Patients diagnosed with unresectable or metastatic melanoma, cutaneous, ocular, mucosal and unknown primary tumor
Conditions
Interventions
Trade Name: Yervoy
Pharmaceutical Form: Concentrate for solution for injection/infusion
Sponsors
Oslo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Histologically or cytologically confirmed diagnosis of malignant melanoma •Previously-treated unresectable Stage III or Stage IV melanoma (AJCC 2010) •Prior adjuvant melanoma therapy is permitted; any number of previous treatments for melanoma are permitted. •ECOG performance status of 0 or 1. •Men and women = 18 years of age •Adequate hematologic, renal and hepatic function, specifically: - WBC = 2500/uL - Absolute neutrophil count (ANC) = 1000/uL - Platelets = 75 x 103/uL - Hemoglobin = 9 g/dL - Creatinine = 2.5 x ULN - AST/ALT = 3 x ULN for subjects without liver metastasis; = 5 x ULN for subjects with liver metastasis - Total bilirubin = 3 x ULN, (except subjects with Gilbert’s Syndrome, who must have a total bilirubin less than 3.0 mg/dL) •Women of childbearing potential (WOCBP) and men must be using an acceptable method as described in section 7.2 to prevent pregnancy. •Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations. 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: • History of or current active autoimmune diseases, including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis (scleroderma and variants), systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies (eg, Guillain-Barre syndrome). Patients with vitiligo is NOT excluded. • MRI detected active brain metastatis wich require other therapies such as surgery and/or radio therapy. Patients already treated for their brain metastasis, surgery or radio therapy, and have had stable desease for more than two month and NOT requiring steroids may however be includet in this trial. • Uncontrolled infectious diseases – requires negative tests for clinically suspected HIV, HBV and HCV. If positive results are not indicative of true active or chronic infection, the subject may enter the study after discussion and agreement between the Investigator and the Medical Monitor. • History of or current immunodeficiency disease, splenectomy or splenic irradiation • Prior allogeneic stem cell transplantation •Pregnancy • Women who are breastfeeding • Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of AEs, such as a condition associated with frequent diarrhea • History of allergic reaction to parenteral administered recombinant protein product • Any reason why, in the opinion of the investigator, the patient should not participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To estimate the incidence and severity of adverse reactions in adult patients treated with ipilimumab in the post-approval setting. •To describe the management of adverse reactions (eg, diarrhea, colitis, hepatitis, elevated liver enzymes, hypopituitarism, hypothyroidism, rash, neurologic syndromes) and their outcomes in ipilimumab-treated patients in the post-approval setting ;Secondary Objective: •To describe patterns of care for adult patients receiving any therapy for unresectable or metastatic melanoma (dosing, regimen, indication, treatment rationales, management of treatment-related adverse events, reasons for treatment termination, etc.) • To describe Health-Related Quality of Life (HRQL) and impact on work productivity, and overall satisfaction among patients receiving any therapy for unresectable or metastatic melanoma •To describe real-world use in the treatment of unresectable or metastatic melanoma including ipilimumab (i.e identify type and incidence of toxicities and the manner they are managed in routine clinical practice. •To assess Overall Survival (OS) and Progression Free Survival (PFS) in patients receiving ipilimumab for unresectable or metastatic melanoma Exploratory objective:Identify predictive biomarkers of long term study survivors who might have substantially benefited from ipilimumab therapy.;Primary end point(s): The study is an observational study and not intended to test any hypothesis, but can be hypothesis generating. The goal of this study is to understand how ipilimumab is being used, its safety profile, and the manner in which ARs are managed in routine clinical practice. Another goal is to identify predictive biomarkers. Further, this study will provide information on the influence that the availability of ipilimumab as a treatment option exerts on the following health outcomes for patients with unresectable or metastatic melanoma: • Real-world patterns of care • Quality of life • Treatment effectiveness (Ove | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not defined;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Norway
Contacts
Public ContactCoordinating MD/Medical monitor
Oslo University Hospital
Outcome results
None listed