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

Study acronym: Ipi4
StatusActive, Not Recruiting
PhasePhase 4
Started2014-01
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 24, 2023 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2023-03-23
5 amendments v7-v11
5 re-verifications since 2018-08-07, no change to tracked fields
2018-07-05
Study Status, Sponsor/Collaborators, Outcome Measures, Contacts/Locations v6
Primary completion date2018-12→2025-12
Completion date2019-12→2026-12
Secondary endpoints3 to 5 entries
Time to Overall Response Time to Duration of Response
2016-04-06
Study Status v5
Re-verified, no change to tracked fields
2015-04-09
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v4
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2015-12→2018-12
Enrollment targetestimated 100→confirmed 150
Study sitesdetails revised at 8 of 8 sites
2014-11-21
Active, Not Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusActive, Not Recruiting→Recruiting
Study sitesdetails revised at 8 of 8 sites
Show 2 earlier versions
2014-10-30
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v2
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 8 of 8 sites
2014-08-28
Study Status v1
Re-verified, no change to tracked fields
2014-02-18
Original filing
Oslo University Hospital
220 trials monitored
See 3 trials at risk
Melanoma
1,020 trials monitored
See 45 trials at risk
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.
Trial Details
NCT Number NCT02068196
Lead Sponsor Oslo University Hospital
Conditions Malignant Melanoma
Enrollment 150 participants
Start Date 2014-01
Primary Completion 2025-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2023-03-24