Comparing IMA203 with nivolumab plus relatlimab for cutaneous malignant melanoma

Exclusion

• −History of hypersensitivity to CY, FLU, or IL-2 or presence of any contraindications and other limitations for planned treatment with investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s choice as laid down in the current versions of the respective PIs / SmPCs
• −Known hypersensitivity to any of the rescue medications
• −Patients with active brain metastases or leptomeningeal metastases
• −Positive for HIV infection or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.
• −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 protocolProtocolThe detailed plan a study must follow.Read more →
• −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 or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the investigator
• −Any condition contraindicating leukapheresis
• −Any other condition that would, in the investigator's or sponsorSponsorThe organisation responsible for the study overall.Read more →'s judgment, contraindicate the patient's participation in the clinical trialInterventional studyA study where participants are given something to see what happens.Read more → 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,
• −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
• −Patient has received any investigational therapies, inactivated vaccines, chronic use of systemic corticosteroids or IV antibiotics within 1 week prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →, 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 inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →/exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → could apply
• −Pregnant or breastfeeding
• −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.