Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 3
Immatics US, Inc. (Voir sur ClinicalTrials)
janvier 2025
octobre 2031
20 juillet 2026
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/
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Caroline ROBERT | 20/07/2026 11:55:04 | Contacter | ||
Critères
Tous
- 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