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NCT03729245 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study, sponsored by Nektar Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 623
- Enrollment target
NCT03729245: Clinical Trial Phase 3 study, sponsored by Nektar Therapeutics.
NCT03729245 is a Phase 3 study that was terminated before completion, run by Nektar Therapeutics. The registered enrollment target is 623 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03729245, a Phase 3 study, was terminated before completion, sponsored by Nektar Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 623 participants
- Enrollment target
Study Summary
The main purpose of this study is to compare the objective response rate (ORR) and overall survival (OS) of bempegaldesleukin (NKTR-214: BEMPEG) combined with nivolumab to that of tyrosine kinase inhibitor (TKI) monotherapy (sunitinib or cabozantinib) in IMDC intermediate- or poor-risk patients and IMDC all-risk patients with previously untreated advanced renal cell carcinoma (RCC).
Primary Outcome
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 (whet
Interventions
- BIOLOGICAL nivolumab
- DRUG sunitinib
- DRUG cabozantinib
- BIOLOGICAL bempegaldesleukin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 623 participants |
| Start Date | 2018-12-18 |
| Est. Completion | 2022-10-19 |
| Phase | Phase 3 |
Why NCT03729245 stopped before completion
NCT03729245 is an interventional study that assigns participants to a tested intervention. The registered 623 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% lower).
The record links to 0 conditions, and to 4 interventions - of which nivolumab is the first listed.
NCT03729245 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03729245 about?
NCT03729245 is a clinical study titled "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)". The main purpose of this study is to compare the objective response rate (ORR) and overall survival (OS) of bempegaldesleukin (NKTR-214: BEMPEG) combined with nivolumab to that of tyrosine kinase inhibitor (TKI) monotherapy (sunitinib or cabozantinib) in IMDC intermediate- or poor-risk patients and ...
What is the current status of trial NCT03729245?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 623 participants. The study started on 2018-12-18. Estimated completion is 2022-10-19.
What interventions are being tested in trial NCT03729245?
The interventions under investigation include: nivolumab (BIOLOGICAL), sunitinib (DRUG), cabozantinib (DRUG), bempegaldesleukin (BIOLOGICAL).
Who is sponsoring clinical trial NCT03729245?
This trial is sponsored by Nektar Therapeutics, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03729245's enrollment target sits among peer trials
623 588th of 2000 higher than 1,413 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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