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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005379-18 | EudraCT Number |
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| Name | Class |
|---|---|
| Ono Pharma USA Inc | INDUSTRY |
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The purpose of this study is to evaluate the pharmacodynamic and biologic properties of BMS-936558 in subjects with metastatic renal cell carcinoma.
Intervention Model: Parallel Dose Comparison
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: BMS-936558 | Experimental |
| |
| Arm 2: BMS-936558 | Experimental |
| |
| Arm 3: BMS-936558 | Experimental |
| |
| Arm 4: BMS-936558 | Experimental | (treatment naive) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-936558 (Anti-PD-1) | Drug | Solution, Intravenous infusion, 0.3 mg/kg, Every 3 weeks, Indefinitely depending on response |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Activated and Memory T Cells | The objective of the study was to investigate the pharmacodynamic immunomodulatory activity of anti-PD-1 antibody in activated and memory T cells with metastatic clear-cell Renal Cell Carcinoma (RCC) | Baseline, Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 8, Cycle 2 Day 8, Cycle 4 Day 1 |
| Mean Serum Cytokines: CXCL9 | Objective is to investigate the pharmacodynamic immunomodulatory activity of serum chemokines (CXCL9, CXCL10) | Baseline, Cycle 1 Day 1 3 Hrs Post, Cycle 1 Day 1 7 Hr Post, Cycle 1 Day 2 24 Hr Post, Cycle 2 Day 1 0 Hr Pre, Cycle 2 Day 8 168 Hrs Post, Cycle 4 Day 1 O Hr Pre (~39 months) |
| Mean Serum Cytokines CXCL10 (IP10) | Objective is to investigate the pharmacodynamic immunomodulatory activity of serum chemokines (CXCL9, CXCL10) | Baseline, Cycle 1 Day 1 3 Hrs Post, Cycle 1 Day 1 7 Hr Post, Cycle 1 Day 2 24 Hr Post, Cycle 2 Day 1 0 Hr Pre, Cycle 2 Day 8 168 Hrs Post, Cycle 4 Day 1 O Hr Pre (~39 months) |
| Mean CD4 T Cell Infiltration | The objective of the study was to investigate the pharmacodynamic immunomodulatory activity of anti-PD-1 antibody on circulating CD4 infiltrations in tumors in participants with metastatic clear-cell Renal Cell Carcinoma (RCC). | Cycle 2 Day 8 168 Hr post dose |
| Mean CD8 T Cell Infiltration | The objective of the study was to investigate the pharmacodynamic immunomodulatory activity of anti-PD-1 antibody on circulating CD8 infiltrations in tumors in participants with metastatic clear-cell Renal Cell Carcinoma (RCC). | 168 hour post does Cycle 2 Day 8 in evaluable participates (First active dose of study medication to cycle two day eight post injection) |
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response in the BMS-936558 Arms | Baseline and post-nivolumab treatment modulation of serum levels of interferon-gamma stimulated chemokines CXCL9 and CXCL10 (IP10) were assessed. The participant's best response designation over the study as a whole, recorded between the date of first study drug administration and the date of objectively documented progression per Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ucsf Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94115 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33658305 | Derived | Ross-Macdonald P, Walsh AM, Chasalow SD, Ammar R, Papillon-Cavanagh S, Szabo PM, Choueiri TK, Sznol M, Wind-Rotolo M. Molecular correlates of response to nivolumab at baseline and on treatment in patients with RCC. J Immunother Cancer. 2021 Mar;9(3):e001506. doi: 10.1136/jitc-2020-001506. | |
| 32371459 | Derived |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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119 participants were enrolled, 92 participants were randomized of whom 1 was randomized but not treated. 27 participants did not enter treatment period due to: Participant withdrawal n = 1, Death n = 1, No longer meets criteria n = 22, Other reasons n = 3
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| ID | Title | Description |
|---|---|---|
| FG000 | Nivolumab 0.3 mg/kg (Previously-treated) | Nivolumab was administered as a 60 minute IV infusion to participants who were previously treated with at least one anti-angiogenic therapy. Participants were dosed every 3 weeks until discontinuation or the end of the study. |
| FG001 | Nivolumab 2 mg/kg (Previously-treated) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| BMS-936558 (Anti-PD-1) | Drug | Solution, Intravenous infusion, 2 mg/kg, Every 3 weeks, Indefinitely depending on response |
|
| BMS-936558 (Anti-PD-1) | Drug | Solution, Intravenous infusion, 10 mg/kg, Every 3 weeks, Indefinitely depending on response |
|
| Assessed at a minimum of every 3 weeks up to 70 days following discontinuation of study drug (up to approximately 39 months) |
| Progression Free Survival Rate in BMS-936558 | PFS is defined as the time from treatment arm assignment to the date of first documented disease progression. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last tumor assessment. Participants who did not have any on study tumor assessments will be censored on the date they were assigned a treatment arm. PFS rate is the percentage of participants who did not have disease progression at particular time points (16 weeks, 24 weeks, 48 weeks) | Progression free survival rate will be assessed in each individual treatment arm by tumor assessments at 16, 24, and 48 weeks. From initial dose to end of study (assessed up to 39 months) |
| Objective Response Rate in BMS-936558 | The total number of subjects whose best overall response (BOR) is either a complete response (CR) or partial response (PR) divided by the total number of participants in the population of interest, and expressed as a percentage. | Up to 22 months after study start |
| Duration of Objective Response for BMS-936558 | The duration of response is defined as the time when the measurement criteria are first met for PR or CR (whichever is reported first) until the date of documented disease progression or death. For subjects who neither progress nor die, the duration of response will be censored at the date of their last tumor assessment. | The time when the measurement criteria are first met for PR or CR (whichever is reported first) until the date of documented disease progression or death (assessed up to 39 months) |
| Duration of Stable Disease for BMS-936558 as Measured in Participants Whose Best Overall Response is Stable Disease as the Time From Baseline Until the Date of Documented Disease Progression or Death | Duration of stable disease (SD) is defined in participants whose BOR is SD at the time from treatment arm assignment until the criteria for progression are met or death (whichever occurs first). Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last tumor assessment | The time from treatment arm assignment until the criteria for progression are met or death (whichever occurs first)(assessed up to 39 months) |
| Immunogenicity of BMS-936558 as Measured by the Detection of Human Antibodies Against BMS-936558 | Blood samples to evaluate the development of a positive anti-drug antibodies (ADA) response at the doses tested will be collected at time-points pre-dose, C4D1, C8D1 and during follow-up. | Pre-dose, Cycle 4 Day 1, Cycle 8 Day 1 and during follow-up. |
| Yale University School Of Medicine |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| H. Lee Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| University Of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| The Bunting-Blaustein Cancer Research Building | Baltimore | Maryland | 21231 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Dana Farber Cancer Inst | Boston | Massachusetts | 02215 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Providence Portland Med Ctr | Portland | Oregon | 97213 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Upmc Cancer Pavilion | Pittsburgh | Pennsylvania | 15232 | United States |
| University Of Wisconsin Carbone Cancer Center | Madison | Wisconsin | 53705 | United States |
| Local Institution | Villejuif | 94805 | France |
| Local Institution | Pamplona | 31192 | Spain |
| Zhou Q, Qi Y, Wang Z, Zeng H, Zhang H, Liu Z, Huang Q, Xiong Y, Wang J, Chang Y, Bai Q, Xia Y, Wang Y, Liu L, Xu L, Dai B, Guo J, Zhu Y, Zhang W, Xu J. CCR5 blockade inflames antitumor immunity in BAP1-mutant clear cell renal cell carcinoma. J Immunother Cancer. 2020 Apr;8(1):e000228. doi: 10.1136/jitc-2019-000228. |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls | View source |
Nivolumab was administered as a 60 minute IV infusion to participants who were previously treated with at least one anti-angiogenic therapy. Participants were dosed every 3 weeks until discontinuation or the end of the study. |
| FG002 | Nivolumab 10 mg/kg (Previously-treated) | Nivolumab was administered as a 60 minute IV infusion to participants who were previously treated with at least one anti-angiogenic therapy. Participants were dosed every 3 weeks until discontinuation or the end of the study. |
| FG003 | Nivolumab 10 mg/kg (Treatment-naive) | Nivolumab was administered as a 60 minute IV infusion to treatment-naive participants. Participants were dosed every 3 weeks until discontinuation or the end of the study. |
| COMPLETED | Completed = continuing in the treatment period |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nivolumab 0.3 mg/kg (Previously-treated) | Nivolumab was administered as a 60 minute IV infusion to participants who were previously treated with at least one anti-angiogenic therapy. Participants were dosed every 3 weeks until discontinuation or the end of the study. |
| BG001 | Nivolumab 2 mg/kg (Previously-treated) | Nivolumab was administered as a 60 minute IV infusion to participants who were previously treated with at least one anti-angiogenic therapy. Participants were dosed every 3 weeks until discontinuation or the end of the study. |
| BG002 | Nivolumab 10 mg/kg (Previously-treated) | Nivolumab was administered as a 60 minute IV infusion to participants who were previously treated with at least one anti-angiogenic therapy. Participants were dosed every 3 weeks until discontinuation or the end of the study. |
| BG003 | Nivolumab 10 mg/kg (Treatment-naive) | Nivolumab was administered as a 60 minute IV infusion to treatment-naive participants. Participants were dosed every 3 weeks until discontinuation or the end of the study. |
| 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Percent Change From Baseline in Activated and Memory T Cells | The objective of the study was to investigate the pharmacodynamic immunomodulatory activity of anti-PD-1 antibody in activated and memory T cells with metastatic clear-cell Renal Cell Carcinoma (RCC) | All participants in the biomarker data set with baseline measurement and at least one on treatment measurement were included in pharmacodynamic analyses. | Posted | Mean | 95% Confidence Interval | Percentage | Baseline, Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 8, Cycle 2 Day 8, Cycle 4 Day 1 |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | Mean Serum Cytokines: CXCL9 | Objective is to investigate the pharmacodynamic immunomodulatory activity of serum chemokines (CXCL9, CXCL10) | Biomarker evaluable population: All treated participants with at least one measurement for a specific marker were included in the data set for that marker. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Cycle 1 Day 1 3 Hrs Post, Cycle 1 Day 1 7 Hr Post, Cycle 1 Day 2 24 Hr Post, Cycle 2 Day 1 0 Hr Pre, Cycle 2 Day 8 168 Hrs Post, Cycle 4 Day 1 O Hr Pre (~39 months) |
| ||||||||||||||||||||||||||||||||||||
| Primary | Mean Serum Cytokines CXCL10 (IP10) | Objective is to investigate the pharmacodynamic immunomodulatory activity of serum chemokines (CXCL9, CXCL10) | Biomarker evaluable population: All treated participants with at least one measurement for a specific marker were included in the data set for that marker. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Cycle 1 Day 1 3 Hrs Post, Cycle 1 Day 1 7 Hr Post, Cycle 1 Day 2 24 Hr Post, Cycle 2 Day 1 0 Hr Pre, Cycle 2 Day 8 168 Hrs Post, Cycle 4 Day 1 O Hr Pre (~39 months) |
| ||||||||||||||||||||||||||||||||||||
| Primary | Mean CD4 T Cell Infiltration | The objective of the study was to investigate the pharmacodynamic immunomodulatory activity of anti-PD-1 antibody on circulating CD4 infiltrations in tumors in participants with metastatic clear-cell Renal Cell Carcinoma (RCC). | Biomarker evaluable population: All treated participants with at least one measurement for a specific marker were included in the data set for that marker. | Posted | Mean | Standard Deviation | Number of CD4+ Cells | Cycle 2 Day 8 168 Hr post dose |
| ||||||||||||||||||||||||||||||||||||
| Primary | Mean CD8 T Cell Infiltration | The objective of the study was to investigate the pharmacodynamic immunomodulatory activity of anti-PD-1 antibody on circulating CD8 infiltrations in tumors in participants with metastatic clear-cell Renal Cell Carcinoma (RCC). | Biomarker evaluable population: All treated participants at least one measurement for a specific marker were included in the data set for that marker. | Posted | Mean | Standard Deviation | Number of CD8 cells | 168 hour post does Cycle 2 Day 8 in evaluable participates (First active dose of study medication to cycle two day eight post injection) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Best Overall Response in the BMS-936558 Arms | Baseline and post-nivolumab treatment modulation of serum levels of interferon-gamma stimulated chemokines CXCL9 and CXCL10 (IP10) were assessed. The participant's best response designation over the study as a whole, recorded between the date of first study drug administration and the date of objectively documented progression per Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR | All treated participants | Posted | Count of Participants | Participants | Assessed at a minimum of every 3 weeks up to 70 days following discontinuation of study drug (up to approximately 39 months) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival Rate in BMS-936558 | PFS is defined as the time from treatment arm assignment to the date of first documented disease progression. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last tumor assessment. Participants who did not have any on study tumor assessments will be censored on the date they were assigned a treatment arm. PFS rate is the percentage of participants who did not have disease progression at particular time points (16 weeks, 24 weeks, 48 weeks) | All treated participants | Posted | Number | 95% Confidence Interval | percent | Progression free survival rate will be assessed in each individual treatment arm by tumor assessments at 16, 24, and 48 weeks. From initial dose to end of study (assessed up to 39 months) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate in BMS-936558 | The total number of subjects whose best overall response (BOR) is either a complete response (CR) or partial response (PR) divided by the total number of participants in the population of interest, and expressed as a percentage. | All treated participants | Posted | Number | 95% Confidence Interval | percent | Up to 22 months after study start |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Objective Response for BMS-936558 | The duration of response is defined as the time when the measurement criteria are first met for PR or CR (whichever is reported first) until the date of documented disease progression or death. For subjects who neither progress nor die, the duration of response will be censored at the date of their last tumor assessment. | All treated participants | Posted | Median | 95% Confidence Interval | weeks | The time when the measurement criteria are first met for PR or CR (whichever is reported first) until the date of documented disease progression or death (assessed up to 39 months) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Stable Disease for BMS-936558 as Measured in Participants Whose Best Overall Response is Stable Disease as the Time From Baseline Until the Date of Documented Disease Progression or Death | Duration of stable disease (SD) is defined in participants whose BOR is SD at the time from treatment arm assignment until the criteria for progression are met or death (whichever occurs first). Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last tumor assessment | All treated participants | Posted | Median | 95% Confidence Interval | weeks | The time from treatment arm assignment until the criteria for progression are met or death (whichever occurs first)(assessed up to 39 months) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Immunogenicity of BMS-936558 as Measured by the Detection of Human Antibodies Against BMS-936558 | Blood samples to evaluate the development of a positive anti-drug antibodies (ADA) response at the doses tested will be collected at time-points pre-dose, C4D1, C8D1 and during follow-up. | ADA-Positive Subject: A subject with at least one ADA-positive sample at any time after initiation of treatment. ADA-Negative Subject: A subject with no ADA-positive sample after the initiation of treatment | Posted | Number | percentage | Pre-dose, Cycle 4 Day 1, Cycle 8 Day 1 and during follow-up. |
|
From first dose to within 100 days of last dose. (10/2011 - 01/2015). From First dose up to 100 days after last dose of study drug, assessed up to January 2017 (approximately 39 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BMS 0.3 mg/kg | Nivolumab was administered as a 60 minute IV infusion to participants who were previously treated with at least one anti-angiogenic therapy. Participants were dosed every 3 weeks until discontinuation or the end of the study. | 13 | 22 | 22 | 22 | ||
| EG001 | BMS 2 mg/kg | Nivolumab was administered as a 60 minute IV infusion to participants who were previously treated with at least one anti-angiogenic therapy. Participants were dosed every 3 weeks until discontinuation or the end of the study. | 11 | 22 | 22 | 22 | ||
| EG002 | BMS 10 mg/kg | Nivolumab was administered as a 60 minute IV infusion to participants who were previously treated with at least one anti-angiogenic therapy. Participants were dosed every 3 weeks until discontinuation or the end of the study. | 12 | 23 | 23 | 23 | ||
| EG003 | BMS 10 mg/Kg-N | Nivolumab was administered as a 60 minute IV infusion to treatment-naive participants. Participants were dosed every 3 weeks until discontinuation or the end of the study. | 13 | 24 | 24 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial flutter | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Papilloedema | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Metastases to testicle | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Central nervous system necrosis | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
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| Renal colic | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Renal mass | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Haematemesis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Thermal burn | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Amylase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 20.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
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| Ataxia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Facial nerve disorder | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Paralysis | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | MedDRA 20.0 | Systematic Assessment |
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| Eye pruritus | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20.0 | 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 | Clinical.Trials@bms.com |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Cycle 1 Day 2 |
|
| Cycle 1 Day 8 |
|
| Cycle 2 Day 8 |
|
| Cycle 4 Day 1 |
|
| OG003 | Nivolumab 10 mg/kg (Treatment-naive) | Nivolumab was administered as a 60 minute IV infusion to treatment-naive participants. Participants were dosed every 3 weeks until discontinuation or the end of the study. |
|
|
| OG003 | Nivolumab 10 mg/kg (Treatment-naive) | Nivolumab was administered as a 60 minute IV infusion to treatment-naive participants. Participants were dosed every 3 weeks until discontinuation or the end of the study. |
|
|
| OG003 | Nivolumab 10 mg/kg (Treatment-naive) | Nivolumab was administered as a 60 minute IV infusion to treatment-naive participants. Participants were dosed every 3 weeks until discontinuation or the end of the study. |
|
|
Nivolumab was administered as a 60 minute IV infusion to participants who were previously treated with at least one anti-angiogenic therapy. Participants were dosed every 3 weeks until discontinuation or the end of the study.
| OG003 | Nivolumab 10 mg/kg (Treatment-naive) | Nivolumab was administered as a 60 minute IV infusion to treatment-naive participants. Participants were dosed every 3 weeks until discontinuation or the end of the study. |
|
|
| OG002 | Nivolumab 10 mg/kg (Previously-treated) | Nivolumab was administered as a 60 minute IV infusion to participants who were previously treated with at least one anti-angiogenic therapy. Participants were dosed every 3 weeks until discontinuation or the end of the study. |
| OG003 | Nivolumab 10 mg/kg (Treatment-naive) | Nivolumab was administered as a 60 minute IV infusion to treatment-naive participants. Participants were dosed every 3 weeks until discontinuation or the end of the study. |
|
|
| OG002 | Nivolumab 10 mg/kg (Previously-treated) | Nivolumab was administered as a 60 minute IV infusion to participants who were previously treated with at least one anti-angiogenic therapy. Participants were dosed every 3 weeks until discontinuation or the end of the study. |
| OG003 | Nivolumab 10 mg/kg (Treatment-naive) | Nivolumab was administered as a 60 minute IV infusion to treatment-naive participants. Participants were dosed every 3 weeks until discontinuation or the end of the study. |
|
|
| OG003 | Nivolumab 10 mg/kg (Treatment-naive) | Nivolumab was administered as a 60 minute IV infusion to treatment-naive participants. Participants were dosed every 3 weeks until discontinuation or the end of the study. |
|
|
Nivolumab was administered as a 60 minute IV infusion to participants who were previously treated with at least one anti-angiogenic therapy. Participants were dosed every 3 weeks until discontinuation or the end of the study.
| OG003 | Nivolumab 10 mg/kg (Treatment-naive) | Nivolumab was administered as a 60 minute IV infusion to treatment-naive participants. Participants were dosed every 3 weeks until discontinuation or the end of the study. |
|
|
| OG002 | Nivolumab 10 mg/kg (Previously-treated) | Nivolumab was administered as a 60 minute IV infusion to participants who were previously treated with at least one anti-angiogenic therapy. Participants were dosed every 3 weeks until discontinuation or the end of the study. |
| OG003 | Nivolumab 10 mg/kg (Treatment-naive) | Nivolumab was administered as a 60 minute IV infusion to treatment-naive participants. Participants were dosed every 3 weeks until discontinuation or the end of the study. |
|
|
Nivolumab was administered as a 60 minute IV infusion to participants who were previously treated with at least one anti-angiogenic therapy. Participants were dosed every 3 weeks until discontinuation or the end of the study.
| OG003 | Nivolumab 10 mg/kg (Treatment-naive) | Nivolumab was administered as a 60 minute IV infusion to treatment-naive participants. Participants were dosed every 3 weeks until discontinuation or the end of the study. |
|
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