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.
Name: High Dose Interleukin-2 (IL-2)
Name: ACT with TIL Infusion
Name: Vemurafenib
Name: Lymphodepletion
Description: Overall response (OR) is defined as the patient being alive at week 6, confirmed at week 12 and tumor size evaluated at both times using the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 to be a complete response (CR) or partial response (PR). Evaluations will be made by CT scan approximately 6 weeks after the cell infusion, then confirmed by CT scanning approximately 12 weeks after the cell infusion, and by clinical evaluation during the first 12 weeks. The complete response rate, complete and partial response rate (CPR) will be summarized using both a point estimate and its 95% exact confidence interval based on the binomial distribution.
Measure: Overall Response (OR) Time: 12 monthsDescription: The drop-out rate will be summarized using both a point estimate and its 95% exact confidence interval based on the binomial distribution. For the secondary endpoint, drop-out rate, the power will be 0.66 and 0.91 at the end of stage 1 and 2, respectively, for detecting a desired drop-out rate of ≤ 20% against an expected baseline drop-out rate of ≥ 40% (based on our experience, that of the National Cancer Institute, and that seen at MD Anderson Cancer Center) using a one-sided binomial test at alpha error of 0.05.
Measure: Drop Out Rate Time: Up to 12 monthsDescription: Progression-free survival (PFS), defined as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier, will be summarized with the Kaplan-Meier curve. Confidence intervals for the median and survival rates at different time points will be constructed if needed and appropriate. This secondary endpoint will be reported descriptively.
Measure: Number of Participants with Progression Free Survival (PFS) Time: 12 monthsAllocation: N/A
Single Group Assignment
There is one SNP
- Residual measurable disease after resection of target lesion(s) for TIL growth - Tumor must have a B-RAF V600E, D or K mutation by pyrosequencing, Cobas assay, or equivalent (43) - Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 - 1. ECOG performance status of 0-1 will be inferred if the patient's level of energy is ≥ 50% of baseline. --- V600E ---