMB) using DNA derived from tumor specimens was defined as the time from date of first treatment to the date of death due to any cause. A participant who has not died will be censored at the last known date alive. High TMB = ≥ 10 mutations per megabase Low TMB = < 10 mutations per megabase | From the date of first treatment to the date of death due to any cause (Up to approximately 72 months) |
| Progression Free Survival (PFS) by Tumor Mutation Burden (TMB) Levels - Part 1 | Progression Free Survival (PFS) by tumor mutational burden (TMB) using DNA derived from tumor specimens was defined as the time between the date of first dose and the first date of documented progression, as determined by blinded independent central review (BICR), or death due to any cause, whichever occurred first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. High TMB = ≥ 10 mutations per megabase Low TMB = < 10 mutations per megabase | From first dose to the first date of documented progression, or death due to any cause, whichever occurred first (Up to approximately 72 months) |
| Objective Response Rate (ORR) by Tumor Mutation Burden (TMB) Levels - Part 1 | Objective response rate (ORR) by tumor mutational burden (TMB) using DNA derived from tumor specimens was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on Blinded Independent Central Review (BICR) assessment. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. High TMB = ≥ 10 mutations per megabase Low TMB = < 10 mutations per megabase | From first dose up to approximately 72 months |
| Plainville |
| Connecticut |
| 06062 |
| United States |
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States |
| Winship Cancer Institute. | Atlanta | Georgia | 30322 | United States |
| Summit Cancer Care | Savannah | Georgia | 31405 | United States |
| Cancer Center Of Kansas | Wichita | Kansas | 67214 | United States |
| University Of Louisville Medical Center, Inc., Dba | Louisville | Kentucky | 40202 | United States |
| Johns Hopkins Cancer Center | Baltimore | Maryland | 21287 | United States |
| Local Institution - 0029 | Boston | Massachusetts | 02114-2621 | United States |
| Local Institution - 0030 | Boston | Massachusetts | 02114-2621 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Local Institution - 0015 | Lincoln | Nebraska | 68506 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Local Institution - 0036 | Albuquerque | New Mexico | 87106 | United States |
| Lovelace Cancer Care | Albuquerque | New Mexico | 87131 | United States |
| New Mexico Cancer Care Alliance | Albuquerque | New Mexico | 87131 | United States |
| New Mexico Cancer Care Center | Albuquerque | New Mexico | 87131 | United States |
| The Cancer Center at Presbyterian | Albuquerque | New Mexico | 87131 | United States |
| Local Institution - 0010 | Mineola | New York | 11501 | United States |
| Memorial Sloan Kettering Nassau | New York | New York | 10065 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Novant Health Oncology Specialists | Winston-Salem | North Carolina | 27103 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111-2412 | United States |
| Local Institution - 0006 | Pittsburgh | Pennsylvania | 15212 | United States |
| Charleston Hematology Oncology Associates, Pa | Charleston | South Carolina | 29414 | United States |
| Tennessee Oncology, PLLC - SCRI - PPDS | Nashville | Tennessee | 37203 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232-6307 | United States |
| Local Institution - 0022 | Kingston | Ontario | K7L 2V7 | Canada |
| Local Institution - 0023 | Sault Ste. Marie | Ontario | P6B 0A8 | Canada |
| Csss De St-Jerome | Saint-Jérôme | Quebec | J7Z 5T3 | Canada |
| BMS Clinical Trial Patient Recruiting | View source |
| FDA Safety Alerts and Recalls | View source |
| Investigator Inquiry Form | View source |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nivolumab+Ipilimumab | Part 1 Nivolumab IV 3 mg/kg Q2W + Ipilimumab IV 1 mg/kg Q6W |
| BG001 | Nivolumab+Ipilimumab+Chemotherapy | Part 2 Nivolumab IV 360mg Q3W + Ipilimumab IV 1 mg/kg Q6W + 2 cycles Platinum Doublet Chemotherapy |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) by PD-L1 Positive and Negative Levels - Part 1 | Objective response rate (ORR) in PD-L1 positive (PD-L1 ≥1%) and PD-L1 negative (PD-L1 <1%) participants was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on Blinded Independent Central Review (BICR) assessment. | All PD-L1 evaluable participants -Part 1 | Posted | Number | 95% Confidence Interval | Percentage of participants | From first dose to database lock (Up to 18 months) |
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| Primary | Number of Participants With Dose Limiting Toxicities (DLTs) - Part 2 | Dose limiting toxicities (DLTs) were defined as any of the items listed below.
| All treated participants -Part 2 | Posted | Count of Participants | Participants | 9 weeks after first dose |
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| Primary | Number of Participants With Adverse Events (AEs) - Part 2 | Number of participants with adverse events (AEs) including serious adverse events (SAEs) and deaths graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Ipilimumab combined with chemotherapy. | All treated participants -Part 2 | Posted | Count of Participants | Participants | Deaths are from first dose to database lock (Up to 24 months). AEs and SAEs are from first dose to 30 days post last dose |
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| Primary | Number of Participants With Laboratory Abnormalities in Hepatic Tests - Part 2 | Number of participant with specific liver laboratory abnormalities graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Ipilimumab combined with chemotherapy. | All treated participants with at least one on-treatment measurement of the corresponding laboratory parameter -Part 2 | Posted | Count of Participants | Participants | From first dose to 30 days post last dose |
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| Primary | Number of Participants With Laboratory Abnormalities in Thyroid Tests - Part 2 | Number of participants with specific thyroid laboratory abnormalities graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Ipilimumab combined with chemotherapy. | All treated participants with at least one on-treatment TSH measurement -Part 2 | Posted | Count of Participants | Participants | From first dose to 30 days post last dose |
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| Secondary | Overall Survival (OS) - Part 1 | Overall survival (OS) was defined as the time from date of first treatment to the date of death due to any cause. A participant who has not died will be censored at the last known date alive. | All treated participants in Part 1 | Posted | Median | 95% Confidence Interval | Months | From the date of first treatment to the date of death due to any cause (Up to approximately 72 months) |
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| Secondary | Overall Survival (OS) - Part 2 | Overall survival (OS) was defined as the time from date of first treatment to the date of death due to any cause. A participant who has not died will be censored at the last known date alive. | All treated participants in Part 2 | Posted | Median | 95% Confidence Interval | Months | From the date of first treatment to the date of death due to any cause (Up to approximately 59 months) |
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| Secondary | Progression Free Survival (PFS) - Part 1 | Progression Free Survival (PFS) was defined as the time between the date of first dose and the first date of documented progression, as determined by blinded independent central review (BICR), or death due to any cause, whichever occurred first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | All treated participants in Part 1 | Posted | Median | 95% Confidence Interval | Months | From first dose to the first date of documented progression, or death due to any cause, whichever occurred first (Up to approximately 72 months) |
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| Secondary | Progression Free Survival (PFS) - Part 2 | Progression Free Survival (PFS) was defined as the time between the date of first dose and the first date of documented progression, as determined by investigator (per RECIST 1.1), or death due to any cause, whichever occurred first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | All treated participants in Part 2 | Posted | Median | 95% Confidence Interval | Months | From first dose to the first date of documented progression, or death due to any cause, whichever occurred first (Up to approximately 59 months) |
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| Secondary | Objective Response Rate (ORR) - Part 1 | Objective response rate (ORR) was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on Blinded Independent Central Review (BICR) assessment. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | All treated participants in Part 1 | Posted | Number | 95% Confidence Interval | Percentage of participants | From first dose up to approximately 72 months |
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| Secondary | Objective Response Rate (ORR) - Part 2 | Objective response rate (ORR) was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on investigator assessment. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | All treated participants in Part 2 | Posted | Number | 95% Confidence Interval | Percentage of participants | From first dose up to approximately 59 months |
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| Secondary | Overall Survival (OS) by PD-L1 Expression Levels - Part 1 | Overall survival (OS) by PD-L1 expression levels was defined as the time from date of first treatment to the date of death due to any cause. A participant who has not died will be censored at the last known date alive. PD-L1 ≥1% = PD-L1 positive (membranous staining in ≥ 1% tumor cells) PD-L1 <1% = PD-L1 negative (membranous staining in <1% tumor cells) | All PD-L1 evaluable participants in Part 1. Data was pre-specified to be collected only in Part 1 arm | Posted | Median | 95% Confidence Interval | Months | From the date of first treatment to the date of death due to any cause (Up to approximately 72 months) |
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| Secondary | Progression Free Survival (PFS) by PD-L1 Expression Levels - Part 1 | Progression Free Survival (PFS) by PD-L1 expression levels was defined as the time between the date of first dose and the first date of documented progression, as determined by blinded independent central review (BICR), or death due to any cause, whichever occurred first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PD-L1 ≥1% = PD-L1 positive (membranous staining in ≥ 1% tumor cells) PD-L1 <1% = PD-L1 negative (membranous staining in <1% tumor cells) | All PD-L1 evaluable participants in Part 1. Data was pre-specified to be collected only in Part 1 arm | Posted | Median | 95% Confidence Interval | Months | From first dose to the first date of documented progression, or death due to any cause, whichever occurred first (Up to approximately 72 months) |
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| Secondary | Objective Response Rate (ORR) by PD-L1 Expression Levels-Part 1 | Objective response rate (ORR) by PD-L1 expression levels was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on Blinded Independent Central Review (BICR) assessment. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD-L1 ≥1% = PD-L1 positive (membranous staining in ≥ 1% tumor cells) PD-L1 <1% = PD-L1 negative (membranous staining in <1% tumor cells) | All PD-L1 evaluable participants in Part 1. Data was pre-specified to be collected only in Part 1 arm | Posted | Number | 95% Confidence Interval | Percentage of participants | From first dose up to approximately 72 months |
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| Secondary | Overall Survival (OS) by Tumor Mutation Burden (TMB) Levels - Part 1 | Overall survival (OS) by tumor mutational burden (TMB) using DNA derived from tumor specimens was defined as the time from date of first treatment to the date of death due to any cause. A participant who has not died will be censored at the last known date alive. High TMB = ≥ 10 mutations per megabase Low TMB = < 10 mutations per megabase | All TMB evaluable participants in Part 1. Data was pre-specified to be collected only in Part 1 arm | Posted | Median | 95% Confidence Interval | Months | From the date of first treatment to the date of death due to any cause (Up to approximately 72 months) |
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| Secondary | Progression Free Survival (PFS) by Tumor Mutation Burden (TMB) Levels - Part 1 | Progression Free Survival (PFS) by tumor mutational burden (TMB) using DNA derived from tumor specimens was defined as the time between the date of first dose and the first date of documented progression, as determined by blinded independent central review (BICR), or death due to any cause, whichever occurred first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. High TMB = ≥ 10 mutations per megabase Low TMB = < 10 mutations per megabase | All TMB evaluable participants in Part 1. Data was pre-specified to be collected only in Part 1 arm | Posted | Median | 95% Confidence Interval | Months | From first dose to the first date of documented progression, or death due to any cause, whichever occurred first (Up to approximately 72 months) |
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| Secondary | Objective Response Rate (ORR) by Tumor Mutation Burden (TMB) Levels - Part 1 | Objective response rate (ORR) by tumor mutational burden (TMB) using DNA derived from tumor specimens was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on Blinded Independent Central Review (BICR) assessment. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. High TMB = ≥ 10 mutations per megabase Low TMB = < 10 mutations per megabase | All TMB evaluable participants in Part 1. Data was pre-specified to be collected only in Part 1 arm | Posted | Number | 95% Confidence Interval | Percentage of participants | From first dose up to approximately 72 months |
|
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Part 1: SAEs and AEs are assessed from first dose to 30 days post last dose (Up to approximately 25 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to approximately 72 months). Part 2: SAEs and AEs are assessed from first dose to 30 days post last dose (Up to approximately 25 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to approximately 59 months).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nivolumab+Ipilimumab | Part 1 Nivolumab IV 3 mg/kg Q2W + Ipilimumab IV 1 mg/kg Q6W | 209 | 288 | 171 | 288 | 282 | 288 |
| EG001 | Nivolumab+Ipilimumab+Chemotherapy | Part 2 Nivolumab IV 360mg Q3W + Ipilimumab IV 1 mg/kg Q6W + 2 cycles Platinum Doublet Chemotherapy | 28 | 36 | 26 | 36 | 35 | 36 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 25.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | 25.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 25.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Acute left ventricular failure | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | 25.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | 25.0 | Systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | 25.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Autoimmune colitis | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Autoimmune enteropathy | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Enterovesical fistula | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Asthenia | General disorders | 25.0 | Systematic Assessment |
| |
| Chills | General disorders | 25.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 25.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | 25.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | 25.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 25.0 | Systematic Assessment |
| |
| Pain | General disorders | 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 25.0 | Systematic Assessment |
| |
| Sudden death | General disorders | 25.0 | Systematic Assessment |
| |
| Swelling face | General disorders | 25.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | 25.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | 25.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | 25.0 | Systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | 25.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | 25.0 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Adrenalitis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Empyema | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Large intestine infection | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 25.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 25.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | 25.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | 25.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | 25.0 | Systematic Assessment |
| |
| Influenza B virus test positive | Investigations | 25.0 | Systematic Assessment |
| |
| Liver function test increased | Investigations | 25.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | 25.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Glucose tolerance impaired | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | Systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | Systematic Assessment |
| |
| Metastases to spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | Systematic Assessment |
| |
| Metastases to stomach | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | Systematic Assessment |
| |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Paraneoplastic encephalomyelitis | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Unintended pregnancy | Pregnancy, puerperium and perinatal conditions | 25.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | 25.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 25.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | 25.0 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | 25.0 | Systematic Assessment |
| |
| Urethral stenosis | Renal and urinary disorders | 25.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | 25.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | 25.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Laryngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Pulmonary pain | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | 25.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 25.0 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | 25.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | 25.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | 25.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | 25.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 25.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 25.0 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | 25.0 | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | 25.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 25.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 25.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | 25.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | 25.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | 25.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | 25.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Asthenia | General disorders | 25.0 | Systematic Assessment |
| |
| Chills | General disorders | 25.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 25.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | 25.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | 25.0 | Systematic Assessment |
| |
| Malaise | General disorders | 25.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | 25.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | 25.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 25.0 | Systematic Assessment |
| |
| Pain | General disorders | 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 25.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 25.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | 25.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 25.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | 25.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 25.0 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | 25.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | 25.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | 25.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 25.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 25.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | 25.0 | Systematic Assessment |
| |
| Weight increased | Investigations | 25.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 25.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Taste disorder | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | 25.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | 25.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | 25.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 25.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | 25.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | 25.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 25.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 25.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 25.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 25.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 25.0 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please Email | Clinical.Trials@bms.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 25, 2019 | Jun 10, 2021 | SAP_001.pdf |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000074324 | Ipilimumab |
| C053518 | CP protocol |
| D002945 | Cisplatin |
| D000068437 | Pemetrexed |
| 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 |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000600 | Amino Acids, Dicarboxylic |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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