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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: Clinical Trial Phase 1 study, sponsored by Alliance Foundation Trials.
NCT03656627 is a Phase 1 study that was terminated before completion, run by Alliance Foundation Trials. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The DLT determination period is the first six weeks after cycle 1 day 1. Dose limiting toxicities are further defined in the trial protocol.
Interventions
- DRUG Nivolumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2019-06-27 |
| Est. Completion | 2021-03-18 |
| Phase | Phase 1 |
Why NCT03656627 stopped before completion
NCT03656627 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which Nivolumab is the first listed.
NCT03656627 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03656627's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 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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