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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001941-26 | EudraCT Number |
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This is a safety and efficacy study of different administration regimens of nivolumab plus Ipilimumab in subjects with previously untreated, unresectable or metastatic melanoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nivolumab and Ipilimumab Concomitant Administration | Experimental | Followed by Nivolumab monotherapy |
|
| Nivolumab and Ipilimumab Sequential Administration | Experimental | Followed by Nivolumab monotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Biological | -Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Affected by Adverse Events (AEs) in the Broad Scope MedDRA Anaphylactic Reaction Standardized MedDRA Queries (SMQ) | This outcome describes the percentage of participants experiencing at least 1 AE in the MedDRA Anaphylactic Reaction broad scope SMQ. Such AEs include any acute systemic reaction characterized by a large list of terms, including (but not limited to) pruritus, urticaria, flushing, hypotension, respiratory distress, and vascular insufficiency. It also includes other signs and symptoms such as asthma, choking sensation, coughing, sneezing, and difficulty breathing due to laryngeal spasm and/or bronchospasm. Less frequent clinical presentations are also captured and include hyperventilation, sensation of foreign body, and ocular edema. | Within 2 days from administration of any of the 4 doses in part 1 period (approximately 12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Affected by AEs in the Narrow Scope MedDRA Anaphylactic Reaction SMQ | This outcome describes the percentage of participants experiencing at least 1 AE in the MedDRA Anaphylactic Reaction narrow scope SMQ. The narrow scope SMQ is composed of a large list of terms, including (but not limited to) anaphylactic shock and reaction, shock and shock symptoms, and circulatory collapse, among the others. |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Melanoma Institute Australia | North Sydney | New South Wales | Australia | |||
| Greenslopes Private Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40614118 | Derived | Menzies AM, Salman P, Frontera OA, Pook D, Hocking CM, Zakharia Y, Gurney H, Gedye C, Goh JC, Telivala B, Grob JJ, Lebbe C, de la Cruz Merino L, Machet L, Neidhardt EM, Qureshi A, Hosein F, Hamuro L, Simsek B, Amin A. Administration of nivolumab plus ipilimumab: Infusion of the fixed-ratio combination versus sequential infusions in two randomized controlled trials of metastatic melanoma (CheckMate 742) and renal cell carcinoma (CheckMate 800). Cancer. 2025 Jul 15;131(14):e35962. doi: 10.1002/cncr.35962. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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106 participants were randomized and treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fixed Ratio Combination | Concomitant administration of Nivolumab and Ipilimumab (1:3 protein-mass ratio) every 3 weeks for 4 doses followed by Nivolumab flat dose in the Maintenance Phase |
| FG001 | Sequential Combination |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Treatment Phase Part 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 | Aug 18, 2017 | Oct 20, 2020 |
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| Ipilimumab | Biological | -Specified dose on specified days |
|
| Within 2 days from administration of any of the 4 doses in part 1 period (approximately 12 weeks) |
| Percentage of Participants Affected by Hypersensitivity/Infusion Reaction Select AEs | This outcome describes the percentage of participants experiencing at least 1 AE in the Hypersensitivity/Infusion select AEs category. The select AEs consist of a list of preferred terms defined by the Sponsor and represent AEs with a potential immune-mediated etiology. The following 5 MedDRA preferred terms are included in the hypersensitivity/infusion reaction select AE category: Anaphylactic Reaction, Anaphylactic Shock, Bronchospasm, Hypersensitivity, and Infusion Related Reaction | Within 2 days from administration of any of the 4 doses in part 1 period (approximately 12 weeks) |
| Percentage of Participants Affected by All Causality Grade 3 - 5 AEs | This outcome describes the percentage of participants who experienced at least 1 AE of Grade 3 or higher defined using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria | From initial dose of study treatment and within 30 days of the last dose of study treatment (approximately 25 months) |
| Percentage of Participants Affected by Drug-related Grade 3 - 5 AEs | This outcome describes the percentage of participants who experienced at least 1 Drug-related AE of Grade 3 or higher defined using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria | From initial dose of study treatment and within 30 days of the last dose of study treatment (approximately 25 months) |
| Geometric Mean Concentration of Ipilimumab at End of Infusion (EOI) | From Cycle 1, Day 1 to Cycle 4, Day 1 (approximately 9 weeks). Each cycle lasts 3 weeks. Cycle 1 day 1, Cycle 2 day 1 and Cycle 4 day 1 values reported. |
| Geometric Mean Concentration of Nivolumab at End of Infusion (EOI) | From Cycle 1, Day 1 to Cycle 4, Day 1 (approximately 9 weeks). Each cycle lasts 3 weeks. Cycle 1 day 1, Cycle 2 day 1 and Cycle 4 day 1 values reported |
| Geometric Mean Trough Concentration of Ipilimumab | From Cycle 2, Day 1 to Cycle 4, Day 1 (approximately 6 weeks). Each cycle lasts 3 weeks. |
| Geometric Mean Trough Concentration of Nivolumab | From Cycle 2, Day 1 to Cycle 4, Day 1 (approximately 6 weeks). Each cycle lasts 3 weeks. |
| Objective Response Rate (ORR) | The ORR is defined as the proportion of participants with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). The BOR is defined as the best response designation, as determined by the investigator, recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of subsequent anti-cancer therapy, whichever occurs first. | Week 12 following randomization, every 8 weeks for the first 12 months and then every 12 weeks until disease progression (approximately 20 months) |
| Progression Free Survival (PFS) | PFS is defined as the time between the date of randomization and the first date of documented progression, as determined by the investigator, or death due to any cause, whichever occurs first. | From the date of randomization to the first date of documented progression (approximately 26 months) |
| Greenslopes |
| Queensland |
| Australia |
| Cabrini Hospital | Malvern | Victoria | Australia |
| Local Institution | Lyon | 69373 | France |
| Hopital De La Timone | Marseille | 13385 | France |
| Local Institution | Nantes | 44093 | France |
| Hopital Saint Louis | Paris | 75475 | France |
| Local Institution | Paris | 75679 | France |
| Hopital Trousseau - Chru Tours | Tours | 37044 | France |
| Istituto Nazionale Per La Ricerca Sul Cancro - Oncologia Med | Genova | 16128 | Italy |
| Istituto Scientifico Romagnolo Per Lo Studio E Cura Tumori | Meldola (FC) | 47014 | Italy |
| Istituto Europeo Di Oncologia | Milan | 20141 | Italy |
| Azienda Ospedaliera Citta della Salute e della Scienza | Torino | 10137 | Italy |
| Local Institution | Barcelona | 08036 | Spain |
| Local Institution | Madrid | 28007 | Spain |
| Local Institution | Seville | 41071 | Spain |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls | View source |
Sequential administration of Nivolumab and Ipilimumab every 3 weeks for 4 doses followed by Nivolumab flat dose in the Maintenance Phase
|
| COMPLETED | Completed = Continuing in study |
|
| NOT COMPLETED |
|
|
| Transition From Part 1 to Part 2 |
|
|
| Maintenance Phase Part 2 |
|
|
All treated participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Fixed Ratio Combination | Concomitant administration of Nivolumab and Ipilimumab (1:3 protein-mass ratio) every 3 weeks for 4 doses followed by Nivolumab flat dose in the Maintenance Phase |
| BG001 | Sequential Combination | Sequential administration of Nivolumab and Ipilimumab every 3 weeks for 4 doses followed by Nivolumab flat dose in the Maintenance Phase |
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Percentage of Participants Affected by AEs in the Narrow Scope MedDRA Anaphylactic Reaction SMQ | This outcome describes the percentage of participants experiencing at least 1 AE in the MedDRA Anaphylactic Reaction narrow scope SMQ. The narrow scope SMQ is composed of a large list of terms, including (but not limited to) anaphylactic shock and reaction, shock and shock symptoms, and circulatory collapse, among the others. | All treated participants | Posted | Number | 95% Confidence Interval | Percent of Participants | Within 2 days from administration of any of the 4 doses in part 1 period (approximately 12 weeks) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Affected by Hypersensitivity/Infusion Reaction Select AEs | This outcome describes the percentage of participants experiencing at least 1 AE in the Hypersensitivity/Infusion select AEs category. The select AEs consist of a list of preferred terms defined by the Sponsor and represent AEs with a potential immune-mediated etiology. The following 5 MedDRA preferred terms are included in the hypersensitivity/infusion reaction select AE category: Anaphylactic Reaction, Anaphylactic Shock, Bronchospasm, Hypersensitivity, and Infusion Related Reaction | All treated participants | Posted | Number | Percent of Participants | Within 2 days from administration of any of the 4 doses in part 1 period (approximately 12 weeks) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Affected by All Causality Grade 3 - 5 AEs | This outcome describes the percentage of participants who experienced at least 1 AE of Grade 3 or higher defined using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria | All treated participants | Posted | Number | Percent of participants | From initial dose of study treatment and within 30 days of the last dose of study treatment (approximately 25 months) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Affected by Drug-related Grade 3 - 5 AEs | This outcome describes the percentage of participants who experienced at least 1 Drug-related AE of Grade 3 or higher defined using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria | All treated participants | Posted | Number | Percent of participants | From initial dose of study treatment and within 30 days of the last dose of study treatment (approximately 25 months) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Concentration of Ipilimumab at End of Infusion (EOI) | All treated participants | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (ug/mL) | From Cycle 1, Day 1 to Cycle 4, Day 1 (approximately 9 weeks). Each cycle lasts 3 weeks. Cycle 1 day 1, Cycle 2 day 1 and Cycle 4 day 1 values reported. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Concentration of Nivolumab at End of Infusion (EOI) | All treated participants | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (ug/mL) | From Cycle 1, Day 1 to Cycle 4, Day 1 (approximately 9 weeks). Each cycle lasts 3 weeks. Cycle 1 day 1, Cycle 2 day 1 and Cycle 4 day 1 values reported |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Trough Concentration of Ipilimumab | All treated participants | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (ug/mL) | From Cycle 2, Day 1 to Cycle 4, Day 1 (approximately 6 weeks). Each cycle lasts 3 weeks. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Trough Concentration of Nivolumab | All treated participants | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (ug/mL) | From Cycle 2, Day 1 to Cycle 4, Day 1 (approximately 6 weeks). Each cycle lasts 3 weeks. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | The ORR is defined as the proportion of participants with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). The BOR is defined as the best response designation, as determined by the investigator, recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of subsequent anti-cancer therapy, whichever occurs first. | All treated participants | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 12 following randomization, every 8 weeks for the first 12 months and then every 12 weeks until disease progression (approximately 20 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | PFS is defined as the time between the date of randomization and the first date of documented progression, as determined by the investigator, or death due to any cause, whichever occurs first. | All treated participants | Posted | Median | 95% Confidence Interval | Months | From the date of randomization to the first date of documented progression (approximately 26 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Affected by Adverse Events (AEs) in the Broad Scope MedDRA Anaphylactic Reaction Standardized MedDRA Queries (SMQ) | This outcome describes the percentage of participants experiencing at least 1 AE in the MedDRA Anaphylactic Reaction broad scope SMQ. Such AEs include any acute systemic reaction characterized by a large list of terms, including (but not limited to) pruritus, urticaria, flushing, hypotension, respiratory distress, and vascular insufficiency. It also includes other signs and symptoms such as asthma, choking sensation, coughing, sneezing, and difficulty breathing due to laryngeal spasm and/or bronchospasm. Less frequent clinical presentations are also captured and include hyperventilation, sensation of foreign body, and ocular edema. | All treated participants | Posted | Number | 95% Confidence Interval | Percent of Participants | Within 2 days from administration of any of the 4 doses in part 1 period (approximately 12 weeks) |
|
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 | Fixed Ratio Combination | Concomitant administration of Nivolumab and Ipilimumab (1:3 protein-mass ratio) every 3 weeks for 4 doses followed by Nivolumab flat dose in the Maintenance Phase | 14 | 53 | 35 | 53 | 51 | 53 |
| EG001 | Sequential Combination | Sequential administration of Nivolumab and Ipilimumab every 3 weeks for 4 doses followed by Nivolumab flat dose in the Maintenance Phase | 14 | 53 | 35 | 53 | 51 | 53 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | 22.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | 22.1 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | 22.1 | Systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | 22.1 | Systematic Assessment |
| |
| Thyroiditis | Endocrine disorders | 22.1 | Systematic Assessment |
| |
| Iridocyclitis | Eye disorders | 22.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 22.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 22.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | 22.1 | Systematic Assessment |
| |
| Autoimmune colitis | Gastrointestinal disorders | 22.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | 22.1 | Systematic Assessment |
| |
| Cyclic vomiting syndrome | Gastrointestinal disorders | 22.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 22.1 | Systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | 22.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | 22.1 | Systematic Assessment |
| |
| Erosive duodenitis | Gastrointestinal disorders | 22.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | 22.1 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | 22.1 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | 22.1 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | 22.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | 22.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | 22.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | 22.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 22.1 | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | 22.1 | Systematic Assessment |
| |
| Chest pain | General disorders | 22.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | 22.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 22.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 22.1 | Systematic Assessment |
| |
| Acute hepatic failure | Hepatobiliary disorders | 22.1 | Systematic Assessment |
| |
| Autoimmune hepatitis | Hepatobiliary disorders | 22.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | 22.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | 22.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | 22.1 | Systematic Assessment |
| |
| Hepatocellular injury | Hepatobiliary disorders | 22.1 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | 22.1 | Systematic Assessment |
| |
| Autoimmune disorder | Immune system disorders | 22.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | 22.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | 22.1 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | 22.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | 22.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | 22.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | 22.1 | Systematic Assessment |
| |
| Meningitis aseptic | Infections and infestations | 22.1 | Systematic Assessment |
| |
| Parotitis | Infections and infestations | 22.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 22.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | 22.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 22.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | 22.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 22.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 22.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 22.1 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | 22.1 | Systematic Assessment |
| |
| Pancreatic enzymes increased | Investigations | 22.1 | Systematic Assessment |
| |
| Pneumocystis test positive | Investigations | 22.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | 22.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 22.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 22.1 | Systematic Assessment |
| |
| Haematoma muscle | Musculoskeletal and connective tissue disorders | 22.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.1 | Systematic Assessment |
| |
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.1 | Systematic Assessment |
| |
| Lip squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.1 | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.1 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.1 | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | 22.1 | Systematic Assessment |
| |
| Guillain-Barre syndrome | Nervous system disorders | 22.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 22.1 | Systematic Assessment |
| |
| Meningorrhagia | Nervous system disorders | 22.1 | Systematic Assessment |
| |
| Motor neurone disease | Nervous system disorders | 22.1 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | 22.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | 22.1 | Systematic Assessment |
| |
| Glomerulonephritis rapidly progressive | Renal and urinary disorders | 22.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | 22.1 | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | 22.1 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | 22.1 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | 22.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 22.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 22.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | 22.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 22.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 22.1 | Systematic Assessment |
| |
| Dermatitis bullous | Skin and subcutaneous tissue disorders | 22.1 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | 22.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 22.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | 22.1 | Systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | 22.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | 22.1 | Systematic Assessment |
| |
| Thyroiditis | Endocrine disorders | 22.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | 22.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 22.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 22.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | 22.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 22.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 22.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | 22.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 22.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 22.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 22.1 | Systematic Assessment |
| |
| Asthenia | General disorders | 22.1 | Systematic Assessment |
| |
| Chills | General disorders | 22.1 | Systematic Assessment |
| |
| Fatigue | General disorders | 22.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | 22.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 22.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 22.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | 22.1 | Systematic Assessment |
| |
| Hepatocellular injury | Hepatobiliary disorders | 22.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 22.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 22.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | 22.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | 22.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 22.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 22.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 22.1 | Systematic Assessment |
| |
| Amylase increased | Investigations | 22.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 22.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | 22.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | 22.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | 22.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 22.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 22.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 22.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 22.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 22.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 22.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 22.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 22.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | 22.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 22.1 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | 22.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | 22.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 22.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 22.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 22.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 22.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | 22.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | 22.1 | Systematic Assessment |
| |
| Lichenoid keratosis | Skin and subcutaneous tissue disorders | 22.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | 22.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 22.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 22.1 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | 22.1 | Systematic Assessment |
| |
| Vitiligo | Skin and subcutaneous tissue disorders | 22.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | 22.1 | 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_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 23, 2017 | Oct 20, 2020 | SAP_003.pdf |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Study drug toxicity |
|
| Death |
|
| Participant withdrew consent |
|
| Adverse Event |
|
| Maximum Clinical Benefit |
|
| 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 |
|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|