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-DE
- 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:
Serum creatinine > 1.5 × upper limit of normal (ULN) &/or creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 50 mL/min, Total bilirubin > 1.5 × ULN, exc. for patients with Gilbert's syndrome who are excluded if tot. 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, corrected calcium or phosphate abnormality of NCI CTCAE (v4.03) > grade 1
2.History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or monoclonal antibodies
3.Clinically significant cardiac disease or impaired cardiac function, including any of the following:
•Clinically significant &/or uncontrolled heart disease such as congestive heart failure (NYHA grade = 2), uncontrolled hypertension, or clinically significant arrhythmia currently requiring 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 (CNS) metastases, or CNS metastases that require doses of corticosteroids within the prior 3 weeks to study Day 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 syst. antibiotic therapy. Patients requiring syst. antibiotics for infection must have completed therapy at least 1 week prior to the first dose of study drug 6.Known history of HIV infection
7.Active HBV or HCV infection per institutional protocol
8.Malignant disease, other than that being treated in this study. Exception: 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.Medical condition that would, in the invest.'s or Sponsor's judgment, prevent the patient's participation 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. Local steroid therapies (eg, otic, ophthalmic, intra-articular or inhaled medications) 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 (minimally invasive procedures such as bronchoscopy, tumor biopsy, insertion of a central venous access device, and insertion of a feeding tube are not considered major);16.Radiotherapy within 2 weeks of the first dose of study drug, exception: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 growth factors (eg, G-CSF, GMCSF, M-CSF) = 2 weeks prior to start of stu
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