IMA203 for Skin Cancer
(SUPRAME Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness and safety of a new treatment called IMA203 for individuals with skin cancer that has spread or cannot be surgically removed. It compares IMA203 to other treatments selected by doctors to determine which better controls the cancer. The trial seeks participants with skin cancer that has worsened after at least one other treatment and who have a specific genetic marker (HLA-A*02:01 positive). As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have received systemic corticosteroids within 2 weeks before a certain procedure, or any anti-cancer therapy or radiotherapy within 1 week before starting the trial treatment.
Is there any evidence suggesting that IMA203 is likely to be safe for humans?
Research has shown that IMA203, a cell therapy for skin cancer, is generally well tolerated. In earlier studies, patients demonstrated a consistent and positive safety record, with most side effects being minor. The treatment also produced encouraging results, with more than half of the patients responding positively. Although side effects can occur, evidence suggests that IMA203 is safe for individuals when administered as part of a clinical trial.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for skin cancer, such as nivolumab or pembrolizumab, IMA203 is unique because it targets specific cancer cells through a novel approach. IMA203 is a type of personalized immunotherapy that uses non-myeloablative chemotherapy for lymphodepletion, followed by a one-time administration of IMA203, and then adjunctive therapy with low-dose interleukin-2. This combination aims to enhance the body's immune response against cancer cells more effectively. Researchers are excited about IMA203 because it has the potential to improve outcomes by focusing on precision targeting, offering a new way to potentially boost the effectiveness of treatment against skin cancer.
What evidence suggests that IMA203 might be an effective treatment for skin cancer?
Research has shown that IMA203, which participants in this trial may receive, effectively treats melanoma, a type of skin cancer. It reduced tumor size in 85% of patients and controlled the disease in 92% of cases. On average, the disease remained stable for about 6.1 months, and patients lived for an average of 15.9 months. In patients with cutaneous melanoma, IMA203 demonstrated a 54% overall response rate. These results suggest that IMA203 could be a promising treatment option for people with melanoma.16789
Who Is on the Research Team?
Cedrik Britten, M.D.
Principal Investigator
Immatics US, Inc.
Are You a Good Fit for This Trial?
This trial is for adults with confirmed cutaneous melanoma that's spread and can't be removed by surgery. They must have tried a PD-1 inhibitor treatment before, have good organ function, and an ECOG status of 0-1 (which means they're fully active or restricted in physically strenuous activity but can do light work). Women who can have children and men must agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Manufacturing
IMA203 products will be made from the patients' white blood cells
Treatment
Lymphodepletion with cyclophosphamide and fludarabine followed by IMA203 infusion and low dose IL-2 for up to 10 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- IMA203
Find a Clinic Near You
Who Is Running the Clinical Trial?
Immatics US, Inc.
Lead Sponsor