A National Phase IV Study With Ipilimumab for Patients With Advanced Malignant Melanoma. (Ipi4)
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|ClinicalTrials.gov Identifier: NCT02068196|
Recruitment Status : Active, not recruiting
First Posted : February 21, 2014
Last Update Posted : March 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Malignant Melanoma||Procedure: Blood sampling for Pre-existing immunity Drug: Ipilimumab||Phase 4|
In Norway ipilimumab (Yervoy®) has been available for treating patients with advanced, locally advanced or metastatic melanoma, but was not approved for reimbursement until recently. The Department of Health and Social Services decided that in Norway a national Phase IV interventional study examining survival and Quality of Life should be performed. In addition a research project should be launched aiming at isolating biological markers to identify patients who would benefit the most from ipilimumab therapy.
Because ipilimumab is a new therapeutic agent with a novel mechanism of action, it is important to understand the scope of its impact once being widely available as a treatment option, i.e. real-world experience. Treatment guidelines and clinical research provide information on how unresectable or metastatic melanoma is to be treated with ipilimumab and how Adverse Events should be managed, but may not reflect what actually occurs in clinical practice compared to controlled trials.
The results of the study will provide a more extensive understanding of the safety profile of ipilimumab in oncology practices in Norway in patients who may differ substantially from those included in the clinical trial program. In addition, the study results will provide information on how treatment patterns, patient-reported outcomes, clinical outcomes such as survival and disease progression may be influenced by ipilimumab. The proposed study objectives are: assessment of the safety of ipilimumab and analysis of health outcomes, in routine clinical practice, to ensure appropriate patient and provider utilization of ipilimumab.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase IV Ipilimumab in Melanoma: A National, Multicenter, Interventional Study in Patients With Unresectable or Metastatic Melanoma|
|Actual Study Start Date :||January 2014|
|Estimated Primary Completion Date :||December 2025|
|Estimated Study Completion Date :||December 2026|
Procedure: Blood sampling for Pre-existing immunity
Identify predictive biomarkers of long term study survivors who have substantially benefited from ipilimumab therapy
- Number of Patients with Serious and Non-Serious Adverse Reactions [ Time Frame: Up to 5 years ]CTCAE version 4
- Health-Related Quality of Life (HRQL) [ Time Frame: Up to 5 years ]EORTC QLQ-C30 at baseline, before each ipilimumab infusion and every 12 week until progression.
- Time to Overall Survival (OS) [ Time Frame: Up to 10 years ]From date of start treatment until date of death from any cause, assessed up to 5 years.
- Time to Disease Progression [ Time Frame: Up to 10 years ]From date of treatment start until the date of first documented progression by RECIST 1.1 or date of death from any cause, whichever came first, assessed up to 10 years.
- Time to Overall Response [ Time Frame: Up to 10 years ]From date of treatment start until the date of best documented response by RECIST 1.1, assessed up to 10 years.
- Time to Duration of Response [ Time Frame: Up to 10 years ]From date of treatment response until the date of first documented progression by RECIST 1.1 or date of death from any cause, whichever came first, assessed up to 10 years.
- Biomarkers associated with clinical efficacy and toxicity [ Time Frame: Pre-dose week 1, 4, 7, and month 3, 6, 12, 24, and 36. ]Serum and plasma biomarkers, SNP, RNA, and immunological response analyses.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02068196
|Haukeland University Hospital|
|Nordland Hospital Bodø|
|Sørlandet Hospital, Kristiansand|
|Oslo University Hospital|
|Stavanger University Hospital|
|University Hospital of North Norway|
|Trondheim University Hospital, St.Olavs Hospital|
|Principal Investigator:||Tormod K Guren, MD PhD||Oslo University Hospital|