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NCT02983045 · ClinicalTrials.gov registry record · Phase 1
A Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With Select Advanced Solid Tumors
A Phase 1 study, sponsored by Nektar Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 557
- Enrollment target
NCT02983045: Completed Phase 1 study, sponsored by Nektar Therapeutics.
NCT02983045 is a Phase 1 study that has completed, run by Nektar Therapeutics. The registered enrollment target is 557 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (828% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02983045, a Phase 1 study, has completed, sponsored by Nektar Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 557 participants
- Enrollment target
Study Summary
In this four-part study, NKTR-214 was administered in combination with nivolumab and with/without other anticancer therapies. Part 1 considered escalating doublet (NKTR 214 + nivolumab) doses to determine the RP2D. Part 2 considered dose expansion cohorts for the doublet (NKTR 214 + nivolumab ± chemotherapy). Part 3 was schedule-finding for a triplet therapy (NKTR 214 + nivolumab + ipilimumab). Part 4 dose expansion for the triplet (NKTR 214 + nivolumab + ipilimumab) was planned to further assess the efficacy of the RP2D triplet combination at dosing schedules from Part 3.
Primary Outcome
Part 1of the study was a dose-escalation phase that evaluated the safety and tolerability and defined the maximum tolerated dose or recommended Phase 2 dose of the NKTR-214/nivolumab doublet across 5 dosage/schedule levels. The results presented are for the DLT Population.
Interventions
- DRUG Dose Escalation Doublet: Combination of NKTR-214 + nivolumab
- DRUG Dose Expansion Doublet: Combination of NKTR-214 + nivolumab
- DRUG Schedule Finding Triplet: Combination of NKTR-214+ nivolumab+ ipilimumab
- DRUG Dose Expansion Triplet: Combination of NKTR-214+ nivolumab+ ipilimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 557 participants |
| Start Date | 2016-12-19 |
| Est. Completion | 2022-04-28 |
| Phase | Phase 1 |
What the finished NCT02983045 record still lists
NCT02983045 is an interventional study that assigns participants to a tested intervention. The registered 557 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 (828% higher).
The record links to 0 conditions, and to 4 interventions - of which Dose Escalation Doublet: Combination of NKTR-214 + nivolumab is the first listed.
NCT02983045 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02983045 about?
NCT02983045 is a clinical study titled "A Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With Select Advanced Solid Tumors". In this four-part study, NKTR-214 was administered in combination with nivolumab and with/without other anticancer therapies. Part 1 considered escalating doublet (NKTR 214 + nivolumab) doses to determine the RP2D. Part 2 considered dose expansion cohorts for the doublet (NKTR 214 + nivolumab ± chem...
What is the current status of trial NCT02983045?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 557 participants. The study started on 2016-12-19. Estimated completion is 2022-04-28.
What interventions are being tested in trial NCT02983045?
The interventions under investigation include: Dose Escalation Doublet: Combination of NKTR-214 + nivolumab (DRUG), Dose Expansion Doublet: Combination of NKTR-214 + nivolumab (DRUG), Schedule Finding Triplet: Combination of NKTR-214+ nivolumab+ ipilimumab (DRUG), Dose Expansion Triplet: Combination of NKTR-214+ nivolumab+ ipilimumab (DRUG).
Who is sponsoring clinical trial NCT02983045?
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 NCT02983045's enrollment target sits among peer trials
557 35th of 2000 higher than 1,966 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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