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NCT03785925 · ClinicalTrials.gov registry record · Phase 2
A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer
A Phase 2 study, sponsored by Nektar Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 192
- Enrollment target
NCT03785925: Completed Phase 2 study, sponsored by Nektar Therapeutics.
NCT03785925 is a Phase 2 study that has completed, run by Nektar Therapeutics. The registered enrollment target is 192 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03785925, a Phase 2 study, has completed, sponsored by Nektar Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 192 participants
- Enrollment target
Study Summary
The main purpose of this study is to evaluate the anti-tumor activity of bempegaldesleukin (NKTR-214) in combination with nivolumab by assessing the objective response rate (ORR) in cisplatin ineligible, locally advanced or metastatic urothelial cancer patients.
Primary Outcome
To evaluate the anti-tumor activity of NKTR-214 in combination with nivolumab by assessing the ORR by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per blinded independent central review (BICR) in patients whose tumors have low programmed cell death ligand 1 (PD-L1) expression. ORR was defined as the percentage of patients with confirmed objective response of Complete Response (CR) or Partial Response (PR) on or before the first progressive disease and any subsequent anti
Interventions
- BIOLOGICAL Nivolumab
- BIOLOGICAL Bempegaldesleukin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 192 participants |
| Start Date | 2019-04-29 |
| Est. Completion | 2022-06-30 |
| Phase | Phase 2 |
What the finished NCT03785925 record still lists
NCT03785925 is an interventional study that assigns participants to a tested intervention. The registered 192 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% higher).
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT03785925 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03785925 about?
NCT03785925 is a clinical study titled "A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer". The main purpose of this study is to evaluate the anti-tumor activity of bempegaldesleukin (NKTR-214) in combination with nivolumab by assessing the objective response rate (ORR) in cisplatin ineligible, locally advanced or metastatic urothelial cancer patients.
What is the current status of trial NCT03785925?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 192 participants. The study started on 2019-04-29. Estimated completion is 2022-06-30.
What interventions are being tested in trial NCT03785925?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Bempegaldesleukin (BIOLOGICAL).
Who is sponsoring clinical trial NCT03785925?
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 NCT03785925's enrollment target sits among peer trials
192 352nd of 2000 higher than 1,648 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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