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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002898-35 | EudraCT Number |
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The purpose of this study is to demonstrate the clinical activity of nivolumab in combination with ipilimumab in multiple types of tumors based on their Tumor Mutational Burden status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nivolumab + Ipilimumab Combination | Experimental |
| |
| Nivolumab Monotherapy | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Biological | Specified dose on specified days |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) - Arm A | ORR was defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR) based on Blinded Independent Central Review (BICR) assessment. RECIST Criteria: CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. RANO Criteria: CR= Disappearance of all enhancing measurable and nonmeasurable disease; stable or improved nonenhancing T2/FLAIR lesions; off corticosteroids; and stable or improved clinically PR= ≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions; no progression of nonmeasureable disease; no new lesions; stable or improved nonenhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; and stable or improved clinically. | From date of randomization up to 42 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) - Arm B | ORR was defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR) based on Blinded Independent Central Review (BICR) assessment. RECIST Criteria: CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. RANO Criteria: CR= Disappearance of all enhancing measurable and nonmeasurable disease; stable or improved nonenhancing T2/FLAIR lesions; off corticosteroids; and stable or improved clinically PR= ≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions; no progression of nonmeasureable disease; no new lesions; stable or improved nonenhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; and stable or improved clinically. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria apply.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Wayne Cancer Center | Santa Monica | California | 90404 | United States | ||
| Rocky Mountain Cancer Centers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39107131 | Derived | Schenker M, Burotto M, Richardet M, Ciuleanu TE, Goncalves A, Steeghs N, Schoffski P, Ascierto PA, Maio M, Lugowska I, Lupinacci L, Leary A, Delord JP, Grasselli J, Tan DSP, Friedmann J, Vuky J, Tschaika M, Konduru S, Vemula SV, Slepetis R, Kollia G, Pacius M, Duong Q, Huang N, Doshi P, Baden J, Di Nicola M. Randomized, open-label, phase 2 study of nivolumab plus ipilimumab or nivolumab monotherapy in patients with advanced or metastatic solid tumors of high tumor mutational burden. J Immunother Cancer. 2024 Aug 6;12(8):e008872. doi: 10.1136/jitc-2024-008872. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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Salvage setting describes participants with a refractory, metastatic, or unresectable histologically or cytologically confirmed solid malignant tumor with Tumor Mutational Burden-High (TMB-H) who are refractory to standard therapies per local management guidelines, or for which no standard treatment per local management guidelines is available.
Participants randomized to the Nivolumab monotherapy arm B were allowed to rollover to Nivolumab+Ipilimumab arm A at the time of progression.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Nivolumab+Ipilimumab | Nivolumab 240 mg every 2 weeks (Q2W) + Ipilimumab 1 mg/kg every 6 weeks (Q6W) up to 24 months |
| FG001 | Arm B: Nivolumab | Nivolumab Monotherapy 480 mg every 4 weeks (Q4W) up to 24 months |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Pre-treatment |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 4, 2021 |
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| Ipilimumab | Biological | Specified dose on specified days |
|
|
| From date of randomization up to 57 months |
| Objective Response Rate (ORR) Per Investigator | ORR was defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR) based on investigator assessment. Calculated using Clopper-Pearson method. RECIST Criteria: CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. RANO Criteria: CR= Disappearance of all enhancing measurable and nonmeasurable disease; stable or improved nonenhancing T2/FLAIR lesions; off corticosteroids; and stable or improved clinically PR= ≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions; no progression of nonmeasureable disease; no new lesions; stable or improved nonenhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; and stable or improved clinically. | From date of randomization up to 57 months |
| Duration of Response (DoR) Per Investigator | DoR was defined as the time from first confirmed complete or partial response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first. Calculated using KM method. RECIST Criteria: CR= Disappearance of all target lesions. PR= ≥ 30% decrease in the sum of diameters of target lesions. PD= ≥ 20% increase in the sum of diameters of target lesions. RANO Criteria: CR= Disappearance of all enhancing measurable and nonmeasurable disease; stable/improved T2/FLAIR; off corticosteroids; stable/improved clinically PR= ≥ 50% decrease in the sum of diameters of all measurable enhancing lesions; no progression of nonmeasurable disease; no new lesions; stable/improved T2/FLAIR; stable/improved clinically. PD= ≥ 25% increase in sum of diameters of enhancing lesions, on stable/increasing doses of corticosteroids; significant increase in T2/FLAIR; any new lesion; clear clinical deterioration or clear progression of nonmeasurable disease. | From date of randomization to date of first documented tumor progression, or date of death, whichever occurs first (Up to 57 months) |
| Duration of Response (DoR) Per Blinded Independent Central Review (BICR) | DoR was defined as the time from first confirmed complete or partial response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first. Calculated using KM method. RECIST Criteria: CR= Disappearance of all target lesions. PR= ≥ 30% decrease in the sum of diameters of target lesions. PD= ≥ 20% increase in the sum of diameters of target lesions. RANO Criteria: CR= Disappearance of all enhancing measurable and nonmeasurable disease; stable/improved T2/FLAIR; off corticosteroids; stable/improved clinically PR= ≥ 50% decrease in the sum of diameters of all measurable enhancing lesions; no progression of nonmeasurable disease; no new lesions; stable/improved T2/FLAIR; stable/improved clinically. PD= ≥ 25% increase in sum of diameters of enhancing lesions, on stable/increasing doses of corticosteroids; significant increase in T2/FLAIR; any new lesion; clear clinical deterioration or clear progression of nonmeasurable disease. | From date of randomization to date of first documented tumor progression, or date of death, whichever occurs first (Up to 57 months) |
| Time to Objective Response (TTR) Per Investigator | TTR is defined as the time from randomization date to the date of the first confirmed response (complete response (CR) or partial response (PR)), based on investigator assessment. RECIST Criteria: CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. RANO Criteria: CR= Disappearance of all enhancing measurable and nonmeasurable disease; stable or improved nonenhancing T2/FLAIR lesions; off corticosteroids; and stable or improved clinically PR= ≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions; no progression of nonmeasureable disease; no new lesions; stable or improved nonenhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; and stable or improved clinically. | From date of randomization to date of first confirmed response (CR or PR) (Up to 57 months) |
| Time to Objective Response (TTR) Per Blinded Independent Central Review (BICR) | TTR is defined as the time from randomization date to the date of the first confirmed response (complete response (CR) or partial response (PR)), based on Blinded Independent Central Review (BICR) assessment. RECIST Criteria: CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. RANO Criteria: CR= Disappearance of all enhancing measurable and nonmeasurable disease; stable or improved nonenhancing T2/FLAIR lesions; off corticosteroids; and stable or improved clinically PR= ≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions; no progression of nonmeasureable disease; no new lesions; stable or improved nonenhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; and stable or improved clinically. | From date of randomization to date of first confirmed response (CR or PR) (Up to 57 months) |
| Clinical Benefit Rate (CBR) Per Investigator | CBR is defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR) or stable disease (SD) based on investigator assessment. RECIST Criteria: CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm PR= ≥ 30% decrease in the sum of diameters of target lesions SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD RANO Criteria: CR= Disappearance of all enhancing disease; stable or improved nonenhancing T2/FLAIR lesions; off corticosteroids; and stable or improved clinically PR= ≥ 50% decrease in the sum of products of perpendicular diameters of all measurable enhancing lesions; no progression of nonmeasureable disease; no new lesions; stable or improved nonenhancing (T2/FLAIR) lesions; stable or improved clinically SD= does not qualify for CR, PR, or progression; stable nonenhancing T2/FLAIR lesions | From date of randomization up to 57 months |
| Clinical Benefit Rate (CBR) Per Blinded Independent Central Review (BICR) | CBR is defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR) or stable disease (SD) per Blinded Independent Central Review (BICR) assessment. RECIST Criteria: CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm PR= ≥ 30% decrease in the sum of diameters of target lesions SD= does not qualify for PR or progressive disease RANO Criteria: CR= Disappearance of all enhancing disease; stable or improved nonenhancing T2/FLAIR lesions; off corticosteroids; and stable or improved clinically PR= ≥ 50% decrease in the sum of products of perpendicular diameters of all measurable enhancing lesions; no progression of nonmeasureable disease; no new lesions; stable or improved nonenhancing (T2/FLAIR) lesions; stable or improved clinically SD= does not qualify for CR, PR, or progression; stable nonenhancing T2/FLAIR lesions | From date of randomization up to 57 months |
| Progression Free Survival (PFS) Per Investigator | PFS is defined as the time from randomization date to the date of the first documented tumor progression, determined by investigator assessment, or death due to any cause, whichever occurs first. Calculated using KM method. RECIST Criteria: Progressive Disease (PD)= ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of ≥ 5 mm. RANO Criteria: PD= ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement obtained either at baseline or best response, on stable or increasing doses of corticosteroids; significant increase in T2/FLAIR nonenhancing lesions on stable or increasing doses of corticosteroids compared with baseline scan or best response after initiation of therapy; any new lesion; clear clinical deterioration or clear progression of nonmeasurable disease. | From date of randomization to date of first documented tumor progression, or date of death, whichever occurs first (Up to 57 months) |
| Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR) | PFS is defined as the time from randomization date to the date of the first documented tumor progression, determined by Blinded Independent Central Review (BICR) assessment, or death due to any cause, whichever occurs first. Calculated using KM method. RECIST Criteria: Progressive Disease (PD)= ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of ≥ 5 mm. RANO Criteria: PD= ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement obtained either at baseline or best response, on stable or increasing doses of corticosteroids; significant increase in T2/FLAIR nonenhancing lesions on stable or increasing doses of corticosteroids compared with baseline scan or best response after initiation of therapy; any new lesion; clear clinical deterioration or clear progression of nonmeasurable disease. | From date of randomization to date of first documented tumor progression, or date of death, whichever occurs first (Up to 57 months) |
| Overall Survival (OS) | OS is defined as the time between the date of randomization and the date of death due to any cause. Participants who did not have a date of death were censored on the last date for which a participant was known to be alive. Calculated using KM method. | From date of randomization to date of death (Up to 57 months) |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of participants with any grade adverse events (AEs), serious adverse events (SAEs), drug-related AEs, and drug-related SAEs by Tumor Mutational Burden- High (TMB-H) status using worst grade per national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) v5 criteria. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. TMB-H = ≥ 10 mutations per megabase bTMB-H and tTMB-H are not mutually exclusive | From first dose to 30 days post last dose (Up to 25 months) |
| Number of Participants With On-Treatment Laboratory Parameters | Number of participants with grade 3-4 on-treatment laboratory parameters. Parameters include hematology, chemistry, liver function, and renal function using worst grade per national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) v5 criteria. Grade 3=Severe event Grade 4=Life threatening event TMB-H = ≥ 10 mutations per megabase bTMB-H and tTMB-H are not mutually exclusive | From first dose to 30 days post last dose (Up to 25 months) |
| Denver |
| Colorado |
| 80218 |
| United States |
| Local Institution - 0093 | Minneapolis | Minnesota | 55404 | United States |
| Broome Oncology | Johnson City | New York | 13790 | United States |
| Duke Cancer Institute | Durham | North Carolina | 27710 | United States |
| Local Institution - 0079 | Portland | Oregon | 97239 | United States |
| Local Institution - 0095 | Austin | Texas | 78731 | United States |
| Local Institution - 0094 | Dallas | Texas | 75231 | United States |
| Local Institution - 0090 | Houston | Texas | 77030 | United States |
| Texas Oncology - Northeast Texas | Tyler | Texas | 75702 | United States |
| Local Institution - 0016 | Ciudad Autonoma Beunos Aires | Buenos Aires | 1431 | Argentina |
| Local Institution - 0087 | Ciudad Autónoma de Buenos Aires | Buenos Aires | 1280 | Argentina |
| Local Institution - 0078 | CABA | 1199 | Argentina |
| Local Institution - 0015 | CABA | 1426 | Argentina |
| Local Institution - 0119 | Córdoba | 5000 | Argentina |
| Local Institution - 0118 | St Leonards | New South Wales | 2065 | Australia |
| Local Institution - 0062 | Sydney | New South Wales | 2010 | Australia |
| Local Institution - 0117 | Woolloongabba | Queensland | 4102 | Australia |
| Local Institution - 0112 | Brussels | 1090 | Belgium |
| Local Institution - 0113 | Brussels | 1200 | Belgium |
| Local Institution - 0114 | Leuven | 3000 | Belgium |
| Local Institution - 0010 | Edmonton | Alberta | T6G 1Z2 | Canada |
| Local Institution - 0060 | Hamilton | Ontario | L8V 5C2 | Canada |
| Local Institution - 0036 | Montreal | Quebec | H2X 3E4 | Canada |
| Local Institution - 0088 | Montreal | Quebec | H3T 1E2 | Canada |
| Local Institution - 0018 | Santiago | Santiago Metropolitan | 8330024 | Chile |
| Local Institution - 0082 | Santiago | Santiago Metropolitan | 8420383 | Chile |
| Local Institution - 0080 | Copenhagen | 2100 | Denmark |
| Local Institution - 0081 | Herlev | 2730 | Denmark |
| Local Institution - 0072 | Lyon | 69373 | France |
| Local Institution - 0075 | Marseille | 13273 | France |
| Local Institution - 0073 | Paris | 75248 | France |
| Local Institution - 0074 | Toulouse | 31100 | France |
| Local Institution - 0085 | Villejuif | 94805 | France |
| Local Institution - 0039 | Berlin | 12200 | Germany |
| Local Institution - 0001 | Bonn | 53127 | Germany |
| Local Institution - 0002 | Dresden | 01307 | Germany |
| Local Institution - 0086 | Essen | 45147 | Germany |
| Local Institution - 0043 | Würzburg | 97080 | Germany |
| Local Institution - 0032 | Genova | 16132 | Italy |
| IRCCS Istituto Nazionale Tumori Milano | Milan | 20133 | Italy |
| Local Institution - 0029 | Naples | 80131 | Italy |
| Local Institution - 0031 | Siena | 53100 | Italy |
| Local Institution - 0116 | Rotterdam | South Holland | 3015 GD | Netherlands |
| Local Institution - 0115 | Amsterdam | 1066 CX | Netherlands |
| Local Institution - 0076 | Warsaw | Masovian Voivodeship | 02-781 | Poland |
| Local Institution - 0077 | Gdansk | 80-214 | Poland |
| Fundacion De Investigacion | San Juan | 00927 | Puerto Rico |
| Local Institution - 0068 | Cluj-Napoca | Cluj | 400015 | Romania |
| Local Institution - 0069 | Bucharest | 022328 | Romania |
| Local Institution - 0067 | Craiova | 200542 | Romania |
| Local Institution - 0070 | Floreşti | 407280 | Romania |
| Local Institution - 0071 | Timisoara, Timis | 300239 | Romania |
| Local Institution - 0065 | Singapore | Central Singapore | 168583 | Singapore |
| Local Institution - 0066 | Singapore | 117599 | Singapore |
| Local Institution - 0084 | Barcelona | 08035 | Spain |
| Local Institution - 0083 | Madrid | 28041 | Spain |
| Local Institution - 0110 | Pamplona | 31008 | Spain |
| Local Institution - 0106 | London | Greater London | W12 OHS | United Kingdom |
| Local Institution - 0107 | Preston | PR2 9HT | United Kingdom |
| BMS Clinical Trial Patient Recruiting | View source |
| FDA Safety Alerts and Recalls | View source |
| bTMB-H Started | Randomized in a salvage setting |
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| tTMB-H Started | Randomized in a salvage setting |
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| COMPLETED | Treated |
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| NOT COMPLETED |
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| Treatment |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Nivolumab+Ipilimumab | Nivolumab 240 mg every 2 weeks (Q2W) + Ipilimumab 1 mg/kg every 6 weeks (Q6W) up to 24 months |
| BG001 | Arm B: Nivolumab | Nivolumab Monotherapy 480 mg every 4 weeks (Q4W) up to 24 months |
| BG002 | 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, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | 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 | ||||||||||||||||||||||
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| Primary | Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) - Arm A | ORR was defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR) based on Blinded Independent Central Review (BICR) assessment. RECIST Criteria: CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. RANO Criteria: CR= Disappearance of all enhancing measurable and nonmeasurable disease; stable or improved nonenhancing T2/FLAIR lesions; off corticosteroids; and stable or improved clinically PR= ≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions; no progression of nonmeasureable disease; no new lesions; stable or improved nonenhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; and stable or improved clinically. | All participants randomized in a salvage setting to arm A by TMB-High status | Posted | Number | 95% Confidence Interval | Precentage of participants | From date of randomization up to 42 months |
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| Secondary | Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) - Arm B | ORR was defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR) based on Blinded Independent Central Review (BICR) assessment. RECIST Criteria: CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. RANO Criteria: CR= Disappearance of all enhancing measurable and nonmeasurable disease; stable or improved nonenhancing T2/FLAIR lesions; off corticosteroids; and stable or improved clinically PR= ≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions; no progression of nonmeasureable disease; no new lesions; stable or improved nonenhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; and stable or improved clinically. | All participants randomized in a salvage setting to arm B by TMB-High status | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of randomization up to 57 months |
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| Secondary | Objective Response Rate (ORR) Per Investigator | ORR was defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR) based on investigator assessment. Calculated using Clopper-Pearson method. RECIST Criteria: CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. RANO Criteria: CR= Disappearance of all enhancing measurable and nonmeasurable disease; stable or improved nonenhancing T2/FLAIR lesions; off corticosteroids; and stable or improved clinically PR= ≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions; no progression of nonmeasureable disease; no new lesions; stable or improved nonenhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; and stable or improved clinically. | All participants randomized in a salvage setting by TMB-High status | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of randomization up to 57 months |
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| Secondary | Duration of Response (DoR) Per Investigator | DoR was defined as the time from first confirmed complete or partial response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first. Calculated using KM method. RECIST Criteria: CR= Disappearance of all target lesions. PR= ≥ 30% decrease in the sum of diameters of target lesions. PD= ≥ 20% increase in the sum of diameters of target lesions. RANO Criteria: CR= Disappearance of all enhancing measurable and nonmeasurable disease; stable/improved T2/FLAIR; off corticosteroids; stable/improved clinically PR= ≥ 50% decrease in the sum of diameters of all measurable enhancing lesions; no progression of nonmeasurable disease; no new lesions; stable/improved T2/FLAIR; stable/improved clinically. PD= ≥ 25% increase in sum of diameters of enhancing lesions, on stable/increasing doses of corticosteroids; significant increase in T2/FLAIR; any new lesion; clear clinical deterioration or clear progression of nonmeasurable disease. | All responders (CR or PR) randomized in a salvage setting by TMB-High status | Posted | Median | 95% Confidence Interval | Months | From date of randomization to date of first documented tumor progression, or date of death, whichever occurs first (Up to 57 months) |
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| Secondary | Duration of Response (DoR) Per Blinded Independent Central Review (BICR) | DoR was defined as the time from first confirmed complete or partial response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first. Calculated using KM method. RECIST Criteria: CR= Disappearance of all target lesions. PR= ≥ 30% decrease in the sum of diameters of target lesions. PD= ≥ 20% increase in the sum of diameters of target lesions. RANO Criteria: CR= Disappearance of all enhancing measurable and nonmeasurable disease; stable/improved T2/FLAIR; off corticosteroids; stable/improved clinically PR= ≥ 50% decrease in the sum of diameters of all measurable enhancing lesions; no progression of nonmeasurable disease; no new lesions; stable/improved T2/FLAIR; stable/improved clinically. PD= ≥ 25% increase in sum of diameters of enhancing lesions, on stable/increasing doses of corticosteroids; significant increase in T2/FLAIR; any new lesion; clear clinical deterioration or clear progression of nonmeasurable disease. | All responders (CR or PR) randomized in a salvage setting by TMB-High status | Posted | Median | 95% Confidence Interval | Months | From date of randomization to date of first documented tumor progression, or date of death, whichever occurs first (Up to 57 months) |
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| Secondary | Time to Objective Response (TTR) Per Investigator | TTR is defined as the time from randomization date to the date of the first confirmed response (complete response (CR) or partial response (PR)), based on investigator assessment. RECIST Criteria: CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. RANO Criteria: CR= Disappearance of all enhancing measurable and nonmeasurable disease; stable or improved nonenhancing T2/FLAIR lesions; off corticosteroids; and stable or improved clinically PR= ≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions; no progression of nonmeasureable disease; no new lesions; stable or improved nonenhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; and stable or improved clinically. | All responders (CR or PR) randomized in a salvage setting by TMB-High status | Posted | Mean | Standard Deviation | Months | From date of randomization to date of first confirmed response (CR or PR) (Up to 57 months) |
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| Secondary | Time to Objective Response (TTR) Per Blinded Independent Central Review (BICR) | TTR is defined as the time from randomization date to the date of the first confirmed response (complete response (CR) or partial response (PR)), based on Blinded Independent Central Review (BICR) assessment. RECIST Criteria: CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. RANO Criteria: CR= Disappearance of all enhancing measurable and nonmeasurable disease; stable or improved nonenhancing T2/FLAIR lesions; off corticosteroids; and stable or improved clinically PR= ≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions; no progression of nonmeasureable disease; no new lesions; stable or improved nonenhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; and stable or improved clinically. | All responders (CR or PR) randomized in a salvage setting by TMB-High status | Posted | Mean | Standard Deviation | Months | From date of randomization to date of first confirmed response (CR or PR) (Up to 57 months) |
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| Secondary | Clinical Benefit Rate (CBR) Per Investigator | CBR is defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR) or stable disease (SD) based on investigator assessment. RECIST Criteria: CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm PR= ≥ 30% decrease in the sum of diameters of target lesions SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD RANO Criteria: CR= Disappearance of all enhancing disease; stable or improved nonenhancing T2/FLAIR lesions; off corticosteroids; and stable or improved clinically PR= ≥ 50% decrease in the sum of products of perpendicular diameters of all measurable enhancing lesions; no progression of nonmeasureable disease; no new lesions; stable or improved nonenhancing (T2/FLAIR) lesions; stable or improved clinically SD= does not qualify for CR, PR, or progression; stable nonenhancing T2/FLAIR lesions | All participants randomized in a salvage setting by TMB-High status | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of randomization up to 57 months |
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| Secondary | Clinical Benefit Rate (CBR) Per Blinded Independent Central Review (BICR) | CBR is defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR) or stable disease (SD) per Blinded Independent Central Review (BICR) assessment. RECIST Criteria: CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm PR= ≥ 30% decrease in the sum of diameters of target lesions SD= does not qualify for PR or progressive disease RANO Criteria: CR= Disappearance of all enhancing disease; stable or improved nonenhancing T2/FLAIR lesions; off corticosteroids; and stable or improved clinically PR= ≥ 50% decrease in the sum of products of perpendicular diameters of all measurable enhancing lesions; no progression of nonmeasureable disease; no new lesions; stable or improved nonenhancing (T2/FLAIR) lesions; stable or improved clinically SD= does not qualify for CR, PR, or progression; stable nonenhancing T2/FLAIR lesions | All participants randomized in a salvage setting by TMB-High status | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of randomization up to 57 months |
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| Secondary | Progression Free Survival (PFS) Per Investigator | PFS is defined as the time from randomization date to the date of the first documented tumor progression, determined by investigator assessment, or death due to any cause, whichever occurs first. Calculated using KM method. RECIST Criteria: Progressive Disease (PD)= ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of ≥ 5 mm. RANO Criteria: PD= ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement obtained either at baseline or best response, on stable or increasing doses of corticosteroids; significant increase in T2/FLAIR nonenhancing lesions on stable or increasing doses of corticosteroids compared with baseline scan or best response after initiation of therapy; any new lesion; clear clinical deterioration or clear progression of nonmeasurable disease. | All participants randomized in a salvage setting by TMB-High status | Posted | Median | 95% Confidence Interval | Months | From date of randomization to date of first documented tumor progression, or date of death, whichever occurs first (Up to 57 months) |
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| Secondary | Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR) | PFS is defined as the time from randomization date to the date of the first documented tumor progression, determined by Blinded Independent Central Review (BICR) assessment, or death due to any cause, whichever occurs first. Calculated using KM method. RECIST Criteria: Progressive Disease (PD)= ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of ≥ 5 mm. RANO Criteria: PD= ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement obtained either at baseline or best response, on stable or increasing doses of corticosteroids; significant increase in T2/FLAIR nonenhancing lesions on stable or increasing doses of corticosteroids compared with baseline scan or best response after initiation of therapy; any new lesion; clear clinical deterioration or clear progression of nonmeasurable disease. | All participants randomized in a salvage setting by TMB-High status | Posted | Median | 95% Confidence Interval | Months | From date of randomization to date of first documented tumor progression, or date of death, whichever occurs first (Up to 57 months) |
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| Secondary | Overall Survival (OS) | OS is defined as the time between the date of randomization and the date of death due to any cause. Participants who did not have a date of death were censored on the last date for which a participant was known to be alive. Calculated using KM method. | All participants randomized in a salvage setting by TMB-High status | Posted | Median | 95% Confidence Interval | Months | From date of randomization to date of death (Up to 57 months) |
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| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of participants with any grade adverse events (AEs), serious adverse events (SAEs), drug-related AEs, and drug-related SAEs by Tumor Mutational Burden- High (TMB-H) status using worst grade per national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) v5 criteria. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. TMB-H = ≥ 10 mutations per megabase bTMB-H and tTMB-H are not mutually exclusive | All treated participants by TMB-High status | Posted | Count of Participants | Participants | From first dose to 30 days post last dose (Up to 25 months) |
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| Secondary | Number of Participants With On-Treatment Laboratory Parameters | Number of participants with grade 3-4 on-treatment laboratory parameters. Parameters include hematology, chemistry, liver function, and renal function using worst grade per national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) v5 criteria. Grade 3=Severe event Grade 4=Life threatening event TMB-H = ≥ 10 mutations per megabase bTMB-H and tTMB-H are not mutually exclusive | All treated participants with on-treatment laboratory measures by TMB-H status | Posted | Count of Participants | Participants | From first dose to 30 days post last dose (Up to 25 months) |
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SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
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 | Arm A: Nivolumab+Ipilimumab | Nivolumab 240 mg every 2 weeks (Q2W) + Ipilimumab 1 mg/kg every 6 weeks (Q6W) up to 24 months | 97 | 136 | 90 | 135 | 121 | 135 |
| EG001 | Arm B: Nivolumab | Nivolumab Monotherapy 480 mg every 4 weeks (Q4W) up to 24 months | 42 | 76 | 39 | 76 | 64 | 76 |
| EG002 | Arm B: Nivolumab+Ipilimumab (Rollover) | Nivolumab 240 mg every 2 weeks (Q2W) + Ipilimumab 1 mg/kg every 6 weeks (Q6W) | 20 | 22 | 11 | 22 | 13 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 26.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | 26.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | 26.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | 26.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | 26.0 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | 26.0 | Systematic Assessment |
| |
| Pericarditis malignant | Cardiac disorders | 26.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | 26.0 | Systematic Assessment |
| |
| Adrenocortical insufficiency acute | Endocrine disorders | 26.0 | Systematic Assessment |
| |
| Adrenocorticotropic hormone deficiency | Endocrine disorders | 26.0 | Systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | 26.0 | Systematic Assessment |
| |
| Hypopituitarism | Endocrine disorders | 26.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | 26.0 | Systematic Assessment |
| |
| Secondary adrenocortical insufficiency | Endocrine disorders | 26.0 | Systematic Assessment |
| |
| Thyroiditis | Endocrine disorders | 26.0 | Systematic Assessment |
| |
| Abdominal adhesions | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Gastric perforation | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Large intestinal stenosis | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Pancreatitis chronic | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Death | General disorders | 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 26.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | 26.0 | Systematic Assessment |
| |
| Hyperpyrexia | General disorders | 26.0 | Systematic Assessment |
| |
| Malaise | General disorders | 26.0 | Systematic Assessment |
| |
| Pain | General disorders | 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 26.0 | Systematic Assessment |
| |
| Sudden death | General disorders | 26.0 | Systematic Assessment |
| |
| Biliary obstruction | Hepatobiliary disorders | 26.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | 26.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | 26.0 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | 26.0 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | 26.0 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Lymph gland infection | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Pelvic inflammatory disease | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Prostate infection | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | 26.0 | Systematic Assessment |
| |
| Urinary tract injury | Injury, poisoning and procedural complications | 26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 26.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | 26.0 | Systematic Assessment |
| |
| Urine output decreased | Investigations | 26.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 26.0 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 26.0 | Systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 26.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 26.0 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Device occlusion | Product Issues | 26.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | 26.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 26.0 | Systematic Assessment |
| |
| Obstructive nephropathy | Renal and urinary disorders | 26.0 | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | 26.0 | Systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | 26.0 | Systematic Assessment |
| |
| Female genital tract fistula | Reproductive system and breast disorders | 26.0 | Systematic Assessment |
| |
| Uterine fistula | Reproductive system and breast disorders | 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 26.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | 26.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | 26.0 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | 26.0 | Systematic Assessment |
| |
| Pelvic venous thrombosis | Vascular disorders | 26.0 | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 26.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | 26.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 26.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | 26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 26.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | 26.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | 26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 26.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | 26.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | 26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | 26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 26.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 26.0 | 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 |
| Apr 24, 2023 |
| Prot_SAP_000.pdf |
| 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
| Death |
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| Adverse Event unrelated to Study drug |
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| Withdrawal by Subject |
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| Participant request to discontinue study treatment |
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| Maximum Clinical Benefit |
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| Participants completed treatment |
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| Other reasons |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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Nivolumab Monotherapy 480 mg every 4 weeks (Q4W) up to 24 months
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Nivolumab Monotherapy 480 mg every 4 weeks (Q4W) up to 24 months
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Nivolumab Monotherapy 480 mg every 4 weeks (Q4W) up to 24 months
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Nivolumab Monotherapy 480 mg every 4 weeks (Q4W) up to 24 months
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| Participants |
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