Trial · NCT04410445
Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence
NCT04410445, Phase 3, Terminated, Nektar Therapeutics; results first posted 2023-04-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence. Trials, record NCT04410445. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04410445
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence
- NCT number
- NCT04410445
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 765 participants, actual
- Lead sponsor
- Nektar Therapeutics
- Conditions
- Melanoma, Melanoma Stage III, Melanoma Stage IV, Melanoma (Skin)
- Interventions
- Bempegaldesleukin, Nivolumab
- First posted
- 2020-06-01
- Last updated
- 2023-04-21
- Results first posted
- 2023-04-21
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recurrence-free Survival (RFS) by Blinded Independent Central Review (BICR) of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone. | Up to 21 months | Recurrence-free Survival (RFS) of bempegaldesleukin plus nivolumab versus nivolumab alone is determined based on the disease recurrence date provided by Blinded Independent Central Review (BICR) and is defined as the time between date of randomization and date of first recurrence (local, regional, or distant metastasis by BICR), new primary melanoma (by BICR), or all-cause death, whichever occurs first. |
| Secondary | Overall Survival (OS) of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone | Up to 21 months | Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. Patients who do not have a date of death will be censored on the last date for which a patient was known to be alive. |
| Secondary | Distant Metastasis-Free Survival (DMFS) by Investigator in Patients Who Are Stage III at Study Entry. | Up to 21 months | Distant metastasis-free survival (DMFS) by Investigator is defined as the time between the date of randomization and the date of first distant metastasis by Investigator or date of death due to any cause, in patients who have Stage III melanoma at study entry. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Approximately up to 21 months | To evaluate safety and tolerability of (NKTR-214) 0.006 mg/kg in combination with nivolumab 360 mg IV infusion (or 4.5 mg/kg IV infusion q3w for patients \<40 kg) and nivolumab 480 mg IV infusion (or 6.0 mg/kg IV infusion q4w for patients \< 40 kg). Treatment-emergent adverse event (TEAE) is defined as an AE that was not present prior to treatment with study drug but appeared following treatment or was present at treatment start date but worsened during treatment-emergent period. The treatment-emergent period is defined as the period from the date of the first dose of study drug up to 30 days after the date of the last dose of study drug or the day prior to the initiation of subsequent anticancer treatment, whichever occurs first. |
| Secondary | Changes at 6 Months of Treatment From Baseline in Scores for the Global Health/Quality of Life (GH/QoL) and Physical Functioning Subscales of the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire | From baseline, up to approximately 6 months | The EORTC QLQ-C30 comprises 30 items (i.e. single questions). 24 of which are aggregated into nine multi-item scales, that is, five functioning scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and one global health status scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the global health status/quality of life scale indicates a better level of functioning, and positive changes from baseline indicate improvement. A change of 5 - 10 points is considered a small change, and a change of 10 - 20 points is considered a moderate change. Due to the study termination, results for the mean change from baseline for GH/QoL and the physical functioning subscale were analyzed at approximately 6 months of treatment. |
| Secondary | Programmed Death-Ligand 1 (PD-L1) Expression as a Predictive Biomarker for Recurrence-free Survival (RFS) | Up to 21 months | The predictive strength of Programmed Death-Ligand 1 (PD-L1) expression as a biomarker will be measured by the endpoint RFS by BICR based on PD-L1 expression level. |
| Secondary | Recurrence-free Survival (RFS) by Investigator of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone. | Up to 21 months | Recurrence-free Survival by Investigator is defined as the time between the date of randomization and the date of first recurrence (local, regional, or distant metastasis by Investigator), new primary melanoma (by Investigator), or all-cause death, whichever occurs first. |
| Secondary | Time to Disease Progression After the Next Line of Treatment for Study Patients Following Discontinuation of Bempegaldesleukin Plus Nivolumab Versus Nivolumab | Up to 21 months | Time to disease progression after the next line of treatment is defined as time from randomization to progression per Investigator after the start of next line of therapy or death, whichever occurs first. Patients who were alive and without progression after the next line of therapy can be censored at last known alive date. |
| Secondary | Distant Metastasis-Free Survival (DMFS) by Blinded Independent Central Review (BICR) in Patients Who Are Stage III at Study Entry. | Up to 21 months | Distant Metastasis-Free Survival (DMFS) by Blinded Independent Central Review (BICR) is defined as the time between the date of randomization and the date of first distant metastasis by BICR or date of death due to any cause, whichever occurs first, in patients who have Stage III melanoma at study entry. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Recurrence-free Survival (RFS) by Blinded Independent Central Review (BICR) of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone. | Up to 21 months | The study was terminated early due to the closure of the bempegaldesleukin clinical development program due to lack of enhanced efficacy being observed in combination with nivolumab therapy over nivolumab monotherapy for metastatic melanoma. As a consequence, no aggregate blinded independent central review data were collected; no comparative analyses between bempegaldesleukin + nivolumab arm vs nivolumab arm were conducted for this efficacy endpoint. | ||
| SECONDARY | Overall Survival (OS) of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone | Up to 21 months | For this outcome measure, the results were not estimable due to insufficient number of events. The study was terminated early due to the closure of the bempegaldesleukin clinical program due to lack of enhanced efficacy being observed in combination with nivolumab therapy over nivolumab monotherapy for metastatic melanoma. As a consequence, no comparative analyses between bempegaldesleukin + nivolumab arm vs nivolumab arm were conducted for this efficacy endpoint. | months | MEDIAN |
| SECONDARY | Distant Metastasis-Free Survival (DMFS) by Investigator in Patients Who Are Stage III at Study Entry. | Up to 21 months | Participants include only patients who have Stage III melanoma at study entry. The results were not estimable due to insufficient number of events. The study was terminated early due to the closure of the bempegaldesleukin clinical development program due to lack of enhanced efficacy being observed in combination with nivolumab therapy over nivolumab monotherapy for metastatic melanoma. | months | MEDIAN |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Approximately up to 21 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Changes at 6 Months of Treatment From Baseline in Scores for the Global Health/Quality of Life (GH/QoL) and Physical Functioning Subscales of the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire | From baseline, up to approximately 6 months | score on a scale | MEAN | |
| SECONDARY | Programmed Death-Ligand 1 (PD-L1) Expression as a Predictive Biomarker for Recurrence-free Survival (RFS) | Up to 21 months | The study was terminated early due to the closure of the bempegaldesleukin clinical development program due to lack of enhanced efficacy being observed in combination with nivolumab therapy over nivolumab monotherapy for metastatic melanoma. As a consequence, no aggregate blinded independent central review data were collected; no comparative analyses between bempegaldesleukin + nivolumab arm vs nivolumab arm were conducted for this efficacy endpoint. | ||
| SECONDARY | Recurrence-free Survival (RFS) by Investigator of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone. | Up to 21 months | months | MEDIAN | |
| SECONDARY | Time to Disease Progression After the Next Line of Treatment for Study Patients Following Discontinuation of Bempegaldesleukin Plus Nivolumab Versus Nivolumab | Up to 21 months | The study was terminated early due to the closure of the bempegaldesleukin clinical development program due to lack of enhanced efficacy being observed in combination with nivolumab therapy over nivolumab monotherapy for metastatic melanoma. As a consequence, no data were collected for this efficacy endpoint. | ||
| SECONDARY | Distant Metastasis-Free Survival (DMFS) by Blinded Independent Central Review (BICR) in Patients Who Are Stage III at Study Entry. | Up to 21 months | The study was terminated early due to the closure of the bempegaldesleukin clinical development program due to lack of enhanced efficacy being observed in combination with nivolumab therapy over nivolumab monotherapy for metastatic melanoma. As a consequence, no blinded independent central review data were collected; no comparative analyses between bempegaldesleukin + nivolumab arm vs nivolumab arm were conducted for this efficacy endpoint. |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone | Bempegaldesleukin (NKTR-214) + Nivolumab | NA | 95% Confidence Interval 16.9 to NA | months | |
| Overall Survival (OS) of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone | Nivolumab | NA | 95% Confidence Interval NA to NA | months | |
| Distant Metastasis-Free Survival (DMFS) by Investigator in Patients Who Are Stage III at Study Entry. | Bempegaldesleukin (NKTR-214) + Nivolumab | NA | 95% Confidence Interval NA to NA | months | |
| Distant Metastasis-Free Survival (DMFS) by Investigator in Patients Who Are Stage III at Study Entry. | Nivolumab | NA | 95% Confidence Interval NA to NA | months | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Bempegaldesleukin (NKTR-214) + Nivolumab | Patients who had a TEAE | 370 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Nivolumab | Patients who had a TEAE | 330 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Bempegaldesleukin (NKTR-214) + Nivolumab | Patients who had a Serious TEAE | 74 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Nivolumab | Patients who had a Serious TEAE | 33 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Bempegaldesleukin (NKTR-214) + Nivolumab | Patients who had a TEAE of Grade 3 or higher | 120 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Nivolumab | Patients who had a TEAE of Grade 3 or higher | 50 | Participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bempegaldesleukin (NKTR-214) + Nivolumab | 378 | |
| Overall Study | STARTED | Nivolumab | 387 | |
| Overall Study | COMPLETED | Bempegaldesleukin (NKTR-214) + Nivolumab | 348 | |
| Overall Study | COMPLETED | Nivolumab | 363 | |
| Overall Study | NOT COMPLETED | Bempegaldesleukin (NKTR-214) + Nivolumab | 30 | |
| Overall Study | NOT COMPLETED | Nivolumab | 24 |
Source ClinicalTrials.gov
Adverse events300
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 | Pyrexia | General disorders | Combination of Bempegaldesleukin (NKTR-214) + Nivolumab | 160 | 378 | |
| other | Pyrexia | General disorders | Nivolumab | 22 | 387 | |
| other | Fatigue | General disorders | Combination of Bempegaldesleukin (NKTR-214) + Nivolumab | 154 | 378 | |
| other | Fatigue | General disorders | Nivolumab | 112 | 387 | |
| other | Influenza like illness | General disorders | Combination of Bempegaldesleukin (NKTR-214) + Nivolumab | 114 | 378 | |
| other | Influenza like illness | General disorders | Nivolumab | 11 | 387 | |
| other | Asthenia | General disorders | Combination of Bempegaldesleukin (NKTR-214) + Nivolumab | 70 | 378 | |
| other | Asthenia | General disorders | Nivolumab | 38 | 387 | |
| other | Chills | General disorders | Combination of Bempegaldesleukin (NKTR-214) + Nivolumab | 55 | 378 | |
| other | Chills | General disorders | Nivolumab | 7 | 387 |
1 to 10 of 300Source ClinicalTrials.gov
See all 300 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Combination of Bempegaldesleukin (NKTR-214) + Nivolumab | 9 | 378 |
| Total, all-cause mortality | Nivolumab | 4 | 387 |
| Total, other adverse events | Combination of Bempegaldesleukin (NKTR-214) + Nivolumab | 369 | 378 |
| Total, other adverse events | Nivolumab | 329 | 387 |
| Total, serious adverse events | Combination of Bempegaldesleukin (NKTR-214) + Nivolumab | 74 | 378 |
| Total, serious adverse events | Nivolumab | 33 | 387 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35073733 | DERIVED |
Source PubMed
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 |
|---|---|
| Combination of Bempegaldesleukin (NKTR-214) + Nivolumab vs Nivolumab: deaths from any cause | Trial comparisons |
| Combination of Bempegaldesleukin (NKTR-214) + 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/NCT04410445
GET https://conductscience.org/api/trials/v1/NCT04410445/results?page=2