NCT06743126 · Immatics US, Inc.
SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma
(SUPRAME)
What this study is about
This clinical trial is a forward-looking, conducted at multiple hospitals, where both patients and doctors know the treatment given, randomly assigned, actively controlled, parallel-group Phase 3 clinical trial to evaluate the effectiveness, safety and how well patients handle the treatment of treatment with IMA203 administered at the recommended phase 2 dose versus investigator's choice of treatment in patients with previously treated, unresectable or metastatic cutaneous melanoma.
View original scientific description
This clinical trial is a prospective, multicenter, open-label, randomized, actively controlled, parallel-group Phase 3 clinical trial to evaluate the efficacy, safety and tolerability of treatment with IMA203 administered at the recommended phase 2 dose versus investigator's choice of treatment in patients with previously treated, unresectable or metastatic cutaneous melanoma.
Interventions
BIOLOGICAL
IMA203
one-time administration of IMA203, and adjunctive therapy with low dose interleukin (IL)-2 for up to 10 days, starting approximately 24 h after IMA203 infusion, optional bridging therapy
BIOLOGICAL
nivolumab plus relatlimab
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
BIOLOGICAL
lifileucel
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
BIOLOGICAL
nivolumab
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
BIOLOGICAL
pembrolizumab
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
BIOLOGICAL
ipilimumab
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
DRUG
Dacarbazine
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
DRUG
temozolomide
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
DRUG
paclitaxel
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
DRUG
paclitaxel plus carboplatin
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
DRUG
Albumin-Bound Paclitaxel
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
Primary outcome measures
Progression-free survival assessed by BICR
Time frame: up to 5 years post first treatment of last patient
progression-free survival (PFS), centrally assessed (by blinded independent central review) using RECIST 1.1
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Pathologically confirmed and documented cutaneous melanoma- CM patients (including acral melanoma) with unresectable or metastatic disease
- HLA-A\*02:01 positive
- Adequate selected organ function per protocol
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Disease progression (resistance, toxicity) on or after at least one PD-1 inhibitor, applied either as monotherapy or in combination with other therapies as treatment for unresectable or metastatic cutaneous melanoma
- Patients with BRAF mutation should have been treated with one prior line of BRAF-directed therapy (with or without a MEK inhibitor) prior to initial eligibility assessment, unless deemed not clinically indicated at Investigator's discretion due to concurrent medical condition, prior toxicity, or if declined by the patient
- Life expectancy more than 6 months
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
- Female patient of childb
Where
- Phoenix, Arizona
- Scottsdale, Arizona
- Duarte, California
- La Jolla, California
- Los Angeles, California
- San Francisco, California
- Stanford, California
- Aurora, Colorado
- New Haven, Connecticut
- Jacksonville, Florida
- Miami, Florida
- Tampa, Florida
And 23 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 10, 2026 · Source of record for eligibility and locations