Phase 1b/2 Study Combining Hepatic Percutaneous Perfusion with Ipilimumab plus Nivolumab in advanced Uveal Melanoma
- Conditions
- malignant cancer of the eyeuveal melanoma10027476
- Registration Number
- NL-OMON52669
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 88
Age between 18-80 years
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 systemic immunosuppressive medications >= 10mg/day prednisone or
equivalent. Topical, inhaled, nasal and ophthalmic steroids, and adrenal
replacement therapy are allowed.
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 <= 1.5 x ULN, 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
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method