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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.
 
ClinicalTrials.gov Identifier: NCT02068196
Recruitment Status : Active, not recruiting
First Posted : February 21, 2014
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
Tormod Kyrre Guren, Oslo University Hospital

Tracking Information
First Submitted Date  ICMJE December 20, 2013
First Posted Date  ICMJE February 21, 2014
Last Update Posted Date March 4, 2020
Actual Study Start Date  ICMJE January 2014
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2014)
Number of Patients with Serious and Non-Serious Adverse Reactions [ Time Frame: Up to 5 years ]
CTCAE version 4
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2018)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2014)
  • 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 5 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 5 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 5 years.
Current Other Pre-specified Outcome Measures
 (submitted: February 18, 2014)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A National Phase IV Study With Ipilimumab for Patients With Advanced Malignant Melanoma.
Official Title  ICMJE Phase IV Ipilimumab in Melanoma: A National, Multicenter, Interventional Study in Patients With Unresectable or Metastatic Melanoma
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Malignant Melanoma
Intervention  ICMJE
  • Procedure: Blood sampling for Pre-existing immunity
    Identify predictive biomarkers of long term study survivors who have substantially benefited from ipilimumab therapy
  • Drug: Ipilimumab
Study Arms  ICMJE Experimental: Ipilimumab
Ipilimumab 3mg/kg
Interventions:
  • Procedure: Blood sampling for Pre-existing immunity
  • Drug: Ipilimumab
Publications * Nyakas M, Aamdal E, Jacobsen KD, Guren TK, Aamdal S, Hagene KT, Brunsvig P, Yndestad A, Halvorsen B, Tasken KA, Aukrust P, Maelandsmo GM, Ueland T. Prognostic biomarkers for immunotherapy with ipilimumab in metastatic melanoma. Clin Exp Immunol. 2019 Jul;197(1):74-82. doi: 10.1111/cei.13283. Epub 2019 Mar 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 9, 2015)
150
Original Estimated Enrollment  ICMJE
 (submitted: February 18, 2014)
100
Estimated Study Completion Date  ICMJE December 2026
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02068196
Other Study ID Numbers  ICMJE Ipi4
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tormod Kyrre Guren, Oslo University Hospital
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tormod K Guren, MD PhD Oslo University Hospital
PRS Account Oslo University Hospital
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP