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The purpose of this study is to evaluate two different dose combinations of nivolumab and ipilimumab in the treatment of melanoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV | Experimental | Specified dose on specified days |
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| Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV | Experimental | Specified dose on specified days |
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| Nivolumab 6 mg/kg IV + Ipilimumab 1 mg/kg | Experimental | Specified dose on specified days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab 3 mg/kg IV | Biological | Followed by Nivolumab monotherapy |
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| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants With Drug-Related Grade 3 - 5 Adverse Events (AEs) | The percentage of participants who experienced at least 1 AE of Grade 3 or higher, judged to be related to study drug by the investigator, and with onset on or after the first dose of study treatment and within 30 days of the last dose of study treatment. AE grade was defined using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria. | From first dose of study treatment up to primary completion date 20-Apr-2017 (up to approximately 12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | The percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). BOR is defined as the best response, as determined by the investigator, recorded between the date of randomization and the date of progression per RECIST 1.1 or the date of subsequent anticancer therapy, whichever occurred first. For subjects without documented progression or subsequent therapy, all available response designations will contribute to the BOR assessment. Tumor assessments are scheduled at Week 12 following randomization, every 8 weeks for the first 12 months and then every 12 weeks until disease progression. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
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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 |
|---|---|---|---|---|---|---|
| University Of Colorado Cancer Center | Aurora | Colorado | 80045 | United States | ||
| H. Lee Moffitt Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39504507 | Derived | Long GV, Larkin J, Schadendorf D, Grob JJ, Lao CD, Marquez-Rodas I, Wagstaff J, Lebbe C, Pigozzo J, Robert C, Ascierto PA, Atkinson V, Postow MA, Atkins MB, Sznol M, Callahan MK, Topalian SL, Sosman JA, Kotapati S, Thakkar PK, Ritchings C, Pe Benito M, Re S, Soleymani S, Hodi FS. Pooled Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone in Patients With Advanced Melanoma. J Clin Oncol. 2025 Mar 10;43(8):938-948. doi: 10.1200/JCO.24.00400. Epub 2024 Nov 6. | |
| 30811280 |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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387 participants were randomized, 385 were treated. Cohort C/N6I1 assessed for exploratory outcome measures not being reported in the Outcome Measures module. Safety data included with AE data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV | nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks. |
| FG001 | Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Pre-Treatment Period |
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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 | Feb 13, 2017 | Jun 17, 2022 |
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| Ipilimumab 1 mg/kg IV | Biological | Followed by Nivolumab monotherapy |
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| Nivolumab 1 mg/kg IV | Biological |
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| Ipilimumab 3 mg/kg IV | Biological |
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| Nivolumab 6 mg/kg IV | Biological | A dose of 240mg is identical to a dose of 3mg/kg, therefore 6mg/kg is approximately equal to ~ 480mg. |
|
| From date of randomization to date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 5 years) |
| Overall Survival (OS) | The time between the date of randomization and the date of death due to any cause. A participant who has not died will be censored at the last known alive date. OS will be followed continuously while participants are on the study drug and every 3 months via in-person or phone contact after participants discontinue the study drug. Based on Kaplan-Meier Estimates. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up tp approximately 5 years) |
| Progression Free Survival (PFS) | The time between the date of randomization and the first date of documented progression, determined by the investigator, or death due to any cause, whichever occurs first. Participants who die without a reported progression will be considered to have progressed on the date of their death. Those who did not progress or die will be censored on the date of their last evaluable tumor assessment. Participants without on study tumor assessments and who did not die will be censored on their date of randomization. Participants who started anti-cancer therapy without a prior reported progression will be censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy. Based on Kaplan-Meier Estimates. Progression is defined as at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | From randomization to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 5 years) |
| Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Physical Functioning Scale | Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Physical Functioning Scale sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points. | Weeks 7, 16, 20, 24, 28, 32, 36, 40 |
| Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Role Functioning Scale | Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Role Functioning Scale sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points. | Weeks 7, 16, 20, 24, 28, 32, 36, 40 |
| Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Emotional Functioning Scale | Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Emotional Functioning Scale sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points. | Weeks 7, 16, 20, 24, 28, 32, 36, 40 |
| Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Cognitive Functioning Scale | Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Cognitive Functioning Scale sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points. | Weeks 7, 16, 20, 24, 28, 32, 36, 40 |
| Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Social Functioning Scale | Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Social Functioning Scale sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points. | Weeks 7, 16, 20, 24, 28, 32, 36, 40 |
| Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Global Health Status | Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The EORTC QLQ-C30 comprises 6 functional scales (role function, physical functioning, cognitive functioning, emotional functioning, social functioning and global quality of life) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline. | Weeks 7, 16, 20, 24, 28, 32, 36, 40 |
| Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Dyspnea | Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Dyspnea sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points. | Weeks 7, 16, 20, 24, 28, 32, 36, 40 |
| Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Insomnia | Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Insomnia sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points. | Weeks 7, 16, 20, 24, 28, 32, 36, 40 |
| Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Appetite Loss | Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Appetite loss sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points. | Weeks 7, 16, 20, 24, 28, 32, 36, 40 |
| Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Constipation | Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Constipation sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points | Weeks 7, 16, 20, 24, 28, 32, 36, 40 |
| Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Diarrhea | Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Diarrhea sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points. | Weeks 7, 16, 20, 24, 28, 32, 36, 40 |
| Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Financial Difficulties | Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Financial difficulties sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points | Weeks 7, 16, 20, 24, 28, 32, 36, 40 |
| Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Fatigue | Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Fatigue sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points | Weeks 7, 16, 20, 24, 28, 32, 36, 40 |
| Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Nausea and Vomiting | Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Nausea and Vomiting sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points for the various scales of the EORTC QLQ-C30 | Weeks 7, 16, 20, 24, 28, 32, 36, 40 |
| Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Pain | Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Pain sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points | Weeks 7, 16, 20, 24, 28, 32, 36, 40 |
| Tampa |
| Florida |
| 33612 |
| United States |
| Allina Health | Fridley | Minnesota | 55432 | United States |
| Washington University School Of Medicine | St Louis | Missouri | 63110 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89148 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
| Lehigh Valley Health Network | Allentown | Pennsylvania | 18103 | United States |
| University Of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
| University of Washington - Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| Local Institution | North Sydney | New South Wales | 2060 | Australia |
| Local Institution - 0045 | Waratah | New South Wales | 2298 | Australia |
| Local Institution | Greenslopes | Queensland | 4120 | Australia |
| Local Institution | Melbourne | Victoria | 3004 | Australia |
| Local Institution - 0007 | Edmonton | Alberta | T6G 1Z2 | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| CHU de Quebec - Universite Laval | Québec | Quebec | G1R 2J6 | Canada |
| Local Institution - 0063 | Aarhus N | 8200 | Denmark |
| Local Institution - 0065 | Herlev | 2730 | Denmark |
| Local Institution - 0064 | Odense | 5000 | Denmark |
| Hopital Saint Andre | Bordeaux | 33075 | France |
| Chru De Lille | Lille | 59037 | France |
| Hopital De La Timone | Marseille | 13385 | France |
| Hopital Hotel Dieu | Nantes | 44093 | France |
| Hopital Saint Louis | Paris | 75475 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69310 | France |
| Institut Claudius Regaud | Toulouse | 31059 | France |
| Local Institution - 0019 | Villejuif | 94805 | France |
| Universitaetsklinikum Essen | Essen | 45147 | Germany |
| Universitaetsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Ludwig-Maximilians-Universitaet | München | 80337 | Germany |
| Universitaetsklinikum Tuebingen | Tübingen | 72076 | Germany |
| Local Institution | Ramat Gan | 5262100 | Israel |
| Local Institution - 0039 | Bergamo | 24127 | Italy |
| Local Institution - 0042 | Milan | 20133 | Italy |
| Local Institution - 0040 | Naples | 80131 | Italy |
| Istituto Oncologico Veneto IOV | Padova | 35128 | Italy |
| Local Institution - 0041 | Siena | 53100 | Italy |
| Ospedale San Vincenzo | Taormina | 98039 | Italy |
| Local Institution - 0052 | Amsterdam | 1066 CX | Netherlands |
| Local Institution | Amsterdam | 1081 HV | Netherlands |
| University Medical Center Groningen (Umcg) | Groningen | 9700RB | Netherlands |
| Uniwersyteckie Centrum Kliniczne Klinika Onkologii I Radiote | Gdansk | 80-214 | Poland |
| Klinika Nowotworow Ukladowych i Uogolnionych | Krakow | 31-115 | Poland |
| Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow | Warsaw | 02-781 | Poland |
| Local Institution | Moscow | 115478 | Russia |
| Local Institution | Badalona-barcelona | 08916 | Spain |
| Local Institution - 0024 | Barcelona | 08036 | Spain |
| Local Institution | Madrid | 28007 | Spain |
| Local Institution - 0027 | Madrid | 28034 | Spain |
| Local Institution | San Sabastian Gipuzkoa | 20014 | Spain |
| Local Institution | Valencia | 46014 | Spain |
| Local Institution | Manchester | Greater Manchester | M20 4XB | United Kingdom |
| Local Institution | Oxford | Oxfordshire | OX3 7LJ | United Kingdom |
| Local Institution | Guildford | GU2 7XX | United Kingdom |
| Local Institution | London | SW3 6JJ | United Kingdom |
| Derived |
| Lebbe C, Meyer N, Mortier L, Marquez-Rodas I, Robert C, Rutkowski P, Menzies AM, Eigentler T, Ascierto PA, Smylie M, Schadendorf D, Ajaz M, Svane IM, Gonzalez R, Rollin L, Lord-Bessen J, Saci A, Grigoryeva E, Pigozzo J. Evaluation of Two Dosing Regimens for Nivolumab in Combination With Ipilimumab in Patients With Advanced Melanoma: Results From the Phase IIIb/IV CheckMate 511 Trial. J Clin Oncol. 2019 Apr 10;37(11):867-875. doi: 10.1200/JCO.18.01998. Epub 2019 Feb 27. |
| BMS Clinical Trial Patient Recruiting | View source |
| FDA Safety Alerts and Recalls | View source |
nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks
| FG002 | Cohort C, Nivolumab 6 mg/kg + Ipilimumab 1 mg/kg | nivolumab 6 mg/kg plus ipilimumab 1 mg/kg followed by nivolumab 480 mg Flat Dose 4 weeks later and repeated every 8 weeks |
| COMPLETED | Moved to treatment period |
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| NOT COMPLETED |
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| Treatment Period |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV | nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks. |
| BG001 | Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV | nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks |
| BG002 | Cohort C, Nivolumab 6 mg/kg + Ipilimumab 1 mg/kg | nivolumab 6 mg/kg plus ipilimumab 1 mg/kg followed by nivolumab 480 mg Flat Dose 4 weeks later and repeated every 8 weeks |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | The Percentage of Participants With Drug-Related Grade 3 - 5 Adverse Events (AEs) | The percentage of participants who experienced at least 1 AE of Grade 3 or higher, judged to be related to study drug by the investigator, and with onset on or after the first dose of study treatment and within 30 days of the last dose of study treatment. AE grade was defined using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria. | All treated participants in cohorts A and B | Posted | Number | 95% Confidence Interval | Percentage of participants | From first dose of study treatment up to primary completion date 20-Apr-2017 (up to approximately 12 months) |
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| Post-Hoc | The Percentage of Participants With Drug-Related Grade 3 - 5 Adverse Events (AEs) - Extended Collection | The percentage of participants who experienced at least 1 AE of Grade 3 or higher, judged to be related to study drug by the investigator, and with onset on or after the first dose of study treatment and within 30 days of the last dose of study treatment. AE grade was defined using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria. Note: This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date. (Assessments were made until study completion date: 28-May-2021) | All treated participants in cohorts A and B | Posted | Number | 95% Confidence Interval | Percentage of participants | From first dose of study treatment to 30 days after the last dose of study treatment (up to approximately 30 months) |
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| Secondary | Objective Response Rate (ORR) | The percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). BOR is defined as the best response, as determined by the investigator, recorded between the date of randomization and the date of progression per RECIST 1.1 or the date of subsequent anticancer therapy, whichever occurred first. For subjects without documented progression or subsequent therapy, all available response designations will contribute to the BOR assessment. Tumor assessments are scheduled at Week 12 following randomization, every 8 weeks for the first 12 months and then every 12 weeks until disease progression. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | All treated participants in cohorts A and B | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of randomization to date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 5 years) |
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| Secondary | Overall Survival (OS) | The time between the date of randomization and the date of death due to any cause. A participant who has not died will be censored at the last known alive date. OS will be followed continuously while participants are on the study drug and every 3 months via in-person or phone contact after participants discontinue the study drug. Based on Kaplan-Meier Estimates. | All treated participants in cohorts A and B | Posted | Median | 95% Confidence Interval | Months | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up tp approximately 5 years) |
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| Secondary | Progression Free Survival (PFS) | The time between the date of randomization and the first date of documented progression, determined by the investigator, or death due to any cause, whichever occurs first. Participants who die without a reported progression will be considered to have progressed on the date of their death. Those who did not progress or die will be censored on the date of their last evaluable tumor assessment. Participants without on study tumor assessments and who did not die will be censored on their date of randomization. Participants who started anti-cancer therapy without a prior reported progression will be censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy. Based on Kaplan-Meier Estimates. Progression is defined as at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | All treated participants in cohorts A and B | Posted | Median | 95% Confidence Interval | Months | From randomization to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 5 years) |
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| Secondary | Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Physical Functioning Scale | Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Physical Functioning Scale sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points. | All treated participants in cohorts A and B | Posted | Mean | Standard Deviation | Scores on a scale | Weeks 7, 16, 20, 24, 28, 32, 36, 40 |
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| Secondary | Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Role Functioning Scale | Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Role Functioning Scale sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points. | All treated participants in cohorts A and B | Posted | Mean | Standard Deviation | Scores on a scale | Weeks 7, 16, 20, 24, 28, 32, 36, 40 |
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| Secondary | Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Emotional Functioning Scale | Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Emotional Functioning Scale sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points. | All treated participants in cohorts A and B | Posted | Mean | Standard Deviation | Scores on a scale | Weeks 7, 16, 20, 24, 28, 32, 36, 40 |
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| Secondary | Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Cognitive Functioning Scale | Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Cognitive Functioning Scale sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points. | All treated participants in cohorts A and B | Posted | Mean | Standard Deviation | Scores on a scale | Weeks 7, 16, 20, 24, 28, 32, 36, 40 |
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| Secondary | Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Social Functioning Scale | Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Social Functioning Scale sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points. | All treated participants in cohorts A and B | Posted | Mean | Standard Deviation | Scores on a scale | Weeks 7, 16, 20, 24, 28, 32, 36, 40 |
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| Secondary | Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Global Health Status | Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The EORTC QLQ-C30 comprises 6 functional scales (role function, physical functioning, cognitive functioning, emotional functioning, social functioning and global quality of life) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline. | All treated participants in cohorts A and B | Posted | Mean | Standard Deviation | Scores on a scale | Weeks 7, 16, 20, 24, 28, 32, 36, 40 |
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| Secondary | Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Dyspnea | Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Dyspnea sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points. | All treated participants in cohorts A and B | Posted | Mean | Standard Deviation | Scores on a scale | Weeks 7, 16, 20, 24, 28, 32, 36, 40 |
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| Secondary | Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Insomnia | Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Insomnia sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points. | All treated participants in cohorts A and B | Posted | Mean | Standard Deviation | Scores on a scale | Weeks 7, 16, 20, 24, 28, 32, 36, 40 |
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| Secondary | Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Appetite Loss | Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Appetite loss sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points. | All treated participants in cohorts A and B | Posted | Mean | Standard Deviation | Scores on a scale | Weeks 7, 16, 20, 24, 28, 32, 36, 40 |
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| Secondary | Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Constipation | Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Constipation sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points | All treated participants in cohorts A and B | Posted | Mean | Standard Deviation | Scores on a scale | Weeks 7, 16, 20, 24, 28, 32, 36, 40 |
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| Secondary | Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Diarrhea | Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Diarrhea sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points. | All treated participants in cohorts A and B | Posted | Mean | Standard Deviation | Scores on a scale | Weeks 7, 16, 20, 24, 28, 32, 36, 40 |
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| Secondary | Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Financial Difficulties | Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Financial difficulties sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points | All treated participants in cohorts A and B | Posted | Mean | Standard Deviation | Scores on a scale | Weeks 7, 16, 20, 24, 28, 32, 36, 40 |
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| Secondary | Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Fatigue | Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Fatigue sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points | All treated participants in cohorts A and B | Posted | Mean | Standard Deviation | Scores on a scale | Weeks 7, 16, 20, 24, 28, 32, 36, 40 |
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| Secondary | Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Nausea and Vomiting | Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Nausea and Vomiting sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points for the various scales of the EORTC QLQ-C30 | All treated participants in cohorts A and B | Posted | Mean | Standard Deviation | Scores on a scale | Weeks 7, 16, 20, 24, 28, 32, 36, 40 |
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| Secondary | Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Pain | Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Pain sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points | All treated participants in cohorts A and B | Posted | Mean | Standard Deviation | Scores on a scale | Weeks 7, 16, 20, 24, 28, 32, 36, 40 |
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|
Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
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 3 mg/kg IV + Ipilimumab 1 mg/kg IV | nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks. | 85 | 180 | 109 | 180 | 169 | 180 |
| EG001 | Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV | nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks | 78 | 180 | 127 | 178 | 172 | 178 |
| EG002 | Cohort C, Nivolumab 6 mg/kg + Ipilimumab 1 mg/kg | nivolumab 6 mg/kg plus ipilimumab 1 mg/kg followed by nivolumab 480 mg Flat Dose 4 weeks later and repeated every 8 weeks | 15 | 27 | 14 | 27 | 26 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
| |
| Haemolysis | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
| |
| Lymph node pain | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Immune-mediated myocarditis | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | 24.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | 24.0 | Systematic Assessment |
| |
| Adrenocortical insufficiency acute | Endocrine disorders | 24.0 | Systematic Assessment |
| |
| Adrenocorticotropic hormone deficiency | Endocrine disorders | 24.0 | Systematic Assessment |
| |
| Glucocorticoid deficiency | Endocrine disorders | 24.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | 24.0 | Systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | 24.0 | Systematic Assessment |
| |
| Hypopituitarism | Endocrine disorders | 24.0 | Systematic Assessment |
| |
| Thyroiditis | Endocrine disorders | 24.0 | Systematic Assessment |
| |
| Diplopia | Eye disorders | 24.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | 24.0 | Systematic Assessment |
| |
| Keratitis | Eye disorders | 24.0 | Systematic Assessment |
| |
| Orbital myositis | Eye disorders | 24.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Autoimmune colitis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Gastrointestinal necrosis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Gastrointestinal perforation | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | 24.0 | Systematic Assessment |
| |
| Chest pain | General disorders | 24.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | 24.0 | Systematic Assessment |
| |
| Hyperthermia | General disorders | 24.0 | Systematic Assessment |
| |
| Inflammation | General disorders | 24.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | 24.0 | Systematic Assessment |
| |
| Pain | General disorders | 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 24.0 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | 24.0 | Systematic Assessment |
| |
| Autoimmune hepatitis | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Hepatic cytolysis | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | 24.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | 24.0 | Systematic Assessment |
| |
| Sarcoidosis | Immune system disorders | 24.0 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Chorioretinitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Diverticulitis intestinal perforated | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Infected cyst | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Lymph gland infection | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Meningoencephalitis viral | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Spinal cord infection | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 24.0 | Systematic Assessment |
| |
| Antibiotic level below therapeutic | Investigations | 24.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | 24.0 | Systematic Assessment |
| |
| General physical condition abnormal | Investigations | 24.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | 24.0 | Systematic Assessment |
| |
| Influenza A virus test positive | Investigations | 24.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | 24.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Fasciitis | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Intracranial tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Dystonia | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Hyperaesthesia | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Meningism | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Meningoradiculitis | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Motor dysfunction | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Mania | Psychiatric disorders | 24.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | 24.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 24.0 | Systematic Assessment |
| |
| Autoimmune nephritis | Renal and urinary disorders | 24.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | 24.0 | Systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | 24.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | 24.0 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | 24.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | 24.0 | Systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Lower respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Pulmonary sarcoidosis | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Pemphigoid | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Toxic skin eruption | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | 24.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | 24.0 | Systematic Assessment |
| |
| Peripheral artery stenosis | Vascular disorders | 24.0 | Systematic Assessment |
| |
| Peripheral embolism | Vascular disorders | 24.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | 24.0 | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | 24.0 | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | 24.0 | Systematic Assessment |
| |
| Vasculitis | Vascular disorders | 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | 24.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | 24.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | 24.0 | Systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | 24.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | 24.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | 24.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | 24.0 | Systematic Assessment |
| |
| Chills | General disorders | 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 24.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | 24.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | 24.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 24.0 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Hepatic cytolysis | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 24.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | 24.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 24.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | 24.0 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | 24.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | 24.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 24.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | 24.0 | Systematic Assessment |
| |
| Blood magnesium decreased | Investigations | 24.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone decreased | Investigations | 24.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | 24.0 | Systematic Assessment |
| |
| Cortisol decreased | Investigations | 24.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | 24.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | 24.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | 24.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 24.0 | Systematic Assessment |
| |
| Protein total decreased | Investigations | 24.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | 24.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 24.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | 24.0 | Systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Intertrigo | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Skin hypopigmentation | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Vitiligo | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 24.0 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | 24.0 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email: | Clinical.Trials@bms.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 30, 2018 | Jan 2, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Adverse event unrelated to study drug |
|
| Request to discontinue treatment |
|
| Participant withdrew consent |
|
| Maximum clinical benefit |
|
| Administrative reason by sponsor |
|
| Other reasons |
|
| Completed treatment as per protocol |
|
| Not reported |
|
| >= 65 AND < 75 |
|
| >= 75 |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Estimated Difference of rates |
| -12.7 |
| 2-Sided |
| 95 |
| -22.7 |
| -2.6 |
Estimate of NIVO 3 + IPI 1- NIVO 1 + IPI 3 is based on Cochran-Mantel-Haenszel (CMH) method of weighting, adjusting for PD-L1 expression and M stage at screening as entered into the IVRS |
| Superiority |
| Units | Counts |
|---|---|
| Participants |
|
|
|
nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks |
|
|
|
|
|
nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks |
|
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
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| Participants |
|
|
| Participants |
|
|
|
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| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|