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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000461-23 | EudraCT Number |
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The purpose of this study is to determine whether nivolumab is an effective treatment for cancer that has advanced or has spread. Various tumor types may be eligible for enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nivolumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Biological | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR is defined as the percentage of participants with a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR). Best overall response is defined as the best response designation, as determined by investigator, recorded in the specified timeframe, according to the RECIST 1.1 criteria. | From first dose to the date of objectively documented progression (per tumor-specific response criteria) or the date of subsequent therapy, whichever occurs first (up to approximately 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) | DOR is defined as the time from first confirmed response (Complete Response, CR or Partial Response, PR) to the date of the first documented tumor progression (as determined by investigator) or death due to any cause, whichever occurs first. Median DOR computed using Kaplan-Meier method | From the time of first confirmed response to the date of the first documented progression (up to approximately 22 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 |
|---|---|---|---|---|---|---|
| Arizona Oncology Associates, PC | Tucson | Arizona | 85711 | United States | ||
| CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
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239 participants were treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Advanced Malignancies Cohort | Treatment period 1: Nivolumab 240 mg Q2W for 8 doses. Treatment period 2: Nivolumab 480 mg Q4W |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
|
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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 | May 31, 2018 | Oct 20, 2020 |
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| Time to Objective Response (TTR) | TTR is defined as the time from first dosing date to the date of the first confirmed response (Complete Response, CR or Partial Response, PR), as assessed by investigator. | From the first dosing date to the date of the first confirmed response (up to approximately 10 months) |
| Clinical Benefit Rate (CBR) | CBR is defined as the percentage of participants with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) or Stable Disease (SD). | From the first dosing date to the date of the last dose (approximately 24 months) |
| Overall Survival Rate at 1 Year | Overall Survival (OS) is defined as the time from the first dosing date to the date of death. A participant who has not died will be censored at last known date alive. OS rate at 1 year is measured as the percent of participants still alive at 1 year after first dosing, measured from Kaplan-Meier curve of OS. | From the first dosing date to 1 year later |
| Number of Participants Who Died | Number of participants who died for any cause | From first dose to 100 days following last dose (up approximately 27 months) |
| Number of Participants Experiencing Adverse Events (AEs) | Number of participants who experienced any grade, any cause AEs | From first dose to 30 days following the last dose (up to approximately 25 months) |
| Number of Participants Experiencing Serious Adverse Events (SAEs) | Number of participants who experienced any grade, any cause SAEs | From first dose to 100 days following the last dose (up to approximately 27 months) |
| Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation | Number of participants who experienced AEs leading to discontinuation of study therapy | From first dose to 30 days following the last dose (up to approximately 25 months) |
| Number of Participants Experiencing Immune-mediated Adverse Events (IMAEs) | Number of participants who experienced IMAEs. IMAEs are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity. | From first dose to 100 days following the last dose (up to approximately 27 months) |
| Number of Participants Experiencing Select Adverse Events | Number of participants who experienced Select Adverse Events. Select Adverse Events categories include: gastrointestinal, hepatic, pulmonary, renal, skin, hypersensitivity/infusion reaction. | From first dose to 30 days following the last dose (up to approximately 25 months) |
| Number of Participants Experiencing Adverse Events (AEs) Leading to Dose Delay or Dose Reduction | Number of participants who experienced AEs leading to dose delay or dose reduction. A dose will be considered as delayed if the delay is exceeding 3 days after the intended dose date (i.e., greater than or equal to 4 days from scheduled dosing date) | From first dose to 30 days following the last dose (up to approximately 25 months) |
| Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests | Number of participants who experienced the laboratory abnormalities in specific liver tests described in the individual categories. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal | From first dose to 30 days following the last dose (up to approximately 25 months) |
| Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests | Number of participants who experienced the laboratory abnormalities in specific thyroid tests described in the individual categories. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal | From first dose to 100 days following the last dose (up to approximately 27 months) |
| Bakersfield |
| California |
| 93309 |
| United States |
| St. Jude Hospital Yorba Linda | Fullerton | California | 92835 | United States |
| LACN | Los Angeles | California | 90017 | United States |
| UCLA Main Campus - University California Los Angeles | Los Angeles | California | 90095 | United States |
| Torrence Health Association, DBA Torrance Memorial;Physician Network/Cancer Care Associates | Redondo Beach | California | 90277 | United States |
| Coastal Integrative Cancer Care | San Luis Obispo | California | 93401 | United States |
| Cancer Center of Santa Barbara with Sansum Clinic | Santa Barbara | California | 93105 | United States |
| Central Coast Medical Oncology Corporation | Santa Maria | California | 93454 | United States |
| Rocky Mountain Cancer Centers - Denver Midtwon | Denver | Colorado | 80218 | United States |
| St. Mary's Hospital And Regional Medical Center | Grand Junction | Colorado | 81501 | United States |
| Memorial Healthcare System | Hollywood | Florida | 33021 | United States |
| Florida Cancer Affiliates | Ocala | Florida | 34471 | United States |
| Orlando Health, Inc | Orlando | Florida | 32806 | United States |
| Florida Cancer Specialists & Research Institute | St. Petersburg | Florida | 33705 | United States |
| Florida Cancer Specialists | West Palm Beach | Florida | 33401 | United States |
| Illinois Cancer Specialists | Niles | Illinois | 60714 | United States |
| Fort Wayne Medical Oncology and Hematology, Inc. | Fort Wayne | Indiana | 46845 | United States |
| Maryland Oncology Hematology P.A. | Columbia | Maryland | 21044 | United States |
| Minnesota Oncology Hematology, P.A. | Minneapolis | Minnesota | 55404 | United States |
| HCA Midwest Healthcare | Kansas City | Missouri | 64132 | United States |
| Oncology Hematology West P.C. dba Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | United States |
| Texas Oncology-Austin Central | Las Vegas | Nevada | 89148 | United States |
| Saint Barnabas Medical Cancer Center | Livingston | New Jersey | 07039 | United States |
| USOR - New York Oncology Hematology, P.C. | Albany | New York | 12206 | United States |
| Hematology Oncology Associates, PC | Medford | Oregon | 97504 | United States |
| Willamette Valley Cancer Institute and Research Center | Springfield | Oregon | 97477 | United States |
| Northwest Cancer Specialists, P.C. | Tualatin | Oregon | 97062 | United States |
| Greenville Health System | Greenville | South Carolina | 29615 | United States |
| West Cancer Center | Germantown | Tennessee | 38138 | United States |
| Tennessee Oncology | Lebanon | Tennessee | 37090 | United States |
| Texas Oncology - Baylor Charles A. Simmons Cancer Center | Dallas | Texas | 75246 | United States |
| Texas Oncology, P.A. | Fort Worth | Texas | 76104 | United States |
| The University of Texas MD Anderson Cancer Center-merge | Houston | Texas | 77030 | United States |
| Texas Oncology, P.A. | San Antonio | Texas | 78240 | United States |
| Texas Oncology The Woodlands | The Woodlands | Texas | 77380 | United States |
| Texas Oncology - Waco | Waco | Texas | 76712 | United States |
| Virginia Cancer Care Specialist, PC | Fairfax | Virginia | 22031 | United States |
| Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care | Wytheville | Virginia | 24382 | United States |
| Local Institution | Berlin | 12200 | Germany |
| Local Institution | Bonn | 53127 | Germany |
| Local Institution | Dresden | 01307 | Germany |
| Local Institution | Essen | 45147 | Germany |
| Local Institution | Freiburg im Breisgau | 79106 | Germany |
| Klinikum Rechts der Isar der Technischen Universitaet Muenchen | München | 81675 | Germany |
| FDA Safety Alerts and Recalls | View source |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Transition From Period 1 to Period 2 |
|
|
| Treatment Period 2 |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Advanced Malignancies Cohort | Treatment period 1: Nivolumab 240 mg Q2W for 8 doses. Treatment period 2: Nivolumab 480 mg Q4W |
| 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 |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Objective Response Rate (ORR) | ORR is defined as the percentage of participants with a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR). Best overall response is defined as the best response designation, as determined by investigator, recorded in the specified timeframe, according to the RECIST 1.1 criteria. | All treated participants | Posted | Number | 95% Confidence Interval | Percent of Participants | From first dose to the date of objectively documented progression (per tumor-specific response criteria) or the date of subsequent therapy, whichever occurs first (up to approximately 24 months) |
|
|
| |||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | DOR is defined as the time from first confirmed response (Complete Response, CR or Partial Response, PR) to the date of the first documented tumor progression (as determined by investigator) or death due to any cause, whichever occurs first. Median DOR computed using Kaplan-Meier method | All Responders (Participants with a confirmed CR or PR) | Posted | Median | Full Range | Months | From the time of first confirmed response to the date of the first documented progression (up to approximately 22 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Objective Response (TTR) | TTR is defined as the time from first dosing date to the date of the first confirmed response (Complete Response, CR or Partial Response, PR), as assessed by investigator. | All Responders (Participants with a confirmed CR or PR) | Posted | Mean | Standard Deviation | Months | From the first dosing date to the date of the first confirmed response (up to approximately 10 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Clinical Benefit Rate (CBR) | CBR is defined as the percentage of participants with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) or Stable Disease (SD). | All treated participants | Posted | Number | 95% Confidence Interval | Percent of participants | From the first dosing date to the date of the last dose (approximately 24 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival Rate at 1 Year | Overall Survival (OS) is defined as the time from the first dosing date to the date of death. A participant who has not died will be censored at last known date alive. OS rate at 1 year is measured as the percent of participants still alive at 1 year after first dosing, measured from Kaplan-Meier curve of OS. | All treated participants | Posted | Number | 95% Confidence Interval | Percent of participants | From the first dosing date to 1 year later |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants Who Died | Number of participants who died for any cause | All treated participants | Posted | Count of Participants | Participants | From first dose to 100 days following last dose (up approximately 27 months) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing Adverse Events (AEs) | Number of participants who experienced any grade, any cause AEs | All treated participants | Posted | Count of Participants | Participants | From first dose to 30 days following the last dose (up to approximately 25 months) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing Serious Adverse Events (SAEs) | Number of participants who experienced any grade, any cause SAEs | All treated participants | Posted | Count of Participants | Participants | From first dose to 100 days following the last dose (up to approximately 27 months) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation | Number of participants who experienced AEs leading to discontinuation of study therapy | All treated participants | Posted | Count of Participants | Participants | From first dose to 30 days following the last dose (up to approximately 25 months) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing Immune-mediated Adverse Events (IMAEs) | Number of participants who experienced IMAEs. IMAEs are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity. | All treated participants | Posted | Count of Participants | Participants | From first dose to 100 days following the last dose (up to approximately 27 months) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing Select Adverse Events | Number of participants who experienced Select Adverse Events. Select Adverse Events categories include: gastrointestinal, hepatic, pulmonary, renal, skin, hypersensitivity/infusion reaction. | All treated participants | Posted | Count of Participants | Participants | From first dose to 30 days following the last dose (up to approximately 25 months) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing Adverse Events (AEs) Leading to Dose Delay or Dose Reduction | Number of participants who experienced AEs leading to dose delay or dose reduction. A dose will be considered as delayed if the delay is exceeding 3 days after the intended dose date (i.e., greater than or equal to 4 days from scheduled dosing date) | All treated participants | Posted | Count of Participants | Participants | From first dose to 30 days following the last dose (up to approximately 25 months) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests | Number of participants who experienced the laboratory abnormalities in specific liver tests described in the individual categories. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal | All treated participants with available measurements | Posted | Count of Participants | Participants | From first dose to 30 days following the last dose (up to approximately 25 months) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests | Number of participants who experienced the laboratory abnormalities in specific thyroid tests described in the individual categories. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal | All treated participants with available measurements | Posted | Count of Participants | Participants | From first dose to 100 days following the last dose (up to approximately 27 months) |
|
|
All-cause mortality was assessed from first dose to study completion date (approximately 64 months). SAEs and Other AEs were assessed from first dose to 100 days following administration of the last dose (approximately 27 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 | Advanced Malignancies Cohort | Treatment period 1: Nivolumab 240 mg Q2W for 8 doses. Treatment period 2: Nivolumab 480 mg Q4W | 156 | 239 | 148 | 239 | 216 | 239 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | 24.0 | Systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | 24.0 | Systematic Assessment |
| |
| Eye pain | Eye disorders | 24.0 | Systematic Assessment |
| |
| Eye swelling | Eye disorders | 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Gastrointestinal oedema | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 24.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | 24.0 | Systematic Assessment |
| |
| Localised oedema | General disorders | 24.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | 24.0 | Systematic Assessment |
| |
| Pain | General disorders | 24.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 24.0 | Systematic Assessment |
| |
| Sudden death | General disorders | 24.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Hepatic lesion | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | 24.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Cholecystitis infective | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Fungaemia | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Perinephric abscess | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Renal abscess | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Post procedural fever | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 24.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | 24.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Adenoid cystic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Infected neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Malignant neoplasm of cornea | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Mesothelioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Penis carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Intracranial mass | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Neuritis cranial | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | 24.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | 24.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 24.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | 24.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | 24.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | 24.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | 24.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | 24.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | 24.0 | Systematic Assessment |
| |
| Vulvovaginal pain | Reproductive system and breast disorders | 24.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Bronchostenosis | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Laryngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | 24.0 | Systematic Assessment |
| |
| Venous stenosis | Vascular disorders | 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Chills | General disorders | 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 24.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 24.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 24.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | 24.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 24.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | 24.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 24.0 | 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 | Jun 24, 2018 | Oct 20, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| 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
| Lost to Follow-up |
|
| Study Drug Toxicity |
|
| Participant request to discontinue |
|
| Participant withdrew consent |
|
| Other reasons |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
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