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

Sponsor
Oslo University Hospital
Study ID
NCT02068196
Phase
PHASE4
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Blood sampling for Pre-existing immunity — PROCEDURE
    Identify predictive biomarkers of long term study survivors who have substantially benefited from ipilimumab therapy
  • Ipilimumab — DRUG

Study Details

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.

Key Dates

Start date
Jan 31, 2014
Status verified
Mar 2023
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
150 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ipilimumab
    Ipilimumab 3mg/kg

Primary Outcome Measure

Number of Patients with Serious and Non-Serious Adverse Reactions [ Time Frame: Up to 5 years ]

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