A Phase 3 interventional study of NKTR-214 and Nivolumab in Melanoma, sponsored by Bristol-Myers Squibb. Completed at 167 sites in 27 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2025-04-01.
Sponsored by Bristol-Myers Squibb · Phase 3, Interventional, and Treatment
The purpose of the study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus nivolumab given alone in participants with previously untreated melanoma skin cancer that is either unable to be surgically removed or has spread
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 783 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma 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:
Other protocol defined inclusion/exclusion criteria apply
NKTR-214 + Nivolumab
Biological: NKTR-214 · Biological: Nivolumab
Nivolumab
Biological: Nivolumab
Specified dose on specified days
Also known as: Bempegaldesleukin, BMS-986321
Specified dose on specified days
Also known as: Opdivo, BMS-936558
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)
ORR is defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) using RECIST v 1.1 per blinded independent central review (BICR) assessment. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.
Time frame: From date of randomization to disease progression (Up to 37 months)
Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR)
PFS is defined as the time between the date of randomization and the first date of documented tumor progression using RECIST v 1.1 per blinded independent central review (BICR), or death due to any cause, whichever comes first. Progressive disease (PD)=At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm.
Time frame: From date of randomization to disease progression, or death, whichever comes first (Up to 37 months)
Overall Survival (OS)
OS is defined as the time between the date of randomization and the date of death due to any cause. Participants who do not have a date of death will be censored on the last date for which a participant was known to be alive.
Time frame: From date of randomization to date of death (Up to 37 months)
Clinical Benefit Rate (CBR) Per Blinded Independent Central Review (BICR)
CBR, or equivalently the disease control rate (DCR) is defined as the percentage of participants with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) as assessed by blinded independent central review (BICR) using RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Time frame: From date of randomization to disease progression (Up to 37 months)
Duration of Response (DoR) Per Blinded Independent Central Review (BICR)
DOR is defined for participants who have a confirmed complete response (CR) or partial results (PR) as the date from first documented CR or PR using RECIST v 1.1 to the date of the documentation of disease progression per blinded independent central review (BICR) assessment or death due to any cause, whichever is earlier. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.
Time frame: From date of randomization to disease progression, or death, whichever is earlier (Up to 37 months)
Time to Objective Response (TTR) Per Blinded Independent Central Review (BICR)
Time to response (TTR) is defined for participants who had a confirmed complete response (CR) or partial response (PR) as the time from the date of randomization to date of first documented CR or PR per blinded independent central review (BICR) assessment using RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.
Time frame: From date of randomization to disease progression (Up to 37 months)
Objective Response Rate (ORR) Per Investigator
ORR is defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) using RECIST v 1.1 per investigator assessment. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.
Time frame: From date of randomization to disease progression (Up to 37 months)
Progression-free Survival (PFS) Per Investigator
PFS is defined as the time between the date of randomization and the first date of documented tumor progression using RECIST v 1.1 per investigator, or death due to any cause, whichever comes first. Progressive disease (PD)=At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm.
Time frame: From date of randomization to disease progression, or death, whichever comes first (Up to 37 months)
Clinical Benefit Rate (CBR) Per Investigator
CBR, or equivalently the disease control rate (DCR) is defined as the percentage of participants with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) as assessed by investigator using RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Time frame: From date of randomization to disease progression (Up to 37 months)
Duration of Response (DoR) Per Investigator
DOR is defined for participants who have a confirmed complete response (CR) or partial results (PR) as the date from first documented CR or PR using RECIST v 1.1 to the date of the documentation of disease progression per investigator assessment or death due to any cause, whichever is earlier. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.
Time frame: From date of randomization to disease progression, or death, whichever is earlier (Up to 37 months)
Time to Objective Response (TTR) Per Investigator
Time to response (TTR) is defined for participants who had a confirmed complete response (CR) or partial response (PR) as the time from the date of randomization to date of first documented CR or PR per investigator assessment using RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.
Time frame: From date of randomization to disease progression (Up to 37 months)
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by Baseline PD-L1 Status
ORR by baseline PD-L1 tumor cells expression (PD-L1 negative: \<1%) vs. (PD-L1 positive: \>=1%). ORR is defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) using RECIST v 1.1 per blinded independent central review (BICR) assessment. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.
Time frame: From date of randomization to disease progression (Up to 37 months)
Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR) by Baseline PD-L1 Status
PFS by baseline PD-L1 tumor cells expression (PD-L1 negative: \<1%) vs. (PD-L1 positive: \>=1%). PFS is defined as the time between the date of randomization and the first date of documented tumor progression using RECIST v 1.1 per blinded independent central review (BICR), or death due to any cause, whichever comes first. Progressive disease (PD)=At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm.
Time frame: From date of randomization to disease progression, or death, whichever comes first (Up to 37 months)
Overall Survival (OS) by Baseline PD-L1 Status
OS by baseline PD-L1 tumor cells expression (PD-L1 negative: \<1%) vs. (PD-L1 positive: \>=1%). OS is defined as the time between the date of randomization and the date of death due to any cause. Participants who do not have a date of death will be censored on the last date for which a participant was known to be alive.
Time frame: From date of randomization to date of death (Up to 37 months)
Number of Participants With Adverse Events (AEs)
Number of participants with any grade adverse events (AEs) including treatment-related AEs, AEs leading to discontinuation of any drug, serious adverse events (SAEs), treatment-related SAEs, and deaths from first dose to 30 days post last dose. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Time frame: From first dose to 30 days post last dose (Average of 11 months and a maximum up to 26 months)
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline
Number of participants with on-treatment laboratory parameters that worsened relative to baseline. Parameters include hematology, chemistry, liver function, and renal function using worst grade (grade 1-4 and grade 3-4) per national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) v5 criteria. Grade 1=Mild event Grade 2=Moderate event Grade 3=Severe event Grade 4=Life threatening event
Time frame: From first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months)
| Milestone | Bempegaldesleukin + Nivolumab | Nivolumab |
|---|---|---|
| Started | 391 | 392 |
| Completed | 388 | 382 |
| Not completed | 3 | 10 |
| Withdrew: Withdrawal by subject | 0 | 7 |
| Withdrew: Participant no longer meets study criteria | 1 | 0 |
| Withdrew: Other reasons | 0 | 1 |
| Withdrew: Disease progression | 0 | 1 |
| Withdrew: Adverse event unrelated to study drug | 2 | 1 |
| Milestone | Bempegaldesleukin + Nivolumab | Nivolumab |
|---|---|---|
| Started | 388 | 382 |
| Completed | 82 | 96 |
| Not completed | 306 | 286 |
| Withdrew: Participant request to discontinue study treatment | 6 | 7 |
| Withdrew: Withdrawal by subject | 3 | 5 |
| Withdrew: Death | 3 | 5 |
| Withdrew: Poor/non-compliance | 2 | 1 |
| Withdrew: Participant no longer meets study criteria | 1 | 4 |
| Withdrew: Other reasons | 7 | 4 |
| Withdrew: Disease progression | 230 | 201 |
| Withdrew: Study drug toxicity | 35 | 36 |
| Withdrew: Adverse event unrelated to study drug | 15 | 15 |
| Withdrew: Maximum clinical benefit | 3 | 5 |
| Withdrew: Administrative reason by the sponsor | 1 | 2 |
| Withdrew: Lost to follow-up | 0 | 1 |
ORR is defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) using RECIST v 1.1 per blinded independent central review (BICR) assessment. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.
| Percentage of participants | Bempegaldesleukin + Nivolumab | Nivolumab |
|---|---|---|
| Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) | 27.7 (22.4 to 33.4) | 36.0 (30.3 to 42.0) |
PFS is defined as the time between the date of randomization and the first date of documented tumor progression using RECIST v 1.1 per blinded independent central review (BICR), or death due to any cause, whichever comes first. Progressive disease (PD)=At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm.
| Months | Bempegaldesleukin + Nivolumab | Nivolumab |
|---|---|---|
| Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR) | 4.17 (3.52 to 5.55) | 4.99 (4.14 to 7.82) |
OS is defined as the time between the date of randomization and the date of death due to any cause. Participants who do not have a date of death will be censored on the last date for which a participant was known to be alive.
| Months | Bempegaldesleukin + Nivolumab | Nivolumab |
|---|---|---|
| Overall Survival (OS) | 29.67 (22.14 to NA) | 28.88 (21.32 to NA) |
CBR, or equivalently the disease control rate (DCR) is defined as the percentage of participants with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) as assessed by blinded independent central review (BICR) using RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
| Percentage of participants | Bempegaldesleukin + Nivolumab | Nivolumab |
|---|---|---|
| Clinical Benefit Rate (CBR) Per Blinded Independent Central Review (BICR) | 56.1 (50.0 to 62.1) | 58.5 (52.4 to 64.4) |
DOR is defined for participants who have a confirmed complete response (CR) or partial results (PR) as the date from first documented CR or PR using RECIST v 1.1 to the date of the documentation of disease progression per blinded independent central review (BICR) assessment or death due to any cause, whichever is earlier. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.
| Months | Bempegaldesleukin + Nivolumab | Nivolumab |
|---|---|---|
| Duration of Response (DoR) Per Blinded Independent Central Review (BICR) | 29.67 (18.89 to NA) | NA (26.74 to NA) |
Time to response (TTR) is defined for participants who had a confirmed complete response (CR) or partial response (PR) as the time from the date of randomization to date of first documented CR or PR per blinded independent central review (BICR) assessment using RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.
| Months | Bempegaldesleukin + Nivolumab | Nivolumab |
|---|---|---|
| Time to Objective Response (TTR) Per Blinded Independent Central Review (BICR) | 2.17 (1.0 to 15.3) | 2.20 (1.2 to 15.5) |
ORR is defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) using RECIST v 1.1 per investigator assessment. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.
| Percentage of participants | Bempegaldesleukin + Nivolumab | Nivolumab |
|---|---|---|
| Objective Response Rate (ORR) Per Investigator | 29.2 (23.8 to 35.0) | 36.4 (30.7 to 42.4) |
PFS is defined as the time between the date of randomization and the first date of documented tumor progression using RECIST v 1.1 per investigator, or death due to any cause, whichever comes first. Progressive disease (PD)=At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm.
| Months | Bempegaldesleukin + Nivolumab | Nivolumab |
|---|---|---|
| Progression-free Survival (PFS) Per Investigator | 4.27 (4.04 to 6.14) | 6.21 (4.60 to 10.25) |
CBR, or equivalently the disease control rate (DCR) is defined as the percentage of participants with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) as assessed by investigator using RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
| Percentage of participants | Bempegaldesleukin + Nivolumab | Nivolumab |
|---|---|---|
| Clinical Benefit Rate (CBR) Per Investigator | 60.5 (54.4 to 66.4) | 61.8 (55.7 to 67.6) |
DOR is defined for participants who have a confirmed complete response (CR) or partial results (PR) as the date from first documented CR or PR using RECIST v 1.1 to the date of the documentation of disease progression per investigator assessment or death due to any cause, whichever is earlier. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.
| Months | Bempegaldesleukin + Nivolumab | Nivolumab |
|---|---|---|
| Duration of Response (DoR) Per Investigator | NA (17.31 to NA) | NA (21.68 to NA) |
Time to response (TTR) is defined for participants who had a confirmed complete response (CR) or partial response (PR) as the time from the date of randomization to date of first documented CR or PR per investigator assessment using RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.
| Months | Bempegaldesleukin + Nivolumab | Nivolumab |
|---|---|---|
| Time to Objective Response (TTR) Per Investigator | 2.14 (1.6 to 18.3) | 2.14 (1.8 to 12.2) |
ORR by baseline PD-L1 tumor cells expression (PD-L1 negative: \<1%) vs. (PD-L1 positive: \>=1%). ORR is defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) using RECIST v 1.1 per blinded independent central review (BICR) assessment. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.
| Percentage of participants | Bempegaldesleukin + Nivolumab | Nivolumab |
|---|---|---|
| Participants with baseline PD-L1 expression <1% | 17.6 (10.8 to 26.4) | 25.2 (17.3 to 34.6) |
| Participants with baseline PD-L1 expression >=1% | 36.4 (28.5 to 45.0) | 47.5 (39.1 to 56.1) |
PFS by baseline PD-L1 tumor cells expression (PD-L1 negative: \<1%) vs. (PD-L1 positive: \>=1%). PFS is defined as the time between the date of randomization and the first date of documented tumor progression using RECIST v 1.1 per blinded independent central review (BICR), or death due to any cause, whichever comes first. Progressive disease (PD)=At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm.
| Months | Bempegaldesleukin + Nivolumab | Nivolumab |
|---|---|---|
| Participants with baseline PD-L1 expression <1% | 3.25 (2.20 to 4.24) | 2.30 (2.17 to 4.17) |
| Participants with baseline PD-L1 expression >=1% | 6.24 (4.47 to 10.45) | 10.51 (6.05 to 28.88) |
OS by baseline PD-L1 tumor cells expression (PD-L1 negative: \<1%) vs. (PD-L1 positive: \>=1%). OS is defined as the time between the date of randomization and the date of death due to any cause. Participants who do not have a date of death will be censored on the last date for which a participant was known to be alive.
| Months | Bempegaldesleukin + Nivolumab | Nivolumab |
|---|---|---|
| Participants with baseline PD-L1 expression <1% | 21.16 (15.51 to 26.68) | 21.13 (16.62 to NA) |
| Participants with baseline PD-L1 expression >=1% | NA (29.67 to NA) | NA (28.88 to NA) |
Number of participants with any grade adverse events (AEs) including treatment-related AEs, AEs leading to discontinuation of any drug, serious adverse events (SAEs), treatment-related SAEs, and deaths from first dose to 30 days post last dose. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
| Participants | Bempegaldesleukin + Nivolumab | Nivolumab |
|---|---|---|
| AEs | 378 | 364 |
| Drug-related AEs | 351 | 281 |
| SAEs | 132 | 130 |
| Drug-related SAEs | 57 | 32 |
| AEs leading to discontinuation of any Drug | 65 | 56 |
| Deaths | 21 | 21 |
Number of participants with on-treatment laboratory parameters that worsened relative to baseline. Parameters include hematology, chemistry, liver function, and renal function using worst grade (grade 1-4 and grade 3-4) per national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) v5 criteria. Grade 1=Mild event Grade 2=Moderate event Grade 3=Severe event Grade 4=Life threatening event
| Participants | Bempegaldesleukin + Nivolumab | Nivolumab |
|---|---|---|
| Hemoglobin decreased grade 1-4 | 194 | 173 |
| Hemoglobin decreased grade 3-4 | 17 | 22 |
| Platelet count decreased grade 1-4 | 36 | 41 |
| Platelet count decreased grade 3-4 | 2 | 6 |
| Leukocytes decreased grade 1-4 | 29 | 46 |
| Leukocytes decreased grade 3-4 | 2 | 2 |
| Lymphocytes (absolute) decreased grade 1-4 | 304 | 194 |
| Lymphocytes (absolute) decreased grade 3-4 | 199 | 30 |
| Absolute Neutrophil count decreased grade 1-4 | 71 | 31 |
| Absolute Neutrophil, count decreased grade 3-4 | 8 | 2 |
| Neutrophils (absolute) decreased grade 1-4 | 57 | 29 |
| Neutrophils (absolute) decreased grade 3-4 | 10 | 2 |
| Alkaline Phosphatase increased grade 1-4 | 96 | 90 |
| Alkaline Phosphatase increased grade 3-4 | 2 | 6 |
| Aspartate Aminotransferase increased grade 1-4 | 96 | 115 |
| Aspartate Aminotransferase increased grade 3-4 | 9 | 17 |
| Alanine Aminotransferase increased grade 1-4 | 104 | 132 |
| Alanine Aminotransferase increased grade 3-4 | 11 | 13 |
| Bilirubin, total increased grade 1-4 | 36 | 46 |
| Bilirubin, total increased grade 3-4 | 2 | 4 |
| Creatinine increased grade 1-4 | 81 | 94 |
| Creatinine increased grade 3-4 | 2 | 6 |
| Amylase increased grade 1-4 | 51 | 78 |
| Amylase increased grade 3-4 | 3 | 6 |
| Lipase, total increased grade 1-4 | 90 | 126 |
| Lipase, total increased grade 3-4 | 17 | 17 |
| Hypernatremia grade 1-4 | 29 | 47 |
| Hypernatremia grade 3-4 | 2 | 0 |
| Hyponatremia grade 1-4 | 112 | 123 |
| Hyponatremia grade 3-4 | 6 | 11 |
| Hyperkalemia grade 1-4 | 91 | 85 |
| Hyperkalemia grade 3-4 | 9 | 6 |
| Hypokalemia grade 1-4 | 32 | 51 |
| Hypokalemia grade 3-4 | 5 | 2 |
| Hypercalcemia grade 1-4 | 45 | 45 |
| Hypercalcemia grade 3-4 | 1 | 0 |
| Hypocalcemia grade 1-4 | 78 | 82 |
| Hypocalcemia grade 3-4 | 5 | 0 |
| Hypoglycemia grade 1-4 | 42 | 39 |
| Hypoglycemia grade 3-4 | 3 | 0 |
Collected over Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bempegaldesleukin + Nivolumab | 170/391 (43.5%) | 161/388 (41.5%) | 357/388 (92%) |
| Nivolumab | 173/392 (44.1%) | 172/382 (45%) | 336/382 (88%) |
| Event | Bempegaldesleukin + Nivolumab | Nivolumab |
|---|---|---|
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 37/388 | 40/382 |
| PneumoniaInfections and infestations | 4/388 | 8/382 |
| Cerebrovascular accidentNervous system disorders | 7/388 | 1/382 |
| Acute kidney injuryRenal and urinary disorders | 7/388 | 3/382 |
| DiarrhoeaGastrointestinal disorders | 3/388 | 6/382 |
| COVID-19Infections and infestations | 2/388 | 5/382 |
| MyositisMusculoskeletal and connective tissue disorders | 1/388 | 5/382 |
| SepsisInfections and infestations | 5/388 | 4/382 |
| MyocarditisCardiac disorders | 3/388 | 4/382 |
| FatigueGeneral disorders | 2/388 | 4/382 |
| Event | Bempegaldesleukin + Nivolumab | Nivolumab |
|---|---|---|
| PyrexiaGeneral disorders | 147/388 | 39/382 |
| FatigueGeneral disorders | 128/388 | 104/382 |
| PruritusSkin and subcutaneous tissue disorders | 121/388 | 80/382 |
| NauseaGastrointestinal disorders | 113/388 | 67/382 |
| RashSkin and subcutaneous tissue disorders | 108/388 | 63/382 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 99/388 | 67/382 |
| DiarrhoeaGastrointestinal disorders | 96/388 | 80/382 |
| HypothyroidismEndocrine disorders | 74/388 | 52/382 |
| Influenza like illnessGeneral disorders | 71/388 | 9/382 |
| AstheniaGeneral disorders | 68/388 | 42/382 |
| Age, Continuous(Years) | Bempegaldesleukin + Nivolumab | Nivolumab | Total |
|---|---|---|---|
| Mean | 61.3 ± 13.2 | 60.4 ± 13.5 | 60.8 ± 13.3 |
| Sex: Female, Male(Participants) | Bempegaldesleukin + Nivolumab | Nivolumab | Total |
|---|---|---|---|
| Female | 162 | 163 | 325 |
| Male | 229 | 229 | 458 |
| Ethnicity (NIH/OMB)(Participants) | Bempegaldesleukin + Nivolumab | Nivolumab | Total |
|---|---|---|---|
| Hispanic or Latino | 81 | 73 | 154 |
| Not Hispanic or Latino | 165 | 153 | 318 |
| Unknown or Not Reported | 145 | 166 | 311 |
| Race/Ethnicity, Customized(Participants) | Bempegaldesleukin + Nivolumab | Nivolumab | Total |
|---|---|---|---|
| White | 379 | 379 | 758 |
| Black or African American | 2 | 4 | 6 |
| Asian | 1 | 0 | 1 |
| American Indian or Alaska Native | 5 | 2 | 7 |
| Other | 4 | 7 | 11 |
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