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IMCgp 100-202

AcronymISRCTNEudraCTClinicaltrials.govDRKS
2015-003153-18

Status: Active

Purpose / Objectives

Primary Outcome

The Primary objective is to compare the OS in patients treated with IMCgp100 monotherapy versus Investigator's Choice in HLA-A*0201 positive patients with advanced UM with no Prior Treatment in the metastatic Setting.

Secondary Outcomes

The secondary objectives of the study are:

 

To characterize the safety and tolerability of IMCgp100 in the intra-Patient dose escalation Regimen.

To characterize the pharmocokinetic (PK) Profile of single-Agent IMCgp100 in the intra-Patient dose escalation Regimen.

To assess the objective Response rate (ORR) between IMCgp100 and investigator's Choice using Responsive Evaluation Criteria in Solid Tumors (RECIST) v1.1 Response criteria.

To assess the anti-Tumor efficacy of IMCgp100 with the Parameters of ORR, Progression free survival (PFS), Duration of Response (DOR), and disease control rate (DCR)

To evaluate the Treatment and disease Impact to health-related Quality of life (HGQoL) in patients treated with IMCgp100 versus patients treated with investigator's choice. HRQoL will be assessed using 2 established Patient reported outcome instruments:

The EuroQoL-5 Dimensions - 5-levels of disease severity scale (EQ-5D, 5 L), to enable an assessment of health Status compared to Population norms.

The European Organization for Research and Treatment of Cancer (EORTC) LLQ-C30 to provide an insight into Domains of cancer-specific Patient health

To evaluate the incidence of anti-IMCgp100 antibody Formation following multiple infusions of IMCgp100 in the intra-Patient dose excalation Regimen.

 

Diagnosis

Patient attributes

Stage

IV

Age

18-99

Inclusion criteria

Male or female patients Age ≥ 18 years of Age at the time of informed consent

Ability to provide and understand written informed consent Prior to any study procedure.

Histologically or cytologically confirmed metastativ 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 local, liver-directed therapy including chemotherapy, radiotherapy, radiofrequency Ablation (RFA), or embolization

Prior neoadjuvant or adjuvant therapy is allowed provided administered in the curative Setting in patients with localized disease. Patientes may not be re-treated with an Investigator's choice therapy that was administered as adjuvant or neo-adjuvant Treatment.

HLA-A*0201 positive by central Assay

Life expectancy of ≥3 months as estimated by the Investigator

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at Screening

Patients must have measurable disease according to RECIST v.1.1 criteria

All other relevant medical conditions muss be well-managed and stable, in the opinion of the investigator, for at least 28 days Prior to first Administration of study drug.

 

Exclusion criteria

Patient with any out-of-range laboratory values defined as:

 

Serum creatinine ≥ 1,5 x upper Limit of normal (ULN) and/or creatinine clearance (calculated using Cockroft-Gault formula, or measured) < 50 mL/Minute

Total Bilirubin ≥ 1,5 x ULN, except for patients with Gilbert' s Syndrome who are excluded if total Bilirubin > 3.0 x ULN or direct Bilirubin > 1.5 x ULN

Alanine aminotransferase > 3 x ULN

Aspartate aminotransferase > 3 x ULN

Absolute neutrophil Count < 1.0 x 109/L

Absolute lymphocyte Count  < 0.5 x 109/L

Platelet Count < 75 x 109/L

Hemoglobin 8 g/dL

Potassium, Magnesium, corrected calcium or Phosphate abnormality of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade > 1

History of severe hypersensitivity reactions (e.g., anaphylaxis) to other biological drugs or monoclonal antibodies

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 (New York Heart Association grade ≥ 2), uncontrolled Hypertension or clinically significant arrhythmia currently requiring medical Treatment

QTcF > 470 msec on sreening electrocardiogram (ECG) or congenial Long QT Syndrome

Acute myocardia infarction or unstable Angina pectoris < 6 months Prior to Screening

Presence of symptomatic or untreated central nervous System (CNS) metastases, or CNS metastases that require doses of corticosteriods within the Prior 3 weeks to study Day 1. Patients with brain metastases are eligible oif lesions have been treated with localized therapy and there is no evidence of Progression for at least 4 weeks by magnetic resonance Imaging (MRI) Prior to the first dose of study drug.

Active infection requiring systemic antibiotic therapy. Patients requiring systemic antibiotics for infection must have completed therapy at least 1 week Prior to the first dose of study drug.

Known history of human immunodeficiency Virus infection (HIV). Testing for HIV Status is not necessary unless clinically indicated

Active Hepatitis B Virus (HBV) or hepatits C Virus (HCV) infection per institutionlal protocol. Testing for HBV or HCV Status is not necessary unless clinically indicated or the Patient has a history of HBV or HCV infection.

Malignant disease, other than being treated in this study. Exceptions to this exclusion include the following: Malignancies that 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.

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.

Patients receiving systemic Steroid therapy or any other systemic immunosuppressive medication at any dose Level. Local Steroid therapies (eg., otic, opthalmic, intra-articular or inhaled medications) are acceptable

History of adrenal insufficiency

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 surgery and are not exclusionary).  

Radiotherapy within 2 weeks of the first dose of study drug, with the exception of palliative readiotherapy to a limited field, such as for hte Treatment of bone pain or a focally painful Tumor mass

Use of hematopoietic colony-stimulating growth factors (e.g., G-CSF, GMCSF, M-CSF) ≤ 2 weeks Prior to start of study drug. An erythroid stimulating Agent is allowed as Long as it was initiated at least 2 weeks Prior to the first dose of study Treatment and the Patient ist not red blood cell Transfusion dependent.

Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the Termination of gestation)

Women of child-bearing potential who are sexually active with a non-sterilized male Partner, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective contraception during study Treatment (defined in Section 6.7), and must agree to continue using such precautions for 6 months after the final dose of investigational product; cessation of birth control after this Point should be discussed  with a responsible physician. Highly effective methods of contraception are described in Section 6.7

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.

 

Trial design

  • Phase II
  • Multicenter
  • Randomized
  • Two-arm
  • Open Label

Documents (password protected)

Responsibilities in overall trial

Immunocore

    Study Sites

    Klinik & Poliklinik für Dermatologie & Venerologie Köln

    Status

    Active

    Principal Investigator

    Univ.-Prof. Dr. med. Dr. Cornelia Mauch

    Deputy of Principal Investigator

    • Dr. Nicole Kreuzberg

    Subinvestigator

    • Carina Gärtner

    Contact at Site