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NCT03215810 · ClinicalTrials.gov registry record · Phase 1
Nivolumab and Tumor Infiltrating Lymphocytes (TIL) in Advanced Non-Small Cell Lung Cancer
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT03215810: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT03215810 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03215810, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
Investigators plan to study the safety, side effects, and benefits of tumor-infiltrating lymphocytes (TILs) when they are given with the drug nivolumab. Nivolumab is a type of immunotherapy - a drug that is used to boost the ability of the immune system to fight cancer, infection, and other diseases.
Primary Outcome
Investigators plan to demonstrate that treatment with nivolumab in patients undergoing TIL therapy is safe with a continuous Pocock-type stopping boundary for serious toxicity of \< 17%, with safety reported based upon Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria. DLT defined as: any grade ≥3 immune-related adverse event definitely attributable to nivolumab. DLT related to adoptive cell therapy will be defined as a non-hematologic grade 4 or higher adverse event th
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Nivolumab
- OTHER Tumor-infiltrating Lymphocyte Therapy
- PROCEDURE Tumor-infiltrating Lymphocytes (TIL)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2017-10-11 |
| Est. Completion | 2023-06-09 |
| Phase | Phase 1 |
What the finished NCT03215810 record still lists
NCT03215810 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03215810 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03215810 about?
NCT03215810 is a clinical study titled "Nivolumab and Tumor Infiltrating Lymphocytes (TIL) in Advanced Non-Small Cell Lung Cancer". Investigators plan to study the safety, side effects, and benefits of tumor-infiltrating lymphocytes (TILs) when they are given with the drug nivolumab. Nivolumab is a type of immunotherapy - a drug that is used to boost the ability of the immune system to fight cancer, infection, and other diseases...
What is the current status of trial NCT03215810?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2017-10-11. Estimated completion is 2023-06-09.
What interventions are being tested in trial NCT03215810?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Nivolumab (DRUG), Tumor-infiltrating Lymphocyte Therapy (OTHER), Tumor-infiltrating Lymphocytes (TIL) (PROCEDURE).
Who is sponsoring clinical trial NCT03215810?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03215810's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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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