Trial · NCT03729245
A Study of Bempegaldesleukin (NKTR-214: BEMPEG) in Combination With Nivolumab Compared With the Investigator's Choice of a Tyrosine Kinase Inhibitor (TKI) Therapy (Either Sunitinib or Cabozantinib Monotherapy) for Advanced Metastatic Renal Cell Carcinoma (RCC)
NCT03729245, Phase 3, Terminated, Nektar Therapeutics; results first posted 2023-04-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Bempegaldesleukin (NKTR-214: BEMPEG) in Combination With Nivolumab Compared With the Investigator's Choice of a Tyrosine Kinase Inhibitor (TKI) Therapy (Either Sunitinib or Cabozantinib Monotherapy) for Advanced Metastatic Renal Cell Carcinoma (RCC). Trials, record NCT03729245. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03729245
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study of Bempegaldesleukin (NKTR-214: BEMPEG) in Combination With Nivolumab Compared With the Investigator's Choice of a Tyrosine Kinase Inhibitor (TKI) Therapy (Either Sunitinib or Cabozantinib Monotherapy) for Advanced Metastatic Renal Cell Carcinoma (RCC)
- NCT number
- NCT03729245
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 623 participants, actual
- Lead sponsor
- Nektar Therapeutics
- Conditions
- Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma
- Interventions
- bempegaldesleukin, sunitinib, nivolumab, cabozantinib
- First posted
- 2018-11-02
- Last updated
- 2023-04-11
- Results first posted
- 2023-04-11
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) Per mRECIST 1.1 by BICR in IMDC All-risk Patients and Intermediate- or Poor (I/P)-Risk Patients With Previously Untreated Advanced RCC | Approximately 32 months | ORR using modified Response Evaluation Criteria in Solid Tumors (mRECIST) 1.1 by Blinded Independent Central Review (BICR) in International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) All-risk patients and intermediate- or poor-risk patients. ORR is defined as the proportion of enrolled participants who achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR is calculated as the sum of CR and PR. |
| Primary | Overall Survival (OS) in IMDC All-Risk and Intermediate- or Poor-risk Patients With Previously Untreated Advanced RCC | Approximately 32 months | OS is defined as the time from date of first dose to the date of death from any cause. Patients without a date of death were censored at their last known alive date. |
| Secondary | Progression Free Survival (PFS) Per mRECIST 1.1 by BICR in IMDC All-risk Patients and Intermediate- or Poor (I/P)-Risk Patients With Previously Untreated Advanced RCC | Approximately 32 months | Progression-free survival is defined as the time between the date of randomization and the first date of documented tumor progression using mRECIST 1.1 per BICR or death due to any cause, whichever comes first. |
Source ClinicalTrials.gov
Outcomes3
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 mRECIST 1.1 by BICR in IMDC All-risk Patients and Intermediate- or Poor (I/P)-Risk Patients With Previously Untreated Advanced RCC | Approximately 32 months | A total of 623 patients randomized in the ITT All-risk population, including 514 patients for the ITT I/P-risk population:~* NKTR-214/nivolumab: 311 (ITT All-risk population) and 256 (ITT I/P-risk population), respectively~* Sunitinib or Cabozantinib (TKI): 312 (ITT All-risk population) and 258 (ITT I/P-risk population), respectively | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Overall Survival (OS) in IMDC All-Risk and Intermediate- or Poor-risk Patients With Previously Untreated Advanced RCC | Approximately 32 months | A total of 623 patients randomized in the ITT All-risk population, including 514 patients for the ITT I/P-risk population:~* NKTR-214/nivolumab: 311 (ITT All-risk population) and 256 (ITT I/P-risk population), respectively~* Sunitinib or Cabozantinib (TKI): 312 (ITT All-risk population) and 258 (ITT I/P-risk population), respectively | months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) Per mRECIST 1.1 by BICR in IMDC All-risk Patients and Intermediate- or Poor (I/P)-Risk Patients With Previously Untreated Advanced RCC | Approximately 32 months | A total of 623 patients randomized in the ITT All-risk population, including 514 patients for the ITT I/P-risk population:~* NKTR-214/nivolumab: 311 (ITT All-risk population) and 256 (ITT I/P-risk population), respectively~* Sunitinib or Cabozantinib (TKI): 312 (ITT All-risk population) and 258 (ITT I/P-risk population), respectively | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group12
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 mRECIST 1.1 by BICR in IMDC All-risk Patients and Intermediate- or Poor (I/P)-Risk Patients With Previously Untreated Advanced RCC | Combination of Bempegaldesleukin + Nivolumab | ORR per mRECIST 1.1 by BICR, ITT All-risk population | 73 | Participants | |
| Objective Response Rate (ORR) Per mRECIST 1.1 by BICR in IMDC All-risk Patients and Intermediate- or Poor (I/P)-Risk Patients With Previously Untreated Advanced RCC | Sunitinib or Cabozantinib | ORR per mRECIST 1.1 by BICR, ITT All-risk population | 109 | Participants | |
| Objective Response Rate (ORR) Per mRECIST 1.1 by BICR in IMDC All-risk Patients and Intermediate- or Poor (I/P)-Risk Patients With Previously Untreated Advanced RCC | Combination of Bempegaldesleukin + Nivolumab | ORR per mRECIST 1.1 by BICR, ITT I/P-risk population | 59 | Participants | |
| Objective Response Rate (ORR) Per mRECIST 1.1 by BICR in IMDC All-risk Patients and Intermediate- or Poor (I/P)-Risk Patients With Previously Untreated Advanced RCC | Sunitinib or Cabozantinib | ORR per mRECIST 1.1 by BICR, ITT I/P-risk population | 79 | Participants | |
| Overall Survival (OS) in IMDC All-Risk and Intermediate- or Poor-risk Patients With Previously Untreated Advanced RCC | Combination of Bempegaldesleukin + Nivolumab | OS, ITT All-risk population | NA | 95% Confidence Interval 29.0 to NA | months |
| Overall Survival (OS) in IMDC All-Risk and Intermediate- or Poor-risk Patients With Previously Untreated Advanced RCC | Sunitinib or Cabozantinib | OS, ITT All-risk population | NA | 95% Confidence Interval NA to NA | months |
| Overall Survival (OS) in IMDC All-Risk and Intermediate- or Poor-risk Patients With Previously Untreated Advanced RCC | Combination of Bempegaldesleukin + Nivolumab | OS, ITT I/P-risk population | 29 | 95% Confidence Interval 25.6 to NA | months |
| Overall Survival (OS) in IMDC All-Risk and Intermediate- or Poor-risk Patients With Previously Untreated Advanced RCC | Sunitinib or Cabozantinib | OS, ITT I/P-risk population | NA | 95% Confidence Interval 25.6 to NA | months |
| Progression Free Survival (PFS) Per mRECIST 1.1 by BICR in IMDC All-risk Patients and Intermediate- or Poor (I/P)-Risk Patients With Previously Untreated Advanced RCC | Combination of Bempegaldesleukin + Nivolumab | PFS per mRECIST 1.1. by BICR, ITT All-risk population | 8.2 | 95% Confidence Interval 6.2 to 10.0 | Months |
| Progression Free Survival (PFS) Per mRECIST 1.1 by BICR in IMDC All-risk Patients and Intermediate- or Poor (I/P)-Risk Patients With Previously Untreated Advanced RCC | Sunitinib or Cabozantinib | PFS per mRECIST 1.1. by BICR, ITT All-risk population | 10.3 | 95% Confidence Interval 8.5 to 12.4 | Months |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Combination of Bempegaldesleukin + Nivolumab | 311 | |
| Overall Study | STARTED | Sunitinib or Cabozantinib | 312 | |
| Overall Study | COMPLETED | Combination of Bempegaldesleukin + Nivolumab | 289 | |
| Overall Study | COMPLETED | Sunitinib or Cabozantinib | 287 | |
| Overall Study | NOT COMPLETED | Combination of Bempegaldesleukin + Nivolumab | 22 | |
| Overall Study | NOT COMPLETED | Sunitinib or Cabozantinib | 25 |
Source ClinicalTrials.gov
Adverse events502
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 | Diarrhoea | Gastrointestinal disorders | Combination of Bempegaldesleukin + Nivolumab | 87 | 310 | |
| other | Diarrhoea | Gastrointestinal disorders | Sunitinib or Cabozantinib | 161 | 306 | |
| other | Nausea | Gastrointestinal disorders | Combination of Bempegaldesleukin + Nivolumab | 100 | 310 | |
| other | Nausea | Gastrointestinal disorders | Sunitinib or Cabozantinib | 119 | 306 | |
| other | Vomiting | Gastrointestinal disorders | Combination of Bempegaldesleukin + Nivolumab | 61 | 310 | |
| other | Vomiting | Gastrointestinal disorders | Sunitinib or Cabozantinib | 74 | 306 | |
| other | Abdominal pain | Gastrointestinal disorders | Combination of Bempegaldesleukin + Nivolumab | 32 | 310 | |
| other | Abdominal pain | Gastrointestinal disorders | Sunitinib or Cabozantinib | 50 | 306 | |
| other | Constipation | Gastrointestinal disorders | Combination of Bempegaldesleukin + Nivolumab | 30 | 310 | |
| other | Constipation | Gastrointestinal disorders | Sunitinib or Cabozantinib | 49 | 306 |
1 to 10 of 502Source ClinicalTrials.gov
See all 502 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Combination of Bempegaldesleukin + Nivolumab | 109 | 310 |
| Total, all-cause mortality | Sunitinib or Cabozantinib | 114 | 306 |
| Total, other adverse events | Combination of Bempegaldesleukin + Nivolumab | 307 | 310 |
| Total, other adverse events | Sunitinib or Cabozantinib | 304 | 306 |
| Total, serious adverse events | Combination of Bempegaldesleukin + Nivolumab | 113 | 310 |
| Total, serious adverse events | Sunitinib or Cabozantinib | 91 | 306 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38838287 | 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 + Nivolumab vs Sunitinib or Cabozantinib: deaths from any cause | Trial comparisons |
| Combination of Bempegaldesleukin + Nivolumab vs Sunitinib or Cabozantinib: 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.
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