A clinical trial comparing the safety and activity of IMCgp100 to Investigator's Choice. This study will only take place in patients who have a particular type (HLA-A*0201) of the uveal melanoma (a cancer which started and then spread from the coloured cells of the eye).
- Conditions
- veal MelanomaMedDRA version: 21.1Level: PTClassification code 10025650Term: Malignant melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2015-003153-18-BE
- Lead Sponsor
- Immunocore Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 369
Patients eligible for inclusion in this study must meet all of the following criteria:
1. Male or female patients age = 18 years of age at the time of informed consent
2. Ability to provide and understand written informed consent prior to any study procedures
3. Histologically or cytologically confirmed metastatic UM
4. 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 local, liver-directed therapy including chemotherapy, radiotherapy, radiofrequency ablation (RFA), or embolization
• Prior surgical resection of oligometastatic liver disease is allowed
• Prior neoadjuvant or adjuvant therapy is allowed provided administered in the curative setting in patients with localized disease. Patients may not be re-treated with Investigator’s Choice therapy that was administered as adjuvant or neoadjuvant treatment
5. HLA-A*0201 positive by central assay
6. Life expectancy of > 3 months as estimated by the investigator
7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at Screening
8. Patients must have measurable disease according to RECIST v.1.1
9. All other relevant medical conditions must be well-managed and stable, in the opinion of the
investigator, for at least 28 days prior to first administration of study drug
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 129
1.Patient with any out-of-range lab. values defined as:
•Serum creatinine > 1.5 × upper limit of normal &/or creatinine
clearance < 50 mL/min
•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 × 10^9/L
•Absolute lymphocyte count < 1,0 × 10^9/L
•Platelet count < 75 × 10^9/L
•Hemoglobin < 8 g/dL
•Potassium, magnesium, corr. calcium or phosphate abnormality of (v4.03) > grade 1
2.History of severe hypersensitivity reactions to other biologic drugs or monoclonal antibodies
3.Clinically significant cardiac disease or impaired cardiac funct., including any of the following:
•Clinically significant &/or uncontrolled heart disease such as congestive heart failure, uncontrolled hypertension, or clinically significant arrhythmia currently req. medical treatment
*QT interval corrected by Fridericia's formula (QTcF) > 470 msec on screening ECG or congenital long QT syndrome
•Acute myocardial infarction or unstable angina pectoris < 6 months prior to Screening
4.Presence of symptomatic or untreated central nervous system metastases, or CNS metastases that require doses of corticosteroids within the prior 3 weeks to study D. 1. Patients with brain metastases are eligible if lesions have been treated with localized therapy and there is no evidence of PD for at least 4 weeks by MRI prior to the first dose of study drug
5.Active infection requiring systemic antibiotic therapy. Pat. requiring systemic antibiotics for infection must have completed therapy at least 1 week prior to the first dose of study drug
6.Known history of human immunodeficiency virus infection. Testing for HIV status is not necessary unless clinically indicated
7.Active hepatitis B virus or hepatitis C virus infection per institutional prot. Testing for HBV or HCV status is not necessary unless clinically indicated or the pat. has a history of HBV or HCV infection
8.Malignant disease, other than that being treated in this study.
Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers; any malignancy considered to be indolent and that has never required therapy; and completely resected carcinoma in situ of any type
9.Any medical condition that would, in the inv.'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
10.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. Local steroid therapies are acceptable
11.History of adrenal insufficiency
12.History of interstitial lung disease
13.History of pneumonitis that required corticosteroid treatment or current pneumonitis
14.History of colitis or inflammatory bowel disease
15.Major surgery within 2 weeks of the first dose of study drug
16.Radiotherapy within 2 weeks of the first dose of study drug, with the exception of palliative radiotherapy to a limited field, such as for the
treatment of bone pain or a focally painful tumor mass
17.Use of hematopoietic colony-stimulating growt
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method