A National Phase IV Study With Ipilimumab for Patients With Advanced Malignant Melanoma.

• Status: Active, not recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this study is to understand how ipilimumab is being used, its safety profile, and the manner in which Adverse Reactions are managed in routine clinical practice. Another goal is to identify predictive biomarkers. The study is an observational study and not intended to test any hypothesis, but can be hypothesis generating.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oslo University Hospital
• Treatments: Antibodies, Monoclonal; Ipilimumab

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of malignant melanoma

• Unresectable Stage III or Stage IV melanoma

• 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 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.

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 metastasis 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 disease for more than two months and NOT requiring steroids may, however, be included 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.