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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001645-64 | EudraCT Number |
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A study in patients with metastatic or recurrent squamous cell cancer of the head and neck to evaluate the effectiveness of Nivolumab plus Ipilumumab vs. Nivolumab alone (CheckMate 714)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nivolumab and Ipilimumab | Experimental | Specified dose on specified days |
|
| Nivolumab and Ipilimumab-placebo | Active Comparator | Specified dose on specified days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Biological |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup | ORR is defined as best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | Approximately up to 30 months (from FPFV to Data base lock) |
| Duration of Response (DOR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup | The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first. | Approximately up to 30 months (from FPFV to Data base lock) |
| Time to Response (TTR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup | Time to Response (TTR) for participants demonstrating a response (either CR or PR) was defined as the time from the date of randomization to the date of the first confirmed response. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | Approximately up to 30 months (from FPFV to Data base lock) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup | ORR is defined as percentage of participants with a complete response (CR) or partial response (PR). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
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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 |
|---|---|---|---|---|---|---|
| University of Arizona Cancer Center | Tucson | Arizona | 85724-5024 | United States | ||
| Local Institution - 0034 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37022706 | Derived | Harrington KJ, Ferris RL, Gillison M, Tahara M, Argiris A, Fayette J, Schenker M, Bratland A, Walker JWT, Grell P, Even C, Chung CH, Redman R, Coutte A, Salas S, Grant C, de Azevedo S, Soulieres D, Hansen AR, Wei L, Khan TA, Miller-Moslin K, Roberts M, Haddad R. Efficacy and Safety of Nivolumab Plus Ipilimumab vs Nivolumab Alone for Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck: The Phase 2 CheckMate 714 Randomized Clinical Trial. JAMA Oncol. 2023 Jun 1;9(6):779-789. doi: 10.1001/jamaoncol.2023.0147. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
Not provided
425 randomized and 423 participants treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment A - Platinum Refractory Subgroup | Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Randomization |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 25, 2018 | Sep 27, 2021 |
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| Ipilimumab |
| Biological |
|
| Placebo | Other |
|
| From randomization to end of study. Approximately 63 Months |
| Duration of Response (DOR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup | The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first. | From randomization to disease progression or death. Approximately 63 Months |
| Progression Free Survival (PFS) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup | The time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | From randomization to disease progression or death. Approximately 63 Months |
| Progression Free Survival (PFS) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup | the time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | From randomization to disease progression or death. Approximately 63 Months |
| Overall Survival (OS) | Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. | From randomization to death. Approximately 63 Months |
| Overall Survival (OS) - Platinum Refractory Subgroup | Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. | From randomization to death. Approximately 63 Months |
| Overall Survival (OS) - Platinum Eligible Subgroup | Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. | From randomization to death. Approximately 63 Months |
| ORR - Platinum Eligible Subgroup Based on HPV p-16 Status | ORR is defined as the best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | From randomization to end of study. Approximately 63 Months |
| ORR - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Biomarker | ORR is defined as the best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group. Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | From randomization to end of study. Approximately 63 Months |
| ORR - Platinum Refractory Subgroup Based on HPV p-16 Status | ORR is defined as the best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | From randomization to end of study. Approximately 63 Months |
| ORR - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Biomarker | ORR is defined as the best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group. Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | From randomization to end of study. Approximately 63 Months |
| Duration of Response (DOR) - Platinum Refractory Subgroup Based on HPV p-16 Status | The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first. | From randomization to disease progression or death. Approximately 63 Months |
| Duration of Response (DOR) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status | The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first. Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb | From randomization to disease progression or death. Approximately 63 Months |
| Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on HPV p-16 Status | the time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | From randomization to disease progression or death. Approximately 63 Months |
| Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status | the time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first. Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | From randomization to disease progression or death. Approximately 63 Months |
| Overall Survival (OS) - Platinum Refractory Subgroup Based on HPV p-16 Status | Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. | From randomization to death. Approximately 63 Months |
| Overall Survival (OS) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status | Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb | From randomization to death. Approximately 63 Months |
| Overall Survival (OS) - Platinum Eligible Subgroup Based on HPV p-16 Status | Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. | From randomization to death. Approximately 63 Months |
| Overall Survival (OS) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status | Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb | From randomization to death. Approximately 63 Months |
| Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status | the time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first. Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | From randomization to disease progression or death. Approximately 63 Months |
| Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on HPV p-16 Status | the time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | From randomization to disease progression or death. Approximately 63 Months |
| Duration of Response (DOR) - Platinum Eligible Subgroup Based on HPV p-16 Status | The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | From randomization to disease progression or death. Approximately 63 Months |
| Duration of Response (DOR) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status | The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first. Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | From randomization to disease progression or death. Approximately 63 Months |
| Duration of Response (DOR) - Platinum Refractory Subgroup Based on PD-L1 Status | The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | From randomization to disease progression or death. Approximately 63 Months |
| ORR - Platinum Refractory Subgroup Based on PD-L1 Expression | ORR is defined as the best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | From randomization to end of study. Approximately 63 Months |
| Overall Survival (OS) - Platinum Refractory Subgroup Based on PD-L1 Status | Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay | From randomization to death. Approximately 63 Months |
| Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on PD-L1 Status | The time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | From randomization to disease progression or death. Approximately 63 Months |
| Duration of Response (DOR) - Platinum Eligible Subgroup Based on PD-L1 Status | The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | From randomization to disease progression or death. Approximately 63 Months |
| ORR - Platinum Eligible Subgroup Based on PD-L1 Expression | ORR is defined as the best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | From randomization to end of study. Approximately 63 Months |
| Overall Survival (OS) - Platinum Eligible Subgroup Based on PD-L1 Status | Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay | From randomization to death. Approximately 63 Months |
| Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on PD-L1 Status | The time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | From randomization to disease progression or death. Approximately 63 Months |
| Duarte |
| California |
| 91010 |
| United States |
| Los Angeles Cancer Network | Los Angeles | California | 90017 | United States |
| Ucla Department Of Medicine | Los Angeles | California | 90095 | United States |
| Local Institution - 0098 | Redondo Beach | California | 90277 | United States |
| Local Institution - 0004 | Sacramento | California | 95816 | United States |
| Local Institution - 0072 | San Francisco | California | 94158 | United States |
| Local Institution - 0097 | San Luis Obispo | California | 93401 | United States |
| Central Coast Med Oncology | Santa Maria | California | 93454 | United States |
| Local Institution - 0101 | New Haven | Connecticut | 06520 | United States |
| Local Institution - 0007 | Tampa | Florida | 33612 | United States |
| Local Institution - 0010 | Atlanta | Georgia | 30322 | United States |
| Local Institution - 0015 | Decatur | Georgia | 30033 | United States |
| Local Institution - 0087 | Chicago | Illinois | 60637 | United States |
| Ft. Wayne Med Onco-Hema Inc | Fort Wayne | Indiana | 46845 | United States |
| Local Institution - 0005 | Louisville | Kentucky | 40202 | United States |
| Oncology Associated Of Western Kentucky | Paducah | Kentucky | 42003 | United States |
| Local Institution - 0001 | Boston | Massachusetts | 02215 | United States |
| Local Institution - 0071 | Boston | Massachusetts | 02215 | United States |
| Local Institution - 0042 | Rochester | Minnesota | 55905 | United States |
| Mission Hospital, Inc | Asheville | North Carolina | 28801 | United States |
| Local Institution - 0103 | Cincinnati | Ohio | 45219 | United States |
| Local Institution - 0070 | Cleveland | Ohio | 44106 | United States |
| Local Institution - 0008 | Portland | Oregon | 97239 | United States |
| Local Institution - 0006 | Pittsburgh | Pennsylvania | 15232 | United States |
| Donald Guthrie Foundation | Sayre | Pennsylvania | 18840 | United States |
| Local Institution - 0102 | Dallas | Texas | 75390 | United States |
| Local Institution - 0038 | Seattle | Washington | 98109 | United States |
| Local Institution - 0121 | Pergamino | Buenos Aires | 0 | Argentina |
| Local Institution - 0111 | Buenos Aires | C1181ACH | Argentina |
| Local Institution - 0023 | Ghent | 9000 | Belgium |
| Local Institution - 0074 | Sint-Niklaas | 9100 | Belgium |
| Local Institution - 0053 | Yvoir | 5530 | Belgium |
| Local Institution - 0046 | Belo Horizonte | Minas Gerais | 30130-090 | Brazil |
| Local Institution - 0124 | Ipatinga | Minas Gerais | 35160-158 | Brazil |
| Local Institution - 0047 | Curitiba | Paraná | 81480-580 | Brazil |
| Local Institution - 0125 | Caxias do Sul | Rio Grande do Sul | 95070-560 | Brazil |
| Local Institution - 0051 | Ijuà | Rio Grande do Sul | 98700-000 | Brazil |
| Local Institution - 0052 | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Local Institution - 0045 | Barretos | São Paulo | 14784-400 | Brazil |
| Local Institution - 0123 | Santo André | São Paulo | 09060-870 | Brazil |
| Local Institution - 0048 | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| Local Institution | Rio de Janeiro | 20231-050 | Brazil |
| Local Institution - 0049 | São Paulo | 04039-004 | Brazil |
| Local Institution - 0050 | São Paulo | 05403-010 | Brazil |
| Local Institution - 0013 | Edmonton | Alberta | T6G 1Z2 | Canada |
| Local Institution - 0056 | Ottawa | Ontario | K1H 8L6 | Canada |
| Local Institution - 0012 | Toronto | Ontario | M5G 1Z5 | Canada |
| Local Institution - 0016 | Montreal | Quebec | H2X 3E4 | Canada |
| Local Institution - 0014 | Québec | Quebec | G1J 1Z4 | Canada |
| Local Institution - 0115 | Santiago | Santiago Metropolitan | Chile |
| Local Institution - 0022 | Brno | 656 53 | Czechia |
| Local Institution - 0020 | Hradec Králové | 500 05 | Czechia |
| Local Institution - 0021 | Olomouc | 779 00 | Czechia |
| Local Institution - 0069 | Helsinki | 00290 | Finland |
| Local Institution - 0032 | Amiens | 80054 | France |
| Local Institution - 0120 | Bordeaux | 33075 | France |
| Local Institution - 0073 | Clermont-Ferrand | 63011 | France |
| Local Institution - 0089 | Clichy | 92110 | France |
| Local Institution - 0029 | Lyon | 69373 | France |
| Local Institution - 0075 | Marseille | 13385 | France |
| Local Institution - 0079 | Nice | 06189 | France |
| Local Institution - 0030 | Rennes | 35042 | France |
| Local Institution - 0088 | Villejuif | 94805 | France |
| Local Institution - 0026 | Dublin | Dublin | Ireland |
| Local Institution | Milan | 20133 | Italy |
| Local Institution - 0119 | Naples | 80131 | Italy |
| Local Institution - 0090 | Mérida | Yucatán | 97070 | Mexico |
| Local Institution - 0107 | Mérida | Yucatán | 97138 | Mexico |
| Local Institution - 0108 | Oaxaca City | 68040 | Mexico |
| Local Institution - 0068 | Amsterdam | 1066 CX | Netherlands |
| Local Institution - 0028 | Amsterdam | 1081 HV | Netherlands |
| Local Institution - 0027 | Groningen | 9713 GZ | Netherlands |
| Local Institution - 0065 | Bergen | 5021 | Norway |
| Local Institution - 0064 | Oslo | 0379 | Norway |
| Local Institution - 0055 | Bucharest | 010991 | Romania |
| Local Institution - 0054 | Cluj-Napoca | 400015 | Romania |
| Local Institution - 0033 | Craiova | 200347 | Romania |
| Local Institution - 0060 | Iași | 700483 | Romania |
| Local Institution - 0059 | Suceava | 720237 | Romania |
| Local Institution - 0031 | Moscow | 121309 | Russia |
| Local Institution - 0092 | Ryazan | 390011 | Russia |
| Local Institution | Port Elizabeth | Eastern Cape | 6045 | South Africa |
| Local Institution | Pretoria | Gauteng | 0084 | South Africa |
| Local Institution - 0017 | Sandton | Gauteng | 2199 | South Africa |
| Local Institution | Cape Town | Western Cape | 7700 | South Africa |
| Local Institution - 0040 | A Coruña | 15009 | Spain |
| Local Institution - 0116 | Barcelona | 08035 | Spain |
| Local Institution - 0039 | Barcelona | 08036 | Spain |
| Local Institution - 0077 | Madrid | 28041 | Spain |
| Local Institution - 0076 | Marbella | 29603 | Spain |
| Local Institution - 0041 | San Sabastian Gipuzkoa | 20014 | Spain |
| Local Institution - 0067 | Gothenburg | 413 45 | Sweden |
| Local Institution - 0037 | Lund | 221 85 | Sweden |
| Local Institution - 0035 | Stockholm | 171 76 | Sweden |
| Local Institution - 0063 | Adana | 01250 | Turkey (Türkiye) |
| Local Institution - 0066 | Antalya | 07070 | Turkey (Türkiye) |
| Local Institution - 0062 | Izmir | 35340 | Turkey (Türkiye) |
| Local Institution - 0110 | Aberdeen | Aberdeenshire | AB25 2ZN | United Kingdom |
| Local Institution - 0086 | London | Greater London | SW3 6JJ | United Kingdom |
| Local Institution - 0083 | Metropolitan Borough of Wirral | Merseyside | L63 4JY | United Kingdom |
| Local Institution - 0081 | Sutton | Surrey | SM2 5PT | United Kingdom |
| Local Institution - 0114 | Cardiff | CF14 2TL | United Kingdom |
| Local Institution - 0084 | Glasgow | G12 0YN | United Kingdom |
| Local Institution - 0082 | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| BMS Clinical Trial Patient Recruiting | View source |
| FDA Safety Alerts and Recalls | View source |
| Treatment B - Platinum Refractory Subgroup |
Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W |
| FG002 | Treatment A - Platinum Eligible Subgroup | Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W |
| FG003 | Treatment B - Platinum Eligible Subgroup | Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W |
| COMPLETED | Continuing to Treatment Period |
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| NOT COMPLETED |
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| Treatment Period |
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All Randomized Participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment A - Platinum Refractory Subgroup | Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W |
| BG001 | Treatment B - Platinum Refractory Subgroup | Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W |
| BG002 | Treatment A - Platinum Eligible Subgroup | Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W |
| BG003 | Treatment B - Platinum Eligible Subgroup | Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W |
| BG004 | 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, Categorical | All Randomized Participants is the total of the 2 subgroups | Count of Participants | Participants |
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| Sex: Female, Male | All Randomized Participants is the total of the 2 subgroups | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | All Randomized Participants is the total of the 2 subgroups | Count of Participants | Participants |
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| Race (NIH/OMB) | All Randomized Participants is the total of the 2 subgroups | 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) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup | ORR is defined as best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | All Randomized Participants - Platinum Refractory Subgroup | Posted | Number | 95% Confidence Interval | percentage of participants | Approximately up to 30 months (from FPFV to Data base lock) |
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| Primary | Duration of Response (DOR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup | The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first. | Platinum Refractory Responders | Posted | Median | 95% Confidence Interval | Months | Approximately up to 30 months (from FPFV to Data base lock) |
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| Primary | Time to Response (TTR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup | Time to Response (TTR) for participants demonstrating a response (either CR or PR) was defined as the time from the date of randomization to the date of the first confirmed response. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | Platinum refractory responders | Posted | Median | Full Range | Months | Approximately up to 30 months (from FPFV to Data base lock) |
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| Secondary | Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup | ORR is defined as percentage of participants with a complete response (CR) or partial response (PR). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | All Randomized Participants - Platinum Eligible Subgroup | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to end of study. Approximately 63 Months |
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| Secondary | Duration of Response (DOR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup | The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first. | Platinum eligible subgroup responders | Posted | Median | 95% Confidence Interval | Months | From randomization to disease progression or death. Approximately 63 Months |
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| Secondary | Progression Free Survival (PFS) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup | The time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | Platinum Refractory subgroup all randomized | Posted | Median | 95% Confidence Interval | Months | From randomization to disease progression or death. Approximately 63 Months |
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| Secondary | Progression Free Survival (PFS) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup | the time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | Platinum Eligible subgroup all randomized | Posted | Median | 95% Confidence Interval | Months | From randomization to disease progression or death. Approximately 63 Months |
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| Secondary | Overall Survival (OS) | Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. | All Randomized Participants | Posted | Median | 95% Confidence Interval | Months | From randomization to death. Approximately 63 Months |
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| Secondary | Overall Survival (OS) - Platinum Refractory Subgroup | Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. | All Randomized Participants - Platinum Refractory Subgroup | Posted | Median | 95% Confidence Interval | Months | From randomization to death. Approximately 63 Months |
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| Secondary | Overall Survival (OS) - Platinum Eligible Subgroup | Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. | All Randomized Participants - Platinum Eligible Subgroup | Posted | Median | 95% Confidence Interval | Months | From randomization to death. Approximately 63 Months |
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| Secondary | ORR - Platinum Eligible Subgroup Based on HPV p-16 Status | ORR is defined as the best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | All Randomized Participants - Platinum Eligible Subgroup | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to end of study. Approximately 63 Months |
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| Secondary | ORR - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Biomarker | ORR is defined as the best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group. Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | All Randomized Participants - Platinum Eligible Subgroup | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to end of study. Approximately 63 Months |
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| Secondary | ORR - Platinum Refractory Subgroup Based on HPV p-16 Status | ORR is defined as the best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | All Randomized Participants - Platinum Refractory Subgroup | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to end of study. Approximately 63 Months |
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| Secondary | ORR - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Biomarker | ORR is defined as the best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group. Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | All Randomized Participants - Platinum Refractory Subgroup | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to end of study. Approximately 63 Months |
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| Secondary | Duration of Response (DOR) - Platinum Refractory Subgroup Based on HPV p-16 Status | The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first. | All treated participants in the Platinum Refractory subgroup with a response | Posted | Median | 95% Confidence Interval | Months | From randomization to disease progression or death. Approximately 63 Months |
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| Secondary | Duration of Response (DOR) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status | The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first. Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb | All treated participants in the Platinum Refractory subgroup with a response | Posted | Median | 95% Confidence Interval | Months | From randomization to disease progression or death. Approximately 63 Months |
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| Secondary | Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on HPV p-16 Status | the time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | Platinum Refractory subgroup all randomized | Posted | Median | 95% Confidence Interval | Months | From randomization to disease progression or death. Approximately 63 Months |
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| Secondary | Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status | the time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first. Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | Platinum Refractory subgroup all randomized | Posted | Median | 95% Confidence Interval | Months | From randomization to disease progression or death. Approximately 63 Months |
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| Secondary | Overall Survival (OS) - Platinum Refractory Subgroup Based on HPV p-16 Status | Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. | All Randomized Participants - Platinum Refractory Subgroup | Posted | Median | 95% Confidence Interval | Months | From randomization to death. Approximately 63 Months |
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| Secondary | Overall Survival (OS) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status | Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb | All Randomized Participants - Platinum Refractory Subgroup | Posted | Median | 95% Confidence Interval | Months | From randomization to death. Approximately 63 Months |
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| Secondary | Overall Survival (OS) - Platinum Eligible Subgroup Based on HPV p-16 Status | Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. | All Randomized Participants - Platinum Eligible Subgroup | Posted | Median | 95% Confidence Interval | Months | From randomization to death. Approximately 63 Months |
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| Secondary | Overall Survival (OS) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status | Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb | All Randomized Participants - Platinum Eligible Subgroup | Posted | Median | 95% Confidence Interval | Months | From randomization to death. Approximately 63 Months |
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| Secondary | Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status | the time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first. Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | Platinum eligible subgroup all randomized | Posted | Median | 95% Confidence Interval | Months | From randomization to disease progression or death. Approximately 63 Months |
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| Secondary | Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on HPV p-16 Status | the time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | Platinum eligible subgroup | Posted | Median | 95% Confidence Interval | Months | From randomization to disease progression or death. Approximately 63 Months |
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| Secondary | Duration of Response (DOR) - Platinum Eligible Subgroup Based on HPV p-16 Status | The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | All treated participants in the Platinum Eligible subgroup with a response | Posted | Median | 95% Confidence Interval | Months | From randomization to disease progression or death. Approximately 63 Months |
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| Secondary | Duration of Response (DOR) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status | The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first. Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | All treated participants in the Platinum eligible subgroup with a response | Posted | Median | 95% Confidence Interval | Months | From randomization to disease progression or death. Approximately 63 Months |
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| Secondary | Duration of Response (DOR) - Platinum Refractory Subgroup Based on PD-L1 Status | The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | All treated participants in the Platinum refractory subgroup with a response | Posted | Median | 95% Confidence Interval | Months | From randomization to disease progression or death. Approximately 63 Months |
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| Secondary | ORR - Platinum Refractory Subgroup Based on PD-L1 Expression | ORR is defined as the best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | Platinum Refractory subgroup | Posted | Number | 95% Confidence Interval | Percentage of Participants | From randomization to end of study. Approximately 63 Months |
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| Secondary | Overall Survival (OS) - Platinum Refractory Subgroup Based on PD-L1 Status | Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay | Platinum refractory subgroup | Posted | Median | 95% Confidence Interval | Months | From randomization to death. Approximately 63 Months |
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| Secondary | Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on PD-L1 Status | The time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | Platinum Refractory subgroup | Posted | Median | 95% Confidence Interval | Months | From randomization to disease progression or death. Approximately 63 Months |
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| Secondary | Duration of Response (DOR) - Platinum Eligible Subgroup Based on PD-L1 Status | The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | Platinum Eligible Responders | Posted | Median | 95% Confidence Interval | Months | From randomization to disease progression or death. Approximately 63 Months |
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| Secondary | ORR - Platinum Eligible Subgroup Based on PD-L1 Expression | ORR is defined as the best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | Platinum Eligible Subgroup | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to end of study. Approximately 63 Months |
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| Secondary | Overall Survival (OS) - Platinum Eligible Subgroup Based on PD-L1 Status | Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay | Platinum Eligible Subgroup | Posted | Median | 95% Confidence Interval | months | From randomization to death. Approximately 63 Months |
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| Secondary | Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on PD-L1 Status | The time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | Platinum eligible subgroup | Posted | Median | 95% Confidence Interval | Months | From randomization to disease progression or death. Approximately 63 Months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup - Post Hoc Analysis | ORR is defined as best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | All Randomized Participants - Platinum Refractory Subgroup | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to end of study. Approximately 63 Months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Duration of Response (DOR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup - Post Hoc Analysis | The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | Platinum Refractory Responders | Posted | Median | 95% Confidence Interval | Months | From randomization to disease progression or death. Approximately 63 Months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Time to Response (TTR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup - Post Hoc Analysis | Time to Response (TTR) for participants demonstrating a response (either CR or PR) was defined as the time from the date of randomization to the date of the first confirmed response. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | Platinum refractory responders | Posted | Median | Full Range | Months | From randomization to a confirmed response. Approximately 35 Months |
|
Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 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 | Treatment A - Platinum Refractory Subgroup | Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | 131 | 159 | 103 | 158 | 139 | 158 |
| EG001 | Treatment B - Platinum Refractory Subgroup | Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W | 71 | 82 | 52 | 82 | 76 | 82 |
| EG002 | Treatment A - Platinum Eligible Subgroup | Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | 102 | 123 | 89 | 122 | 118 | 122 |
| EG003 | Treatment B - Platinum Eligible Subgroup | Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W | 49 | 61 | 35 | 61 | 54 | 61 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
| |
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
| |
| Lymph node pain | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | 24.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | 24.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | 24.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | 24.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | 24.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | 24.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | 24.1 | Systematic Assessment |
| |
| Vestibular disorder | Ear and labyrinth disorders | 24.1 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | 24.1 | Systematic Assessment |
| |
| Adrenocortical insufficiency acute | Endocrine disorders | 24.1 | Systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | 24.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Autoimmune colitis | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Hernial eventration | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Oesophageal fistula | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Palatal disorder | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Chest pain | General disorders | 24.1 | Systematic Assessment |
| |
| Death | General disorders | 24.1 | Systematic Assessment |
| |
| Drug intolerance | General disorders | 24.1 | Systematic Assessment |
| |
| Face oedema | General disorders | 24.1 | Systematic Assessment |
| |
| Fatigue | General disorders | 24.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | 24.1 | Systematic Assessment |
| |
| Generalised oedema | General disorders | 24.1 | Systematic Assessment |
| |
| Hyperthermia | General disorders | 24.1 | Systematic Assessment |
| |
| Impaired healing | General disorders | 24.1 | Systematic Assessment |
| |
| Inflammation | General disorders | 24.1 | Systematic Assessment |
| |
| Malaise | General disorders | 24.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | 24.1 | Systematic Assessment |
| |
| Pain | General disorders | 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 24.1 | Systematic Assessment |
| |
| Sudden death | General disorders | 24.1 | Systematic Assessment |
| |
| Swelling | General disorders | 24.1 | Systematic Assessment |
| |
| Autoimmune hepatitis | Hepatobiliary disorders | 24.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | 24.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | 24.1 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | 24.1 | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | 24.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | 24.1 | Systematic Assessment |
| |
| Abscess neck | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Empyema | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Epiglottitis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Focal peritonitis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Hepatic infection bacterial | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Infective myositis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Ludwig angina | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Lymph node abscess | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Oral infection | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Pneumococcal sepsis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Sepsis syndrome | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Staphylococcal scalded skin syndrome | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Tracheitis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Tracheostomy infection | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Vascular access site infection | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Viral myocarditis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
| |
| Tracheal haemorrhage | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
| |
| Vasoplegia syndrome | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | 24.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 24.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | 24.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Feeding disorder | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.1 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.1 | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.1 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.1 | Systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.1 | Systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.1 | Systematic Assessment |
| |
| Second primary malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.1 | Systematic Assessment |
| |
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.1 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.1 | Systematic Assessment |
| |
| Carotid aneurysm rupture | Nervous system disorders | 24.1 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | 24.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | 24.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | 24.1 | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | 24.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | 24.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 24.1 | Systematic Assessment |
| |
| Device dislocation | Product Issues | 24.1 | Systematic Assessment |
| |
| Device leakage | Product Issues | 24.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 24.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 24.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | 24.1 | Systematic Assessment |
| |
| Autoimmune lung disease | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Laryngeal dyspnoea | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Laryngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Laryngeal obstruction | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Pharyngeal oedema | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | 24.1 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | 24.1 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | 24.1 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | 24.1 | Systematic Assessment |
| |
| Peripheral venous disease | Vascular disorders | 24.1 | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | 24.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | 24.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Asthenia | General disorders | 24.1 | Systematic Assessment |
| |
| Chills | General disorders | 24.1 | Systematic Assessment |
| |
| Face oedema | General disorders | 24.1 | Systematic Assessment |
| |
| Fatigue | General disorders | 24.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | 24.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 24.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 24.1 | Systematic Assessment |
| |
| Amylase increased | Investigations | 24.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 24.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | 24.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 24.1 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | 24.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | 24.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | 24.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 24.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 24.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | 24.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 24.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 24.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 24.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please Email | Clinical.Trials@bms.gov |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 30, 2018 | Sep 27, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Maximum Clinical Benefit |
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| Lost to Follow-up |
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| Participant withdrew consent |
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| Participant request to discontinue |
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| Adverse Event unrelated to to study Drug |
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| Study Drug Toxicity |
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| Disease Progression |
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| Other reasons |
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| Participant no longer meets study criteria |
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| Death |
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| Between 18 and 65 years |
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| >=65 years |
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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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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Participants |
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| Participants |
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Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy.
Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
|
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| Units | Counts |
|---|---|
| Participants |
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Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy.
Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
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Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W |
|
|
| Participants |
|
|
|
|
| Participants |
|
|
|
|
Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W |
|
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|
|
|
|
Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W |
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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