Full Title
A Prospective, Multicenter, Open-label, Randomized, Actively Controlled, Parallel-group Phase 3 Clinical Trial to Evaluate Efficacy, Safety, and Tolerability of IMA203 Versus Investigator’s Choice of Treatment in Patients with Previously Treated, Unresectable or Metastatic Cutaneous Melanoma (ACTengineTM IMA203-301) (WCG)Purpose
Researchers are comparing IMA203 cellular therapy with standard treatment in people with melanoma of the skin. Their melanoma is inoperable (cannot be surgically removed) or metastatic (has spread) and keeps growing despite treatment.
If you take part in this study, you will be randomly assigned to get IMA203 or a standard treatment chosen by the doctor. The standard treatments include cellular therapy with tumor-infiltrating lymphocytes (TIL), immunotherapy, and chemotherapy drugs used to treat advanced melanoma.
IMA203 is a treatment in which immune cells called T cells are modified to better recognize and kill melanoma cells. If you get IMA203, you will first have chemotherapy with fludarabine and cyclophosphamide to briefly weaken your immune system. This chemotherapy will help prepare your body for IMA203. After treatment, you will get interleukin-2, which is already used to treat advanced melanoma.
Who Can Join
To join this study, there are a few conditions. You must:
- Have inoperable or metastatic cutaneous melanoma that keeps growing despite treatment.
- Carry the gene for HLA A 02:01, which you will be tested for as part of screening.
- Have recovered from the serious side effects of previous therapies before getting the study treatment.
- Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
- Be age 18 or older.
Contact
For more information and to see if you can join this study, please call Dr. James Smithy’s office at 646-608-2091.