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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000462-11 | EudraCT Number |
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| Name | Class |
|---|---|
| Yale University | OTHER |
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The purpose of this study is to explore the possible links between participant characteristics and their cancer, with how effective the combination of nivolumab with ipilimumab is, in participants with Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination therapy | Experimental | Nivolumab + Ipilimumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Biological | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Per Investigator by Blood TMB (bTMB) Within PD-L1 Subgroup (TMB Cut-point = 16 Mutations/MB) | Objective response rate (ORR) is defined as the percent of treated participants with a best overall response of a complete response (CR) or partial response (PR) assessed by investigator per Response Evaluation Criteria In Solid Tumors (RECIST 1.1). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR is disappearance of all target lesions and a reduction in pathological lymph node (whether target or non-target) short axis to <10 mm. Blood tumor mutational burden (bTMB) is the total number of nonsynonymous somatic mutations produced by a tumor that are detected in serum. CR+PR, confidence interval based on the Clopper and Pearson method. | From first dose up to the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy (up to approximately 58 months) |
| Objective Response Rate (ORR) Per Investigator by Blood TMB (bTMB) Within PD-L1 Subgroup (Blood TMB Cut-point = 21-mutations/MB) | Objective response rate (ORR) is defined as the percent of treated participants with a best overall response of a complete response (CR) or partial response (PR) assessed by investigator per Response Evaluation Criteria In Solid Tumors (RECIST 1.1). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR is disappearance of all target lesions and a reduction in pathological lymph node (whether target or non-target) short axis to <10 mm. Blood tumor mutational burden (bTMB) is the total number of nonsynonymous somatic mutations produced by a tumor that are detected in serum. CR+PR, confidence interval based on the Clopper and Pearson method. | From first dose up to the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy (up to approximately 58 months) |
| Objective Response Rate (ORR) Per Investigator by Tissue TMB Within PD-L1 Subgroup (Tissue TMB Cut-point = 10-mutations/MB) | Objective response rate (ORR) is defined as the percent of treated participants with a best overall response of a complete response (CR) or partial response (PR) assessed by investigator per Response Evaluation Criteria In Solid Tumors (RECIST 1.1). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR is disappearance of all target lesions and a reduction in pathological lymph node (whether target or non-target) short axis to <10 mm. Tissue tumor mutational burden (tTMB) is the total number of nonsynonymous somatic mutations produced by a tumor that are detected in tumor tissue samples. CR+PR, confidence interval based on the Clopper and Pearson method. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) for All Treated Participants by Investigator Per RECIST 1.1 | Objective response rate (ORR) is defined as the percent of treated participants with a best overall response of a complete response (CR) or partial response (PR) assessed by investigator per Response Evaluation Criteria In Solid Tumors (RECIST 1.1). Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response (CR) is disappearance of all target lesions and a reduction in pathological lymph node (whether target or non-target) short axis to <10 mm. CR+PR, confidence interval based on the Clopper and Pearson method. |
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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 |
|---|---|---|---|---|---|---|
| Local Institution - 0006 | Springdale | Arkansas | 72762 | United States | ||
| Local Institution - 0001 |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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In Part 1, upon determination of PD-L1 status (cut-off of 1%), 2 cohorts were defined: PD-L1 positive and negative.
In Part 2, a separate group of participants were treated regardless of their PD-L1 status.
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| ID | Title | Description |
|---|---|---|
| FG000 | PART 1: PD-L1+ Status | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 18, 2019 |
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| Ipilimumab | Biological | Specified dose on specified days |
|
|
| From first dose up to the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy (up to approximately 58 months) |
| From first dose until the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy, whichever occurs first (Up to approximately 67 months) |
| Disease Control Rate (DCR) for Part 1 | Disease control rate (DCR) is the percent of treated participants with a best overall response of a complete response (CR), partial response (PR), or stable disease (SD), assessed by investigator per Response Evaluation Criteria In Solid Tumors (RECIST 1.1). PR is at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as reference. CR is disappearance of all target lesions and a reduction in short axis to <10 mm of any pathological lymph nodes (target or non-target). SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking smallest sum diameters as reference. PD is at least a 20% increase in the sum of diameters of target lesions, taking the smallest sum as reference. The sum must also demonstrate an absolute increase of at least 5 mm. (one or more new lesions is also considered progression). CR+PR, confidence interval based on the Clopper and Pearson method. | From first dose until the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy, whichever occurs first (Up to approximately 67 months) |
| Duration of Response (DOR) for Part 1 | DOR is the time between first confirmed response (Complete/Partial Response) and first documented tumor progression (per RECIST 1.1) or death due to any cause. Participants who don't progress or die are censored on the date of their last evaluable tumor assessment. Participants who started subsequent anti-cancer therapy without prior reported progression were censored at the last evaluable tumor assessment prior to or on the date of subsequent anti-cancer therapy. PR is at least 30% decrease in the sum of diameters of target lesions, using baseline sum diameters as reference. CR is disappearance of all target lesions and reduction in short axis to <10 mm of any pathological lymph nodes (target or non-target). Progressive Disease (PD) is at least 20% increase in the sum of diameters of target lesions, taking the smallest sum as reference. The sum must also show an overall increase of > 5 mm. (one or more new lesions is also progression). Median computed using Kaplan-Meier method. | From first dose to the date of the first documented tumor progression or death due to any cause (Up to approximately 67 months) |
| Time to Response (TTR) for Part 1 | TTR is the time taken from first dosing date to the time the criteria for Complete Response (CR)/Partial Response (PR) are first met. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. | From first dose to the time the criteria for Complete Response/Partial Response are first met (Up to approximately 67 months) |
| Progression Free Survival (PFS) | PFS is defined as the time from first dosing date to the date of the first documented tumor progression (per RECIST 1.1) or death due to any cause. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. Participants who started any subsequent anti-cancer therapy without a prior reported progression will be censored at the last evaluable tumor assessment prior to or on the date of initiation of subsequent anti-cancer therapy. Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking the smallest sum on study as reference. The sum must also show an overall increase of > 5 mm. (one or more new lesions is also progression). Median calculated using Kaplan-Meier estimates. | From first dose to the date of the first documented tumor progression or death due to any causes (Assessed up to approximately 67 months) |
| Overall Survival (OS) | OS is defined as the time from first dosing date to the date of death. If a participant didn't die, OS will be censored on the last date the participant was known to be alive. Median based on Kaplan-Meier estimates. | From first dose to the date of death (Assessed up to approximately 67 months) |
| Number of Participants With Adverse Events (AEs) for Study Part 2 | An Adverse Event (AE) is any new untoward medical occurrence or worsening preexisting medical condition in a treated participant and that does not necessarily have a causal relationship with treatment. An AE can be any unfavorable, unintended sign, symptom, or disease temporally associated with the use of treatment, whether or not related to the treatment. | From first dose to 30 days after last dosing date (assessed up to approximately 27 months) |
| Number of Participants With Serious Adverse Events (SAEs) for Study Part 2 | A Serious Adverse Event (SAE) 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), or requires inpatient hospitalization or causes prolongation of existing hospitalization. | From first dose to 30 days after last dosing date (assessed up to approximately 27 months) |
| Number of Participants With Select Adverse Events (AEs) for Study Part 2 | An Adverse Event (AE) is any new untoward medical occurrence or worsening preexisting medical condition in a treated participant and that does not necessarily have a causal relationship with treatment. An AE can be any unfavorable, unintended sign, symptom, or disease temporally associated with the use of treatment, whether or not related to the treatment. | From first dose to 30 days after last dosing date (up to approximately 27 months) |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| Local Institution - 0005 | Jacksonville | Florida | 32256 | United States |
| Local Institution - 0009 | Atlanta | Georgia | 30322 | United States |
| Local Institution - 0003 | St Louis | Missouri | 63110 | United States |
| Local Institution - 0038 | The Bronx | New York | 10461 | United States |
| Local Institution - 0002 | Cleveland | Ohio | 44195 | United States |
| Local Institution - 0008 | Cleveland | Ohio | 44195 | United States |
| Local Institution - 0007 | Greenville | South Carolina | 29607 | United States |
| Local Institution - 0004 | Nashville | Tennessee | 37203 | United States |
| Local Institution - 0017 | La Louvière | Hainaut | 7100 | Belgium |
| Local Institution - 0018 | Ghent | 9000 | Belgium |
| Local Institution - 0028 | Ghent | 9000 | Belgium |
| Local Institution - 0027 | Liège | 4000 | Belgium |
| Local Institution - 0016 | Sint-Niklaas | 9100 | Belgium |
| Local Institution - 0036 | Paris | 75248 | France |
| Local Institution - 0033 | Pierre-Bénite | 69495 | France |
| Local Institution - 0034 | Strasbourg | 67091 | France |
| Local Institution - 0039 | Toulon | 83000 | France |
| Local Institution - 0015 | Essen | 45136 | Germany |
| Local Institution - 0014 | Immenstadt im Allgäu | 87509 | Germany |
| Local Institution - 0013 | Löwenstein | 74245 | Germany |
| Local Institution - 0012 | Stuttgart | 70174 | Germany |
| Local Institution - 0023 | Bergamo | 24127 | Italy |
| Local Institution - 0025 | Catania | 95123 | Italy |
| Local Institution - 0026 | Parma | 43100 | Italy |
| Local Institution - 0024 | Perugia | 06129 | Italy |
| Local Institution - 0021 | Amsterdam | 1066 CX | Netherlands |
| Local Institution - 0022 | Nijmegen | 6525 GA | Netherlands |
| Local Institution - 0011 | Cluj-Napoca | Cluj | 400015 | Romania |
| Local Institution - 0010 | Craiova | 200542 | Romania |
| Local Institution - 0031 | Barcelona | 08908 | Spain |
| Local Institution - 0029 | Madrid | 28041 | Spain |
| Local Institution - 0030 | Madrid | 28046 | Spain |
| Local Institution - 0032 | Seville | 41009 | Spain |
| FG001 | PART 1: PD-L1- Status | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first. |
| FG002 | PART 1: Not Evaluable/Indeterminate PD-L1 Status | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first. |
| FG003 | PART 2: PD-L1 Status Independent | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first |
| COMPLETED | Continuing in treatment period |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PART 1: PD-L1+ Status | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first. |
| BG001 | PART 1: PD-L1- Status | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first. |
| BG002 | PART 1: Not Evaluable/Indeterminate PD-L1 Status | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first. |
| BG003 | PART 2: PD-L1 Status Independent | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first |
| BG004 | 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, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Race | 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 | Objective Response Rate (ORR) Per Investigator by Blood TMB (bTMB) Within PD-L1 Subgroup (TMB Cut-point = 16 Mutations/MB) | Objective response rate (ORR) is defined as the percent of treated participants with a best overall response of a complete response (CR) or partial response (PR) assessed by investigator per Response Evaluation Criteria In Solid Tumors (RECIST 1.1). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR is disappearance of all target lesions and a reduction in pathological lymph node (whether target or non-target) short axis to <10 mm. Blood tumor mutational burden (bTMB) is the total number of nonsynonymous somatic mutations produced by a tumor that are detected in serum. CR+PR, confidence interval based on the Clopper and Pearson method. | All treated PD-L1 and bTMB evaluable Part 1 and 2 participants (Blood TMB Cut-point = 16 mutations/MB). Non-evaluable PD-L1 status means that PD-L1 status could not be determined, thus the Arm population did not meet this criteria. Participants in Part 2: PD-L1(+/-) Status groups were stratified from the PART 2: PD-L1 Status Independent Arm. Not all participants were bTMB evaluable. To be analyzed participants had to be both PD-L1 evaluable and bTMB evaluable. | Posted | Number | 95% Confidence Interval | Percent of Participants | From first dose up to the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy (up to approximately 58 months) |
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| Primary | Objective Response Rate (ORR) Per Investigator by Blood TMB (bTMB) Within PD-L1 Subgroup (Blood TMB Cut-point = 21-mutations/MB) | Objective response rate (ORR) is defined as the percent of treated participants with a best overall response of a complete response (CR) or partial response (PR) assessed by investigator per Response Evaluation Criteria In Solid Tumors (RECIST 1.1). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR is disappearance of all target lesions and a reduction in pathological lymph node (whether target or non-target) short axis to <10 mm. Blood tumor mutational burden (bTMB) is the total number of nonsynonymous somatic mutations produced by a tumor that are detected in serum. CR+PR, confidence interval based on the Clopper and Pearson method. | All treated PD-L1 and bTMB evaluable Part 1 and Part 2 participants (Blood TMB Cut-point = 21-mutations/MB). Non-evaluable PD-L1 status means that PD-L1 status could not be determined, thus the Arm population did not meet this criteria. Participants in Part 2: PD-L1(+/-) Status groups were stratified from the PART 2: PD-L1 Status Independent Arm. Not all participants were bTMB evaluable. To be analyzed participants had to be both PD-L1 evaluable and bTMB evaluable. | Posted | Number | 95% Confidence Interval | Percent of Participants | From first dose up to the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy (up to approximately 58 months) |
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| Primary | Objective Response Rate (ORR) Per Investigator by Tissue TMB Within PD-L1 Subgroup (Tissue TMB Cut-point = 10-mutations/MB) | Objective response rate (ORR) is defined as the percent of treated participants with a best overall response of a complete response (CR) or partial response (PR) assessed by investigator per Response Evaluation Criteria In Solid Tumors (RECIST 1.1). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR is disappearance of all target lesions and a reduction in pathological lymph node (whether target or non-target) short axis to <10 mm. Tissue tumor mutational burden (tTMB) is the total number of nonsynonymous somatic mutations produced by a tumor that are detected in tumor tissue samples. CR+PR, confidence interval based on the Clopper and Pearson method. | All treated PD-L1 and bTMB evaluable Part 1 and Part 2 participants (Blood TMB Cut-point = 10-mutations/MB). Non-evaluable PD-L1 status means that PD-L1 status could not be determined, thus the Arm population did not meet this criteria. Participants in Part 2: PD-L1(+/-) Status groups were stratified from the PART 2: PD-L1 Status Independent Arm. Not all participants were bTMB evaluable. To be analyzed participants had to be both PD-L1 evaluable and bTMB evaluable. | Posted | Number | 95% Confidence Interval | Percent of Participants | From first dose up to the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy (up to approximately 58 months) |
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| Secondary | Objective Response Rate (ORR) for All Treated Participants by Investigator Per RECIST 1.1 | Objective response rate (ORR) is defined as the percent of treated participants with a best overall response of a complete response (CR) or partial response (PR) assessed by investigator per Response Evaluation Criteria In Solid Tumors (RECIST 1.1). Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response (CR) is disappearance of all target lesions and a reduction in pathological lymph node (whether target or non-target) short axis to <10 mm. CR+PR, confidence interval based on the Clopper and Pearson method. | All treated Part 1 and Part 2 participants | Posted | Number | 95% Confidence Interval | Percent of Participants | From first dose until the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy, whichever occurs first (Up to approximately 67 months) |
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| Secondary | Disease Control Rate (DCR) for Part 1 | Disease control rate (DCR) is the percent of treated participants with a best overall response of a complete response (CR), partial response (PR), or stable disease (SD), assessed by investigator per Response Evaluation Criteria In Solid Tumors (RECIST 1.1). PR is at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as reference. CR is disappearance of all target lesions and a reduction in short axis to <10 mm of any pathological lymph nodes (target or non-target). SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking smallest sum diameters as reference. PD is at least a 20% increase in the sum of diameters of target lesions, taking the smallest sum as reference. The sum must also demonstrate an absolute increase of at least 5 mm. (one or more new lesions is also considered progression). CR+PR, confidence interval based on the Clopper and Pearson method. | All treated participants in Part 1. Endpoint pre-specified only for participants treated in Part 1. | Posted | Number | 95% Confidence Interval | Percent of Participants | From first dose until the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy, whichever occurs first (Up to approximately 67 months) |
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| Secondary | Duration of Response (DOR) for Part 1 | DOR is the time between first confirmed response (Complete/Partial Response) and first documented tumor progression (per RECIST 1.1) or death due to any cause. Participants who don't progress or die are censored on the date of their last evaluable tumor assessment. Participants who started subsequent anti-cancer therapy without prior reported progression were censored at the last evaluable tumor assessment prior to or on the date of subsequent anti-cancer therapy. PR is at least 30% decrease in the sum of diameters of target lesions, using baseline sum diameters as reference. CR is disappearance of all target lesions and reduction in short axis to <10 mm of any pathological lymph nodes (target or non-target). Progressive Disease (PD) is at least 20% increase in the sum of diameters of target lesions, taking the smallest sum as reference. The sum must also show an overall increase of > 5 mm. (one or more new lesions is also progression). Median computed using Kaplan-Meier method. | All treated participants in Part 1 who had complete or partial response. Endpoint pre-specified only for participants treated in Part 1. | Posted | Median | Full Range | Months | From first dose to the date of the first documented tumor progression or death due to any cause (Up to approximately 67 months) |
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| Secondary | Time to Response (TTR) for Part 1 | TTR is the time taken from first dosing date to the time the criteria for Complete Response (CR)/Partial Response (PR) are first met. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. | All treated participants in Part 1 who had complete or partial response. Endpoint pre-specified only for participants treated in Part 1. | Posted | Median | Full Range | Months | From first dose to the time the criteria for Complete Response/Partial Response are first met (Up to approximately 67 months) |
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| Secondary | Progression Free Survival (PFS) | PFS is defined as the time from first dosing date to the date of the first documented tumor progression (per RECIST 1.1) or death due to any cause. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. Participants who started any subsequent anti-cancer therapy without a prior reported progression will be censored at the last evaluable tumor assessment prior to or on the date of initiation of subsequent anti-cancer therapy. Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking the smallest sum on study as reference. The sum must also show an overall increase of > 5 mm. (one or more new lesions is also progression). Median calculated using Kaplan-Meier estimates. | All treated Part 1 and Part 2 participants | Posted | Median | 95% Confidence Interval | Months | From first dose to the date of the first documented tumor progression or death due to any causes (Assessed up to approximately 67 months) |
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| Secondary | Overall Survival (OS) | OS is defined as the time from first dosing date to the date of death. If a participant didn't die, OS will be censored on the last date the participant was known to be alive. Median based on Kaplan-Meier estimates. | All treated Part 1 and Part 2 participants | Posted | Median | 95% Confidence Interval | Months | From first dose to the date of death (Assessed up to approximately 67 months) |
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| Secondary | Number of Participants With Adverse Events (AEs) for Study Part 2 | An Adverse Event (AE) is any new untoward medical occurrence or worsening preexisting medical condition in a treated participant and that does not necessarily have a causal relationship with treatment. An AE can be any unfavorable, unintended sign, symptom, or disease temporally associated with the use of treatment, whether or not related to the treatment. | All treated Part 2 participants. Endpoint pre-specified only for participants treated in Part 2. | Posted | Count of Participants | Participants | From first dose to 30 days after last dosing date (assessed up to approximately 27 months) |
|
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| Secondary | Number of Participants With Serious Adverse Events (SAEs) for Study Part 2 | A Serious Adverse Event (SAE) 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), or requires inpatient hospitalization or causes prolongation of existing hospitalization. | All treated Part 2 participants. Endpoint pre-specified only for participants treated in Part 2. | Posted | Count of Participants | Participants | From first dose to 30 days after last dosing date (assessed up to approximately 27 months) |
|
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| Secondary | Number of Participants With Select Adverse Events (AEs) for Study Part 2 | An Adverse Event (AE) is any new untoward medical occurrence or worsening preexisting medical condition in a treated participant and that does not necessarily have a causal relationship with treatment. An AE can be any unfavorable, unintended sign, symptom, or disease temporally associated with the use of treatment, whether or not related to the treatment. | All treated Part 2 participants. Endpoint pre-specified only for participants treated in Part 2. | Posted | Count of Participants | Participants | From first dose to 30 days after last dosing date (up to approximately 27 months) |
|
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| Post-Hoc | Extended Collection of Objective Response Rate (ORR) Per Investigator by Blood TMB (bTMB) (TMB Cut-point = 16 Mutations/MB) | Objective response rate (ORR) is defined as the percent of treated participants with a best overall response of a complete response (CR) or partial response (PR) assessed by investigator per Response Evaluation Criteria In Solid Tumors (RECIST 1.1). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR is disappearance of all target lesions and a reduction in pathological lymph node (whether target or non-target) short axis to <10 mm. Blood tumor mutational burden (bTMB) is the total number of nonsynonymous somatic mutations produced by a tumor that are detected in serum. CR+PR, confidence interval based on the Clopper and Pearson method. | All treated PD-L1 and bTMB evaluable Part 1 and 2 participants (Blood TMB Cut-point = 16 mutations/MB). Non-evaluable PD-L1 status means that PD-L1 status could not be determined, thus the Arm population did not meet this criteria. Not all participants were bTMB evaluable. To be analyzed participants had to be both PD-L1 evaluable and bTMB evaluable. | Posted | Number | 95% Confidence Interval | Percent of Participants | From first dose up to the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy (up to approximately 67 months) |
| ||||||||||||||||||||||||||||||||||
| Post-Hoc | Extended Collection of Objective Response Rate (ORR) Per Investigator by Blood TMB (bTMB) (Blood TMB Cut-point = 21-mutations/MB) | Objective response rate (ORR) is defined as the percent of treated participants with a best overall response of a complete response (CR) or partial response (PR) assessed by investigator per Response Evaluation Criteria In Solid Tumors (RECIST 1.1). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR is disappearance of all target lesions and a reduction in pathological lymph node (whether target or non-target) short axis to <10 mm. Blood tumor mutational burden (bTMB) is the total number of nonsynonymous somatic mutations produced by a tumor that are detected in serum. CR+PR, confidence interval based on the Clopper and Pearson method. | All treated PD-L1 and bTMB evaluable Part 1 and Part 2 participants (Blood TMB Cut-point = 21-mutations/MB). Non-evaluable PD-L1 status means that PD-L1 status could not be determined, thus the Arm population did not meet this criteria. Not all participants were bTMB evaluable. To be analyzed participants had to be both PD-L1 evaluable and bTMB evaluable. | Posted | Number | 95% Confidence Interval | Percent of Participants | From first dose up to the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy (up to approximately 67 months) |
| ||||||||||||||||||||||||||||||||||
| Post-Hoc | Extended Collection of Objective Response Rate (ORR) Per Investigator by Tissue TMB (Tissue TMB Cut-point = 10-mutations/MB) | Objective response rate (ORR) is defined as the percent of treated participants with a best overall response of a complete response (CR) or partial response (PR) assessed by investigator per Response Evaluation Criteria In Solid Tumors (RECIST 1.1). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR is disappearance of all target lesions and a reduction in pathological lymph node (whether target or non-target) short axis to <10 mm. Tissue tumor mutational burden (tTMB) is the total number of nonsynonymous somatic mutations produced by a tumor that are detected in tumor tissue samples. CR+PR, confidence interval based on the Clopper and Pearson method. | All treated PD-L1 and bTMB evaluable Part 1 and Part 2 participants (Blood TMB Cut-point = 10-mutations/MB). Non-evaluable PD-L1 status means that PD-L1 status could not be determined, thus the Arm population did not meet this criteria. Not all participants were bTMB evaluable. To be analyzed participants had to be both PD-L1 evaluable and bTMB evaluable. | Posted | Number | 95% Confidence Interval | Percent of Participants | From first dose up to the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy (up to approximately 67 months) |
|
Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 8 months and a maximum of 29 months).
Not provided
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 | PART 1: PD-L1+ Status | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first. | 27 | 31 | 24 | 31 | 31 | 31 |
| EG001 | PART 1: PD-L1- Status | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first. | 22 | 28 | 14 | 28 | 27 | 28 |
| EG002 | PART 1: Not Evaluable/Indeterminate PD-L1 Status | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first. | 1 | 1 | 0 | 1 | 1 | 1 |
| EG003 | PART 2: PD-L1 Status Independent | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first | 134 | 170 | 113 | 170 | 161 | 170 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 26.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | 26.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | 26.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | 26.0 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | 26.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | 26.0 | Systematic Assessment |
| |
| Nodal rhythm | Cardiac disorders | 26.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | 26.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | 26.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | 26.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | 26.0 | Systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | 26.0 | Systematic Assessment |
| |
| Thyroiditis | Endocrine disorders | 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Autoimmune pancreatitis | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | 26.0 | Systematic Assessment |
| |
| Chest pain | General disorders | 26.0 | Systematic Assessment |
| |
| Death | General disorders | 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 26.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | 26.0 | Systematic Assessment |
| |
| Inflammation | General disorders | 26.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | 26.0 | Systematic Assessment |
| |
| Pain | General disorders | 26.0 | Systematic Assessment |
| |
| Performance status decreased | General disorders | 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 26.0 | Systematic Assessment |
| |
| Sudden death | General disorders | 26.0 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | 26.0 | Systematic Assessment |
| |
| Autoimmune hepatitis | Hepatobiliary disorders | 26.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | 26.0 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | 26.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | 26.0 | Systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | 26.0 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | 26.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | 26.0 | Systematic Assessment |
| |
| Brain abscess | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Empyema | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Brachial plexus injury | Injury, poisoning and procedural complications | 26.0 | Systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | 26.0 | Systematic Assessment |
| |
| Depressed fracture | Injury, poisoning and procedural complications | 26.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 26.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | 26.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 26.0 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 26.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | 26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 26.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | 26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 26.0 | Systematic Assessment |
| |
| General physical condition abnormal | Investigations | 26.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | 26.0 | Systematic Assessment |
| |
| Troponin I increased | Investigations | 26.0 | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 26.0 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 26.0 | Systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 26.0 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 26.0 | Systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 26.0 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 26.0 | Systematic Assessment |
| |
| Phaeochromocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 26.0 | Systematic Assessment |
| |
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 26.0 | Systematic Assessment |
| |
| Tumour necrosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 26.0 | Systematic Assessment |
| |
| Tumour ulceration | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 26.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Encephalitis autoimmune | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Radiculopathy | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | 26.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 26.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | 26.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | 26.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | 26.0 | Systematic Assessment |
| |
| Adnexa uteri mass | Reproductive system and breast disorders | 26.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | 26.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | 26.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 26.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | 26.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | 26.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | 26.0 | Systematic Assessment |
| |
| Chills | General disorders | 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 26.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | 26.0 | Systematic Assessment |
| |
| Malaise | General disorders | 26.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | 26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 26.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | 26.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 26.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | 26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 26.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | 26.0 | Systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | 26.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | 26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 26.0 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | 26.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | 26.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 26.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | 26.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 26.0 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Peroneal nerve palsy | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | 26.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | 26.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | 26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 26.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 26.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | 26.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | 26.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | 26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | 26.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | 26.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | 26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 26.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 26.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 26.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 26.0 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trials@bms.com |
| Feb 2, 2023 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Other |
|
|
| bTMB Low (Cut-point = 16-mutations) |
|
|
| OG001 | PART 1: PD-L1- Status | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first. |
| OG002 | PART 1: Not Evaluable/Indeterminate PD-L1 Status | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first. |
| OG003 | PART 2: PD-L1 + Status | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first |
| OG004 | PART 2: PD-L1- Status | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first |
|
|
| OG001 | PART 1: PD-L1- Status | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first. |
| OG002 | PART 1: Not Evaluable/Indeterminate PD-L1 Status | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first. |
| OG003 | PART 2: PD-L1 + Status | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first |
| OG004 | PART 2: PD-L1- Status | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first |
|
|
Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first.
| OG002 | PART 1: Not Evaluable/Indeterminate PD-L1 Status | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first. |
| OG003 | PART 2: PD-L1 Status Independent | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first |
|
|
| OG001 | PART 1: PD-L1- Status | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first. |
| OG002 | PART 1: Not Evaluable/Indeterminate PD-L1 Status | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first. |
|
|
| OG001 | PART 1: PD-L1- Status | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first. |
| OG002 | PART 1: Not Evaluable/Indeterminate PD-L1 Status | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first. |
|
|
| OG002 | PART 1: Not Evaluable/Indeterminate PD-L1 Status | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first. |
|
|
Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first.
| OG002 | PART 1: Not Evaluable/Indeterminate PD-L1 Status | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first. |
| OG003 | PART 2: PD-L1 Status Independent | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first |
|
|
Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first. |
| OG003 | PART 2: PD-L1 Status Independent | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first |
|
|
|
|
|
| OG001 | PART 1: Not Evaluable/Indeterminate PD-L1 Status | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first. |
| OG002 | PART 2 | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first |
|
|
| OG001 | PART 1: Not Evaluable/Indeterminate PD-L1 Status | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first. |
| OG002 | PART 2 | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first |
|
|
| OG001 | PART 1: Not Evaluable/Indeterminate PD-L1 Status | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first. |
| OG002 | PART 2 | Nivolumab + ipilimumab at a flat dose of nivolumab 240 mg as a 30-minute intravenous (IV) infusion every two weeks + ipilimumab 1 mg/kg as a 30-minute IV infusion every 6 weeks. Treatment would continue until disease progression, unacceptable toxicity, withdrawal of consent, the study ending, or a maximum treatment duration of 2 years, whichever occurred first |
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