Safety and efficacy of IMCgp100 versus Investigator’s Choice in advanced uveal melanoma

Trial details

Who runs it

Immunocore Limited

Trial code

EU 2024-517290-24-00

Record updated

2025. június 25.

Original description

The dual primary objectives are:Read full original descriptionShow less

A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared with Investigator’s Choice in HLA-A*0201 Positive Patients with Previously Untreated Advanced Uveal Melanoma

The dual primary objectives are:

1. To compare the OS in all patients randomized to the tebentafusp monotherapy versus all patients randomized to the Investigator’s Choice monotherapy

2. To compare the OS in all patients randomized to the tebentafusp monotherapy who develop a rash within the first week of treatment versus all patients randomized to the Investigator’s Choice monotherapy

Both objectives relate to HLA-A*0201 positive patients with advanced UM with no prior treatment in the metastatic setting.

Inclusion: Patients 18 years of age or older; Ability to provide and understand written informed consent; Histologically or cytologically confirmed metastatic UM; Must meet the following criteria related to prior treatment: • No prior systemic therapy in the metastatic or advanced setting including chemotherapy, immunotherapy, or targeted therapy • No prior regional, liver-directed therapy including chemotherapy, radiotherapy, or embolization • Prior surgical resection of oligometastatic disease is allowed • Prior neoadjuvant or adjuvant therapy is allowed provided administered in the curative setting in patients with localized disease; HLA-A*0201 positive; Life expectancy of > 3 months; ECOG Performance Status of 0 or 1; Patients have measurable disease or non-measurable disease according to RECIST v1.1; All other relevant medical conditions must be well-managed and stable.

Exclusion: Patients receiving systemic steroid therapy or any other systemic immunosuppressive medication at any dose level, as these may interfere with the mechanism of action of study treatment; Major surgery within 2 weeks of the first dose of study drug; Radiotherapy within 2 weeks of the first dose of study drug; Use of hematopoietic colony-stimulating growth factors (eg, G-CSF, GM-CSF, M-CSF) ≤ 2 weeks prior to start of study drug; Male patients must be surgically sterile or use double barrier contraception methods from enrollment through treatment and for 6 months following administration of the last dose of study drug; Contraindication for treatment with Investigator’s Choice alternatives (dacarbazine, ipilimumab and pembrolizumab) as per applicable labelling; History of adrenal insufficiency; History of interstitial lung disease; History of pneumonitis that required corticosteroid treatment or current pneumonitis; History of colitis or inflammatory bowel disease; History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or monoclonal antibodies; Active infection requiring systemic antibiotic therapy; Known history of human immunodeficiency virus infection (HIV); Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection per institutional protocol; Malignant disease, other than that being treated in this study; Any medical condition that would, in the investigator’s or Sponsor’s judgment, prevent the patient’s participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results; Patient with any out-of-range laboratory values defined as: • Serum creatinine > 1.5 × upper limit of normal (ULN) and/or creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 50 mL/minute • Total bilirubin > 1.5 × ULN, except for patients with Gilbert’s syndrome who are excluded if total bilirubin > 3.0 × ULN or direct bilirubin > 1.5 × ULN • Alanine aminotransferase > 3 × ULN • Aspartate aminotransferase > 3 × ULN • Absolute neutrophil count < 1.0 × 109/L • Absolute lymphocyte count < 0.5 × 109/L • Platelet count < 75 × 109/L • Hemoglobin < 8 g/dL; Clinically significant cardiac disease or impaired cardiac function, including any of the following: • Clinically significant and/or uncontrolled heart disease such as congestive heart failure, uncontrolled hypertension, or clinically significant arrhythmia currently requiring medical treatment • QTcF > 470 msec on screening electrocardiogram (ECG) or congenital long QT syndrome. • Acute myocardial infarction or unstable angina pectoris; Pregnant, or lactating; Women of childbearing potential, unless they are using highly effective contraception during study treatment; Patients who are in an institution due to official or judicial order; Patients who are related to the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff thereof, directly involved in the conduct of the study; Presence of symptomatic or untreated central nervous system (CNS) metastases,.

EU CTIS 2024-517290-24-00