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A National Phase IV Study With Ipilimumab for Patients With Advanced Malignant Melanoma. (Ipi4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02068196
Recruitment Status : Active, not recruiting
First Posted : February 21, 2014
Last Update Posted : May 28, 2021
Information provided by (Responsible Party):
Tormod Kyrre Guren, Oslo University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Malignant Melanoma Procedure: Blood sampling for Pre-existing immunity Drug: Ipilimumab Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma
Drug Information available for: Ipilimumab

Arm Intervention/treatment
Experimental: Ipilimumab
Ipilimumab 3mg/kg
Procedure: Blood sampling for Pre-existing immunity
Identify predictive biomarkers of long term study survivors who have substantially benefited from ipilimumab therapy

Drug: Ipilimumab

Primary Outcome Measures :
  1. Number of Patients with Serious and Non-Serious Adverse Reactions [ Time Frame: Up to 5 years ]
    CTCAE version 4

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Other Outcome Measures:
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02068196

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Haukeland University Hospital
Bergen, Norway
Nordland Hospital Bodø
Bodø, Norway
Sørlandet Hospital, Kristiansand
Kristiansand, Norway
Oslo University Hospital
Oslo, Norway
Stavanger University Hospital
Stavanger, Norway
University Hospital of North Norway
Tromsø, Norway
Trondheim University Hospital, St.Olavs Hospital
Trondheim, Norway
Ålesund Hospital
Ålesund, Norway
Sponsors and Collaborators
Oslo University Hospital
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Principal Investigator: Tormod K Guren, MD PhD Oslo University Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Tormod Kyrre Guren, Head of Clinical Cancer Research Unit, Oslo University Hospital Identifier: NCT02068196    
Other Study ID Numbers: Ipi4
First Posted: February 21, 2014    Key Record Dates
Last Update Posted: May 28, 2021
Last Verified: May 2021
Keywords provided by Tormod Kyrre Guren, Oslo University Hospital:
Malignant Melanoma
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action