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Clinical Trials in the UK / NCT06743126
Recruiting Phase 3

SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma

NCT06743126 · tracked via the Priya Life Science UK tracker
Sponsor
Immatics US, Inc.
Phase
Phase 3
Started
2025-01-14
Last updated
2026-08-18

Condition(s) studied

Melanoma, Cutaneous Malignant

Investigational drug(s) / intervention(s)

IMA203nivolumab plus relatlimablifileucelnivolumabpembrolizumabipilimumabDacarbazinetemozolomidepaclitaxelpaclitaxel plus carboplatinAlbumin-Bound Paclitaxel

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

nivolumab plus relatlimab: in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)

lifileucel: in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)

nivolumab: in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)

pembrolizumab: in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)

ipilimumab: in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)

Dacarbazine: in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)

temozolomide: in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)

paclitaxel: in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)

paclitaxel plus carboplatin: in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)

Albumin-Bound Paclitaxel: in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)

Study summary

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.

For patients interested in additional information on how to participate, please follow this link: https://mytomorrows.com/trials/suprame/en-us/

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Pathologically confirmed and documented cutaneous melanoma- CM patients (including acral melanoma and melanoma of unknown primary) 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 and prior to trial treatment start. Exclusion Criteria: * Primary mucosal or uveal melanoma * 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

Primary outcome measure(s)

Trial sites (71)

FacilityCityRegionStatus
Mayo Clinic Phoenix Arizona Recruiting
Honor Health Research Institute Scottsdale Arizona Recruiting
City of Hope National Medical Center Duarte California Recruiting
UC San Diego Moores Cancer Center La Jolla California Recruiting
UCLA Hematology/Oncology Los Angeles California Recruiting
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California Recruiting
Stanford Cancer Center Stanford California Recruiting
University of Colorado, Anschutz Medical Campus Aurora Colorado Recruiting
Yale Cancer Center New Haven Connecticut Recruiting
Mayo Clinic Florida Jacksonville Florida Recruiting
University of Miami - Sylvester Comprehensive Cancer Cente Miami Florida Recruiting
AdventHealth, Orlando Orlando Florida Not Yet Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
Winship Cancer Institute, Emory University Atlanta Georgia Not Yet Recruiting
University of Chicago Medical Center Chicago Illinois Recruiting
University of MD Greenebaum Comprehensive Cancer Center Baltimore Maryland Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts Recruiting
University of Michigan Ann Arbor Michigan Recruiting
Mayo Clinic Rochester Minnesota Recruiting
University of Nebraska Medical Center Omaha Nebraska Recruiting
Atlantic Health System/Morristown Medical Center Morristown New Jersey Recruiting
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health New York New York Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
University of Rochester Rochester New York Recruiting
UNC Hospitals, The University of North Carolina at Chapel Hill Chapel Hill North Carolina Recruiting
Cleveland Clinic, Taussig Cancer Institute Cleveland Ohio Recruiting
Ohio State University Columbus Ohio Recruiting
Providence Cancer Institute Franz Clinic Portland Oregon Recruiting
Lehigh Valley Topper Cancer Institute Allentown Pennsylvania Recruiting
University of Pennsylvania, Abramson Cancer Center Philadelphia Pennsylvania Recruiting
Thomas Jeffersion University, Sidney Kimmel Cancer Center Philadelphia Pennsylvania Recruiting
Fox Chase Cancer Center Philadelphia Pennsylvania Recruiting
UPMC Hillman Cancer Center Pittsburgh Pennsylvania Recruiting
Avera Cancer Institute Sioux Falls South Dakota Recruiting
SCRI Oncology Partners Nashville Tennessee Recruiting
Baylor University Dallas Texas Recruiting
University of Texas Southwestern Medical Center Dallas Texas Recruiting
The University of Texas MD Anderson Cancer Center Houston Texas Recruiting
Huntsman Cancer Institute, University of Utah Salt Lake City Utah Recruiting

+ 31 more sites — see the full list on the official registry below.

On this site

📄 Opdivo (nivolumab) drug profile → 📄 Keytruda (pembrolizumab) drug profile →
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06743126 on ClinicalTrials.gov ↗ ← All trials in the UK