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SUPRAME - ACTengine® IMA203 vs. investigator’s choice of treatment in previously treated, unresectable or metastatic cutaneous melanoma
EU CTIS ID: 2024-517062-42-00
What this study is testing
To evaluate the efficacy of IMA203 compared with control (investigator’s choice)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Confirmed HLA status
- Adequate renal, hepatic and pulmonary function, acceptable coagulation status, adequate organ and marrow function
- Measurable disease according to RECIST 1.1
- Pathologically confirmed and documented cutaneous melanoma, CM patients with unresectable or metastatic (= advanced) disease who must have disease progression (resistance, toxicity) on or after at least one PD-1 inhibitor
You likely can't join if
- Primary mucosal or uveal melanoma
- History of other malignancies within the last 3 years
- Patients with prior allogeneic stem-cell transplantation or solid-organ transplantation
- The patient is pregnant or is breastfeeding.
- History of hypersensitivity to treatment in the IMA203 arm or rescue medications or presence of any contraindications and other limitations for planned treatment with investigator’s choice
- Any condition contraindicating leukapheresis
See the full eligibility criteria
- Patients ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Confirmed HLA status
- Adequate renal, hepatic and pulmonary function, acceptable coagulation status, adequate organ and marrow function
- Measurable disease according to RECIST 1.1
- Pathologically confirmed and documented cutaneous melanoma, CM patients with unresectable or metastatic (= advanced) disease who must have disease progression (resistance, toxicity) on or after at least one PD-1 inhibitor
- Patients with BRAF mutation should have been treated with one prior line of BRAF-directed therapy unless deemed not clinically indicated at Investigator’s discretion due to concurrent medical condition, prior toxicity, or if declined by the patient
- The patient must have recovered from any side effects of prior therapy to grade 1 or lower prior to randomization, and prior to LD and subsequent treat-ment
- Primary mucosal or uveal melanoma
- History of other malignancies within the last 3 years
- Patients with prior allogeneic stem-cell transplantation or solid-organ transplantation
- The patient is pregnant or is breastfeeding.
- History of hypersensitivity to treatment in the IMA203 arm or rescue medications or presence of any contraindications and other limitations for planned treatment with investigator’s choice
- Any condition contraindicating leukapheresis
- The patient has concurrent severe and/or uncontrolled medical disease. Any other condition that would, in the investigator’s judgement, contraindicate the patient’s participation in the clinical trial because of safety concerns or com-pliance with clinical trial procedures
- Patients with active brain metastases or leptomeningeal metastases at VA/VB
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.