Trial · NCT03635983
A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma
NCT03635983, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2022-12-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma. Trials, record NCT03635983. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03635983
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma
- NCT number
- NCT03635983
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 783 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Melanoma
- Interventions
- NKTR-214, Nivolumab
- First posted
- 2018-08-17
- Last updated
- 2025-04-01
- Other registries' IDs
- eudract:2018-001423-40
- Results first posted
- 2022-12-19
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) | From date of randomization to disease progression (Up to 37 months) | 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. |
| Primary | Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR) | From date of randomization to disease progression, or death, whichever comes first (Up to 37 months) | 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. |
| Primary | Overall Survival (OS) | From date of randomization to date of death (Up to 37 months) | 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. |
| Secondary | Clinical Benefit Rate (CBR) Per Blinded Independent Central Review (BICR) | From date of randomization to disease progression (Up to 37 months) | 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. |
| Secondary | Duration of Response (DoR) Per Blinded Independent Central Review (BICR) | From date of randomization to disease progression, or death, whichever is earlier (Up to 37 months) | 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. |
| Secondary | Time to Objective Response (TTR) Per Blinded Independent Central Review (BICR) | From date of randomization to disease progression (Up to 37 months) | 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. |
| Secondary | Objective Response Rate (ORR) Per Investigator | From date of randomization to disease progression (Up to 37 months) | 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. |
| Secondary | Progression-free Survival (PFS) Per Investigator | From date of randomization to disease progression, or death, whichever comes first (Up to 37 months) | 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. |
| Secondary | Clinical Benefit Rate (CBR) Per Investigator | From date of randomization to disease progression (Up to 37 months) | 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. |
| Secondary | Duration of Response (DoR) Per Investigator | From date of randomization to disease progression, or death, whichever is earlier (Up to 37 months) | 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. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) | From date of randomization to disease progression (Up to 37 months) | All randomized participants with at least 6 months of follow-up at the time point of the final ORR analysis. A follow-up time is defined as the time between randomization date and clinical data cut-off date. | Percentage of participants | NUMBER |
| PRIMARY | Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR) | From date of randomization to disease progression, or death, whichever comes first (Up to 37 months) | All randomized participants | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) | From date of randomization to date of death (Up to 37 months) | All randomized participants | Months | MEDIAN |
| SECONDARY | Clinical Benefit Rate (CBR) Per Blinded Independent Central Review (BICR) | From date of randomization to disease progression (Up to 37 months) | All randomized participants with at least 6 months of follow-up at the time point of the final ORR analysis. A follow-up time is defined as the time between randomization date and clinical data cut-off date. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DoR) Per Blinded Independent Central Review (BICR) | From date of randomization to disease progression, or death, whichever is earlier (Up to 37 months) | All randomized participants with partial or complete response and at least 6 months of follow-up at the time point of the final objective response rate analysis. A follow-up time is defined as the time between randomization date and clinical data cut-off date. | Months | MEDIAN |
| SECONDARY | Time to Objective Response (TTR) Per Blinded Independent Central Review (BICR) | From date of randomization to disease progression (Up to 37 months) | All randomized participants with partial or complete response and at least 6 months of follow-up at the time point of the final objective response rate analysis. A follow-up time is defined as the time between randomization date and clinical data cut-off date. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) Per Investigator | From date of randomization to disease progression (Up to 37 months) | All randomized participants with at least 6 months of follow-up at the time point of the final ORR analysis. A follow-up time is defined as the time between randomization date and clinical data cut-off date. | Percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) Per Investigator | From date of randomization to disease progression, or death, whichever comes first (Up to 37 months) | All randomized participants | Months | MEDIAN |
| SECONDARY | Clinical Benefit Rate (CBR) Per Investigator | From date of randomization to disease progression (Up to 37 months) | All randomized participants with at least 6 months of follow-up at the time point of the final ORR analysis. A follow-up time is defined as the time between randomization date and clinical data cut-off date. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DoR) Per Investigator | From date of randomization to disease progression, or death, whichever is earlier (Up to 37 months) | All randomized participants with partial or complete response and at least 6 months of follow-up at the time point of the final objective response rate analysis. A follow-up time is defined as the time between randomization date and clinical data cut-off date. | Months | MEDIAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group126
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) | Bempegaldesleukin + Nivolumab | 27.7 | 95% Confidence Interval 22.4 to 33.4 | Percentage of participants | |
| Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) | Nivolumab | 36.0 | 95% Confidence Interval 30.3 to 42.0 | Percentage of participants | |
| Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR) | Bempegaldesleukin + Nivolumab | 4.17 | 95% Confidence Interval 3.52 to 5.55 | Months | |
| Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR) | Nivolumab | 4.99 | 95% Confidence Interval 4.14 to 7.82 | Months | |
| Overall Survival (OS) | Bempegaldesleukin + Nivolumab | 29.67 | 95% Confidence Interval 22.14 to NA | Months | |
| Overall Survival (OS) | Nivolumab | 28.88 | 95% Confidence Interval 21.32 to NA | Months | |
| Clinical Benefit Rate (CBR) Per Blinded Independent Central Review (BICR) | Bempegaldesleukin + Nivolumab | 56.1 | 95% Confidence Interval 50.0 to 62.1 | Percentage of participants | |
| Clinical Benefit Rate (CBR) Per Blinded Independent Central Review (BICR) | Nivolumab | 58.5 | 95% Confidence Interval 52.4 to 64.4 | Percentage of participants | |
| Duration of Response (DoR) Per Blinded Independent Central Review (BICR) | Bempegaldesleukin + Nivolumab | 29.67 | 95% Confidence Interval 18.89 to NA | Months | |
| Duration of Response (DoR) Per Blinded Independent Central Review (BICR) | Nivolumab | NA | 95% Confidence Interval 26.74 to NA | Months |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Pre-Treatment Period | STARTED | Bempegaldesleukin + Nivolumab | 391 | |
| Pre-Treatment Period | STARTED | Nivolumab | 392 | |
| Pre-Treatment Period | COMPLETED | Bempegaldesleukin + Nivolumab | 388 | |
| Pre-Treatment Period | COMPLETED | Nivolumab | 382 | |
| Pre-Treatment Period | NOT COMPLETED | Bempegaldesleukin + Nivolumab | 3 | |
| Pre-Treatment Period | NOT COMPLETED | Nivolumab | 10 | |
| Treatment Period | STARTED | Bempegaldesleukin + Nivolumab | 388 | |
| Treatment Period | STARTED | Nivolumab | 382 | |
| Treatment Period | COMPLETED | Bempegaldesleukin + Nivolumab | 82 | |
| Treatment Period | COMPLETED | Nivolumab | 96 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events596
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Bempegaldesleukin + Nivolumab | 61 | 388 | |
| other | Anaemia | Blood and lymphatic system disorders | Nivolumab | 63 | 382 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Bempegaldesleukin + Nivolumab | 60 | 388 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Nivolumab | 7 | 382 | |
| other | Hyperthyroidism | Endocrine disorders | Bempegaldesleukin + Nivolumab | 49 | 388 | |
| other | Hyperthyroidism | Endocrine disorders | Nivolumab | 28 | 382 | |
| other | Hypothyroidism | Endocrine disorders | Bempegaldesleukin + Nivolumab | 74 | 388 | |
| other | Hypothyroidism | Endocrine disorders | Nivolumab | 52 | 382 | |
| other | Abdominal pain | Gastrointestinal disorders | Bempegaldesleukin + Nivolumab | 33 | 388 | |
| other | Abdominal pain | Gastrointestinal disorders | Nivolumab | 34 | 382 |
1 to 10 of 596Source ClinicalTrials.gov
See all 596 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bempegaldesleukin + Nivolumab | 170 | 391 |
| Total, all-cause mortality | Nivolumab | 173 | 392 |
| Total, other adverse events | Bempegaldesleukin + Nivolumab | 357 | 388 |
| Total, other adverse events | Nivolumab | 336 | 382 |
| Total, serious adverse events | Bempegaldesleukin + Nivolumab | 161 | 388 |
| Total, serious adverse events | Nivolumab | 172 | 382 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Bempegaldesleukin + Nivolumab vs Nivolumab: deaths from any cause | Trial comparisons |
| Bempegaldesleukin + Nivolumab vs Nivolumab: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03635983
GET https://conductscience.org/api/trials/v1/NCT03635983/results?page=2