A study for patients with metastatic uveal melanoma, in which treatment with ipilimumab and nivolumab is combined with hepatic percutaneous perfusio

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Cancer [C04]; Metastatic uveal melanoma

• Registration Number: EUCTR2018-004248-49-NL
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-26
• Last Update Posted: 3 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Age between 18-70 yrs
World Health Organization (WHO) Performance Status 0 or I
50% or less histologically or cytologically confirmed unresectable metastatic uveal melanoma in the parenchyma of the liver
Hepatic metastases, confined to or predominantly in the liver
No prior systemic treatment (including chemotherapy, vaccine therapy, monoclonal Ab treatment, IL-2)
Local pre-treatment of uveal melanoma metastases is allowed (resection and/or thermal ablation), except for chemotherapy containing procedures (e.g. chemoembolization) and radio-embolization, and as long as patients have progressed with measurable disease according to RECIST 1.1
No concurrent immunosuppressive medications (including dexamethasone, prednisolone, azathioprine)
Screening laboratory values must meet the following criteria: WBC = 2.0x109/L, Neutrophils = 1.0x109/L, Platelets = 100 x109/L, Hemoglobin = 6.5 mmol/L, Creatinine = 2x ULN, AST = 2.5 x ULN, ALT = 2.5 x ULN, Total bilirubin = 1.5 X ULN, INR and PTT in normal range, LDH < 2xULN
Women of child bearing potential (WOCBP) must agree to use a reliable form of contraceptive as described in the research protocol
Men must agree to the use of male contraception as described in the research protocol
Absence of additional severe and/or uncontrolled concurrent disease
No prior, or ongoing other malignancy, except adequately treated basal cell or squamous cell skin cancer, cervical cancer in situ or adequately treated other cancer with eradicative intent for which the patient has been continuously disease-free for > 2 years.
No aberrant vascular anatomy of the liver that precludes PHP

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 85
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

Cerebral or meningeal metastasized uveal melanoma
Subjects with any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, except for subjects with vitiligo or resolved childhood asthma/atopy
Prior immunotherapy (tumor vaccine, cytokine, or growth factor)
Known history of infection with Human Immunodeficiency Virus;
Active infection requiring therapy, positive serology for Hepatitis B surface antigen and/or Hepatitis C ribonucleic acid (RNA)
History of congestive heart failure, active cardiac conditions, including unstable coronary syndromes (unstable or severe angina, recent myocardial infarction), significant arrhythmias and severe valvular disease must be evaluated for risks of undergoing general anesthesia.
History or evidence of clinically significant pulmonary disease e.g. severe COPD that precludes the use of general anesthesia.
Underlying medical conditions that, in the Investigator's opinion, will make the administration of study treatment hazardous or obscure the interpretation of toxicity determination or adverse events;
Latex allergy, and known hypersensitivity/allergy to ipilimumab, nivolumab, melphalan or heparin
Prior Whipple’s Surgery
Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids
History of or current immunodeficiency disease, splenectomy or splenic irradiation; prior allogeneic stem cell transplantation
Patients who are unable to be temporarily removed from chronic anti-coagulation therapy
Patients with active bacterial infections with systemic manifestations (malaise, fever, leucocytosis) are not eligible until completion of appropriate therapy
Use of other investigational drugs before study drug administration for systemic malignancy
Pregnancy or nursing

Study & Design

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