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NCT03526185 · ClinicalTrials.gov registry record · Early Phase 1
A Pilot Study Using Short-Term Cultured Anti-Tumor Autologous Lymphocytes
A Early Phase 1 study, sponsored by Yale University.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 6
- Enrollment target
NCT03526185: Clinical Trial Early Phase 1 study, sponsored by Yale University.
NCT03526185 is a Early Phase 1 study that was terminated before completion, run by Yale University. The registered enrollment target is 6 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03526185, a Early Phase 1 study, was terminated before completion, sponsored by Yale University.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
To determine the feasibility and safety of administering a regimen of TIL/IL-2, using a cell product manufactured in the Yale Advanced Cell Therapy Laboratories, in subjects with metastatic melanoma who are not responding or have progressed after receiving prior therapy with a PD-1/PD-L1 antagonist used alone or in combination with anti-CTLA-4. Additionally, a second cohort of patients with metastatic melanoma who are not responding or have progressed after receiving prior therapy with a PD-1/PD-L1 antagonist alone or in combination with anti-CTLA-4 will receive anti-PD-1 and anti-CTLA-4 therapy with Nivolumab and Ipilimumab.
Primary Outcome
To determine the safety of administering a regimen of TIL/IL-2, incidence of drug-related adverse events (AEs) will be summarized across adverse event type in terms of frequency by event type.
Interventions
- DRUG Tumor Infiltrating Lymphocytes
- DRUG Nivolumab and Ipilimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2018-02-06 |
| Est. Completion | 2020-12-01 |
| Phase | Early Phase 1 |
Why NCT03526185 stopped before completion
NCT03526185 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Tumor Infiltrating Lymphocytes is the first listed.
NCT03526185 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03526185 about?
NCT03526185 is a clinical study titled "A Pilot Study Using Short-Term Cultured Anti-Tumor Autologous Lymphocytes". To determine the feasibility and safety of administering a regimen of TIL/IL-2, using a cell product manufactured in the Yale Advanced Cell Therapy Laboratories, in subjects with metastatic melanoma who are not responding or have progressed after receiving prior therapy with a PD-1/PD-L1 antagonist ...
What is the current status of trial NCT03526185?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 6 participants. The study started on 2018-02-06. Estimated completion is 2020-12-01.
What interventions are being tested in trial NCT03526185?
The interventions under investigation include: Tumor Infiltrating Lymphocytes (DRUG), Nivolumab and Ipilimumab (DRUG).
Who is sponsoring clinical trial NCT03526185?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03526185's enrollment target sits among peer trials
6 1845th of 2000 higher than 114 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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