An open-label study in patients with advanced cancer.

Phase 1

• Conditions: HLA-A*0201 positive patients with advanced antigen-positive cancer with a histologic diagnosis of Non small cell lung carcinoma (NSCLC), melanoma, urothelial carcinoma, or synovial sarcoma with antigen positivity for NY-ESO-1 and/or LAGE-1A; MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: LLTClassification code 10025665Term: Malignant melanoma of skin stage unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10042863Term: Synovial sarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: LLTClassification code 10064467Term: Urothelial carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-002243-15-GB
• Lead Sponsor: Immunocore Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-04
• Last Update Posted: 29 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

Patients must meet all the following inclusion criteria to be eligible for
inclusion in the study:
General
1.Male or female patients age = 18 years of age at the time of informed
consent
2.Ability to understand and provide written informed consent prior to
undergoing any studyprocedures
3.Life expectancy of > 3 months as estimated by the Investigator
4.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0
or 1 at Screening
5.In the opinion of the Investigator, all other relevant medical conditions
must bewell-managed and stable for at least 28 days prior to first
administration of study drug HLA and Tumor Antigen Testing
6.HLA-A*02:01 positive as confirmed by the central laboratory
7.NY-ESO-1 and/or LAGE-1A positive tumor confirmed by the central
laboratory
Phase I: Disease Under Study and Prior Anti-Cancer Treatment
8.Histologically confirmed diagnosis of advanced NSCLC, melanoma,
urothelial carcinoma,or synovial sarcoma
9.Patients must be relapsed from, refractory to, or intolerant to all
approved and availableclasses of therapy known to provide clinical
benefit for their condition
Phase II: Disease Under Study and Prior Anti-Cancer Treatment
10.Histologically confirmed diagnosis of advanced NSCLC, urothelial
carcinoma, or synovialsarcoma
11.Measurable disease per Response Evaluation Criteria in Solid Tumors
(RECIST) v.1.1criteria (Section 13.1)
12.A minimum of 10 patients enrolled in Phase II must have disease that
is amenable tobiopsy, and consent to provide biopsies during Screening
and on treatment
13.Patients will have received the following previous therapies. These
therapies must havebeen given for unresectable / metastatic disease or
given in the adjuvant setting if diseaseprogression occurred during or
within 6 months of completing adjuvant therapy
•NSCLC — PD-1/PD-L1 inhibitor. Patients with a genomic tumor
aberration (eg, EGFR,ALK) that is targeted by Health Authority-approved
agent(s) must be relapsed from,refractory to, or intolerant of relevant
targeted agent(s)
•Urothelial cancer — PD-1/PD-L1 inhibitor
•Synovial sarcoma — at least 1 prior systemic chemotherapy regimen
Contraception
14.Female patients should either be of non-childbearing potential or
must agree to use highly effective methods of contraception from
Screening until 6 months following administration of the last dose of
study drug (see Section 6.14)
15.Male patients must be surgically sterile or use double barrier
contraception from enrollment through treatment and for 6 months
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 53
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Patients with any of the following will not be included in the study:
Disease Under Study and Prior Anti-Cancer Treatment
-Presence of symptomatic or untreated CNS metastases, leptomeningeal disease, cord compression, or CNS
metastases that require doses of corticosteroids within 3 weeks prior to the planned first administration of study drug.
-Systemic anticancer therapy for disease under study within 2 weeks of the planned first administration of study treatment. For
cytotoxic or immunotherapy agents that can present with major delayed toxicity, a 4-week washout period is required
-Radiotherapy within 2 weeks of the planned first administration of
study drug.
-Presence of National Cancer Institute Common Terminology Criteria for AEs = Grade 2 toxicity due to prior cancer therapy (except Grade 2 alopecia, stable Grade 2 peripheral neuropathy, Grade 2 endocrine disorder [on stable replacement doses and without
symptoms]Grade 2 hypophosphatemia [on appropriate replacement therapy] and Grade 2 ototoxicity) Laboratory Parameters
-Patient with any out-of-range laboratory values defined as shown below. Hematology evaluations must be performed = 7 days after any
blood or blood product transfusion and= 14 days after any dose of
hematologic growth factor.
Creatinine clearance (calculated using Cockcroft-Gault formula or
measured)< 40 mL/min
Total bilirubin > 1.5 × upper limit of normal (ULN); NOTE: for patients
with Gilbert's syndrome; exclude if total bilirubin > 3.0 × ULN or direct
bilirubin > 1.5 × ULN)
Alanine aminotransferase (ALT) > 3 × ULN
Aspartate aminotransferase (AST) > 3 × ULN
Absolute neutrophil count (ANC) < 1.0 × 109/L
Absolute lymphocyte count < 0.5 × 109/L
Platelet count < 75 × 109/L
Hemoglobin < 8 g/dL
Medical History and Concomitant Medications
-Any active manifestations of autoimmune disease of the skin, including
psoriasis and scleroderma, or history of severe skin manifestation of
graft versus host disease
-Clinically significant cardiac disease or impaired cardiac function
including any of the following:
-Clinically significant and/or uncontrolled heart disease such as
diagnosed congestive heart failure, uncontrolled hypertension, or clinically significant arrhythmia currently
requiring medical treatment
-Confirmed manually over-read QT interval corrected by Fredericia's method (QTcF)>470 msec on Screening ECG or
known history of congenital long QT syndrome
-History of acute myocardial infarction or unstable angina pectoris < 6 months prior to planned first administration of study drug
-Active infection requiring systemic antibiotic therapy. NOTE: Patients requiring systemic antibiotics for infection must have completed treatment with any IV antibiotics at least 14 days before the planned first administration of study drug and any oral antibiotics at least 7 days before the planned first administration of study drug
-Known history of HIV, Testing for HIV status is not necessary unless clinically indicated
-Active HBV or HCV infection as defined per institutional protocol. Testing for HBV or HCV status is not necessary unless clinically
indicated or the patient has a history of HBV or HCV infection
-Patients receiving systemic treatment with steroid therapy (ie, prednisone > 10mg daily[QD] or the equivalent) or any other immunosuppressive
medication at any dose level that could interfere with the action of the study drugs, in the opinion of the PI
-Treatment for well controll

Study & Design

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