Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000894-19 | EudraCT Number |
Not provided
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| Name | Class |
|---|---|
| Ono Pharmaceutical Co., Ltd. | INDUSTRY |
Not provided
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The purpose of this study is to determine whether Nivolumab is effective in the treatment of Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL)
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nivolumab for population with PCNSL | Experimental | Specified dose on specified days |
|
| Nivolumab for population with PTL | Experimental | Specified dose on specified days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| BICR-Assessed Objective Response Rate (ORR) | Percentage of participants with a confirmed objective response rate (ORR) by blinded independent central review (BICR) assessment was analyzed and reported for both PCNSL and PTL patient populations. This endpoint is further defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR), based on the IPCG Criteria for PCNSL and Lugano 2014 response evaluation for PTL, divided by the number of treated participants within each cohort. | Up to approximately 51 months |
| Measure | Description | Time Frame |
|---|---|---|
| BICR-Assessed Progression Free Survival (PFS) | Progression-free survival (PFS) is defined as the time from first dosing date to the date of the first documented progression using the IPCG Criteria for PCNSL and Lugano 2014 response evaluation for PTL, as determined by BICR, or death due to any cause, whichever occurs first. | Up to approximately 51 months |
Not provided
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
PCNSL subjects should have at least one measurable extranodal brain lesion; PTL subjects should have at least 1 measurable extranodal lesion or nodal lesion
Exclusion Criteria:
PCNSL, and PTL subjects with brain or spinal cord lesion who have received doses of more than 2 mg/day of dexamethasone or equivalent within the 14 days period prior to the first dose of nivolumab are excluded
Other protocol defined inclusion/exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-3410 | United States | ||
| City Of Hope Medical Center |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
Not provided
47 PCNSL participants treated.
19 PTL participants treated.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PCNSL Cohort | Nivolumab dosed to participants with relapsed/refractory Primary Central Nervous System Lymphoma (PCNSL). Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 29, 2017 | Oct 5, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Investigator-Assessed Objective Response Rate (ORR) | Percentage of participants with a confirmed objective response rate (ORR) by investigator assessment was analyzed and reported for both PCNSL and PTL patient populations. This endpoint is further defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR), based on the IPCG Criteria for PCNSL and Lugano 2014 response evaluation for PTL, divided by the number of treated participants within each cohort. | Up to approximately 51 months |
| Investigator-Assessed Duration of Response (DOR) | Duration of response (DOR) by investigator assessment was analyzed and reported for both PCNSL and PTL patient populations. This endpoint is further defined as the time from first response (CR or PR) to the date of initial objectively documented progression as determined using the IPCG Criteria for PCNSL and Lugano 2014 response evaluation for PTL, as determined by BICR, or death due to any cause, whichever occurs first. | Up to approximately 51 months |
| Overall Survival (OS) | Overall survival (OS) was analyzed and reported for both PCNSL and PTL patient populations. OS is defined as the time from first dosing date to the date of death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. | Up to approximately 51 months |
| Duarte |
| California |
| 91010 |
| United States |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | United States |
| H. Lee Moffitt Cancer Center & Research Inst, Inc | Tampa | Florida | 33612 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02215 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Columbia University | New York | New York | 10032 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Baylor Research Institute | Dallas | Texas | 75246 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| Instituto Do Cancer Mae De Deus / Cor Hospital Mae De Deus | Porto Alegre | Rio Grande do Sul | 90470-340 | Brazil |
| Fundacao Pio Xii Hosp Cancer De Barretos | Barretos | São Paulo | 14784-400 | Brazil |
| Hospital Das Clinicas - Fmusp | São Paulo | 05403-000 | Brazil |
| BC Cancer Agency - Vancouver Centre | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| CHU de Quebec | Québec | Quebec | G1J 1Z4 | Canada |
| I. interni klinika - klinika hematologie 1. LF UK a VFN v Praze | Prague | 128 08 | Czechia |
| Local Institution | Bordeaux | 33076 | France |
| Local Institution | Caen | 14000 | France |
| Local Institution | La Tronche | 3870 | France |
| Local Institution | Lille | 59037 | France |
| Local Institution | Paris | 75651 | France |
| Centre Hospitalier Lyon Sud - UPCO | Pierre-Bénite | 69495 | France |
| Local Institution | Rennes | 35033 | France |
| Local Institution | Saint-Cloud | 92210 | France |
| Local Institution | Tours | 37044 | France |
| Klinikum Stuttgart | Stuttgart | 70174 | Germany |
| Local Institution | Hong Kong | Hong Kong |
| Local Institution | Budapest | 1083 | Hungary |
| Belgyogyaszati Onkologia OOI | Budapest | 1122 | Hungary |
| Local Institution | Debrecen | 4032 | Hungary |
| Local Institution | Haifa | 3109601 | Israel |
| Local Institution | Jerusalem | 91120 | Israel |
| Local Institution | Petah Tikva | 4941492 | Israel |
| Local Institution | Tel Aviv | 64239 | Israel |
| Irccs Ospedale S. Raffaele | Milan | 20132 | Italy |
| Fondazione Policlinico Universitario A. Gemelli | Roma | 00168 | Italy |
| Istituto Clinico Humanitas | Rozzano (milano) | 20089 | Italy |
| Local Institution | Nagoya | Aichi-ken | 4648681 | Japan |
| Local Institution | Fukuoka | Fukuoka | 811-1395 | Japan |
| Local Institution | Hidaka-shi | Saitama | 3501298 | Japan |
| Local Institution | Chuo-ku | Tokyo | 1040045 | Japan |
| Local Institution | Kotoku | Tokyo | 1358550 | Japan |
| Local Institution | Mitaka-shi | Tokyo | 181-8611 | Japan |
| Local Institution | Yamagata | 9909585 | Japan |
| Local Institution | Moscow | 121309 | Russia |
| Local Institution | Singapore | 169610 | Singapore |
| FDA Safety Alerts and Recalls | View source |
| FG001 | PTL Cohort | Nivolumab dosed to participants with relapsed/refractory Primary Testicular Lymphoma (PTL). Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion. |
|
| COMPLETED | Completed = continuing in the treatment period |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PCNSL Cohort | Nivolumab dosed to participants with relapsed/refractory Primary Central Nervous System Lymphoma (PCNSL). Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion. |
| BG001 | PTL Cohort | Nivolumab dosed to participants with relapsed/refractory Primary Testicular Lymphoma (PTL). Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion. |
| 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 |
| ||||||||||||||||
| 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 | BICR-Assessed Objective Response Rate (ORR) | Percentage of participants with a confirmed objective response rate (ORR) by blinded independent central review (BICR) assessment was analyzed and reported for both PCNSL and PTL patient populations. This endpoint is further defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR), based on the IPCG Criteria for PCNSL and Lugano 2014 response evaluation for PTL, divided by the number of treated participants within each cohort. | All treated PCNSL and PTL participants | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 51 months |
|
|
| ||||||||||||||||||||||||||||
| Secondary | BICR-Assessed Progression Free Survival (PFS) | Progression-free survival (PFS) is defined as the time from first dosing date to the date of the first documented progression using the IPCG Criteria for PCNSL and Lugano 2014 response evaluation for PTL, as determined by BICR, or death due to any cause, whichever occurs first. | All treated PCNSL and PTL participants | Posted | Median | 95% Confidence Interval | Months | Up to approximately 51 months |
| ||||||||||||||||||||||||||||||
| Secondary | Investigator-Assessed Objective Response Rate (ORR) | Percentage of participants with a confirmed objective response rate (ORR) by investigator assessment was analyzed and reported for both PCNSL and PTL patient populations. This endpoint is further defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR), based on the IPCG Criteria for PCNSL and Lugano 2014 response evaluation for PTL, divided by the number of treated participants within each cohort. | All treated PCNSL and PTL participants | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 51 months |
| ||||||||||||||||||||||||||||||
| Secondary | Investigator-Assessed Duration of Response (DOR) | Duration of response (DOR) by investigator assessment was analyzed and reported for both PCNSL and PTL patient populations. This endpoint is further defined as the time from first response (CR or PR) to the date of initial objectively documented progression as determined using the IPCG Criteria for PCNSL and Lugano 2014 response evaluation for PTL, as determined by BICR, or death due to any cause, whichever occurs first. | All responders PCNSL and PTL participants | Posted | Median | 95% Confidence Interval | Months | Up to approximately 51 months |
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall survival (OS) was analyzed and reported for both PCNSL and PTL patient populations. OS is defined as the time from first dosing date to the date of death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. | All treated PCNSL and PTL participants | Posted | Median | 95% Confidence Interval | Months | Up to approximately 51 months |
|
From first dose to 100 days post last dose (up to approximately 48 months)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PCNSL Cohort Nivolumab 240 mg (Q2W) | Nivolumab dosed to participants with relapsed/refractory Primary Central Nervous System Lymphoma (PCNSL). Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion. | 32 | 47 | 33 | 47 | 40 | 47 |
| EG001 | PTL Cohort Nivolumab 240 mg (Q2W) | Nivolumab dosed to participants with relapsed/refractory Primary Testicular Lymphoma (PTL). Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion. | 13 | 19 | 15 | 19 | 16 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Dysphagia | 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 |
| |
| General physical health deterioration | General disorders | 23.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | 23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 23.1 | Systematic Assessment |
| |
| Sudden death | General disorders | 23.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | 23.1 | Systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | 23.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Meningitis viral | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | 23.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 23.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 23.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
| |
| Lung adenocarcinoma | 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 |
| |
| Tumour flare | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
| |
| Tumour pseudoprogression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Hemianopia homonymous | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Hemiplegia | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Mental impairment | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Neurological decompensation | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Optic neuritis | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Syncope | 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 |
| |
| Renal failure | Renal and urinary disorders | 23.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue 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 |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | 23.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | 23.1 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | 23.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | 23.1 | Systematic Assessment |
| |
| Conjunctival hyperaemia | Eye disorders | 23.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | 23.1 | Systematic Assessment |
| |
| Eye irritation | Eye disorders | 23.1 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | 23.1 | Systematic Assessment |
| |
| Pupils unequal | Eye disorders | 23.1 | Systematic Assessment |
| |
| Vision blurred | Eye 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 |
| |
| Dysphagia | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Stomatitis | 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 |
| |
| Mucosal inflammation | General disorders | 23.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | 23.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 23.1 | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | 23.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | 23.1 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | 23.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Pneumonia | 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 |
| |
| Ankle fracture | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
| |
| Clavicle fracture | 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 |
| |
| Procedural pain | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
| |
| Recall phenomenon | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 23.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 23.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 23.1 | Systematic Assessment |
| |
| Human rhinovirus test positive | Investigations | 23.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | 23.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | 23.1 | Systematic Assessment |
| |
| Neutrophil 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 |
| |
| Hyperglycaemia | 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 |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Hypophosphataemia | 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 |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Facial paresis | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Agitation | Psychiatric 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 |
| |
| Acute kidney injury | Renal and urinary disorders | 23.1 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | 23.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | 23.1 | Systematic Assessment |
| |
| Testicular pain | Reproductive system and breast disorders | 23.1 | Systematic Assessment |
| |
| Testicular swelling | Reproductive system and breast disorders | 23.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Dyspnoea | 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 |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Eczema asteatotic | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Hyperhidrosis | 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 |
| |
| Skin ulcer | Skin and subcutaneous tissue 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_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 9, 2018 | Oct 5, 2020 | SAP_000.pdf |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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
| 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 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|