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The purpose of this study is to evaluate the safety and efficacy of a sequential combination therapy of Nivolumab and Ipilimumab
In order to evaluate the potential synergistic activity of nivolumab and ipilimumab and also because there may be differences in biology between tumors which are stable or responding to therapy and those that are clinically progressing, this study, CA209064, looked at two sequential combination regimens in which the second agent is administered immediately after a pre-specified duration of therapy with the first agent and not delayed until the time of progression after the first agent. This sequential study design looked at pharmacodynamic changes during treatment with one agent which may predict clinical activity to subsequent treatment with the alternate agent. This was done because it has not been scientifically proven whether or not the order in which nivolumab and ipilimumab are given is clinically important.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: Nivolumab followed by Ipilimumab | Experimental | Nivolumab 3 mg/kg solution intravenously every 2 weeks up to 6 doses in Induction period and 3 mg/kg solution intravenously every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent in Continuation period for a maximum of 2 years from 1st study treatment in Induction Period 1. Ipilimumab 3 mg/kg solution intravenously every 3 weeks up to 4 doses in Induction period. |
|
| Cohort B: Ipilimumab followed by Nivolumab | Experimental | Ipilimumab 3 mg/kg solution intravenously every 3 weeks up to 4 doses in Induction period. Nivolumab 3 mg/kg solution intravenously every 2 weeks up to 6 doses in Induction period and 3 mg/kg solution intravenously every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent in Continuation period for a maximum of 2 years from 1st study treatment in Induction Period 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Biological |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment-Related Grade 3-5 Adverse Events (AEs) During the Induction Period (Period 1 and 2) | The percentage of participants with treatment-related grade 3-5 adverse events (AEs) is defined as the number of participants who experienced at least 1 treatment related grade 3 - 5 adverse event (AE) per national cancer institute common terminology criteria for adverse events (NCI CTCAE v4.0, any preferred term) with an onset date after or on first day of Induction Period #1 and not later than discontinuation date from Induction Period #2, divided by the total number of treated participants. Adverse Event (AE) = any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not have a causal relationship with treatment. Treatment-related = having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 3=Severe Gr 4=Potentially Life-threatening or disabling Gr 5=Death | From Day 1 to up to Week 25 |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator-Assessed Response Rate at Week 25 | Response rate is defined as the number of participants who have a complete response (CR) or partial response (PR) at Week 25 per modified RECIST 1.1 criteria, with confirmation on the scheduled scan at Week 33 (or any subsequent scan performed at least 4 weeks after the Week 25 scan), divided by the total number of treated participants. Results of the tumor assessment at Week 13 or any unscheduled tumor assessment obtained prior to Week 25, except for baseline/screening tumor assessment, were not considered in the assessment of response rate at Week 25. |
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For more information regarding BMS 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 |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | United States | ||
| Indiana University Health Melvin And Bren Simon Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32303612 | Derived | Yoshida T, Ichikawa J, Giuroiu I, Laino AS, Hao Y, Krogsgaard M, Vassallo M, Woods DM, Stephen Hodi F, Weber J. C reactive protein impairs adaptive immunity in immune cells of patients with melanoma. J Immunother Cancer. 2020 Apr;8(1):e000234. doi: 10.1136/jitc-2019-000234. | |
| 27269740 | Derived | Weber JS, Gibney G, Sullivan RJ, Sosman JA, Slingluff CL Jr, Lawrence DP, Logan TF, Schuchter LM, Nair S, Fecher L, Buchbinder EI, Berghorn E, Ruisi M, Kong G, Jiang J, Horak C, Hodi FS. Sequential administration of nivolumab and ipilimumab with a planned switch in patients with advanced melanoma (CheckMate 064): an open-label, randomised, phase 2 trial. Lancet Oncol. 2016 Jul;17(7):943-955. doi: 10.1016/S1470-2045(16)30126-7. Epub 2016 Jun 4. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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Of the 140 randomized,138 treated because 1 experienced adverse event unrelated to study drug and 1 no longer met study criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nivolumab Followed by Ipilimumab | Nivolumab 3 mg/kg Q2W IV over 60 min for up to 6 doses during Weeks 1 to 13 in Induction Period 1 followed by Ipilimumab 3 mg/kg Q3W IV over 90 min for up to 4 doses during Weeks 13 to 25 in Induction Period 2. |
| FG001 | Ipilimumab Followed by Nivolumab |
| 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 | Mar 28, 2013 | Jul 22, 2021 |
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| Ipilimumab | Biological |
|
|
| Week 25 |
| Investigator-Assessed Duration of Response (DOR) | Duration of response (DOR) is defined as the time between the Week 25 date of response and the date of objectively documented disease progression as defined by modified RECIST 1.1 criteria or death, whichever occurs first. Median computed using Kaplan-Meier method. | From week 25 to up to date of disease progression or death (Up to 6 years) |
| Investigator-Assessed Rate of Progression | Progression rate at a specific timepoint is defined as the number of participants who have Progressive Disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at that specific timepoint divided by the total number of treated participants. As specified by modified RECIST 1.1, the evaluation of PD at Week 13 and Week 25 used the baseline tumor assessment as reference. A participant who died without a reported prior progression was considered to have progressed on the date of death. Deaths before or at Week 13 are counted as progression outcome. Confidence interval is based on the Clopper and Pearson method. | Week 13 and Week 25 |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02215 | United States |
| Lehigh Valley Health Network | Allentown | Pennsylvania | 18103 | United States |
| University Of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232-6307 | United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| University Of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls | View source |
Ipilimumab 3 mg/kg Q3W IV over 90 min for up to 4 doses during Weeks 1 to 13 in Induction Period 1 followed by Nivolumab 3 mg/kg Q2W IV over 60 min for up to 6 doses during Weeks 13 to 25 in Induction Period 2. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nivolumab Followed by Ipilimumab | Nivolumab 3 mg/kg Q2W IV over 60 min for up to 6 doses during Weeks 1 to 13 in Induction Period 1 followed by Ipilimumab 3 mg/kg Q3W IV over 90 min for up to 4 doses during Weeks 13 to 25 in Induction Period 2. |
| BG001 | Ipilimumab Followed by Nivolumab | Ipilimumab 3 mg/kg Q3W IV over 90 min for up to 4 doses during Weeks 1 to 13 in Induction Period 1 followed by Nivolumab 3 mg/kg Q2W IV over 60 min for up to 6 doses during Weeks 13 to 25 in Induction Period 2. |
| 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
|
| 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 | Percentage of Participants With Treatment-Related Grade 3-5 Adverse Events (AEs) During the Induction Period (Period 1 and 2) | The percentage of participants with treatment-related grade 3-5 adverse events (AEs) is defined as the number of participants who experienced at least 1 treatment related grade 3 - 5 adverse event (AE) per national cancer institute common terminology criteria for adverse events (NCI CTCAE v4.0, any preferred term) with an onset date after or on first day of Induction Period #1 and not later than discontinuation date from Induction Period #2, divided by the total number of treated participants. Adverse Event (AE) = any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not have a causal relationship with treatment. Treatment-related = having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 3=Severe Gr 4=Potentially Life-threatening or disabling Gr 5=Death | All treated participants | Posted | Number | Percentage of participants | From Day 1 to up to Week 25 |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Investigator-Assessed Response Rate at Week 25 | Response rate is defined as the number of participants who have a complete response (CR) or partial response (PR) at Week 25 per modified RECIST 1.1 criteria, with confirmation on the scheduled scan at Week 33 (or any subsequent scan performed at least 4 weeks after the Week 25 scan), divided by the total number of treated participants. Results of the tumor assessment at Week 13 or any unscheduled tumor assessment obtained prior to Week 25, except for baseline/screening tumor assessment, were not considered in the assessment of response rate at Week 25. | All treated participants | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 25 |
| ||||||||||||||||||||||||||||||
| Secondary | Investigator-Assessed Duration of Response (DOR) | Duration of response (DOR) is defined as the time between the Week 25 date of response and the date of objectively documented disease progression as defined by modified RECIST 1.1 criteria or death, whichever occurs first. Median computed using Kaplan-Meier method. | All treated participants with confirmed response at week 25 | Posted | Median | 95% Confidence Interval | months | From week 25 to up to date of disease progression or death (Up to 6 years) |
|
| |||||||||||||||||||||||||||||
| Secondary | Investigator-Assessed Rate of Progression | Progression rate at a specific timepoint is defined as the number of participants who have Progressive Disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at that specific timepoint divided by the total number of treated participants. As specified by modified RECIST 1.1, the evaluation of PD at Week 13 and Week 25 used the baseline tumor assessment as reference. A participant who died without a reported prior progression was considered to have progressed on the date of death. Deaths before or at Week 13 are counted as progression outcome. Confidence interval is based on the Clopper and Pearson method. | All treated participants | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 13 and Week 25 |
|
From first dose to 100 days post last dose (Up to 6 years)
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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 Followed by Ipilimumab | Nivolumab 3 mg/kg Q2W IV over 60 min for up to 6 doses during Weeks 1 to 13 in Induction Period 1 followed by Ipilimumab 3 mg/kg Q3W IV over 90 min for up to 4 doses during Weeks 13 to 25 in Induction Period 2. | 35 | 68 | 59 | 68 | 68 | 68 |
| EG001 | Ipilimumab Followed by Nivolumab | Ipilimumab 3 mg/kg Q3W IV over 90 min for up to 4 doses during Weeks 1 to 13 in Induction Period 1 followed by Nivolumab 3 mg/kg Q2W IV over 60 min for up to 6 doses during Weeks 13 to 25 in Induction Period 2. | 48 | 70 | 57 | 70 | 68 | 70 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | 23.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | 23.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | 23.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | 23.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | 23.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | 23.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | 23.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | 23.1 | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | 23.1 | Systematic Assessment |
| |
| Addison's disease | Endocrine disorders | 23.1 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | 23.1 | Systematic Assessment |
| |
| Adrenocortical insufficiency acute | Endocrine disorders | 23.1 | Systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | 23.1 | Systematic Assessment |
| |
| Hypopituitarism | Endocrine disorders | 23.1 | Systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | 23.1 | Systematic Assessment |
| |
| Macular oedema | Eye disorders | 23.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | 23.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Autoimmune colitis | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Diarrhoea haemorrhagic | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Terminal ileitis | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Asthenia | General disorders | 23.1 | Systematic Assessment |
| |
| Fatigue | General disorders | 23.1 | Systematic Assessment |
| |
| Gait disturbance | General disorders | 23.1 | Systematic Assessment |
| |
| Malaise | General disorders | 23.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | 23.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 23.1 | Systematic Assessment |
| |
| Pain | General disorders | 23.1 | Systematic Assessment |
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| Pyrexia | General disorders | 23.1 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | 23.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | 23.1 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | 23.1 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | 23.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | 23.1 | Systematic Assessment |
| |
| Hepatosplenomegaly | Hepatobiliary disorders | 23.1 | Systematic Assessment |
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| Hyperbilirubinaemia | Hepatobiliary disorders | 23.1 | Systematic Assessment |
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| Autoimmune disorder | Immune system disorders | 23.1 | Systematic Assessment |
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| Appendicitis | Infections and infestations | 23.1 | Systematic Assessment |
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| Bacterial infection | Infections and infestations | 23.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | 23.1 | Systematic Assessment |
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| Clostridium difficile colitis | Infections and infestations | 23.1 | Systematic Assessment |
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| Clostridium difficile infection | Infections and infestations | 23.1 | Systematic Assessment |
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| Cytomegalovirus infection | Infections and infestations | 23.1 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | 23.1 | Systematic Assessment |
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| Encephalitis | Infections and infestations | 23.1 | Systematic Assessment |
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| Infected cyst | Infections and infestations | 23.1 | Systematic Assessment |
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| Mucosal infection | Infections and infestations | 23.1 | Systematic Assessment |
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| Pneumocystis jirovecii pneumonia | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 23.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 23.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | 23.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | 23.1 | Systematic Assessment |
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| Influenza A virus test positive | Investigations | 23.1 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | 23.1 | Systematic Assessment |
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| Lipase increased | Investigations | 23.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
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| Metabolic acidosis | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
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| Polydipsia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
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| Groin pain | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
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| Soft tissue necrosis | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Demyelinating polyneuropathy | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Meningitis noninfective | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Myasthenia gravis | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Vasogenic cerebral oedema | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | 23.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | 23.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 23.1 | Systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | 23.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | 23.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | 23.1 | Systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | 23.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | 23.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | 23.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 23.1 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | 23.1 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | 23.1 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | 23.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | 23.1 | Systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | 23.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | 23.1 | Systematic Assessment |
| |
| Diplopia | Eye disorders | 23.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | 23.1 | Systematic Assessment |
| |
| Photophobia | Eye disorders | 23.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | 23.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Asthenia | General disorders | 23.1 | Systematic Assessment |
| |
| Chills | General disorders | 23.1 | Systematic Assessment |
| |
| Fatigue | General disorders | 23.1 | Systematic Assessment |
| |
| Gait disturbance | General disorders | 23.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | 23.1 | Systematic Assessment |
| |
| Malaise | General disorders | 23.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | 23.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 23.1 | Systematic Assessment |
| |
| Pain | General disorders | 23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 23.1 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 23.1 | Systematic Assessment |
| |
| Amylase increased | Investigations | 23.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 23.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | 23.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | 23.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 23.1 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | 23.1 | Systematic Assessment |
| |
| Blood urea increased | Investigations | 23.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | 23.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | 23.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 23.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | 23.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 23.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | 23.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | 23.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | 23.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 23.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | 23.1 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | 23.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | 23.1 | Systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | 23.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Sinus pain | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Vitiligo | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | 23.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 23.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 23.1 | 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 | Mar 12, 2014 | Jul 22, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| 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 |
Not provided
Not provided
| Male |
|
| Black or African American |
|
| Asian |
|
| American Indian or Alaska Native |
|
| Native Hawaiian or Other Pacific Islander |
|
| Other |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
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| Units | Counts |
|---|---|
| Participants |
|
|