A Phase 4 interventional study of Nivolumab and Ipilimumab in Renal Cell Carcinoma, sponsored by Bristol-Myers Squibb. Completed at 61 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-01.
Sponsored by Bristol-Myers Squibb · Phase 4, Interventional, and Treatment
To investigate the safety of Nivolumab in combination with Ipilimumab in subjects with previously untreated advanced or metastatic Renal Cell Cancer.
1,965 studies on the registry are indexed under Carcinoma, Renal Cell; 378 are open to participants now.
This study's enrollment of 211 is above the median of 42 across 1,480 interventional studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Medical Conditions
Prior/Concomitant Therapy
Other protocol defined inclusion/exclusion criteria apply
Clear-Cell Renal Cell Carcinoma (ccRCC) with Karnofsky Performance Status (KPS) ≥ 70%
Drug: Nivolumab · Drug: Ipilimumab
Non Clear-Cell Renal Cell Carcinoma (nccRCC) with KPS ≥ 70%
Drug: Nivolumab · Drug: Ipilimumab
Renal Cell Carcinoma (RCC) with non-active Brain Metastases, with KPS ≥70%
Drug: Nivolumab · Drug: Ipilimumab
Renal Cell Carcinoma (RCC), regardless of any histology or existing non-active brain metastasis, with KPS 50%-60%
Drug: Nivolumab · Drug: Ipilimumab
Specified dose on specified day
Also known as: BMS-936558, Opdivo
Specified Dose on Specified Day
Also known as: Yervoy, BMS-734016
Number of Participants With High Grade (Grade 3-4) Immune Mediated Adverse Events (IMAEs)
Number of participants with IMAEs in the following categories: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity
Time frame: Approximately 39 Months
Number of Participants With High Grade (Grade 5) Immune Mediated Adverse Events (IMAEs)
Number of participants with IMAEs in the following categories: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity
Time frame: Approximately 39 Months
Time to Onset of Grade 3-5 Immune Mediated Adverse Events (IMAEs)
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 frame: From first dose to the earliest IMAE (grade 3-5) event onset date (up to approximately 116 weeks)
Time to Resolution of Grade 3-5 Immune Mediated Adverse Events (IMAEs)
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
Time frame: From the IMAE onset date to the IMAE end date, up to approximately 194 weeks
Number of Participants Who Received Immune Modulating Medication for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)
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
Time frame: From first dose up to 100 days post last dose (up to approximately 29 months)
Number of Participants Who Received Hormone Replacement Therapy for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)
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
Time frame: From first dose up to 100 days post last dose (up to approximately 29 months)
Number of Participants Who Received ≥ 40mg of Prednisone for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)
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
Time frame: From first dose up to 100 days post last dose (up to approximately 29 months)
Median Progression Free Survival (PFS)
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.
Time frame: From first dose to the date of the first documented progressive disease, up to approximately 12 months
Objective Response Rate (ORR)
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 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)
Time to Response Rate (TRR)
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).
Time frame: From the date of first dose to first documented CR or PR, up to approximately 15 months
Duration of Response (DOR)
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).
Time frame: From first confirmed response to the date of the first documented tumor progression or death, up to approximately 48 months
| Milestone | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|
| Started | 106 | 52 | 28 | 25 |
| Completed | 0 | 0 | 0 | 0 |
| Not completed | 106 | 52 | 28 | 25 |
| Withdrew: Death | 55 | 29 | 15 | 20 |
| Withdrew: Lost to follow-up | 2 | 1 | 0 | 0 |
| Withdrew: Participant withdrew consent | 7 | 5 | 1 | 1 |
| Withdrew: Other reasons | 42 | 17 | 12 | 3 |
| Withdrew: Premature site closure | 0 | 0 | 0 | 1 |
Number of participants with IMAEs in the following categories: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity
| Participants | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|
| Pneumonitis | 1 | 0 | 0 | 0 |
| Diarrhoea/Colitis | 8 | 4 | 2 | 0 |
| Hepatitis | 3 | 1 | 1 | 1 |
| Nephritis and Renal Dysfunction | 0 | 2 | 0 | 0 |
| Rash | 7 | 3 | 1 | 0 |
| Hypersensitivity | 0 | 0 | 0 | 0 |
| Adrenal Insufficiency | 3 | 1 | 0 | 1 |
| Hypothyroidism and Thyroiditis | 0 | 0 | 0 | 1 |
| Diabetes Mellitus | 3 | 0 | 1 | 0 |
| Hyperthyroidism | 0 | 0 | 0 | 0 |
| Hypophysitis | 0 | 1 | 1 | 0 |
Number of participants with IMAEs in the following categories: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity
| Participants | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|
| Pneumonitis | 0 | 0 | 0 | 0 |
| Diarrhoea/Colitis | 0 | 0 | 0 | 0 |
| Hepatitis | 0 | 0 | 0 | 0 |
| Nephritis and Renal Dysfunction | 0 | 0 | 0 | 0 |
| Rash | 0 | 0 | 0 | 0 |
| Hypersensitivity | 0 | 0 | 0 | 0 |
| Adrenal Insufficiency | 0 | 0 | 0 | 0 |
| Hypothyroidism and Thyroiditis | 0 | 0 | 0 | 0 |
| Diabetes Mellitus | 0 | 0 | 0 | 0 |
| Hyperthyroidism | 0 | 0 | 0 | 0 |
| Hypophysitis | 0 | 0 | 0 | 0 |
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
| Weeks | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|
| Pneumonitis | 12.7 (12.7 to 12.7) | — | — | — |
| Diarrhoea/Colitis | 21.79 (1.7 to 115.7) | 10.43 (4.4 to 20.1) | 11.0 (10.1 to 11.9) | — |
| Hepatitis | 8.43 (2.0 to 82.1) | 9.4 (9.4 to 9.4) | 11.6 (11.6 to 11.6) | 10.1 (10.1 to 10.1) |
| Nephritis and Renal Dysfunction | — | 9.43 (1.4 to 17.4) | — | — |
| Rash | 4.00 (1.1 to 80.4) | 6.14 (2.3 to 13.7) | 8.3 (8.3 to 8.3) | — |
| Immune Mediated Arthritis | — | 38.9 (38.9 to 38.9) | — | — |
| Adrenal Insufficiency | 36.21 (21.0 to 51.4) | 12.7 (12.7 to 12.7) | — | 14.9 (14.9 to 14.9) |
| Diabetes Mellitus | — | — | 2.0 (2.0 to 2.0) | — |
| Hypophysitis | — | 18.7 (18.7 to 18.7) | — | — |
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
| Weeks | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|
| Pneumonitis | 0.9 (0.9 to 0.9) | — | — | — |
| Diarrhoea/Colitis | 2.71 (0.7 to 193.9) | 5.93 (0.9 to 16.9) | 1.14 (1.1 to 4.9) | — |
| Hepatitis | NA (7.9 to 144.9) | NA (14.9 to 18.3) | 3.00 (3.0 to 3.0) | 2.1 (2.1 to 2.1) |
| Nephritis and Renal Dysfunction | — | 7.79 (1.1 to 14.4) | — | — |
| Rash | 26.86 (5.3 to 181.6) | 8.00 (3.1 to 69.9) | 5.3 (5.3 to 5.3) | — |
| Adrenal Insufficiency | NA (0.4 to 170.0) | — | — | 6.0 (6.0 to 6.0) |
| Diabetes Mellitus | — | — | 1.1 (1.1 to 1.1) | — |
| Hypophysitis | — | 7.6 (7.6 to 7.6) | — | — |
| Immune Mediated Arthritis | — | 37.0 (37.0 to 37.0) | — | — |
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
| Participants | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|
| Pneumonitis | 1 | 0 | 0 | 0 |
| Diarrhoea/Colitis | 8 | 4 | 2 | 0 |
| Hepatitis | 3 | 1 | 1 | 1 |
| Nephritis and Renal Dysfunction | 0 | 2 | 0 | 0 |
| Rash | 7 | 3 | 1 | 0 |
| Hypersensitivity | 0 | 0 | 0 | 0 |
| Adrenal Insufficiency | 3 | 1 | 0 | 1 |
| Hypothyroidism/Thyroiditis | 0 | 0 | 0 | 1 |
| Diabetes Mellitus | 3 | 0 | 1 | 0 |
| Hyperthyroidism | 0 | 0 | 0 | 0 |
| Hypophysitis | 0 | 1 | 1 | 0 |
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
| Participants | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|
| Pneumonitis | 1 | 0 | 0 | 0 |
| Diarrhoea/Colitis | 8 | 3 | 2 | 0 |
| Hepatitis | 3 | 1 | 1 | 1 |
| Nephritis and Renal Dysfunction | 0 | 2 | 0 | 0 |
| Rash | 7 | 3 | 1 | 0 |
| Adrenal Insufficiency | 2 | 1 | 0 | 1 |
| Diabetes Mellitus | 0 | 0 | 1 | 0 |
| Hypophysitis | 0 | 1 | 0 | 0 |
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
| Participants | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|
| Number of Participants Who Received ≥ 40mg of Prednisone for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs) | 19 | 9 | 5 | 2 |
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.
| Months | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|
| Median Progression Free Survival (PFS) | 4.8 (3.0 to 8.4) | 3.7 (2.7 to 4.6) | 8.5 (2.9 to 12.0) | 3.6 (2.5 to 8.7) |
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).
| Percentage of Participants | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|
| Objective Response Rate (ORR) | 35.4 (25.9 to 45.8) | 21.7 (10.9 to 36.4) | 30.8 (14.3 to 51.8) | 33.3 (13.3 to 59.0) |
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).
| Months | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|
| Time to Response Rate (TRR) | 2.8 (2.5 to 14.6) | 2.8 (2.1 to 4.5) | 2.8 (2.4 to 3.0) | 4.5 (2.5 to 12.1) |
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).
| Months | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|
| Duration of Response (DOR) | 11.01 (7.10 to NA) | 37.68 (10.87 to NA) | 16.51 (3.88 to 47.87) | 19.48 (6.28 to 20.57) |
Collected over 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). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1 | 55/106 (51.9%) | 63/106 (59.4%) | 103/106 (97.2%) |
| Cohort 2 | 29/52 (55.8%) | 29/52 (55.8%) | 50/52 (96.2%) |
| Cohort 3 | 15/28 (53.6%) | 14/28 (50%) | 27/28 (96.4%) |
| Cohort 4 | 20/25 (80%) | 17/25 (68%) | 24/25 (96%) |
| Event | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 15/106 | 6/52 | 5/28 | 5/25 |
| Mental status changesPsychiatric disorders | 2/106 | 0/52 | 0/28 | 2/25 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 1/106 | 0/52 | 0/28 | 2/25 |
| DiarrhoeaGastrointestinal disorders | 4/106 | 1/52 | 2/28 | 0/25 |
| DehydrationMetabolism and nutrition disorders | 3/106 | 0/52 | 2/28 | 0/25 |
| ColitisGastrointestinal disorders | 5/106 | 2/52 | 1/28 | 0/25 |
| PneumoniaInfections and infestations | 5/106 | 2/52 | 1/28 | 0/25 |
| Anaemia of chronic diseaseBlood and lymphatic system disorders | 0/106 | 0/52 | 0/28 | 1/25 |
| Disseminated intravascular coagulationBlood and lymphatic system disorders | 0/106 | 0/52 | 0/28 | 1/25 |
| Acute coronary syndromeCardiac disorders | 0/106 | 0/52 | 0/28 | 1/25 |
| Event | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|
| FatigueGeneral disorders | 62/106 | 31/52 | 14/28 | 2/25 |
| NauseaGastrointestinal disorders | 40/106 | 20/52 | 12/28 | 6/25 |
| DiarrhoeaGastrointestinal disorders | 45/106 | 19/52 | 11/28 | 9/25 |
| AnaemiaBlood and lymphatic system disorders | 21/106 | 6/52 | 9/28 | 4/25 |
| HypothyroidismEndocrine disorders | 19/106 | 6/52 | 9/28 | 7/25 |
| PruritusSkin and subcutaneous tissue disorders | 32/106 | 11/52 | 9/28 | 5/25 |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 13/106 | 10/52 | 6/28 | 8/25 |
| CoughRespiratory, thoracic and mediastinal disorders | 32/106 | 11/52 | 7/28 | 6/25 |
| Weight decreasedInvestigations | 12/106 | 10/52 | 8/28 | 6/25 |
| Abdominal painGastrointestinal disorders | 17/106 | 7/52 | 6/28 | 7/25 |
| Age, Continuous(Years) | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Total |
|---|---|---|---|---|---|
| Mean | 62.8 ± 9.43 | 60.1 ± 14.09 | 61.3 ± 11.06 | 65.2 ± 12.54 | 62.2 ± 11.3 |
| Sex: Female, Male(Participants) | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Total |
|---|---|---|---|---|---|
| Female | 20 | 16 | 4 | 6 | 46 |
| Male | 86 | 36 | 24 | 19 | 165 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 5 | 3 | 1 | 1 | 10 |
| Not Hispanic or Latino | 101 | 48 | 27 | 24 | 200 |
| Unknown or Not Reported | 0 | 1 | 0 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 0 | 0 | 1 |
| Asian | 0 | 1 | 1 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 6 | 1 | 1 | 9 |
| White | 104 | 40 | 26 | 24 | 194 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 4 | 0 | 0 | 5 |
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