For patients with advanced melanoma whose cancer has stopped responding to standard treatments, options are limited. A new phase III clinical trial is now testing a therapy that reprograms a patient's own immune cells to hunt and destroy cancer. Results from prior studies offer a case for optimism.
Providence Cancer Institute is enrolling eligible patients, and it’s the only site in Oregon offering this important trial.
When standard treatments stop working
Melanoma is the most dangerous form of skin cancer. When caught early, it is often curable. But when it spreads to other parts of the body or becomes surgically unremovable, the picture changes dramatically. Over the past decade, a class of drugs called PD-1 inhibitors (immune checkpoint inhibitors) has transformed treatment, helping many patients live longer. But for those whose cancer eventually resists these drugs, there are few good next steps. That is the gap a new therapy called IMA203 is designed to fill.
Using your immune cells as medicine
IMA203, also known as anzutresgene autoleucel, belongs to a category of treatment called adoptive cell therapy, a treatment protocol that includes several steps:
- Immune cells, called T cells, are collected from a patient's blood.
- The cells are genetically modified in a lab to carry a specially designed receptor or molecular lock that recognizes PRAME on melanoma cells. (PRAME is found on the surface of melanoma cells in more than 95% of patients.)
- After a short course of chemotherapy to make room for the new cells, the modified T cells are infused back into the patient.
- A brief course of interleukin-2 (IL-2) is given to help the new cells survive and multiply.
Promising results in early studies
IMA203 has already been tested in a phase I/II clinical trial involving patients with advanced solid tumors. The melanoma results stood out. Among 26 melanoma patients, all of whom had unsuccessfully tried other treatments, 54% achieved a confirmed tumor response, meaning their cancer measurably shrank or disappeared. Tumor shrinkage was seen in 88% of patients overall.
Responses also were durable. At the time of analysis, the median duration of response was over 12 months, with some patients remaining in remission for more than two years. Responses appeared quickly, typically within six weeks of the infusion.
On the safety side, the most common serious side effect was cytokine release syndrome, an immune overreaction that can cause fever, low blood pressure and fatigue. Most cases were mild to moderate and resolved with standard management. There were no treatment-related deaths.
The phase III trial has international reach
Encouraged by the early results, researchers launched the phase III trial to rigorously test whether IMA203 works better than current available treatments.
The trial is enrolling 360 patients across sites in the United States, Europe and Canada. Participants are randomly assigned to receive either IMA203 or a treatment chosen by their physician from currently available options (nivolumab plus relatlimab, lifileucel, nivolumab, pembrolizumab, ipilimumab or chemotherapy). The main measure of success is how long patients live without their cancer getting worse. This is known as progression-free survival.
What this may mean for patients
If the phase III trial succeeds, IMA203 could become the first approved therapy of its kind for melanoma. More broadly, this trial is part of a growing movement to harness the power of the immune system, specifically, precision-engineered T cells, to tackle solid tumors that have long resisted cellular therapies. For melanoma patients running out of options, it represents a genuine reason for hope.
Find out more about the trial
Matthew Taylor, M.D., is the principal investigator. Dr. Taylor is a full member, Earle A. Chiles Research Institute, a division of Providence Cancer Institute and co-medical director, Providence Cancer Institute Melanoma Program
To refer a patient:
- Call 503-215-1979
- Send an email
Find out about other clinical trials at Providence Cancer Institute.
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