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NCT03656627 · ClinicalTrials.gov registry record · Phase 1
Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease
A Phase 1 study, sponsored by Alliance Foundation Trials.
- Terminated
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT03656627 is a Phase 1 study that was terminated before completion, run by Alliance Foundation Trials. The registered enrollment target is 7 participants.
The verdict
NCT03656627, a Phase 1 study, was terminated before completion, sponsored by Alliance Foundation Trials.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
The purpose of this study is to explore the safety, tolerability and activity of Nivolumab, a PD-1 inhibitor, in cohorts of patients with autoimmune disease. Two cohorts of patients will be enrolled, based on autoimmune disease type. Patients will be screened within 28 days prior to the start of dosing. Eligible patients will be enrolled in either of the two cohorts. Patients will receive treatment every two weeks, in an outpatient setting. One cycle is a 28-day period, with Nivolumab given on days 1 and 15 of a 28-day cycle. Subjects will be permitted to continue treatment beyond initial RECIST 1.1.
Interventions
- DRUG Nivolumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2019-06-27 |
| Est. Completion | 2021-03-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03656627
The ClinicalTrials.gov registry entry for NCT03656627 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alliance Foundation Trials, which has 20 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Nivolumab is the first listed.
NCT03656627 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03656627 about?
NCT03656627 is a clinical study titled "Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease". The purpose of this study is to explore the safety, tolerability and activity of Nivolumab, a PD-1 inhibitor, in cohorts of patients with autoimmune disease. Two cohorts of patients will be enrolled, based on autoimmune disease type. Patients will be screened within 28 days prior to the start of do...
What is the current status of trial NCT03656627?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2019-06-27. Estimated completion is 2021-03-18.
What interventions are being tested in trial NCT03656627?
The interventions under investigation include: Nivolumab (DRUG).
Who is sponsoring clinical trial NCT03656627?
This trial is sponsored by Alliance Foundation Trials, which has 20 total clinical trials registered on ClinicalTrials.gov.
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