December 2, 2016
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December 6, 2016
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May 4, 2021
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October 14, 2021
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November 1, 2022
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January 16, 2017
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May 11, 2020 (Final data collection date for primary outcome measure)
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- Number of Participants With High Grade (Grade 3-4) Immune Mediated Adverse Events (IMAEs) [ Time Frame: Approximately 39 Months ]
Number of participants with IMAEs in the following categories: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity
- Number of Participants With High Grade (Grade 5) Immune Mediated Adverse Events (IMAEs) [ Time Frame: Approximately 39 Months ]
Number of participants with IMAEs in the following categories: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity
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Incidence of high grade immune-mediated adverse events (IMAEs) [ Time Frame: Approximately 3 months ] high grade IMAEs: Common Terminology Criteria for Adverse Events (CTCAE) version 4 Grade 3-4 and Grade 5 IMAEs
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- Time to Onset of Grade 3-5 Immune Mediated Adverse Events (IMAEs) [ Time Frame: From first dose to the earliest IMAE (grade 3-5) event onset date (up to approximately 116 weeks) ]
Time to onset is defined as the duration of time in weeks from the first dosing to the immune modulating adverse event onset date. Participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death
- Time to Resolution of Grade 3-5 Immune Mediated Adverse Events (IMAEs) [ Time Frame: From the IMAE onset date to the IMAE end date, up to approximately 194 weeks ]
Time to resolution is defined as the longest time from IMAE onset date to complete resolution or improvement to the grade at baseline experienced by the participant (the IMAE end date). Participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death
- Number of Participants Who Received Immune Modulating Medication for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs) [ Time Frame: From first dose up to 100 days post last dose (up to approximately 29 months) ]
The number of participants who received immune modulating medication for participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death
- Number of Participants Who Received Hormone Replacement Therapy for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs) [ Time Frame: From first dose up to 100 days post last dose (up to approximately 29 months) ]
The number of participants who received Hormone Replacement Therapy for experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death
- Number of Participants Who Received ≥ 40mg of Prednisone for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs) [ Time Frame: From first dose up to 100 days post last dose (up to approximately 29 months) ]
The number of participants who received ≥ 40mg of prednisone for high grade (grades 3-5) IMAEs. Participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death
- Median Progression Free Survival (PFS) [ Time Frame: From first dose to the date of the first documented progressive disease, up to approximately 12 months ]
PFS is defined as the time from first dose to the date of the first documented progressive disease (PD) as determined by the investigator (per RECIST 1.1 criteria or clinical) or death due to any cause whichever occur first. Progressive disease is defined as progression of existing non-target lesions or at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
- Objective Response Rate (ORR) [ Time Frame: From first dose up to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (up to approximately 26 months) ]
ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of response evaluable participants. Best overall response is defined as the best response recorded from the start of the study treatment until the end of treatment. The participant's best overall response assignment will depend on the findings of both target and non-target disease and will also take into consideration the appearance of new lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all lesions and normalization of tumor marker level. All lymph nodes (whether target or non-target) must be non-pathological in size (< 10mm short axis).
- Time to Response Rate (TRR) [ Time Frame: From the date of first dose to first documented CR or PR, up to approximately 15 months ]
TTR is defined as the median percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of response evaluable participants. Best overall response is defined as the best response recorded from the start of the study treatment until the end of treatment. The participant's best overall response assignment will depend on the findings of both target and non-target disease and will also take into consideration the appearance of new lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all lesions and normalization of tumor marker level. All lymph nodes (whether target or non-target) must be non-pathological in size (< 10mm short axis).
- Duration of Response (DOR) [ Time Frame: From first confirmed response to the date of the first documented tumor progression or death, up to approximately 48 months ]
DOR is defined as the time between the date of first confirmed response to the date of the first documented tumor progression per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or death due to any cause, whichever occurs first. DOR will be computed for participants who achieve partial response (PR) or complete response (CR) only. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all lesions and normalization of tumor marker level. All lymph nodes (whether target or non-target) must be non-pathological in size (< 10mm short axis).
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- Time to onset of all high grade IMAEs [ Time Frame: Approximately 3 months ]
- Time to resolution of all high grade IMAEs [ Time Frame: Approximately 48 months ]
- Percentage of patients who received immune modulating medication due to high grade IMAEs [ Time Frame: Approximately 48 months ]
- Progression-free survival at time of initial progression (PFS 1) [ Time Frame: Approximately 48 months ]
- Objective response rate (ORR) [ Time Frame: Approximately 48 months ]
- Time to response (TTR) [ Time Frame: Approximately 48 months ]
- Duration of response (DOR) [ Time Frame: Approximately 48 months ]
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Not Provided
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Not Provided
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A Study to Evaluate the Safety of Nivolumab and Ipilimumab in Subjects With Previously Untreated Advanced or Metastatic Renal Cell Cancer
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Phase 3b/4 Safety Trial of Nivolumab Combined With Ipilimumab in Subjects With Previously Untreated, Advanced or Metastatic RCC (CheckMate 920: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 920)
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To investigate the safety of Nivolumab in combination with Ipilimumab in subjects with previously untreated advanced or metastatic Renal Cell Cancer.
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Not Provided
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Interventional
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Phase 4
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Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
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Renal Cell Carcinoma
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- Experimental: ccRCC KPS ≥ 70%
Clear-Cell Renal Cell Carcinoma (ccRCC) with Karnofsky Performance Status (KPS) ≥ 70%
Interventions:
- Drug: Nivolumab
- Drug: Ipilimumab
- Experimental: Non-ccRCC, KPS ≥ 70%
Non Clear-Cell Renal Cell Carcinoma (nccRCC) with KPS ≥ 70%
Interventions:
- Drug: Nivolumab
- Drug: Ipilimumab
- Experimental: RCC with non-active Brain Mets, KPS ≥70%
Renal Cell Carcinoma (RCC) with non-active Brain Metastases, with KPS ≥70%
Interventions:
- Drug: Nivolumab
- Drug: Ipilimumab
- Experimental: any RCC with KPS 50%-60%
Renal Cell Carcinoma (RCC), regardless of any histology or existing non-active brain metastasis, with KPS 50%-60%
Interventions:
- Drug: Nivolumab
- Drug: Ipilimumab
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- George DJ, Spigel DR, Gordan LN, Kochuparambil ST, Molina AM, Yorio J, Rezazadeh Kalebasty A, McKean H, Tchekmedyian N, Tykodi SS, Zhang J, Askelson M, Johansen JL, Hutson TE. Safety and efficacy of first-line nivolumab plus ipilimumab alternating with nivolumab monotherapy in patients with advanced renal cell carcinoma: the non-randomised, open-label, phase IIIb/IV CheckMate 920 trial. BMJ Open. 2022 Sep 14;12(9):e058396. doi: 10.1136/bmjopen-2021-058396.
- Tykodi SS, Gordan LN, Alter RS, Arrowsmith E, Harrison MR, Percent I, Singal R, Van Veldhuizen P, George DJ, Hutson T, Zhang J, Zoco J, Johansen JL, Rezazadeh Kalebasty A. Safety and efficacy of nivolumab plus ipilimumab in patients with advanced non-clear cell renal cell carcinoma: results from the phase 3b/4 CheckMate 920 trial. J Immunother Cancer. 2022 Feb;10(2):e003844. doi: 10.1136/jitc-2021-003844.
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Completed
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211
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200
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October 6, 2021
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May 11, 2020 (Final data collection date for primary outcome measure)
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Inclusion Criteria:
1. Type of Participant and Target Disease Characteristics
- Advanced or metastatic RCC
- Histologically confirmed, previously untreated (treatment-naive) RCC
- No prior systemic therapy for RCC except for one prior adjuvant or neoadjuvant therapy for completely resectable RCC
- Measurable disease as per RECIST 1.1. Subject must have extracranial metastasis as measurable disease
- Karnofsky Performance Status (KPS) of at least 70% for Cohort 1, 2, and 3; KPS of 50-60% for Cohort 4
- Tumor tissue need be received by the central vendor (block or unstained slides). Note: Fine Needle Aspiration (FNA)and bone metastases samples are not acceptable for submission.
Exclusion Criteria:
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Medical Conditions
- Subjects with any active autoimmune disease or a history of known autoimmune disease
- Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
- Known HIV or AIDS-related illness
- Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection.
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Prior/Concomitant Therapy
- Prior systemic treatment in the metastatic setting with Vascular epithelial growth factor(VEGF) or VEGF receptor targeted therapy
- Prior treatment with an anti-Programmed Death (PD) -1, anti-PD-L1, anti-PD-L2, anti-cluster of differentiation 137 (CD137), or anti-cytotoxic T-lymphocyte-associated antigen 4(CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. This includes the utilization of these agents in the neo-adjuvant or adjuvant setting.
- Anti-cancer therapy less than 28 days prior to the first dose of study drug or palliative, focal radiation therapy less than 14 days prior to the first dose of study drug.
Other protocol defined inclusion/exclusion criteria apply
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Sexes Eligible for Study: |
All |
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18 Years and older (Adult, Older Adult)
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No
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Contact information is only displayed when the study is recruiting subjects
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United States
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NCT02982954
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CA209-920
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Yes
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Studies a U.S. FDA-regulated Drug Product: |
Yes |
Studies a U.S. FDA-regulated Device Product: |
No |
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Not Provided
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Bristol-Myers Squibb
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Same as current
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Bristol-Myers Squibb
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Same as current
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Not Provided
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Study Director: |
Bristol-Myers Squibb |
Bristol-Myers Squibb |
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Bristol-Myers Squibb
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October 2022
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