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NCT03435640 · ClinicalTrials.gov registry record · Phase 1
REVEAL Study of NKTR-262 in Combination With NKTR-214 and Nivolumab in Patients With Locally Advanced / Metastatic Solid Tumor Malignancies
A Phase 1 study, sponsored by Nektar Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
NCT03435640: Clinical Trial Phase 1 study, sponsored by Nektar Therapeutics.
NCT03435640 is a Phase 1 study that was terminated before completion, run by Nektar Therapeutics. The registered enrollment target is 64 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03435640, a Phase 1 study, was terminated before completion, sponsored by Nektar Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
Study Summary
Patients received intratumoral (IT) injections of NKTR-262 in 3-week cycles for up to 3 cycles; bempegaldesleukin with or without nivolumab was administered every 3 weeks (q3w), and treatment continued until unacceptable toxicity, death, or disease progression per RECIST 1.1. Based on Phase 1 results of the study, the decision was made not to start the Phase 2 part of the study and the study was terminated.
Primary Outcome
DLTs were assessed in Cohort 1 through Cohort 9, which had dose levels of NKTR-262 as 0.03mg, 0.06mg, 0.06mg, 0.12mg, 0.24mg, 0.48mg, 0.96mg, 1.92mg, and 3.84mg in combination with bempegaldesleukin (bempeg). There was only 1 DLT that occurred in one of the Cohort 9 patients. Therefore, the maximum tolerated dose (MTD) of NKTR 262 was not reached.
Interventions
- DRUG nivolumab
- DRUG NKTR-262
- DRUG bempegaldesleukin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2018-03-15 |
| Est. Completion | 2022-05-09 |
| Phase | Phase 1 |
Why NCT03435640 stopped before completion
NCT03435640 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which nivolumab is the first listed.
NCT03435640 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03435640 about?
NCT03435640 is a clinical study titled "REVEAL Study of NKTR-262 in Combination With NKTR-214 and Nivolumab in Patients With Locally Advanced / Metastatic Solid Tumor Malignancies". Patients received intratumoral (IT) injections of NKTR-262 in 3-week cycles for up to 3 cycles; bempegaldesleukin with or without nivolumab was administered every 3 weeks (q3w), and treatment continued until unacceptable toxicity, death, or disease progression per RECIST 1.1. Based on Phase 1 result...
What is the current status of trial NCT03435640?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2018-03-15. Estimated completion is 2022-05-09.
What interventions are being tested in trial NCT03435640?
The interventions under investigation include: nivolumab (DRUG), NKTR-262 (DRUG), bempegaldesleukin (DRUG).
Who is sponsoring clinical trial NCT03435640?
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 NCT03435640's enrollment target sits among peer trials
64 808th of 2000 higher than 1,181 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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