Help discover the potential of PRAME melanoma cell therapy through clinical research
The SUPRAME Phase 3 trial is testing an investigational treatment called anzutresgene autoleucel (anzu-cel, IMA203).* It is a one-time cell therapy made from a patient’s own modified immune cells, which may help detect and destroy cancer cells that have a marker called PRAME.1 The goal is to see if anzu-cel can help patients with advanced melanoma live longer or slow disease progression.
About the SUPRAME clinical trial
The SUPRAME Phase 3 clinical trial is exploring a potential new personalized cell therapy, called anzu-cel, to understand how it may benefit people living with advanced melanoma, a type of skin cancer.
PRAME is a protein made inside many tumour cells but rarely in healthy cells. Anzu-cel is created using your own T cells, which are powerful immune cells that are modified in the lab so they can better recognise and attack PRAME-positive cancer cells.
The SUPRAME trial is exploring anzu-cel's potential to help treat people living with cutaneous melanoma (CM) who have experienced disease progression on or after being treated with a checkpoint inhibitor such as OPDIVO (nivolumab) or KEYTRUDA (pembrolizumab).
In the SUPRAME clinical trial, researchers are investigating if anzu-cel may:
Improve progression-free survival
or the length of time a patient lives without their cancer growing or spreading after starting treatment.2
Demonstrate safety and tolerability
or the number of reported side effects.3
Improve day-to-day life
compared to current standard-of-care treatments that doctors commonly use.
Find out if the SUPRAME clinical trial is right for you
To join the SUPRAME trial, you'll need to meet certain requirements.
Please reach out to the nearest clinical trial site for more information.
You may be able to join this trial if you†:
- Are 18 years of age or older
- Have been diagnosed with advanced melanoma that is:
- unresectable (cannot be fully removed with surgery) or
- metastatic (has spread to other areas of your body)
- Have experienced disease progression on or after treatment with a checkpoint inhibitor such as OPDIVO (nivolumab) or KEYTRUDA (pembrolizumab)
- Have a genetic marker called HLA-A*02:01, which can be identified with a simple blood test
- This marker works together with the cancer protein PRAME to help anzu-cel recognize and target melanoma cells
- Nearly half of adults are HLA-A*02:01 positive, and your status does not change over time4
- Are in good enough overall health to take part in a clinical trial
- Are willing and able to travel to the local study center for all study-related visits
†Your trial healthcare provider can check if you fit these requirements. Please note this is not a full list of criteria for joining the study.
Find a SUPRAME clinical trial location
The SUPRAME clinical trial is being conducted by select oncologists at specialised treatment centres to offer the trial. Each site’s coordinators can answer questions, explain the trial, and check eligibility.
Try clearing your search filters.
What to expect from the SUPRAME cell therapy clinical trial
SUPRAME is a Phase 3 clinical trial for people with advanced melanoma. This study is looking at how well anzu-cel works compared with current standard treatments for advanced melanoma. By taking part, you may gain access to a potential new treatment option. You may also play an important role in helping researchers and healthcare providers learn how this treatment may target cancer and potentially improve outcomes for people living with the disease now and in the future.
Below is an overview of what you can expect during the SUPRAME trial. Throughout every step, your safety and well-being come first.
Thinking about participating in the SUPRAME trial? Contact the nearest clinical trial site for enrollment details.
Your journey through the SUPRAME clinical trial
Understanding what to expect during the SUPRAME clinical trial can make you feel more confident about your decision to enroll. You can work with your oncologist to check your HLA status, which will help determine if you are a potential candidate for SUPRAME. This test will also be performed after signing informed consent.
Informed consent review
The first step in the study is to review the informed consent document with the study staff. This document outlines what to expect during the trial as well as potential benefits and risks. The study staff will review all study specifics with you and answer any questions you may have.
HLA-A*2:01 testing (blood)
To receive anzu-cel PRAME cell therapy, a healthcare provider first needs to confirm that you carry a specific genetic marker called human leukocyte antigen (HLA-A*02:01).
This marker works together with a cancer-associated protein called PRAME, allowing anzu-cel to recognise and target melanoma cells more precisely. The purpose of the HLA-A*02:01 test is to confirm that anzu-cel is a good match for your immune system.
The study team will order a confirmatory HLA test to confirm your status and eligibility for the trial.
Screening
If you have the specific HLA genetic marker, you can continue with the screening process. This includes additional tests to confirm the trial is a good fit for you and that you do not have any serious medical issues that would make it unsafe for you to participate.
As part of the screening process, you will also undergo additional testing, including:
- Vital signs and a physical examination
- Blood tests
- Lung and heart function tests
- CT scan
Leukapheresis
After completing the additional testing outlined above the study staff will determine if you are eligible to continue the screening process. If you are eligible to continue, doctors will collect T cells from your blood in a process called leukapheresis (pronounced loo-kuh-fur-EE-sis).5 This step collects the immune cells that will become your personalised treatment. The procedure takes 4–6 hours and is usually done in an outpatient clinic, so you can return home the same day.
Randomisation into trial groups
If you are eligible for the SUPRAME trial, you will be randomly assigned to one of two treatment groups: one that receives anzu-cel or a group that receives one of the currently available cancer therapies.
If you are assigned to the anzu-cel group, you will begin the following treatment process. Each step is designed to prepare your body and your personalised cells for the best possible outcome.
Prepping with a short course of chemotherapy (4 days)
Before receiving anzu-cel, you’ll have a short course of chemotherapy (called lymphodepleting chemotherapy) at the hospital or outpatient centre. This process, called lymphodepletion, helps prepare your body so the modified cells can work more effectively. You may feel tired or have temporary side effects like nausea or low blood counts, which can lead to an increased risk of infection.7 Your care team will monitor you closely during this time. After finishing chemotherapy, you’ll have two days to rest.
Receiving anzu-cel
You will then receive a one-time intravenous infusion of your personalised therapy, anzu-cel, while in the hospital or treatment centre. This therapy was created for you by modifying your T cells to include receptors that help them find and attack cancer cells with a marker called PRAME.6 Your care team will monitor you closely during and after the infusion to help manage any potential side effects and support your recovery.
Additional immune activation doses (10 days)
To help your immune system and support the activity of anzu-cel, you’ll receive low-dose interleukin-2 (IL-2) infusions once or twice a day for up to 10 days. Alternatively, your HCP may allow you to self-administer IL-2 at home.
If you are assigned to the standard-of-care group, you will begin the following treatment process.
Healthcare provider selected treatment
Your healthcare provider will determine together with you which of the available standard of care treatments is best for you.
Follow-up care
After receiving treatment on either arm, you will be followed by your healthcare team. These follow-ups help your care team check your long-term health and may include scans and lab tests to see if your melanoma stays under control. Your healthcare team will also use this time to look for any delayed side effects from the treatment.
How clinical trials protect your safety
Clinical studies are split into phases to keep the risks to participants as low as possible. In each phase, healthcare providers and researchers evaluate if therapies are effective and monitor for side effects. SUPRAME is in Phase 3, which means anzu-cel has demonstrated initial signs of efficacy and has been deemed safe for a broader group of participants.
There are many safeguards in place during each phase of a clinical trial to make sure you are protected. Although no one can predict how you will respond to anzu-cel, it has been shown safe and effective in others with advanced melanoma in an earlier-phase clinical trial.
Why PRAME matters in the future of melanoma treatment
Advanced melanoma’s ability to evade the immune system can make it difficult for currently available therapies to treat. About 330,000 people worldwide are diagnosed with melanoma each year, and about 15% of those cases are advanced melanomas.8-11 Exploring new cell therapies that target cancer-specific proteins, like PRAME, is a critical step in potentially improving outcomes for patients living with advanced melanoma now and in the future.
At least 95% of cutaneous melanomas express PRAME, a protein that is present on the cancer cells but is rarely seen in healthy tissue.12 As a result, immunotherapies can use PRAME as a type of targeting system to help your body’s immune system find and destroy cancer cells.
By studying PRAME-directed cell therapies, healthcare providers, researchers, and participants are working together to develop new and effective treatment options for advanced melanoma.
Immatics is creating the next generation of cancer treatments
Immatics is a biotechnology company committed to making a meaningful impact on the lives of patients with cancer. We are the global leader in precision targeting of PRAME, a target expressed in more than 50 cancers. Our cutting-edge science and robust clinical pipeline form the broadest PRAME franchise with the most PRAME indications and modalities, spanning T-cell therapies and bispecifics.
Frequently asked questions
Unlike treatments that use medicines or radiation to destroy cancer cells, cell therapies use living immune cells to target cancer. Specifically, T-cell therapies like anzu-cel extract a patient's own immune cells, adjust them to target specific proteins (like PRAME), and then return them to patients' bodies through a one-time infusion so they can actively hunt and kill cancer cells.
PRAME is a protein made inside cancer cells that helps them hide from the immune system. It has been found in more than 50 types of cancers that highly express PRAME (i.e. ovarian, endometrial, synovial sarcoma).
About 95% of cutaneous melanomas (a common type of skin cancer) express PRAME, which means they are considered PRAME-positive.12 Because PRAME appears so often in tumours and so rarely in normal cells, it has become an important target for new immunotherapies like anzu-cel that aim to help the body find and destroy cancer cells more precisely.
PRAME is a protein made inside many melanoma cells. About 95% of cutaneous melanomas have it, but it is rarely found in healthy tissue.12 Because of this, PRAME acts like a marker that helps the immune system tell cancer cells apart from normal ones.
Anzu-cel (IMA203) is a personalized cell therapy developed by Immatics to target this marker. The process starts with your own immune T cells, which are collected from your blood and modified in a lab so they can recognise PRAME when it appears on melanoma cells. These cancer cells show small pieces of PRAME on their surface using a genetic feature called HLA-A*02:01 and anzu-cel is designed to find and attack cells that display PRAME this way.
Once your trained T cells, now called anzu-cel, are ready they are given back to you through a one-time IV infusion at the hospital. Your care team will monitor you closely during and after the infusion.
The SUPRAME clinical trial is studying whether anzu-cel can safely and effectively help people with advanced melanoma by teaching their immune systems to find and destroy PRAME-positive cancer cells more precisely.
The immune system uses special proteins called human leukocyte antigens (HLA) to help tell the difference between your body’s own cells and anything foreign, such as infections or cancer cells.
HLA-A*02:01 is one specific type of these immune markers. To join the SUPRAME clinical trial, you must have this HLA type, because it works together with the PRAME protein to help anzu-cel recognise and target melanoma cells.
The only way to know if you have HLA-A*02:01 is through a simple blood test that looks for HLA markers. Nearly half of adults have this immune type, and your HLA status doesn’t change over time.4 Your healthcare provider can help you find a hospital or specialty laboratory that can perform this test.
Many people living with advanced melanoma are first treated with immune checkpoint inhibitors, such as OPDIVO® (nivolumab) or KEYTRUDA® (pembrolizumab). These medicines work by helping your immune system recognise and attack cancer cells.
However, sometimes the cancer can adapt and continue to grow even after this type of treatment. If that happens, you might consider the SUPRAME clinical trial, which is studying a new PRAME-directed cell therapy called anzu-cel (IMA203).
This trial is exploring whether anzu-cel can safely and effectively help people whose melanoma has not responded to—or has stopped responding to—immune checkpoint inhibitors.
To find out more about the clinical trial and if you or a loved one qualify, contact a study coordinator at one of the SUPRAME clinical trial locations.
SUPRAME is currently being tested for safety. There are many safeguards in place to limit the risks of a clinical trial. Research Ethics Committees (RECs) monitor trials for problems and ensure patients are protected. They can even stop a clinical trial if there are safety concerns. Additionally, participants have the right to leave a trial at any time for any reason.
If you have additional questions about the SUPRAME clinical trial, contact a clinical trial site.
*Anzu-cel (anzutresgene autoleucel, IMA203) is still being studied in clinical trials and is not yet approved by health authorities.
References
- Wermke, M., Araujo, D.M., Chatterjee, M. et al. Autologous T cell therapy for PRAME+ advanced solid tumors in HLA-A*02+ patients: a phase 1 trial. Nat Med 31, 2365–2374 (2025). https://doi.org/10.1038/s41591-025-03650-6
- Progression-free survival. NCI Dictionary of Cancer Terms. NIH National Cancer Institute. Accessed October 29, 2025. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/progression-free-survival
- Tolerability & Dosing. Friends of Cancer Research. Published August 19, 2025. Accessed August 20, 2025. https://friendsofcancerresearch.org/tolerability/
- Ellis JM, Henson V, Slack R, et al. Frequencies of HLA-A2 alleles in five U.S. population groups. Human Immunology. 2000;61(3):334-340. https://doi.org/10.1016/s0198-8859(99)00155-x
- Leukapheresis. Cleveland Clinic. May 2, 2022. Accessed August 18, 2025. https://my.clevelandclinic.org/health/treatments/22926-leukapheresis
- CAR-T cell therapy. Mayo Clinic. Accessed August 18, 2025. https://www.mayoclinic.org/tests-procedures/car-t-cell-therapy/about/pac-20585020
- Preparing for CAR T-cell therapy. BMT Infonet. Accessed August 18, 2025. https://bmtinfonet.org/transplant-article/preparing-car-t-cell-therapy
- Skin Cancer. International Agency for Research on Cancer. World Health Organization. Accessed September 3, 2025. https://www.iarc.who.int/cancer-type/skin-cancer/
- Shirley CA, Chhabra G, Amiri D, et al. Immune escape and metastasis mechanisms in melanoma: breaking down the dichotomy. Front Immunol. 22024;15:1336023. https://doi.org/10.3389/fimmu.2024.1336023
- Erdmann F, Lortet-Tieulent J, Schüz, et al. International trends in the incidence of malignant melanoma 1953-2008--are recent generations at higher or lower risk? Int J Cancer. 2013;133(2):385-400. https:// https://pubmed.ncbi.nlm.nih.gov/22532371/
- Ferlay J, Ervik M, Lam F, et. al. (2024). Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. Accessed October 6, 2025. https://gco.iarc.who.int/today
- McCarthy N. PRAME in the frame. Nat Rev Cancer. 2005;5:839. https://doi.org/10.1038/nrc1747
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