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Comparing IMA203 treatment to standard options for advanced melanoma

A Prospective, Multicenter, Open-label, Randomized, Actively Controlled, Parallel-group Phase 3 Clinical Trial to Evaluate Efficacy, Safety, and Tolerability of IMA203 Versus Investigator's Choice of Treatment in Patients With Previously Treated, Unresectable or Metastatic Cutaneous Melanoma (ACTengine® IMA203-301)

Phase 3 Interventional Immatics US, Inc. · NCT06743126

This study is testing a new treatment called IMA203 to see if it works better than standard options for people with advanced melanoma who can't have surgery.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment360 (estimated)
Ages18 Years and up
SexAll
SponsorImmatics US, Inc. Industry-sponsored
Drugs / interventionsnivolumab, relatlimab, pembrolizumab, ipilimumab, chemotherapy, cyclophosphamide, fludarabine
Locations59 sites (Phoenix, Arizona and 58 other locations)
Trial IDNCT06743126 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of IMA203, a novel cellular therapy, in patients with unresectable or metastatic cutaneous melanoma who have previously been treated. The study is a multicenter, open-label, randomized Phase 3 trial where participants are assigned to receive either IMA203 or an investigator's choice of standard treatment options. Patients eligible for the trial must be HLA-A*02:01 positive and undergo leukapheresis for the manufacturing of the IMA203 product. The trial aims to determine if IMA203 can provide better outcomes compared to existing therapies.

Who should consider this trial

Good fit: Ideal candidates include patients with unresectable or metastatic cutaneous melanoma who have previously received treatment and are HLA-A*02:01 positive.

Not a fit: Patients who are not HLA-A*02:01 positive or those with early-stage melanoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new, effective option for patients with advanced melanoma who have limited treatment choices.

How similar studies have performed: Other studies have shown promise with similar cellular therapies in treating melanoma, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 childbearing potential must use adequate contraception from randomization until 12 months after the infusion of IMA203 or in line with the instructions provided for investigator's choice treatment (in the control arm)
* Male patient must agree to use effective contraception or be abstinent while on study and for 6 months after the infusion of IMA203 or in line with the instructions provided for investigator's choice treatment (in the control arm)
* The patient must have recovered from any side effects of prior therapy to Grade 1 or lower prior to randomization.

Exclusion Criteria:

* Primary mucosal or uveal melanoma and melanoma of unknown primary
* History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years
* Serious autoimmune disease Note: At the discretion of the investigator, these patients may be included if their disease is well controlled without the use of immunosuppressive agents.
* History of cardiac conditions as per protocol
* Prior allogenic stem cell transplantation or solid organ transplantation
* Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study
* History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician
* History of hypersensitivity to CY, FLU, or IL-2 or presence of any contraindications and other limitations for planned treatment with investigator's choice as laid down in the current versions of the respective PIs / SmPCs
* Known hypersensitivity to any of the rescue medications
* History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the investigator
* Positive for HIV infection or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.
* Any condition contraindicating leukapheresis
* Pregnant or breastfeeding
* Any other condition that would, in the investigator's or sponsor's judgment, contraindicate the patient's participation in the clinical trial because of safety concerns or compliance with clinical trial procedures (e.g., psychiatric disorders or substance dependence, neurological impairment)
* Patient has received systemic corticosteroids within 2 weeks prior to leukapheresis,
* Patient has received surgery or other anti-cancer therapies, any agent that is likely to suppress bone marrow function, or investigational medicinal products within 7 days prior to leukapheresis.
* Patients with any active infection or ongoing reactivation of infection
* Patients who underwent non-myeloablative lymphodepletion prior to cell therapy within the last 6 months
* Prior treatment with IMA203
* Patients with ascites, pleural or pericardial effusion which requires repeated (2 within 4 weeks) or continuous paracentesis, thoracentesis or pericardiocentesis within last 2 months
* Patients with LDH greater than 2.0-fold ULN
* Concurrent treatment in another clinical trial or a device study that could interfere with the IMA203 treatment or planned investigator's choice treatment
* Patients with active brain metastases or leptomeningeal metastases
* Patient has received any investigational therapies, inactivated vaccines, chronic use of systemic corticosteroids or IV antibiotics within 1 week prior to randomization, or live vaccines within 4 weeks prior to randomization
* Patient has received any anti-cancer therapy (prior anti-cancer treatment or bridging therapy) or radiotherapy within 1 week prior to start of trial treatment
* Other protocol defined inclusion/exclusion criteria could apply

Where this trial is running

Phoenix, Arizona and 58 other locations

+9 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Melanoma, Cutaneous Malignant
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.