18 and older, any sex, with Renal Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With High Grade (Grade 3-4) Immune Mediated Adverse Events (IMAEs)Primary· Approximately 39 Months
Number of participants with IMAEs in the following categories: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity
Pneumonitis
Group
Value
95% CI
Cohort 1
1
Cohort 2
0
Cohort 3
0
Cohort 4
0
Diarrhoea/Colitis
Group
Value
95% CI
Cohort 1
8
Cohort 2
4
Cohort 3
2
Cohort 4
0
Hepatitis
Group
Value
95% CI
Cohort 1
3
Cohort 2
1
Cohort 3
1
Cohort 4
1
Nephritis and Renal Dysfunction
Group
Value
95% CI
Cohort 1
0
Cohort 2
2
Cohort 3
0
Cohort 4
0
Rash
Group
Value
95% CI
Cohort 1
7
Cohort 2
3
Cohort 3
1
Cohort 4
0
Hypersensitivity
Group
Value
95% CI
Cohort 1
0
Cohort 2
0
Cohort 3
0
Cohort 4
0
Adrenal Insufficiency
Group
Value
95% CI
Cohort 1
3
Cohort 2
1
Cohort 3
0
Cohort 4
1
Hypothyroidism and Thyroiditis
Group
Value
95% CI
Cohort 1
0
Cohort 2
0
Cohort 3
0
Cohort 4
1
Number of Participants With High Grade (Grade 5) Immune Mediated Adverse Events (IMAEs)Primary· Approximately 39 Months
Number of participants with IMAEs in the following categories: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity
Pneumonitis
Group
Value
95% CI
Cohort 1
0
Cohort 2
0
Cohort 3
0
Cohort 4
0
Diarrhoea/Colitis
Group
Value
95% CI
Cohort 1
0
Cohort 2
0
Cohort 3
0
Cohort 4
0
Hepatitis
Group
Value
95% CI
Cohort 1
0
Cohort 2
0
Cohort 3
0
Cohort 4
0
Nephritis and Renal Dysfunction
Group
Value
95% CI
Cohort 1
0
Cohort 2
0
Cohort 3
0
Cohort 4
0
Rash
Group
Value
95% CI
Cohort 1
0
Cohort 2
0
Cohort 3
0
Cohort 4
0
Hypersensitivity
Group
Value
95% CI
Cohort 1
0
Cohort 2
0
Cohort 3
0
Cohort 4
0
Adrenal Insufficiency
Group
Value
95% CI
Cohort 1
0
Cohort 2
0
Cohort 3
0
Cohort 4
0
Hypothyroidism and Thyroiditis
Group
Value
95% CI
Cohort 1
0
Cohort 2
0
Cohort 3
0
Cohort 4
0
Time to Onset of Grade 3-5 Immune Mediated Adverse Events (IMAEs)Secondary· 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
Pneumonitis
Group
Value
95% CI
Cohort 1
12.7
12.7 – 12.7
Diarrhoea/Colitis
Group
Value
95% CI
Cohort 1
21.79
1.7 – 115.7
Cohort 2
10.43
4.4 – 20.1
Cohort 3
11.0
10.1 – 11.9
Hepatitis
Group
Value
95% CI
Cohort 1
8.43
2.0 – 82.1
Cohort 2
9.4
9.4 – 9.4
Cohort 3
11.6
11.6 – 11.6
Cohort 4
10.1
10.1 – 10.1
Nephritis and Renal Dysfunction
Group
Value
95% CI
Cohort 2
9.43
1.4 – 17.4
Rash
Group
Value
95% CI
Cohort 1
4.00
1.1 – 80.4
Cohort 2
6.14
2.3 – 13.7
Cohort 3
8.3
8.3 – 8.3
Immune Mediated Arthritis
Group
Value
95% CI
Cohort 2
38.9
38.9 – 38.9
Time to Resolution of Grade 3-5 Immune Mediated Adverse Events (IMAEs)Secondary· 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
Pneumonitis
Group
Value
95% CI
Cohort 1
0.9
0.9 – 0.9
Diarrhoea/Colitis
Group
Value
95% CI
Cohort 1
2.71
0.7 – 193.9
Cohort 2
5.93
0.9 – 16.9
Cohort 3
1.14
1.1 – 4.9
Hepatitis
Group
Value
95% CI
Cohort 1
NA
7.9 – 144.9
Cohort 2
NA
14.9 – 18.3
Cohort 3
3.00
3.0 – 3.0
Cohort 4
2.1
2.1 – 2.1
Nephritis and Renal Dysfunction
Group
Value
95% CI
Cohort 2
7.79
1.1 – 14.4
Rash
Group
Value
95% CI
Cohort 1
26.86
5.3 – 181.6
Cohort 2
8.00
3.1 – 69.9
Cohort 3
5.3
5.3 – 5.3
Adrenal Insufficiency
Group
Value
95% CI
Cohort 1
NA
0.4 – 170.0
Cohort 4
6.0
6.0 – 6.0
Diabetes Mellitus
Group
Value
95% CI
Cohort 3
1.1
1.1 – 1.1
Number of Participants Who Received Immune Modulating Medication for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)Secondary· 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 al
Pneumonitis
Group
Value
95% CI
Cohort 1
1
Cohort 2
0
Cohort 3
0
Cohort 4
0
Diarrhoea/Colitis
Group
Value
95% CI
Cohort 1
8
Cohort 2
4
Cohort 3
2
Cohort 4
0
Hepatitis
Group
Value
95% CI
Cohort 1
3
Cohort 2
1
Cohort 3
1
Cohort 4
1
Nephritis and Renal Dysfunction
Group
Value
95% CI
Cohort 1
0
Cohort 2
2
Cohort 3
0
Cohort 4
0
Rash
Group
Value
95% CI
Cohort 1
7
Cohort 2
3
Cohort 3
1
Cohort 4
0
Hypersensitivity
Group
Value
95% CI
Cohort 1
0
Cohort 2
0
Cohort 3
0
Cohort 4
0
Adrenal Insufficiency
Group
Value
95% CI
Cohort 1
3
Cohort 2
1
Cohort 3
0
Cohort 4
1
Hypothyroidism/Thyroiditis
Group
Value
95% CI
Cohort 1
0
Cohort 2
0
Cohort 3
0
Cohort 4
1
Number of Participants Who Received Hormone Replacement Therapy for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)Secondary· 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 etiolo
Pneumonitis
Group
Value
95% CI
Cohort 1
1
Cohort 2
0
Cohort 3
0
Cohort 4
0
Diarrhoea/Colitis
Group
Value
95% CI
Cohort 1
8
Cohort 2
3
Cohort 3
2
Cohort 4
0
Hepatitis
Group
Value
95% CI
Cohort 1
3
Cohort 2
1
Cohort 3
1
Cohort 4
1
Nephritis and Renal Dysfunction
Group
Value
95% CI
Cohort 1
0
Cohort 2
2
Cohort 3
0
Cohort 4
0
Rash
Group
Value
95% CI
Cohort 1
7
Cohort 2
3
Cohort 3
1
Cohort 4
0
Adrenal Insufficiency
Group
Value
95% CI
Cohort 1
2
Cohort 2
1
Cohort 3
0
Cohort 4
1
Number of Participants Who Received ≥ 40mg of Prednisone for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)Secondary· 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 causali
Group
Value
95% CI
Cohort 1
19
Cohort 2
9
Cohort 3
5
Cohort 4
2
Median Progression Free Survival (PFS)Secondary· 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. T
Group
Value
95% CI
Cohort 1
4.8
3.0 – 8.4
Cohort 2
3.7
2.7 – 4.6
Cohort 3
8.5
2.9 – 12.0
Cohort 4
3.6
2.5 – 8.7
Objective Response Rate (ORR)Secondary· 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 les
Group
Value
95% CI
Cohort 1
35.4
25.9 – 45.8
Cohort 2
21.7
10.9 – 36.4
Cohort 3
30.8
14.3 – 51.8
Cohort 4
33.3
13.3 – 59.0
Time to Response Rate (TRR)Secondary· 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 tar
Group
Value
95% CI
Cohort 1
2.8
2.5 – 14.6
Cohort 2
2.8
2.1 – 4.5
Cohort 3
2.8
2.4 – 3.0
Cohort 4
4.5
2.5 – 12.1
Duration of Response (DOR)Secondary· 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
Group
Value
95% CI
Cohort 1
11.01
7.10 – NA
Cohort 2
37.68
10.87 – NA
Cohort 3
16.51
3.88 – 47.87
Cohort 4
19.48
6.28 – 20.57
Adverse events — posted to ClinicalTrials.gov
Time frame: SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 29 months). Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 56 months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cohort 1
Serious: 63/106 (59%)
Deaths: 55/106
Cohort 2
Serious: 29/52 (56%)
Deaths: 29/52
Cohort 3
Serious: 14/28 (50%)
Deaths: 15/28
Cohort 4
Serious: 17/25 (68%)
Deaths: 20/25
Serious adverse events (131 terms)
Reaction
System
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
—
Colitis
Gastrointestinal disorders
—
—
—
—
Pneumonia
Infections and infestations
—
—
—
—
Atrial fibrillation
Cardiac disorders
—
—
—
—
Adrenal insufficiency
Endocrine disorders
—
—
—
—
Diarrhoea
Gastrointestinal disorders
—
—
—
—
Sepsis
Infections and infestations
—
—
—
—
Dehydration
Metabolism and nutrition disorders
—
—
—
—
Pneumonitis
Respiratory, thoracic and mediastinal disorders
—
—
—
—
Acute myocardial infarction
Cardiac disorders
—
—
—
—
Nausea
Gastrointestinal disorders
—
—
—
—
Pancreatitis
Gastrointestinal disorders
—
—
—
—
Vomiting
Gastrointestinal disorders
—
—
—
—
Asthenia
General disorders
—
—
—
—
Urinary tract infection
Infections and infestations
—
—
—
—
Blood creatinine increased
Investigations
—
—
—
—
Hepatic enzyme increased
Investigations
—
—
—
—
Diabetic ketoacidosis
Metabolism and nutrition disorders
—
—
—
—
Hypercalcaemia
Metabolism and nutrition disorders
—
—
—
—
Hyperglycaemia
Metabolism and nutrition disorders
—
—
—
—
Hyponatraemia
Metabolism and nutrition disorders
—
—
—
—
Syncope
Nervous system disorders
—
—
—
—
Mental status changes
Psychiatric disorders
—
—
—
—
Acute kidney injury
Renal and urinary disorders
—
—
—
—
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
—
—
—
—
Other adverse events (108 terms — click to expand)
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
Last refreshed: 1 November 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02982954.