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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001230-34 | EudraCT Number | ||
| U1111-1229-8927 | Other Identifier | UTN Number |
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The purpose of this study is to determine the effectiveness of nivolumab adjuvant immunotherapy compared to placebo in adults and pediatric participants after complete resection of Stage IIB/C melanoma with no evidence of disease (NED) who are at high risk for recurrence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nivolumab | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Biological | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence Free Survival (RFS) | Recurrence Free Survival (RFS) is defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma (including melanoma in situ), or death (whatever the cause), whichever occurs first. For participants who remain alive and whose disease has not recurred or did not die, RFS will be censored on the date of last evaluable disease assessment. For those participants who remained alive and had no recorded post-randomization tumor assessment, RFS will be censored on the day of randomization. | From randomization up to the date of first recurrence, new primary melanoma, or death (whatever the cause), whichever occurs first (up to 32 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Distant Metastasis-Free Survival (DMFS) | Investigator-assessed distant metastasis-free survival (DMFS) is defined as the time between the date of randomization and the date of first distant metastasis or date of death (whatever the cause), whichever occurs first. Participants with no baseline disease assessment, no on-study disease assessments and no death, and no distant metastasis and no death will be censored. Participants with no baseline disease assessment and no on-study disease assessments and death are censored on the date of randomization. Participants with no recurrence and no death will be censored on the date of their last evaluable disease assessment. |
Not provided
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 |
|---|---|---|---|---|---|---|
| Local Institution - 0088 | Birmingham | Alabama | 35294-3300 | United States | ||
| Local Institution - 0126 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40139004 | Derived | Kirkwood JM, Mohr P, Hoeller C, Grob JJ, Del Vecchio M, Lord-Bessen J, Srinivasan S, Nassar A, Campigotto F, Fairbanks H, Taylor F, Lawrance R, Long GV, Weber J. Patient-reported outcomes with adjuvant nivolumab versus placebo after complete resection of stage IIB/C melanoma in the randomized phase 3 CheckMate 76 K trial. Eur J Cancer. 2025 May 2;220:115371. doi: 10.1016/j.ejca.2025.115371. Epub 2025 Mar 19. | |
| 37845511 |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
Not provided
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
See Plan Description
See Plan Description
980 participants were screened, of which 790 participants were randomized (526 nivolumab/264 placebo) into the study and 788 received either the Nivolumab treatment (524 participants) or placebo (264 participants). 30 eligible participants (2 from the Nivolumab treatment arm and 28 from the placebo arm) received open-label Nivolumab treatment during an optional open-label phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nivolumab | Participants received 480 mg IV Nivolumab in an approximately 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, recurrence/progression, withdrawal of consent, completion of 12 months of treatment from first dose of open-label study treatment, whichever occurred first. |
| FG001 |
| 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 | Apr 28, 2022 |
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| Placebo | Other | Specified dose on specified days |
|
| From randomization up to the date of first distant metastasis or date of death (whatever the cause), whichever occurs first (up to approximately 32 months) |
| Duration of Treatment on Next Line Therapy Per Investigator Assessment | Duration of treatment is an investigator-assessed outcome of next-line therapy (NLT) defined as the time from first dose date of NLT to last dose date of NLT. Participants who did not stop the NLT were censored. | From first dose date of next-line therapy to last dose date of next-line therapy (up to approximately 32 months) |
| Progression-Free Survival Through Next-Line Therapy | Progression-free survival through next-line therapy (PFS2) is defined as the time from randomization to recurrence/objective disease progression after the start of the next-line of systemic anti-cancer therapy, or to the start of a second next-line systemic therapy, or to death from any cause, whichever occurs first. Participants who did not receive subsequent systemic anti-cancer therapy who died will be considered as having the event on the date of death. Participants who received subsequent systemic anti-cancer therapy who had a disease progression after the start of therapy will be considered as having the event on the date of disease progression. Participants who died or started second next-line therapy, the date of death or start date of second next-line therapy will be the event date, whichever is earlier. Participants who did not experience disease progression, death, or second next-line therapy will be censored on the last known alive date. | From randomization to recurrence/objective disease progression after the start of the next-line therapy, or to the start of a second next-line systemic therapy, or to death from any cause, whichever occurs first (up to approximately 32 months) |
| Number of Participants Experiencing Adverse Events (AEs) | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal. | From first dose up to 30 days post last dose of the blinded phase (up to 13 months) |
| Number of Participants Experiencing Adverse Events Leading to Discontinuation | An Adverse Event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. | From first dose up to 30 days post last dose of the blinded phase (up to 13 months) |
| Number of Participants Experiencing Select Adverse Events | The number of participants experiencing all-cause select adverse events (AEs). An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. | From first dose up to 30 days post last dose of the blinded phase (up to 13 months) |
| Number of Participants Experiencing Serious Adverse Events (SAEs) | A Serious Adverse Events (SAE) is defined as any untoward or unfavorable medical occurrence in a participants that results in death, is life threatening, or places the participant at immediate risk of death from the event as it occurred, requires or prolongs hospitalization, causes persistent or significant disability or incapacity, results in congenital anomalies or birth defects, and is another condition which investigators judge to represent significant hazards. | From first dose up to 30 days post last dose of the blinded phase (up to 13 months) |
| Number of Participants Experiencing Death | All study participants who died during the blinded phase of the study following treatment. | From first dose up to 30 days post last dose of the blinded phase (up to 13 months) |
| Number of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities in Selected Hematology Parameters | The number of participants experiencing Grade 3 or 4 laboratory abnormalities in the specific pre-determined hematology tests. | From first dose up to 30 days post last dose of the blinded phase (up to 13 months) |
| Number of Participants Experiencing Laboratory Abnormalities in Selected Liver Parameters | The number of participants experiencing laboratory abnormalities in the specific pre-determined liver tests. | From first dose up to 30 days post last dose of the blinded phase (up to 13 months) |
| Overall Survival (OS) | OS is defined as the time between the date of randomization and the date of death. For those without documentation of death, OS will be censored on the last date the participant was known to be alive. | From randomization up to the date of death or the last date the participant was known to be alive |
| Tucson |
| Arizona |
| 85724-5024 |
| United States |
| Local Institution - 0087 | Springdale | Arkansas | 72762 | United States |
| Local Institution - 0080 | Los Angeles | California | 90025 | United States |
| Local Institution - 0077 | San Francisco | California | 94115 | United States |
| Local Institution - 0119 | San Francisco | California | 94115 | United States |
| Local Institution - 0122 | San Jose | California | 95119 | United States |
| Local Institution - 0121 | Vallejo | California | 94589-2441 | United States |
| Local Institution - 0109 | Vallejo | California | 94589 | United States |
| Local Institution - 0120 | Vallejo | California | 94589 | United States |
| Local Institution - 0091 | Aurora | Colorado | 80045 | United States |
| Local Institution - 0089 | Washington D.C. | District of Columbia | 20057 | United States |
| Local Institution - 0141 | Atlanta | Georgia | 30342 | United States |
| Local Institution - 0132 | Chicago | Illinois | 60611 | United States |
| Local Institution - 0135 | Baltimore | Maryland | 21237 | United States |
| Local Institution - 0078 | Boston | Massachusetts | 02215 | United States |
| Local Institution - 0127 | Boston | Massachusetts | 02215 | United States |
| Local Institution - 0143 | Boston | Massachusetts | 02215 | United States |
| Local Institution - 0151 | Minneapolis | Minnesota | 55407 | United States |
| Local Institution - 0081 | Robbinsdale | Minnesota | 55407 | United States |
| Local Institution - 0079 | Omaha | Nebraska | 68130 | United States |
| Local Institution - 0093 | Hackensack | New Jersey | 07601 | United States |
| Local Institution - 0094 | New York | New York | 10016 | United States |
| Local Institution - 0086 | Charlotte | North Carolina | 28204 | United States |
| Local Institution - 0099 | Cleveland | Ohio | 44195 | United States |
| Local Institution - 0076 | Portland | Oregon | 97213 | United States |
| Local Institution - 0092 | Allentown | Pennsylvania | 18103 | United States |
| Local Institution - 0031 | Pittsburgh | Pennsylvania | 15232 | United States |
| Local Institution - 0148 | Germantown | Tennessee | 38138 | United States |
| Local Institution - 0144 | Austin | Texas | 78731 | United States |
| Local Institution - 0085 | Dallas | Texas | 75246 | United States |
| Local Institution - 0090 | Fairfax | Virginia | 22031 | United States |
| Local Institution - 0018 | Waratah | New South Wales | 2298 | Australia |
| Local Institution - 0025 | Westmead | New South Wales | 2145 | Australia |
| Local Institution - 0016 | Wollstonecraft | New South Wales | 2065 | Australia |
| Local Institution - 0105 | Cairns | Queensland | 4870 | Australia |
| Local Institution - 0017 | Greenslopes | Queensland | 4120 | Australia |
| Local Institution - 0024 | Herston | Queensland | 4029 | Australia |
| Local Institution - 0138 | Southport | Queensland | 4120 | Australia |
| Local Institution - 0019 | Box Hill | Victoria | 3128 | Australia |
| Local Institution - 0125 | Geelong | Victoria | 3220 | Australia |
| Local Institution - 0128 | Malvern | Victoria | 3144 | Australia |
| Local Institution - 0106 | Melbourne | Victoria | 3004 | Australia |
| Local Institution - 0104 | Nedlands | Western Australia | 6009 | Australia |
| Local Institution - 0049 | Graz | 8036 | Austria |
| Local Institution - 0051 | Innsbruck | 6020 | Austria |
| Local Institution - 0050 | Salzburg | 5020 | Austria |
| Local Institution - 0048 | Vienna | 1090 | Austria |
| Local Institution - 0028 | Charleroi | 6000 | Belgium |
| Local Institution - 0011 | Ghent | 9000 | Belgium |
| Local Institution - 0008 | Kortrijk | 8500 | Belgium |
| Local Institution - 0010 | Liège | 4000 | Belgium |
| Local Institution - 0134 | Calgary | Alberta | T2N 4N2 | Canada |
| Local Institution - 0133 | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Local Institution - 0131 | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Local Institution - 0142 | Hamilton | Ontario | L8V 5C2 | Canada |
| Local Institution - 0124 | Kingston | Ontario | K7L 2V7 | Canada |
| Local Institution - 0140 | Toronto | Ontario | M5G 2M9 | Canada |
| Local Institution - 0116 | Montreal | Quebec | H2X 3E4 | Canada |
| Local Institution - 0123 | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Local Institution - 0074 | Prague | Praha 2 | 12808 | Czechia |
| Local Institution - 0075 | Ostrava-Poruba | 708 52 | Czechia |
| Local Institution - 0073 | Prague | 100 34 | Czechia |
| Local Institution - 0007 | Aarhus N | 8200 | Denmark |
| Local Institution - 0012 | Herlev | 2730 | Denmark |
| Local Institution - 0013 | Odense | 5000 | Denmark |
| Local Institution - 0014 | Helsinki | Etelä-Suomen Lääni | 00290 | Finland |
| Local Institution - 0015 | Tampere | Pirkanmaa | 33520 | Finland |
| Local Institution - 0110 | Turku | 20251 | Finland |
| Local Institution - 0113 | Brest | Finistère | 29200 | France |
| Local Institution - 0129 | Besançon | 25030 | France |
| Local Institution - 0112 | Bordeaux | 33075 | France |
| Local Institution - 0111 | Lille | 59037 | France |
| Local Institution - 0033 | Marseille | 13011 | France |
| Local Institution - 0035 | Nantes | 44000 | France |
| Local Institution - 0130 | Nice | 06200 | France |
| Local Institution - 0036 | Paris | 75475 | France |
| Local Institution - 0032 | Pierre-Bénite | 69495 | France |
| Local Institution - 0034 | Villejuif | 94800 | France |
| Local Institution - 0056 | München | Bavaria | 81377 | Germany |
| Local Institution - 0072 | Bonn | 53127 | Germany |
| Local Institution - 0061 | Buxtehude | 21614 | Germany |
| Local Institution - 0098 | Dresden | 01307 | Germany |
| Local Institution - 0054 | Essen | 45122 | Germany |
| Local Institution - 0062 | Gera | 07548 | Germany |
| Local Institution - 0114 | Göttingen | 37075 | Germany |
| Local Institution - 0060 | Hanover | 30625 | Germany |
| Local Institution - 0055 | Heidelberg | 69120 | Germany |
| Local Institution - 0057 | Lübeck | 23538 | Germany |
| Local Institution - 0100 | Mainz | 55131 | Germany |
| Local Institution - 0102 | Regensburg | 93053 | Germany |
| Local Institution - 0058 | Tübingen | 72076 | Germany |
| Local Institution - 0084 | Athens | Attikà | 185 47 | Greece |
| Local Institution - 0082 | Athens | 115 27 | Greece |
| Local Institution - 0083 | Thessaloniki | 57100 | Greece |
| Local Institution - 0046 | Palermo | Sicily | 90127 | Italy |
| Local Institution - 0040 | Bergamo | 24127 | Italy |
| Local Institution - 0037 | Milan | 20133 | Italy |
| Local Institution - 0146 | Milan | 20141 | Italy |
| Local Institution - 0101 | Naples | 80131 | Italy |
| Local Institution - 0039 | Padova | 35128 | Italy |
| Local Institution - 0145 | Perugia | 06132 | Italy |
| Local Institution - 0038 | Siena | 53100 | Italy |
| Local Institution - 0107 | Breda | 4819 EV | Netherlands |
| Local Institution - 0001 | Groningen | 9700RB | Netherlands |
| Local Institution - 0030 | Rotterdam | 3015 AA | Netherlands |
| Local Institution - 0002 | Utrecht | 3584 CX | Netherlands |
| Local Institution - 0063 | Bergen | 5021 | Norway |
| Local Institution - 0027 | Grålum | 1714 | Norway |
| Local Institution - 0005 | Oslo | 0310 | Norway |
| Local Institution - 0103 | Poznan | Greater Poland Voivodeship | 60-569 | Poland |
| Local Institution - 0023 | Gdansk | 80-214 | Poland |
| Local Institution - 0022 | Warsaw | 02-781 | Poland |
| Local Institution - 0047 | Cluj-Napoca | 400015 | Romania |
| Local Institution - 0020 | Craiova | 200542 | Romania |
| Local Institution - 0021 | Sector 2 | 022328 | Romania |
| Local Institution - 0071 | Barcelona | Barcelona [Barcelona] | 08028 | Spain |
| Local Institution - 0067 | A Coruña | 15006 | Spain |
| Local Institution - 0065 | Badalona | 08916 | Spain |
| Local Institution - 0066 | Madrid | 28034 | Spain |
| Local Institution - 0070 | Madrid | 28046 | Spain |
| Local Institution - 0068 | Málaga | 29010 | Spain |
| Local Institution - 0064 | Santander | 39008 | Spain |
| Local Institution - 0069 | Valencia | 46009 | Spain |
| Local Institution - 0026 | Örebro | 701 85 | Sweden |
| Local Institution - 0003 | Linköping | Östergötlands Län [se-05] | 581 85 | Sweden |
| Local Institution - 0053 | Lausanne | 1011 | Switzerland |
| Local Institution - 0052 | Zurich | 8091 | Switzerland |
| Local Institution - 0044 | Cardiff | CF14 2TL | United Kingdom |
| Local Institution - 0095 | Southampton | SO16 6YD | United Kingdom |
| Derived |
| Kirkwood JM, Del Vecchio M, Weber J, Hoeller C, Grob JJ, Mohr P, Loquai C, Dutriaux C, Chiarion-Sileni V, Mackiewicz J, Rutkowski P, Arenberger P, Quereux G, Meniawy TM, Ascierto PA, Menzies AM, Durani P, Lobo M, Campigotto F, Gastman B, Long GV. Adjuvant nivolumab in resected stage IIB/C melanoma: primary results from the randomized, phase 3 CheckMate 76K trial. Nat Med. 2023 Nov;29(11):2835-2843. doi: 10.1038/s41591-023-02583-2. Epub 2023 Oct 16. |
| BMS Clinical Trial Patient Recruiting | View source |
| Placebo |
Nivolumab matched placebo (0.9% Sodium Chloride for Injection/5% Dextrose for Injection) IV in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first. In the event of disease recurrence, participants on the blinded nivolumab or placebo portion will be offered the option to receive open-label on-protocol nivolumab treatment. Participants received 480 mg IV Nivolumab in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, recurrence/progression, withdrawal of consent, completion of 12 months of treatment from first dose of open-label study treatment, whichever occurred first. |
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| COMPLETED | Completed=treated |
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| NOT COMPLETED |
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| Blinded Treatment Phase |
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| Optional Open-Label Phase Pre-Treatment |
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| Optional Open-Label Phase Treatment |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Nivolumab | Participants received 480 mg IV Nivolumab in an approximately 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first. Participants began study treatment (Cycle 1) within 3 calendar days of randomization. Subsequent cycles were initiated within ± 3 days of the target visit date. |
| BG001 | Placebo | Nivolumab matched placebo (0.9% Sodium Chloride for Injection/5% Dextrose for Injection) IV in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first. In the event of disease recurrence, participants on the blinded nivolumab or placebo portion will be offered the option to receive open-label on-protocol nivolumab treatment. Participants received 480 mg IV Nivolumab in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, recurrence/progression, withdrawal of consent, completion of 12 months of treatment from first dose of open-label study treatment, whichever occurred first. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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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 | Recurrence Free Survival (RFS) | Recurrence Free Survival (RFS) is defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma (including melanoma in situ), or death (whatever the cause), whichever occurs first. For participants who remain alive and whose disease has not recurred or did not die, RFS will be censored on the date of last evaluable disease assessment. For those participants who remained alive and had no recorded post-randomization tumor assessment, RFS will be censored on the day of randomization. | All randomized participants | Posted | Median | 95% Confidence Interval | Months | From randomization up to the date of first recurrence, new primary melanoma, or death (whatever the cause), whichever occurs first (up to 32 months) |
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| Secondary | Distant Metastasis-Free Survival (DMFS) | Investigator-assessed distant metastasis-free survival (DMFS) is defined as the time between the date of randomization and the date of first distant metastasis or date of death (whatever the cause), whichever occurs first. Participants with no baseline disease assessment, no on-study disease assessments and no death, and no distant metastasis and no death will be censored. Participants with no baseline disease assessment and no on-study disease assessments and death are censored on the date of randomization. Participants with no recurrence and no death will be censored on the date of their last evaluable disease assessment. | All randomized participants | Posted | Median | 95% Confidence Interval | Months | From randomization up to the date of first distant metastasis or date of death (whatever the cause), whichever occurs first (up to approximately 32 months) |
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| Secondary | Duration of Treatment on Next Line Therapy Per Investigator Assessment | Duration of treatment is an investigator-assessed outcome of next-line therapy (NLT) defined as the time from first dose date of NLT to last dose date of NLT. Participants who did not stop the NLT were censored. | All randomized participants | Posted | Median | 95% Confidence Interval | Months | From first dose date of next-line therapy to last dose date of next-line therapy (up to approximately 32 months) |
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| Secondary | Progression-Free Survival Through Next-Line Therapy | Progression-free survival through next-line therapy (PFS2) is defined as the time from randomization to recurrence/objective disease progression after the start of the next-line of systemic anti-cancer therapy, or to the start of a second next-line systemic therapy, or to death from any cause, whichever occurs first. Participants who did not receive subsequent systemic anti-cancer therapy who died will be considered as having the event on the date of death. Participants who received subsequent systemic anti-cancer therapy who had a disease progression after the start of therapy will be considered as having the event on the date of disease progression. Participants who died or started second next-line therapy, the date of death or start date of second next-line therapy will be the event date, whichever is earlier. Participants who did not experience disease progression, death, or second next-line therapy will be censored on the last known alive date. | All randomized participants | Posted | Median | 95% Confidence Interval | Months | From randomization to recurrence/objective disease progression after the start of the next-line therapy, or to the start of a second next-line systemic therapy, or to death from any cause, whichever occurs first (up to approximately 32 months) |
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| Secondary | Number of Participants Experiencing Adverse Events (AEs) | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal. | All treated participants | Posted | Count of Participants | Participants | From first dose up to 30 days post last dose of the blinded phase (up to 13 months) |
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| Secondary | Number of Participants Experiencing Adverse Events Leading to Discontinuation | An Adverse Event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. | All treated participants | Posted | Count of Participants | Participants | From first dose up to 30 days post last dose of the blinded phase (up to 13 months) |
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| Secondary | Number of Participants Experiencing Select Adverse Events | The number of participants experiencing all-cause select adverse events (AEs). An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. | All treated participants | Posted | Count of Participants | Participants | From first dose up to 30 days post last dose of the blinded phase (up to 13 months) |
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| Secondary | Number of Participants Experiencing Serious Adverse Events (SAEs) | A Serious Adverse Events (SAE) is defined as any untoward or unfavorable medical occurrence in a participants that results in death, is life threatening, or places the participant at immediate risk of death from the event as it occurred, requires or prolongs hospitalization, causes persistent or significant disability or incapacity, results in congenital anomalies or birth defects, and is another condition which investigators judge to represent significant hazards. | All treated participants | Posted | Count of Participants | Participants | From first dose up to 30 days post last dose of the blinded phase (up to 13 months) |
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| Secondary | Number of Participants Experiencing Death | All study participants who died during the blinded phase of the study following treatment. | All treated participants | Posted | Count of Participants | Participants | From first dose up to 30 days post last dose of the blinded phase (up to 13 months) |
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| Secondary | Number of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities in Selected Hematology Parameters | The number of participants experiencing Grade 3 or 4 laboratory abnormalities in the specific pre-determined hematology tests. | Participants with at least one on-treatment measurement of the corresponding laboratory parameter | Posted | Count of Participants | Participants | From first dose up to 30 days post last dose of the blinded phase (up to 13 months) |
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| Secondary | Number of Participants Experiencing Laboratory Abnormalities in Selected Liver Parameters | The number of participants experiencing laboratory abnormalities in the specific pre-determined liver tests. | Participants with at least one on-treatment measurement of the corresponding laboratory parameter | Posted | Count of Participants | Participants | From first dose up to 30 days post last dose of the blinded phase (up to 13 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. For those without documentation of death, OS will be censored on the last date the participant was known to be alive. | Not Posted | Jun 2028 | From randomization up to the date of death or the last date the participant was known to be alive | Participants |
Participants were assessed for all-cause mortality from their randomization to primary completion, (up to approximately 32 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 32 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 | Nivolumab | Participants received 480 mg IV Nivolumab in an approximately 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first. Participants began study treatment (Cycle 1) within 3 calendar days of randomization. Subsequent cycles were initiated within ± 3 days of the target visit date. | 14 | 526 | 95 | 524 | 464 | 524 |
| EG001 | Placebo | Nivolumab matched placebo (0.9% Sodium Chloride for Injection/5% Dextrose for Injection) IV in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first. | 8 | 264 | 37 | 264 | 194 | 264 |
| EG002 | Open-Label Nivolumab | In the event of disease recurrence, participants on the blinded nivolumab or placebo portion will be offered the option to receive open-label on-protocol nivolumab treatment. Participants received 480 mg IV Nivolumab in an approximately 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, recurrence/progression, withdrawal of consent, completion of 12 months of treatment from first dose of open-label study treatment, whichever occurred first. | 2 | 32 | 5 | 30 | 20 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 25.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 25.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | 25.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | 25.0 | Systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | 25.0 | Systematic Assessment |
| |
| Hypopituitarism | Endocrine disorders | 25.0 | Systematic Assessment |
| |
| Lymphocytic hypophysitis | Endocrine disorders | 25.0 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | 25.0 | Systematic Assessment |
| |
| Uveitis | Eye disorders | 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Autoimmune colitis | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Autoimmune enteropathy | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Autoimmune pancreatitis | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Volvulus | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | 25.0 | Systematic Assessment |
| |
| Generalised oedema | General disorders | 25.0 | Systematic Assessment |
| |
| Impaired healing | General disorders | 25.0 | Systematic Assessment |
| |
| Malaise | General disorders | 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 25.0 | Systematic Assessment |
| |
| Sudden death | General disorders | 25.0 | Systematic Assessment |
| |
| Autoimmune hepatitis | Hepatobiliary disorders | 25.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | 25.0 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | 25.0 | Systematic Assessment |
| |
| Contrast media allergy | Immune system disorders | 25.0 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Breast cellulitis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Herpes simplex encephalitis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Infected lymphocele | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Infected seroma | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Infective keratitis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Tendon injury | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 25.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 25.0 | Systematic Assessment |
| |
| Hepatic enzyme abnormal | Investigations | 25.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | 25.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | 25.0 | Systematic Assessment |
| |
| Troponin increased | Investigations | 25.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Ketoacidosis | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Protein deficiency | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Steroid diabetes | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Autoimmune myositis | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Bone lesion | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Immune-mediated myositis | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Osteolysis | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | Systematic Assessment |
| |
| Invasive breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | Systematic Assessment |
| |
| Lentigo maligna | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | Systematic Assessment |
| |
| Melanoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | Systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | Systematic Assessment |
| |
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | Systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | Systematic Assessment |
| |
| Vascular neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | Systematic Assessment |
| |
| Cerebrovascular disorder | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | 25.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 25.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | 25.0 | Systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | 25.0 | Systematic Assessment |
| |
| Nephritis allergic | Renal and urinary disorders | 25.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | 25.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | 25.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | 25.0 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | 25.0 | Systematic Assessment |
| |
| Ovarian hyperstimulation syndrome | Reproductive system and breast disorders | 25.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | 25.0 | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | 25.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | 25.0 | Systematic Assessment |
| |
| Hypertensive urgency | Vascular disorders | 25.0 | Systematic Assessment |
| |
| Lymphocele | Vascular disorders | 25.0 | Systematic Assessment |
| |
| Peripheral artery aneurysm | Vascular disorders | 25.0 | Systematic Assessment |
| |
| Vasculitis | Vascular disorders | 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperthyroidism | Endocrine disorders | 25.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Asthenia | General disorders | 25.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 25.0 | Systematic Assessment |
| |
| Pain | General disorders | 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 25.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 25.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | 25.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | 25.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | 25.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | 25.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 25.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | 25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 25.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 25.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 25.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | 25.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 25.0 | 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 |
| Jun 26, 2023 |
| Prot_SAP_000.pdf |
Not provided
| 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 |
| 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 |
|
| Study drug toxicity |
|
| Participant no longer meets study criteria |
|
| Lost to Follow-up |
|
| Death |
|
| Withdrawal by Subject |
|
| Participant request to discontinue study treatment |
|
| Ongoing treatment |
|
| Maximum clinical benefit |
|
| Study drug toxicity |
|
| Ongoing treatment |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
| OG001 | Placebo | Nivolumab matched placebo (0.9% Sodium Chloride for Injection/5% Dextrose for Injection) IV in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first. In the event of disease recurrence, participants on the blinded nivolumab or placebo portion will be offered the option to receive open-label on-protocol nivolumab treatment. Participants received 480 mg IV Nivolumab in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, recurrence/progression, withdrawal of consent, completion of 12 months of treatment from first dose of open-label study treatment, whichever occurred first. |
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