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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 is a Phase 1 study that has completed, run by Nektar Therapeutics. The registered enrollment target is 557 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02983045
The ClinicalTrials.gov registry entry for NCT02983045 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 557 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nektar Therapeutics, which has 37 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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