Help discover the potential of PRAME melanoma cell therapy through clinical research
SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma (SUPRAME) is a Phase 3 trial 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 that 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 expressed by many tumor cells. It is rarely found 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 recognize and attack PRAME-positive cancer cells.
The SUPRAME trial is exploring anzu-cel's potential to help treat people living with advanced cutaneous melanoma (CM) who have experienced disease progression on or after treatment with a checkpoint inhibitor such as OPDIVO (nivolumab) or KEYTRUDA (pembrolizumab) as monotherapy or in combination.
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.
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
- 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
DISCLAIMER
Please note this is not a full list of criteria for joining the study. If you have further questions about the study, you may speak to your oncologist or other healthcare provider.
How it works
To explore if you may be able to join this trial, please follow these three simple steps:
Share your contact details
- Fill out the contact form so we can connect you with a Patient Navigator.
- Participation is voluntary, and you may stop at any time.
- Your personal information is kept private.
Quick eligibility check
- Answer a few questions to see if you might be able to join the SUPRAME trial.
- We only ask for the basic medical information needed to check if you might qualify.
- If you seem to qualify for the trial, you can schedule a free phone call with a Patient Navigator on a day and time that works for you.
Meet your Patient Navigator
- Your Patient Navigator will explain the basics of the trial, including what to expect and what is required.
- They will check if you meet requirements for the trial, guide you through the next steps, and answer any questions you may have.
- If you are interested and seem to qualify, your Patient Navigator will connect you with a trial site.
Find a trial site near you
The SUPRAME clinical trial is being conducted by selected oncologists at specialized treatment centers. Each site’s coordinators can answer questions, explain the trial, and check eligibility.
Your Patient Navigator will work with you to connect to the right site and answer any questions about travel or logistics.
See if you qualifyView available trial sites on the map below:
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? Start your eligibility check now.
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.
Screening
1. 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.
2. HLA-A*02:01 testing (blood)
To be eligible 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 recognize 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.
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.
3. Additional testing
As part of the screening process, you will also undergo additional testing, including:
- Vital signs and a physical exam
- Blood tests
- Lung and heart function tests
- CT scan
Leukapheresis
After completing the testing outlined above, the study team will determine if you are eligible to continue the process. If you are eligible to continue, your healthcare provider 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 personalized treatment. The procedure takes 4–6 hours and is usually done in an outpatient clinic, so you can return home the same day.
Randomization into trial groups
If you are eligible for the SUPRAME trial, you will be randomly assigned to one of two treatment groups: a group that receives anzu-cel or a group that receives one of the currently available cancer therapies.
During the trial: Patients randomized to anzu-cel
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 personalized cells for the best possible outcome.
1. 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 center. 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.2. Receiving anzu-cel
You will receive a one-time intravenous infusion of your personalized therapy, anzu-cel, while in the hospital or treatment center. 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.
3. Additional immune activation doses (10 days)
To help anzu-cel work better at finding and attacking cancer cells, you’ll receive low-dose interleukin-2 (IL-2) subcutaneous injections once or twice a day for up to 10 days. Alternatively, your HCP may allow you to self-administer subcutaneous IL-2 at home.
During the trial: Patients randomized to standard-of-care
If you are assigned to the standard-of-care group, you will begin the following treatment process.
Healthcare provider selected treatment
Together with your healthcare provider, you will determine which of the available standard of care treatments is best for you.
After study follow-up for all participants
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 will 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 the investigational therapy, 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 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.
About Immatics
Immatics is a biotechnology company committed to making a meaningful impact on the lives of patients with cancer. They are the global leader in precision targeting of PRAME, a target expressed in more than 50 cancers. Their science and robust clinical pipeline form the broadest PRAME franchise with the most PRAME indications and modalities, spanning T-cell therapies and bispecifics.
Learn about immaticsFrequently asked questions
What makes PRAME cell therapy unique?
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.
What are PRAME proteins, and what does PRAME positive mean?
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.
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 solid tumors 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.
How does anzu-cel (IMA203) target PRAME?
PRAME is a protein made inside many melanoma cells. About 95% of cutaneous melanomas express PRAME, 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 recognize 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 express PRAME this way.
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.
How do I know if I have the HLA-A*02:01 genetic marker?
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 recognize 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.
When should I consider enrolling in a PRAME cell therapy trial like SUPRAME?
Many people living with advanced melanoma are first treated with immune checkpoint inhibitors, such as OPDIVO® (nivolumab) or KEYTRUDA® (pembrolizumab) monotherapy or in combination. These medicines work by helping your immune system recognize and attack cancer cells.
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 advanced melanoma has not responded to—or has stopped responding to—immune checkpoint inhibitors.
Where can I learn more about the SUPRAME clinical trial?
To find out more about the clinical trial and if you or a loved one qualify, complete the form and connect with a Patient Navigator. They can help you learn more about the SUPRAME trial and see if SUPRAME is a good option for you. You can also refer to the official trial listing on clinical trials.gov or speak to your healthcare provider.
What safeguards are in place to ensure clinical trials are as safe as possible?
SUPRAME is currently being tested for safety. There are many safeguards in place to limit the risks of a clinical trial. Institutional review boards (IRBs) 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.
DISCLAIMER
*Anzu-cel (anzutresgene autoleucel, IMA203) is being studied in clinical trials and is not yet approved by any health authority.
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
Please read, your consent is required
If you or a loved one has been diagnosed with advanced melanoma, and you are interested in this clinical trial, you are invited to complete some pre-screening questions on the following pages. These questions are designed to help determine whether you or the person you care for may be potentially eligible for participation in this clinical trial. If you would like to complete the pre-screening questions on behalf of another person, you will need to provide certain personal and medical information on their behalf. The information collected may include contact details, demographic data, and relevant medical history. This pre-screening is intended for adults aged 18 years or older. If you complete this form on behalf of another person, you confirm that you are legally authorized to provide information on their behalf.
In this notice, “we” or “us” refers to myTomorrows, which Immatics has engaged in managing clinical trial recruitment for this trial by collecting pre-screening information through this website.
With your consent, we will use this information to evaluate your or your loved one’s eligibility for the trial.
The information that could identify you or the person you care for will not be shared with Immatics. Only de-identified data will be shared with Immatics.
You may withdraw your consent at any time. Upon withdrawal of your consent, we will promptly delete your or your loved one’s personal data, except to the extent required to comply with our legal obligations. However, if you decide to withdraw your consent after you have been referred to a clinical trial, this means that information already shared with a clinical trial site cannot be retrieved but will no longer be used for new purposes. If you have a question, wish to withdraw consent, or exercise your other privacy rights, please contact myTomorrows at dataprotection@mytomorrows.com, as Immatics will not receive any information that can directly identify you.
If your answers to the pre-screening questions indicate you might be eligible for this trial, you will have the opportunity to schedule a call with one of our Patient Navigators, who will collect additional information to assess initial eligibility for this trial. If potentially eligible, they will provide you with further information and answer questions about possible site locations and trial logistics. If we find that you or the person you care for may be eligible for this trial, with your consent, we will share the personal information collected with a clinical trial site. The site will contact you to continue the screening process. Your de-identified information may be shared with other service providers supporting Immatics in the management of clinical trial operations (for example, for secure data hosting or trial site coordination).
If we find that you or the person you care for may be eligible for the trial, the collected data may be transferred internationally if you reside outside the USA. myTomorrows has implemented adequate security measures to ensure it is adequately protected during the transfer.
If you are not eligible and you consent to it, we will retain your or your loved one’s data for 2 years in order to get in touch with you should eligibility criteria change or if another Immatics trial becomes available during this time period.
