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NCT01659151 · ClinicalTrials.gov registry record · Phase 2
Vemurafenib With Lymphodepletion Plus Adoptive Cell Transfer & High Dose IL-2 Metastatic Melanoma
A Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT01659151: Completed Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT01659151 is a Phase 2 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01659151, a Phase 2 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
The purpose of this study is to find out more about the effects of an investigational combination of medicines, which includes special immune cells (T-cells). A T-cell is a type of lymphocyte, or white blood cell. Lymphocytes are a kind of white blood cell that protect the body from viral infections, help other cells fight bacterial and fungal infections, produce antibodies, fight cancers, and coordinate the activities of other cells in the immune system.
Primary Outcome
Overall response (OR) is defined as the patient being alive at month 12, and tumor size evaluated at screening and at month 12 using the RECIST 1.1 criteria to be a complete response (CR) or partial response (PR). Evaluations will be made by CT scan approximately 12 months from the date of tumor harvest, and by clinical evaluation during the first 12 months
Interventions
- DRUG Vemurafenib
- DRUG High Dose Interleukin-2 (IL-2)
- PROCEDURE ACT with TIL Infusion
- DRUG Lymphodepletion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2012-08-03 |
| Est. Completion | 2025-08-19 |
| Phase | Phase 2 |
What the finished NCT01659151 record still lists
NCT01659151 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 4 interventions - of which Vemurafenib is the first listed.
NCT01659151 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01659151 about?
NCT01659151 is a clinical study titled "Vemurafenib With Lymphodepletion Plus Adoptive Cell Transfer & High Dose IL-2 Metastatic Melanoma". The purpose of this study is to find out more about the effects of an investigational combination of medicines, which includes special immune cells (T-cells). A T-cell is a type of lymphocyte, or white blood cell. Lymphocytes are a kind of white blood cell that protect the body from viral infection...
What is the current status of trial NCT01659151?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2012-08-03. Estimated completion is 2025-08-19.
What interventions are being tested in trial NCT01659151?
The interventions under investigation include: Vemurafenib (DRUG), High Dose Interleukin-2 (IL-2) (DRUG), ACT with TIL Infusion (PROCEDURE), Lymphodepletion (DRUG).
Who is sponsoring clinical trial NCT01659151?
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 NCT01659151's enrollment target sits among peer trials
17 1903rd of 2000 higher than 93 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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