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

Primary Purpose

Malignant Melanoma

Status
Active
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Blood sampling for Pre-existing immunity
Ipilimumab
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Melanoma focused on measuring Cancer, Malignant Melanoma, Ipilimumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • 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
  • Ålesund Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ipilimumab

Arm Description

Ipilimumab 3mg/kg

Outcomes

Primary Outcome Measures

Number of Patients with Serious and Non-Serious Adverse Reactions
CTCAE version 4

Secondary Outcome Measures

Health-Related Quality of Life (HRQL)
EORTC QLQ-C30 at baseline, before each ipilimumab infusion and every 12 week until progression.
Time to Overall Survival (OS)
From date of start treatment until date of death from any cause, assessed up to 5 years.
Time to Disease Progression
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
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
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.

Full Information

First Posted
December 20, 2013
Last Updated
March 23, 2023
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02068196
Brief Title
A National Phase IV Study With Ipilimumab for Patients With Advanced Malignant Melanoma.
Acronym
Ipi4
Official Title
Phase IV Ipilimumab in Melanoma: A National, Multicenter, Interventional Study in Patients With Unresectable or Metastatic Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2014 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Melanoma
Keywords
Cancer, Malignant Melanoma, Ipilimumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ipilimumab
Arm Type
Experimental
Arm Description
Ipilimumab 3mg/kg
Intervention Type
Procedure
Intervention Name(s)
Blood sampling for Pre-existing immunity
Intervention Description
Identify predictive biomarkers of long term study survivors who have substantially benefited from ipilimumab therapy
Intervention Type
Drug
Intervention Name(s)
Ipilimumab
Primary Outcome Measure Information:
Title
Number of Patients with Serious and Non-Serious Adverse Reactions
Description
CTCAE version 4
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Health-Related Quality of Life (HRQL)
Description
EORTC QLQ-C30 at baseline, before each ipilimumab infusion and every 12 week until progression.
Time Frame
Up to 5 years
Title
Time to Overall Survival (OS)
Description
From date of start treatment until date of death from any cause, assessed up to 5 years.
Time Frame
Up to 10 years
Title
Time to Disease Progression
Description
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 Frame
Up to 10 years
Title
Time to Overall Response
Description
From date of treatment start until the date of best documented response by RECIST 1.1, assessed up to 10 years.
Time Frame
Up to 10 years
Title
Time to Duration of Response
Description
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.
Time Frame
Up to 10 years
Other Pre-specified Outcome Measures:
Title
Biomarkers associated with clinical efficacy and toxicity
Description
Serum and plasma biomarkers, SNP, RNA, and immunological response analyses.
Time Frame
Pre-dose week 1, 4, 7, and month 3, 6, 12, 24, and 36.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tormod K Guren, MD PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
Country
Norway
Facility Name
Nordland Hospital Bodø
City
Bodø
Country
Norway
Facility Name
Sørlandet Hospital, Kristiansand
City
Kristiansand
Country
Norway
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway
Facility Name
Stavanger University Hospital
City
Stavanger
Country
Norway
Facility Name
University Hospital of North Norway
City
Tromsø
Country
Norway
Facility Name
Trondheim University Hospital, St.Olavs Hospital
City
Trondheim
Country
Norway
Facility Name
Ålesund Hospital
City
Ålesund
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
36116420
Citation
Aamdal E, Skovlund E, Jacobsen KD, Straume O, Kersten C, Herlofsen O, Karlsen J, Hussain I, Amundsen A, Dalhaug A, Nyakas M, Hagene KT, Holmsen K, Aamdal S, Kaasa S, Guren TK, Kyte JA. Health-related quality of life in patients with advanced melanoma treated with ipilimumab: prognostic implications and changes during treatment. ESMO Open. 2022 Oct;7(5):100588. doi: 10.1016/j.esmoop.2022.100588. Epub 2022 Sep 16.
Results Reference
derived
PubMed Identifier
30821848
Citation
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.
Results Reference
derived

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

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