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NCT03278626 · ClinicalTrials.gov registry record · Phase 1
Immune Checkpoint Therapy With Nivolumab Esophageal Squamous Cell Carcinoma
A Phase 1 study, sponsored by NYU Langone Health.
- Terminated
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT03278626 is a Phase 1 study that was terminated before completion, run by NYU Langone Health. The registered enrollment target is 12 participants.
The verdict
NCT03278626, a Phase 1 study, was terminated before completion, sponsored by NYU Langone Health.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
In this multi-institution phase I/II trial, the investigators have chosen paclitaxel and carboplatin using a schedule and doses identical to those used in the CROSS trial. Following a run-in with nivolumab alone at 240 mg IVPB every 2 weeks for 2 doses, nivolumab at 240 mg every 2 weeks will be added to paclitaxel and carboplatin, which will be dosed according to the standard of care established by the CROSS trial: paclitaxel 50 mg/m2 weekly for 6 weeks and carboplatin AUC 2 weekly for 6 weeks. Concurrent radiation will be administered with chemotherapy at 1.8 Gy/fraction × 28 fractions to a total dose of 50.4 Gy, the standard radiation dose administered in the United States for trimodality therapy that includes concurrent therapy with carboplatin and paclitaxel. A decrease in dose to 41.4 Gy per the protocol established by van Hagen, et al. will be permitted before discontinuing therapy due to unacceptable toxicity. While the CROSS study administered only 5 weekly doses of chemotherapy during the 5 weeks of radiation, the higher dose of 50.4 Gy (1.8 Gy/fraction ×28 fractions over 5½ weeks) utilized in this study permits for a sixth dose during the additional week of radiation.
Interventions
- DRUG Nivolimumab+Carboplatin/paclitaxel+Radiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2017-06-27 |
| Est. Completion | 2021-05-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03278626
The ClinicalTrials.gov registry entry for NCT03278626 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Nivolimumab+Carboplatin/paclitaxel+Radiation is the first listed.
NCT03278626 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03278626 about?
NCT03278626 is a clinical study titled "Immune Checkpoint Therapy With Nivolumab Esophageal Squamous Cell Carcinoma". In this multi-institution phase I/II trial, the investigators have chosen paclitaxel and carboplatin using a schedule and doses identical to those used in the CROSS trial. Following a run-in with nivolumab alone at 240 mg IVPB every 2 weeks for 2 doses, nivolumab at 240 mg every 2 weeks will be adde...
What is the current status of trial NCT03278626?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2017-06-27. Estimated completion is 2021-05-31.
What interventions are being tested in trial NCT03278626?
The interventions under investigation include: Nivolimumab+Carboplatin/paclitaxel+Radiation (DRUG).
Who is sponsoring clinical trial NCT03278626?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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