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).

Phase 1

• Conditions: veal Melanoma; MedDRA 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-IT
• Lead Sponsor: IMMUNOCORE LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-15
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 327

Inclusion 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 neo-adjuvant 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 criteria
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

Exclusion Criteria

1.Pt 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 pts 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 < 0,5 x 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
QTcF > 470 msec on screening electrocardiogram (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.
Pts 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.
8.Malignant disease, other than that being treated in this study.
9.Any medical condition that would, in the inv.'s or Sponsor's judgment, prevent the pt's participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results
10.Pts 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 growth factors = 2 weeks prior to start of study drug. 18.Pregnant, likely to become pregnant, or lactating women
19.Women of child-bearing potential who are sexually active
20.Male pts must be surgically sterile or use double barrier contraception methods.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified