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Malignant MelanomaPhase 4Ipi4NCT02068196

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

A Phase 4 study testing Blood sampling for Pre-existing immunity and Ipilimumab in people with Malignant Melanoma, run by Oslo University Hospital at 8 sites in Norway.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Melanoma
What is being tested?
Blood sampling for Pre-existing immunity and Ipilimumab
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
8 sitesNorway
Study dates
Jan 2014to Dec 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Norway8 sites

  • Ålesund Hospital

    Ålesund

  • Haukeland University Hospital

    Bergen

  • Nordland Hospital Bodø

    Bodø

  • Sørlandet Hospital, Kristiansand

    Kristiansand

  • Oslo University Hospital

    Oslo

  • Stavanger University Hospital

    Stavanger

  • University Hospital of North Norway

    Tromsø

  • Trondheim University Hospital, St.Olavs Hospital

    Trondheim

Other trials in Norway

About this study

Official title: Phase IV Ipilimumab in Melanoma: A National, Multicenter, Interventional Study in Patients With Unresectable or Metastatic Melanoma

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.

Read the 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.

Being tested
Blood sampling for Pre-existing immunity, Ipilimumab
Keywords
Cancer, Malignant Melanoma, Ipilimumab
Medical subject headings
Melanoma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood sampling for Pre-existing immunityProcedure or surgery

    Identify predictive biomarkers of long term study survivors who have substantially benefited from ipilimumab therapy

  • IpilimumabDrug

Study groups in NCT02068196
Study groupRoleWhat they receive
IpilimumabExperimentalIpilimumab 3mg/kg
Receives: Procedure: Blood sampling for Pre-existing immunity; Drug: Ipilimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients with Serious and Non-Serious Adverse Reactions

    CTCAE version 4

    Measured: Up to 5 years

Secondary outcomes (5)

  1. Health-Related Quality of Life (HRQL)

    EORTC QLQ-C30 at baseline, before each ipilimumab infusion and every 12 week until progression.

    Measured: Up to 5 years

  2. Time to Overall Survival (OS)

    From date of start treatment until date of death from any cause, assessed up to 5 years.

    Measured: Up to 10 years

  3. 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.

    Measured: Up to 10 years

  4. 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.

    Measured: Up to 10 years

  5. 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.

    Measured: Up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02068196
Sponsor's protocol ID
Ipi4
Acronym
Ipi4
Status last verified
Mar 2023
First submitted
20 Dec 2013
Last updated
24 Mar 2023
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 36116420

  • 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.

    PubMed 30821848

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Blood sampling for Pre-existing immunity and Ipilimumab in people with Malignant Melanoma, run by Oslo University Hospital at 8 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients with Serious and Non-Serious Adverse Reactions (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02068196, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.

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