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

NCT02068196 | Active Not Recruiting Phase 4

• 1 other identifier: Ipi4
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 8

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.

Conditions

Malignant Melanoma

Keywords

Cancer; Malignant Melanoma; Ipilimumab

Outcome Measures

Primary Outcomes (1)

• Number of Patients with Serious and Non-Serious Adverse Reactions

  CTCAE version 4

  Up to 5 years

Secondary Outcomes (5)

• Health-Related Quality of Life (HRQL)

  Up to 5 years

• Time to Overall Survival (OS)

  Up to 10 years

• Time to Disease Progression

  Up to 10 years

• Time to Overall Response

  Up to 10 years

• Time to Duration of Response

  Up to 10 years

Other Outcomes (1)

• Biomarkers associated with clinical efficacy and toxicity

  Pre-dose week 1, 4, 7, and month 3, 6, 12, 24, and 36.

Study Arms (1)

Ipilimumab

EXPERIMENTAL

Ipilimumab 3mg/kg

Procedure: Blood sampling for Pre-existing immunity; Drug: Ipilimumab

Interventions

Blood sampling for Pre-existing immunity PROCEDURE

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

Ipilimumab

Ipilimumab DRUG

Ipilimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (8)

Ålesund Hospital

Ålesund, Norway

Location

Haukeland University Hospital

Bergen, Norway

Location

Nordland Hospital Bodø

Bodø, Norway

Location

Sørlandet Hospital, Kristiansand

Kristiansand, Norway

Location

Oslo University Hospital

Oslo, Norway

Location

Stavanger University Hospital

Stavanger, Norway

Location

University Hospital of North Norway

Tromsø, Norway

Location

Trondheim University Hospital, St.Olavs Hospital

Trondheim, Norway

Location

Related Publications (2)

• 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.

  PMID: 36116420 DERIVED

• 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.

  PMID: 30821848 DERIVED

MeSH Terms

Conditions

Melanoma; Neoplasms

Interventions

Blood Specimen Collection; Ipilimumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Tormod K Guren, MD PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Clinical Cancer Research Unit

Study Record Dates

• First Submitted: December 20, 2013
• First Posted: February 21, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

NO (8)