A Phase I/II Study of IOV-4001 in People with Inoperable or Metastatic Melanoma or Non-Small Cell Lung Cancer


Full Title

A Phase 1/2, Open-label Study of PD-1 Knockout Tumor-infiltrating Lymphocytes (IOV-4001) in Participants with Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer


The purpose of this study is to assess the safety and effectiveness of the investigational treatment IOV-4001, a form of immunotherapy called “tumor-infiltrating lymphocyte (TIL) therapy,” in people with inoperable or metastatic melanoma or non-small cell lung cancer. IOV-4001 is made from white blood cells (lymphocytes or T cells) that come from a piece of a patient’s own tumor, which was removed during surgery. The TILs are developed further in a laboratory, then delivered back to the patient several weeks later. TIL treatments are designed to help the immune system destroy cancer cells. IOV-4001 is given intravenously (by vein).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have stage IIIC, IIID, or IV melanoma or stage III or IV non-small cell lung cancer that continues to grow despite treatment.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.


For more information and to see if you can join this study, please call Dr. Alexander Shoushtari’s office 646-888-4161.




Phase I/II (phases 1 and 2 combined)

Disease Status

Newly Diagnosed & Relapsed/Refractory

ClinicalTrials.gov ID