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NCT03138889 · ClinicalTrials.gov registry record · Phase 1
Bempegaldesleukin and Pembrolizumab With or Without Chemotherapy in Locally Advanced or Metastatic Solid Tumors
A Phase 1 study, sponsored by Nektar Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 162
- Enrollment target
NCT03138889: Clinical Trial Phase 1 study, sponsored by Nektar Therapeutics.
NCT03138889 is a Phase 1 study that was terminated before completion, run by Nektar Therapeutics. The registered enrollment target is 162 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (170% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03138889, a Phase 1 study, was terminated before completion, sponsored by Nektar Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 162 participants
- Enrollment target
Study Summary
This study is to assess the safety and tolerability, and to assess the preliminary clinical benefit of NKTR-214 when combined with pembrolizumab (KEYTRUDA®) with or without chemotherapy. The study is comprised of two groups; dose optimization and dose expansion cohorts. Dose Optimization included first-line and second-line advanced or metastatic solid tumors including non-small cell lung cancer (NSCLC) The dose expansion cohort will include first-line NSCLC patients.
Primary Outcome
DLTs were assesses in the Dose Optimization Cohort 1 a, which had doses of NKTR-214 as 0.008 mg/kg, 0.010 mg/kg, and 0.012 m/kg, I combination with pembrolizumab at 200 mg. A single DLT (hypotension) was reported in 1 patient in dose optimization Cohort 1a.
Interventions
- DRUG Pembrolizumab
- DRUG Cisplatin
- DRUG NKTR-214
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 162 participants |
| Start Date | 2017-06-09 |
| Est. Completion | 2022-08-24 |
| Phase | Phase 1 |
Why NCT03138889 stopped before completion
NCT03138889 is an interventional study that assigns participants to a tested intervention. The registered 162 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (170% higher).
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03138889 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03138889 about?
NCT03138889 is a clinical study titled "Bempegaldesleukin and Pembrolizumab With or Without Chemotherapy in Locally Advanced or Metastatic Solid Tumors". This study is to assess the safety and tolerability, and to assess the preliminary clinical benefit of NKTR-214 when combined with pembrolizumab (KEYTRUDA®) with or without chemotherapy. The study is comprised of two groups; dose optimization and dose expansion cohorts. Dose Optimization included ...
What is the current status of trial NCT03138889?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 162 participants. The study started on 2017-06-09. Estimated completion is 2022-08-24.
What interventions are being tested in trial NCT03138889?
The interventions under investigation include: Pembrolizumab (DRUG), Cisplatin (DRUG), NKTR-214 (DRUG).
Who is sponsoring clinical trial NCT03138889?
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 NCT03138889's enrollment target sits among peer trials
162 336th of 2000 higher than 1,661 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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