Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003662-27 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ono Pharmaceutical Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This purpose of this study is to evaluate nivolumab (BMS-936558) in combination with standard of care (SOC) chemotherapy with bevacizumab for the treatment of first-line metastatic colorectal cancer (mCRC).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Nivo + SOC |
|
| Arm B | Active Comparator | SOC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Biological | Specified dose on specified days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR) | Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented progression, as determined by BICR (per RECIST 1.1), or death due to any cause, whichever occurs first. Baseline tumor assessment is defined as tumor scans prior to or on randomization date. Participants who did not have documented progression per BICR and who did not die or participants who started any subsequent anti-cancer therapy without a prior reported progression per BICR will be censored at the date of the last tumor assessment on or prior to initiation of the subsequent anticancer therapy, if any. Participants who die without a reported prior progression per BICR will be considered to have progressed on the date of death. Participants who did not have any baseline or post baseline tumor assessments and did not die (or died after initiation of the subsequent anti-cancer therapy) will be censored at the randomization date. | From randomization to up to the date of the first documented progression (up to 16 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) Per Investigator Assessment | Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented progression, as determined by Investigator Assessment, or death due to any cause, whichever occurs first. Baseline tumor assessment is defined as tumor scans prior to or on randomization date. Participants who did not have documented progression per Investigator Assessment and who did not die or participants who started any subsequent anti-cancer therapy without a prior reported progression will be censored at the date of the last tumor assessment on or prior to initiation of the subsequent anticancer therapy, if any. Participants who die without a reported prior progression per Investigator Assessment will be considered to have progressed on the date of death. Participants who did not have any baseline or post baseline tumor assessments and did not die (or died after initiation of the subsequent anti-cancer therapy) will be censored at the randomization date. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Suibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uab Comprehensive Cancer Center | Birmingham | Alabama | 35294-3300 | United States | ||
| Local Institution - 0004 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38485190 | Derived | Lenz HJ, Parikh A, Spigel DR, Cohn AL, Yoshino T, Kochenderfer M, Elez E, Shao SH, Deming D, Holdridge R, Larson T, Chen E, Mahipal A, Ucar A, Cullen D, Baskin-Bey E, Kang T, Hammell AB, Yao J, Tabernero J. Modified FOLFOX6 plus bevacizumab with and without nivolumab for first-line treatment of metastatic colorectal cancer: phase 2 results from the CheckMate 9X8 randomized clinical trial. J Immunother Cancer. 2024 Mar 13;12(3):e008409. doi: 10.1136/jitc-2023-008409. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: NIV+mFOLFOX+BEV | Nivolumab 240 mg + Standard of Care (SOC) mFOLFOX6/bevacizuma every 2 weeks |
| FG001 | Arm B: mFOLFOX+BEV | mFOLFOX6/bevacizumab (SOC) every 2 weeks |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Pre-Treatment |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 13, 2020 | Feb 1, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Oxaliplatin | Drug | Specified dose on specified days |
|
| Leucovorin | Drug | Specified dose on specified days |
|
|
| Fluorouracil | Drug | Specified dose on specified days |
|
| Bevacizumab | Drug | Specified dose on specified days |
|
|
| From randomization up to the date of the first documented progression (up to approximately 44 months) |
| Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) | ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). BOR is defined as the best response designation as determined by BICR per RECIST 1.1, recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of subsequent anticancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurs first. PR is defined as at least a 30% decrease in the sum of diameters of target lesions. CR is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to <10 mm. | From the date of randomization up to the date of objectively documented progression or the date of subsequent anticancer therapy, whichever occurs first (up to approximately 44 months) |
| Objective Response Rate (ORR) Per Investigator Assessment | ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). BOR is defined as the best response designation as determined by tumor assessments by the Investigator per RECIST 1.1, recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of subsequent anticancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurs first. PR is defined as at least a 30% decrease in the sum of diameters of target lesions. CR is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to <10 mm. | From the date of randomization up to the date of objectively documented progression or the date of subsequent anticancer therapy, whichever occurs first (up to approximately 44 months) |
| Duration of Response (DoR) Per Blinded Independent Central Review (BICR) | Duration of objective response (DoR) is defined as the time between the date of first confirmed complete response (CR) or partial response (PR) to the date of the first documented tumor progression as assessed by the BICR based on RECIST 1.1 criteria or death due to any cause, whichever occurs first. PR is defined as at least a 30% decrease in the sum of diameters of target lesions. CR is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to <10 mm. | From randomization up to the date of the first documented progression (per RECIST 1.1) or death due to any cause, whichever occurs first (up to 44 months) |
| Duration of Response (DoR) Per Investigator Assessment | Duration of objective response (DoR) is defined as the time between the date of first confirmed complete response (CR) or partial response (PR) to the date of the first documented tumor progression as assessed by the investigator based on RECIST 1.1 criteria or death due to any cause, whichever occurs first. PR is defined as at least a 30% decrease in the sum of diameters of target lesions. CR is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to <10 mm. | From randomization up to the date of the first documented progression (per RECIST 1.1) or death due to any cause, whichever occurs first (up to 44 months) |
| Time to Objective Response Per Blinded Independent Central Review (BICR) | Time to objective response (TTR) is defined as the time from the randomization date to the date of the first confirmed complete response (CR) or partial response (PR) as assessed by BICR. PR is defined as at least a 30% decrease in the sum of diameters of target lesions. CR is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to <10 mm. TTR is derived for responders only. | From the randomization date up to the date of the first confirmed CR or PR (up to approximately 44 months) |
| Time to Objective Response Per Investigator Assessment | TTR is defined as the time from the randomization date to the date of the first confirmed complete response (CR) or partial response (PR) as assessed by investigator. PR is defined as at least a 30% decrease in the sum of diameters of target lesions. CR is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to <10 mm. TTR is derived for responders only. | From the randomization date up to the date of the first confirmed CR or PR (up to 44 months) |
| Overall Survival (OS) | Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For those without documentation of death, OS will be censored on the last date the participant was known to be alive. | From the date of randomization up to the date of death (up to 44 months) |
| Number of Participants With Adverse Events (AEs) | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal. | From first dose to 30 days post last dose (up to 45 months) |
| Number of Participants With Serious Adverse Events (SAEs) | Number of participants with any grade of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine safety and tolerability. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization. | From first dose to 30 days post last dose (up to 45 months) |
| Number of Participants Experiencing Death | The number of participants who died during the treatment period | From first dose up to 6 weeks post last dose (up to 46 months) |
| Number of Participants With Laboratory Abnormalities in Specific Liver Tests | The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal | From first dose up to 30 days post last dose (up to 45 months) |
| Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal | From first dose up to 30 days post last dose (up to 45 months) |
| Disease Control Rate (DCR) Per Blinded Independent Central Review (BICR) | Disease Control Rate (DCR) is defined as the percentage of participants whose Best Overall Response (BOR) is complete response (CR) or partial response (PR) or stable disease (SD). CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. | From the date of randomization up to the date of objectively documented progression or the date of subsequent anticancer therapy, whichever occurs first (up to approximately 44 months) |
| Disease Control Rate (DCR) Per Investigator | Disease Control Rate (DCR) is defined as the percentage of participants whose Best Overall Response (BOR) is complete response (CR) or partial response (PR) or stable disease (SD). CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. | From the date of randomization up to the date of objectively documented progression or the date of subsequent anticancer therapy, whichever occurs first (up to approximately 44 months) |
| Los Angeles |
| California |
| 90033 |
| United States |
| Local Institution - 0010 | Aurora | Colorado | 80045 | United States |
| Local Institution - 0027 | Denver | Colorado | 80218 | United States |
| Local Institution - 0020 | New Haven | Connecticut | 06520 | United States |
| Local Institution - 0039 | Miami | Florida | 33176 | United States |
| Local Institution - 0047 | St. Petersburg | Florida | 33705 | United States |
| Local Institution - 0033 | Arlington Heights | Illinois | 60005 | United States |
| Local Institution - 0044 | Indianapolis | Indiana | 46260 | United States |
| Local Institution - 0021 | Bethesda | Maryland | 20817 | United States |
| Local Institution - 0003 | Boston | Massachusetts | 02114 | United States |
| Local Institution - 0049 | Boston | Massachusetts | 02114 | United States |
| Local Institution - 0052 | Boston | Massachusetts | 02114 | United States |
| Local Institution - 0053 | Boston | Massachusetts | 02114 | United States |
| Local Institution - 0035 | Minneapolis | Minnesota | 55404 | United States |
| Local Institution - 0002 | Rochester | Minnesota | 55905 | United States |
| Local Institution - 0032 | Papillion | Nebraska | 68046 | United States |
| Local Institution - 0029 | Henderson | Nevada | 89074 | United States |
| Local Institution - 0031 | Johnson City | New York | 13790 | United States |
| Local Institution - 0046 | New York | New York | 10016 | United States |
| Levine Cancer Institute | Charlotte | North Carolina | 28262 | United States |
| Local Institution - 0038 | Portland | Oregon | 97227 | United States |
| Local Institution - 0005 | Philadelphia | Pennsylvania | 19104 | United States |
| Local Institution - 0024 | Pittsburgh | Pennsylvania | 15212 | United States |
| Local Institution - 0023 | Sioux Falls | South Dakota | 57104 | United States |
| Erlanger Oncology & Hematology - Univ. of TN | Chattanooga | Tennessee | 37403 | United States |
| Local Institution - 0019 | Nashville | Tennessee | 37203 | United States |
| Local Institution - 0026 | Bedford | Texas | 76022 | United States |
| Local Institution - 0034 | Dallas | Texas | 75246 | United States |
| Local Institution - 0037 | Fort Worth | Texas | 76104 | United States |
| Local Institution - 0040 | San Antonio | Texas | 78217 | United States |
| Local Institution - 0036 | Tyler | Texas | 75702 | United States |
| Local Institution - 0025 | Richmond | Virginia | 23229 | United States |
| Local Institution - 0028 | Roanoke | Virginia | 24014 | United States |
| Local Institution - 0006 | Madison | Wisconsin | 53705 | United States |
| Local Institution - 0017 | Edmonton | Alberta | T6G 1Z2 | Canada |
| Local Institution - 0015 | Ottawa | Ontario | K1H 8L6 | Canada |
| Local Institution - 0014 | Toronto | Ontario | M5G 2M9 | Canada |
| Local Institution - 0048 | Montreal | Quebec | H2X 1P1 | Canada |
| Local Institution - 0012 | Québec | Quebec | G1J 1Z4 | Canada |
| Local Institution - 0013 | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Local Institution - 0016 | Trois-Rivières | Quebec | G8Z 3R9 | Canada |
| Local Institution - 0055 | Nagoya | Aichi-ken | 4648681 | Japan |
| Local Institution - 0051 | Kashiwa-shi | Chiba | 2778577 | Japan |
| Local Institution - 0050 | Sunto-gun | Shizuoka | 4118777 | Japan |
| Local Institution - 0009 | San Juan | 00927 | Puerto Rico |
| Local Institution - 0043 | Barcelona | 08035 | Spain |
| Local Institution - 0042 | Madrid | 28034 | Spain |
| Local Institution - 0041 | Majadahonda - Madrid | 28222 | Spain |
| BMS Clinical Trial Patient Recruiting | View source |
|
| COMPLETED | Completed=Treated |
|
| NOT COMPLETED |
|
|
| Treatment |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: NIV+mFOLFOX+BEV | Nivolumab 240 mg + Standard of Care (SOC) mFOLFOX6/bevacizuma every 2 weeks |
| BG001 | Arm B: mFOLFOX+BEV | mFOLFOX6/bevacizumab (SOC) every 2 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR) | Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented progression, as determined by BICR (per RECIST 1.1), or death due to any cause, whichever occurs first. Baseline tumor assessment is defined as tumor scans prior to or on randomization date. Participants who did not have documented progression per BICR and who did not die or participants who started any subsequent anti-cancer therapy without a prior reported progression per BICR will be censored at the date of the last tumor assessment on or prior to initiation of the subsequent anticancer therapy, if any. Participants who die without a reported prior progression per BICR will be considered to have progressed on the date of death. Participants who did not have any baseline or post baseline tumor assessments and did not die (or died after initiation of the subsequent anti-cancer therapy) will be censored at the randomization date. | All Randomized Participants | Posted | Median | 95% Confidence Interval | Months | From randomization to up to the date of the first documented progression (up to 16 months) |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) Per Investigator Assessment | Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented progression, as determined by Investigator Assessment, or death due to any cause, whichever occurs first. Baseline tumor assessment is defined as tumor scans prior to or on randomization date. Participants who did not have documented progression per Investigator Assessment and who did not die or participants who started any subsequent anti-cancer therapy without a prior reported progression will be censored at the date of the last tumor assessment on or prior to initiation of the subsequent anticancer therapy, if any. Participants who die without a reported prior progression per Investigator Assessment will be considered to have progressed on the date of death. Participants who did not have any baseline or post baseline tumor assessments and did not die (or died after initiation of the subsequent anti-cancer therapy) will be censored at the randomization date. | All Randomized Participants | Posted | Median | 95% Confidence Interval | Months | From randomization up to the date of the first documented progression (up to approximately 44 months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) | ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). BOR is defined as the best response designation as determined by BICR per RECIST 1.1, recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of subsequent anticancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurs first. PR is defined as at least a 30% decrease in the sum of diameters of target lesions. CR is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to <10 mm. | All Randomized Participants | Posted | Number | 95% Confidence Interval | Percentage of Participants | From the date of randomization up to the date of objectively documented progression or the date of subsequent anticancer therapy, whichever occurs first (up to approximately 44 months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) Per Investigator Assessment | ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). BOR is defined as the best response designation as determined by tumor assessments by the Investigator per RECIST 1.1, recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of subsequent anticancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurs first. PR is defined as at least a 30% decrease in the sum of diameters of target lesions. CR is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to <10 mm. | All Randomized Participants | Posted | Number | 95% Confidence Interval | Percentage of participants | From the date of randomization up to the date of objectively documented progression or the date of subsequent anticancer therapy, whichever occurs first (up to approximately 44 months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) Per Blinded Independent Central Review (BICR) | Duration of objective response (DoR) is defined as the time between the date of first confirmed complete response (CR) or partial response (PR) to the date of the first documented tumor progression as assessed by the BICR based on RECIST 1.1 criteria or death due to any cause, whichever occurs first. PR is defined as at least a 30% decrease in the sum of diameters of target lesions. CR is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to <10 mm. | All randomized participants with a CR or PR that were assessed by BICR | Posted | Median | 95% Confidence Interval | Months | From randomization up to the date of the first documented progression (per RECIST 1.1) or death due to any cause, whichever occurs first (up to 44 months) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) Per Investigator Assessment | Duration of objective response (DoR) is defined as the time between the date of first confirmed complete response (CR) or partial response (PR) to the date of the first documented tumor progression as assessed by the investigator based on RECIST 1.1 criteria or death due to any cause, whichever occurs first. PR is defined as at least a 30% decrease in the sum of diameters of target lesions. CR is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to <10 mm. | All randomized participants with a CR or PR | Posted | Median | 95% Confidence Interval | Months | From randomization up to the date of the first documented progression (per RECIST 1.1) or death due to any cause, whichever occurs first (up to 44 months) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Objective Response Per Blinded Independent Central Review (BICR) | Time to objective response (TTR) is defined as the time from the randomization date to the date of the first confirmed complete response (CR) or partial response (PR) as assessed by BICR. PR is defined as at least a 30% decrease in the sum of diameters of target lesions. CR is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to <10 mm. TTR is derived for responders only. | All randomized participants with a CR or PR | Posted | Median | Standard Deviation | Months | From the randomization date up to the date of the first confirmed CR or PR (up to approximately 44 months) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Objective Response Per Investigator Assessment | TTR is defined as the time from the randomization date to the date of the first confirmed complete response (CR) or partial response (PR) as assessed by investigator. PR is defined as at least a 30% decrease in the sum of diameters of target lesions. CR is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to <10 mm. TTR is derived for responders only. | All randomized participants with a CR or PR | Posted | Median | Standard Deviation | Months | From the randomization date up to the date of the first confirmed CR or PR (up to 44 months) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For those without documentation of death, OS will be censored on the last date the participant was known to be alive. | All Randomized Participants | Posted | Median | 95% Confidence Interval | Months | From the date of randomization up to the date of death (up to 44 months) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal. | All treated participants | Posted | Count of Participants | Participants | From first dose to 30 days post last dose (up to 45 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serious Adverse Events (SAEs) | Number of participants with any grade of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine safety and tolerability. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization. | All treated participants | Posted | Count of Participants | Participants | From first dose to 30 days post last dose (up to 45 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing Death | The number of participants who died during the treatment period | All treated participants | Posted | Count of Participants | Participants | From first dose up to 6 weeks post last dose (up to 46 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal | All treated participants with at least one on-treatment measurement of the corresponding laboratory parameter | Posted | Number | Participants | From first dose up to 30 days post last dose (up to 45 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal | All Treated Participants with at Least One On-Treatment TSH measurement | Posted | Number | Participants | From first dose up to 30 days post last dose (up to 45 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) Per Blinded Independent Central Review (BICR) | Disease Control Rate (DCR) is defined as the percentage of participants whose Best Overall Response (BOR) is complete response (CR) or partial response (PR) or stable disease (SD). CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. | All randomized participants | Posted | Number | 95% Confidence Interval | Percentage of participants | From the date of randomization up to the date of objectively documented progression or the date of subsequent anticancer therapy, whichever occurs first (up to approximately 44 months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) Per Investigator | Disease Control Rate (DCR) is defined as the percentage of participants whose Best Overall Response (BOR) is complete response (CR) or partial response (PR) or stable disease (SD). CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. | All randomized participants | Posted | Number | 95% Confidence Interval | Percentage of participants | From the date of randomization up to the date of objectively documented progression or the date of subsequent anticancer therapy, whichever occurs first (up to approximately 44 months) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR) - Extended Collection | PFS is the time from randomization to the date of first documented progression, as determined by BICR, or death due to any cause, whichever occurs first. Baseline tumor assessment is defined as tumor scans prior to or on randomization date. Participants who did not have documented progression and did not die or participants who started any subsequent anti-cancer therapy without a prior reported progression were censored on date of last tumor assessment on or prior to initiation of the subsequent anticancer therapy, if any. Participants who died without prior progression were considered to have progressed on the date of death. Participants who did not have any baseline assessments and did not die (or died after initiation of the subsequent anti-cancer therapy) were censored at the randomization date. Note: This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date. | All Randomized Participants | Posted | Median | 95% Confidence Interval | Months | From randomization to up to the date of the first documented progression (up to 44 months) |
|
Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A: NIV+mFOLFOX+BEV | Nivolumab 240 mg + Standard of Care (SOC) mFOLFOX6/bevacizuma every 2 weeks | 89 | 127 | 67 | 123 | 122 | 123 |
| EG001 | Arm B: mFOLFOX+BEV | mFOLFOX6/bevacizumab (SOC) every 2 weeks | 47 | 68 | 25 | 62 | 61 | 62 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | 25.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | 25.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | 25.1 | Systematic Assessment |
| |
| Intracardiac thrombus | Cardiac disorders | 25.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | 25.1 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | 25.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | 25.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Mesenteric vein thrombosis | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Rectal obstruction | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Rectal perforation | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Asthenia | General disorders | 25.1 | Systematic Assessment |
| |
| Death | General disorders | 25.1 | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | 25.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | 25.1 | Systematic Assessment |
| |
| Pain | General disorders | 25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 25.1 | Systematic Assessment |
| |
| Autoimmune hepatitis | Hepatobiliary disorders | 25.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | 25.1 | Systematic Assessment |
| |
| Hepatic lesion | Hepatobiliary disorders | 25.1 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Abscess neck | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Endocarditis bacterial | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Norovirus infection | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Rectal abscess | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Spontaneous bacterial peritonitis | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 25.1 | Systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | 25.1 | Systematic Assessment |
| |
| Gastrointestinal anastomotic leak | Injury, poisoning and procedural complications | 25.1 | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | 25.1 | Systematic Assessment |
| |
| Stoma prolapse | Injury, poisoning and procedural complications | 25.1 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | 25.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 25.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | 25.1 | Systematic Assessment |
| |
| Blood potassium increased | Investigations | 25.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 25.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 25.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 25.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | 25.1 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | 25.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 25.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | 25.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 25.1 | Systematic Assessment |
| |
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.1 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.1 | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.1 | Systematic Assessment |
| |
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.1 | Systematic Assessment |
| |
| Metastases to ovary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.1 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | 25.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 25.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | 25.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 25.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 25.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 25.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 25.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 25.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 25.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 25.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 25.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | 25.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | 25.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | 25.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 25.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 25.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 25.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 25.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | 25.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | 25.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | 25.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Asthenia | General disorders | 25.1 | Systematic Assessment |
| |
| Chills | General disorders | 25.1 | Systematic Assessment |
| |
| Fatigue | General disorders | 25.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | 25.1 | Systematic Assessment |
| |
| Malaise | General disorders | 25.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | 25.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | 25.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 25.1 | Systematic Assessment |
| |
| Pain | General disorders | 25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 25.1 | Systematic Assessment |
| |
| Temperature intolerance | General disorders | 25.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | 25.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 25.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 25.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 25.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 25.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | 25.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 25.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 25.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 25.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | 25.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 25.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 25.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 25.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 25.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 25.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 25.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | 25.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 25.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 25.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | 25.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 25.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 25.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 25.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 25.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 25.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | 25.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 25.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | 25.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | 25.1 | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | 25.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | 25.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | 25.1 | Systematic Assessment |
| |
| Taste disorder | Nervous system disorders | 25.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | 25.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | 25.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 25.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | 25.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 25.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | 25.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 25.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 25.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | 25.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 25.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 25.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | 25.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | 25.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | 25.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | 25.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 25.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 25.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 25.1 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | 25.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 25.1 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trails@bms.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 18, 2021 | Feb 1, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000077150 | Oxaliplatin |
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| D000068258 | Bevacizumab |
| 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 |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
| Adverse Event Unrelated to Study Drug |
|
| Death |
|
| Study Drug Toxicity |
|
| Disease Progression |
|
| Not reported |
|
| Other reasons |
|
| Poor/non-compliance |
|
| Maximum clinical benefit |
|
| Lost to Follow-up |
|
| Administrative reasons by sponsor |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Asian |
|
| Other |
|
| Not Reported |
|
Hazard Ratio is Arm A: NIV+mFOLFOX+BEV over Arm B: mFOLFOX+BEV |
| Log Rank |
| 0.3022 |
Stratified regular log-rank test |
| Hazard Ratio (HR) |
| 0.81 |
| 2-Sided |
| 95 |
| 0.53 |
| 1.23 |
Stratified Cox proportional hazard model |
| Superiority |
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
|
|
|