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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000367-33 | EudraCT Number |
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| Name | Class |
|---|---|
| Janssen Biotech, Inc. | INDUSTRY |
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The purpose of this study is to determine whether a combination of Nivolumab and Daratumumab is safe and effective when treating Pancreatic, Non-Small Cell Lung or Triple Negative Breast Cancers, that have advanced or have spread.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunotherapy Combination | Experimental | TNBC and PAC participants who are deriving clinical benefit will continue to be treated with the nivolumab plus daratumumab combination therapy |
|
| Nivolumab Monotherapy | Experimental | NSCLC patients who are deriving clinical benefit will be treated with nivolumab monotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Biological | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Number of participants with any grade of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Daratumumab | From first dose to 30 days post last dose (up to 34 months) |
| Number of Participants With Serious Adverse Events (SAEs) | Number of participants with any grade of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Daratumumab | From first dose to 30 days post last dose (up to 34 months) |
| Number of Participants With Laboratory Abnormalities in Specific Liver Tests | Number of participants with laboratory abnormalities in specific liver tests based on US conventional units to determine the safety and tolerability of Nivolumab and Daratumumab. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:
| From first dose to 30 days post last dose (up to 34 months) |
| Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | Number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units to determine the safety and tolerability of Nivolumab and Daratumumab. The number of subjects with the following laboratory abnormalities from on-treatment evaluations will be summarized:
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Objective response rate (ORR) is defined as the percentage of treated participants who achieve a best response of complete response (CR) or partial response (PR) based on investigator assessments (using RECIST v1.1 criteria) | Up to 36 months |
| Duration of Response (DOR) |
Not provided
Inclusion Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Shores Medical Group | Long Beach | California | 90813 | United States | ||
| University Of Colorado |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
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105 participants treated
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| ID | Title | Description |
|---|---|---|
| FG000 | Nivolumab + Daratumumab (TNBC) | Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24) |
| FG001 | Nivolumab + Daratumumab (NSCLC) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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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 | Jul 27, 2018 | Jul 2, 2021 |
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| Daratumumab | Biological | Specified dose on specified days |
|
| From first dose to 30 days post last dose (up to 34 months) |
| Number of Participants With Laboratory Results of Worst CTC Grade | Number of participants with laboratory test results of worst (CTC v4.0) grades 0-4 to determine the safety and tolerability of Nivolumab and Daratumumab | From first dose to 30 days post last dose (up to 34 months) |
Duration of response (DOR) is defined as the time between the date of first documented response (Complete response or partial response) to the date of the first documented tumor progression as determined by Investigator (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first |
| Up to 36 months |
| Best Overall Response (BOR) | Best overall response (BOR) is defined as the best response, as determined by Investigator, recorded between the date of first dose and the date of objectively documented progression per RECIST v1.1 criteria or the date of subsequent therapy, whichever occurs first. | Up to 36 months |
| Progression Free Survival (PFS) | Progression Free Survival (PFS) is defined as the time between the date of treatment start day and the date of first documented tumor progression, based on Investigator assessments (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first. | Up to 36 months |
| Nivolumab Serum Concentrations | Pharmacokinetics (PK) assessed using serum concentration data for Nivolumab | From day 1 to follow-up 2 (up to 36 months) |
| Daratumumab Serum Concentrations | Pharmacokinetics (PK) assessed using serum concentration data for Daratumumab | From day 1 to follow-up 2 (up to 36 months) |
| Percentage of Participants Anti Drug Antibody (ADA) by Positivity | Percentage of participants Anti Drug Antibody (ADA) to assess immunogenicity by ADA positive status and ADA negative status, relative to baseline. ADA positive is a participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (>=) than baseline positive titer) at any time after initiation of treatment. ADA Negative is a participant with no ADA-positive sample after initiation of treatment | Up to 36 months |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| University Of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| Local Institution | St Leonards | New South Wales | 2065 | Australia |
| Local Institution | Edmonton | T6G 1Z2 | Canada |
| Local Institution | Lyon | 69373 | France |
| Local Institution | Marseille | 13273 | France |
| Centre Paul Strauss | Strasbourg | 67085 | France |
| Universitaetsklinikum Carl Gustav Carus | Dresden | 01307 | Germany |
| Medizinische Universitaetsklinik Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Universitaetsklinik Heidelberg | Heidelberg | 69120 | Germany |
| Local Institution | Milan | 20132 | Italy |
| Istituto Nazionale Tumori Fondazione Pascale | Naples | 80131 | Italy |
| Fundacion De Investigacion | San Juan | 00927 | Puerto Rico |
| Hospital Gral. Univ. Gregorio Maranon | Madrid | 28007 | Spain |
| Local Institution | Majadahonda - Madrid | 28222 | Spain |
| Klinik Fur Onkologie | Basel | 4031 | Switzerland |
| University Hospital of Lausanne | Lausanne | 1011 | Switzerland |
| FDA Safety Alerts and Recalls | View source |
Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24) |
| FG002 | Nivolumab + Daratumumab (PAC) | Pancreatic adenocarcinoma cancer (PAC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Nivolumab + Daratumumab (TNBC) | Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24) |
| BG001 | Nivolumab + Daratumumab (NSCLC) | Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24) |
| BG002 | Nivolumab + Daratumumab (PAC) | Pancreatic adenocarcinoma cancer (PAC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24) |
| BG003 | 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/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 | Number of Participants With Adverse Events (AEs) | Number of participants with any grade of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Daratumumab | All treated participants | Posted | Count of Participants | Participants | From first dose to 30 days post last dose (up to 34 months) |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Serious Adverse Events (SAEs) | Number of participants with any grade of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Daratumumab | All treated participants | Posted | Count of Participants | Participants | From first dose to 30 days post last dose (up to 34 months) |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | Number of participants with laboratory abnormalities in specific liver tests based on US conventional units to determine the safety and tolerability of Nivolumab and Daratumumab. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:
| All treated participants with at least one on-treatment measurement of the corresponding laboratory parameter | Posted | Count of Participants | Participants | From first dose to 30 days post last dose (up to 34 months) |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | Number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units to determine the safety and tolerability of Nivolumab and Daratumumab. The number of subjects with the following laboratory abnormalities from on-treatment evaluations will be summarized:
| All treated participants with at least one on-treatment TSH measurement | Posted | Count of Participants | Participants | From first dose to 30 days post last dose (up to 34 months) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | Objective response rate (ORR) is defined as the percentage of treated participants who achieve a best response of complete response (CR) or partial response (PR) based on investigator assessments (using RECIST v1.1 criteria) | All treated participants | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 36 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | Duration of response (DOR) is defined as the time between the date of first documented response (Complete response or partial response) to the date of the first documented tumor progression as determined by Investigator (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first | All treated participants with objective response | Posted | Median | 95% Confidence Interval | Months | Up to 36 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Best Overall Response (BOR) | Best overall response (BOR) is defined as the best response, as determined by Investigator, recorded between the date of first dose and the date of objectively documented progression per RECIST v1.1 criteria or the date of subsequent therapy, whichever occurs first. | All treated participants | Posted | Count of Participants | Participants | Up to 36 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | Progression Free Survival (PFS) is defined as the time between the date of treatment start day and the date of first documented tumor progression, based on Investigator assessments (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first. | All treated participants | Posted | Median | 95% Confidence Interval | Months | Up to 36 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Nivolumab Serum Concentrations | Pharmacokinetics (PK) assessed using serum concentration data for Nivolumab | All pharmacokinetic participants | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | From day 1 to follow-up 2 (up to 36 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Daratumumab Serum Concentrations | Pharmacokinetics (PK) assessed using serum concentration data for Daratumumab | All pharmacokinetic participants | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | From day 1 to follow-up 2 (up to 36 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Anti Drug Antibody (ADA) by Positivity | Percentage of participants Anti Drug Antibody (ADA) to assess immunogenicity by ADA positive status and ADA negative status, relative to baseline. ADA positive is a participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (>=) than baseline positive titer) at any time after initiation of treatment. ADA Negative is a participant with no ADA-positive sample after initiation of treatment | All immunogenicity participants | Posted | Number | Percentage of Participants | Up to 36 months |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Laboratory Results of Worst CTC Grade | Number of participants with laboratory test results of worst (CTC v4.0) grades 0-4 to determine the safety and tolerability of Nivolumab and Daratumumab | All treated participants | Posted | Count of Participants | Participants | From first dose to 30 days post last dose (up to 34 months) |
|
From first dose to 100 days post last dose (up to 36 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 | Nivolumab + Daratumumab (TNBC) | Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24) | 29 | 41 | 36 | 41 | 40 | 41 |
| EG001 | Nivolumab + Daratumumab (NSCLC) | Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24) | 11 | 21 | 17 | 21 | 21 | 21 |
| EG002 | Nivolumab + Daratumumab (PAC) | Pancreatic adenocarcinoma cancer (PAC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24) | 36 | 43 | 36 | 43 | 41 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | 23.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | 23.1 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | 23.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | 23.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | 23.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Asthenia | General disorders | 23.1 | Systematic Assessment |
| |
| Death | General disorders | 23.1 | Systematic Assessment |
| |
| Fatigue | General disorders | 23.1 | Systematic Assessment |
| |
| Generalised oedema | General disorders | 23.1 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | 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 |
| |
| Cholestasis | Hepatobiliary disorders | 23.1 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | 23.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | 23.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | 23.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | 23.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Nosocomial infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Peritonitis bacterial | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Septic shock | 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 |
| |
| Fall | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | 23.1 | Systematic Assessment |
| |
| General physical condition abnormal | Investigations | 23.1 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | 23.1 | Systematic Assessment |
| |
| Procalcitonin increased | Investigations | 23.1 | Systematic Assessment |
| |
| Transaminases 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 |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 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 |
| |
| Metastases to spinal cord | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
| |
| Pancreatic carcinoma | 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 |
| |
| Tumour thrombosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | 23.1 | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | 23.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 23.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | 23.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | 23.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Haemoptysis | 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 |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Embolism | 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 |
| |
| Lymphopenia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | 23.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | 23.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Ascites | 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 |
| |
| 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 |
| |
| Chest pain | General disorders | 23.1 | Systematic Assessment |
| |
| Chills | General disorders | 23.1 | Systematic Assessment |
| |
| Fatigue | 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 |
| |
| Hypersensitivity | Immune system disorders | 23.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Infusion related reaction | 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 alkaline phosphatase increased | Investigations | 23.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | 23.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | 23.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | 23.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | 23.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Bone pain | 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 |
| |
| Dizziness | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | 23.1 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric 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 |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | 23.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | 23.1 | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | 23.1 | Systematic Assessment |
| |
| Ocular discomfort | Eye disorders | 23.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | 23.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | 23.1 | Systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
| |
| Vascular access site pain | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | 23.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | 23.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 23.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | 23.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 23.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Muscle spasms | 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 |
| |
| Dysgeusia | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | 23.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 23.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 23.1 | Systematic Assessment |
| |
| Lymphoedema | 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 | Sep 16, 2020 | Jul 2, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D064726 | Triple Negative Breast Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004067 | Digestive System Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| C556306 | daratumumab |
| 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 |
|
| Other |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG002 | Nivolumab + Daratumumab (PAC) | Pancreatic adenocarcinoma cancer (PAC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24) |
|
|
Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
| OG002 | Nivolumab + Daratumumab (PAC) | Pancreatic adenocarcinoma cancer (PAC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24) |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Not Reported |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Not Reported |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Not Reported |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Not Reported |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Not Reported |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Not Reported |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Not Reported |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Not Reported |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Not Reported |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Not Reported |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Not Reported |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Not Reported |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Not Reported |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Not Reported |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Not Reported |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Not Reported |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Not Reported |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Not Reported |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Not Reported |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Not Reported |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Not Reported |
|