CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 17 enrolled
Drug / intervention
High Dose Interleukin-2 (IL-2) +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01659151
NCT01659151Phase 2Completed
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A Phase II Clinical Trial of Vemurafenib With Lymphodepletion Plus Adoptive Cell Transfer and High Dose IL-2 in Patients With Metastatic Melanoma

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Aug 7, 2012·Updated Feb 20, 2026

In Brief

A Phase 2 clinical trial evaluating High Dose Interleukin-2 (IL-2), ACT with TIL Infusion, and 2 other interventions for Metastatic Melanoma. Completed, enrolled 17 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Melanoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 7, 2012
Enrollment StartAug 3, 2012
Primary CompletionOct 6, 2021
Study CompletionAug 19, 2025
TodayJul 2, 2026
Enrollment to primary: 9.2 yearsPosted 13.9 years ago

Interventions

High Dose Interleukin-2 (IL-2)drug

A high dose regimen of IL-2 will be given after participants receive the infusion of the T-cells.

ACT with TIL Infusionprocedure

Special immune T-cells will be taken from a sample of the participant's tumor tissue that will be surgically removed. Certain parts of these cells will be multiplied, or grown, in the laboratory. They will then be given back to the participant by an infusion in their veins. These cells are called tumor infiltrating lymphocytes (TIL).

Vemurafenibdrug

Vemurafenib is used to slow the growth of certain types of cancer cells. This drug will be given for about 3 weeks while T-cells are being grown in the lab and then again after T-cell infusion for up to 2 years.

Lymphodepletiondrug

The purpose of lymphodepletion in this study is to temporarily reduce the number of normal lymphocytes circulating in the participant's body before they are given the T-cells that were grown in the lab. This is so that there will be more "space" for the lymphocytes (T-cells) that will be infused in their veins. Fludarabine and cyclophosphamide, 2 types of chemotherapy drugs will be used for what is called lymphodepletion.