Ipilimumab +/− Interferon Alfa-2b for Advanced Skin Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial requires a 4-week washout period (time without taking certain medications) between your last treatment and the start of the study therapy. If you are on systemic corticosteroids or other immunosuppressants, you must stop them at least 2 weeks before joining the trial, unless they are replacement doses for adrenal insufficiency.
What data supports the effectiveness of the drug Ipilimumab for advanced skin cancer?
What safety information is available for Ipilimumab and Interferon Alfa-2b in humans?
Ipilimumab, also known as Yervoy, has been linked to immune-related side effects, including skin issues, digestive problems, liver and hormone-related events, and rare blood-related issues. Most side effects are mild to moderate, but some can be severe. Interferon Alfa-2b, known as Intron A or Roferon-A, is not specifically mentioned in the provided research, but it is generally known to have side effects like flu-like symptoms and fatigue.26789
What makes the drug Ipilimumab unique for treating advanced skin cancer?
Ipilimumab is unique because it is an immunotherapy drug that works by blocking CTLA-4, a molecule that normally inhibits the immune system, thereby enhancing the body's ability to attack cancer cells. Unlike traditional chemotherapy, it can lead to a delayed but long-lasting response, improving overall survival in patients with advanced melanoma.123410
What is the purpose of this trial?
This randomized phase II trial studies how well ipilimumab with or without high-dose recombinant interferon alpha-2b works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab, may block tumor growth by targeting certain cells. Recombinant interferon alfa-2b may interfere with the growth of tumor cells. It is not yet known whether ipilimumab is more effective with or without high-dose recombinant interferon alfa-2b in treating melanoma.
Research Team
Ahmad Tarhini
Principal Investigator
ECOG-ACRIN Cancer Research Group
Eligibility Criteria
This trial is for adults with stage III-IV melanoma that can't be surgically removed. Eligible participants must not have other current cancers (except certain cases), no brain metastasis, normal organ function tests, and no history of severe autoimmune diseases or conditions requiring systemic steroids. Women who can bear children and men must use effective contraception.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction
Patients receive ipilimumab and possibly recombinant interferon alfa-2b depending on the arm, with treatments administered over several weeks
Maintenance
Continued administration of ipilimumab and possibly recombinant interferon alfa-2b, with treatments spaced out over a longer period
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ipilimumab
- Recombinant Interferon Alfa-2b
Ipilimumab is already approved in United States, European Union for the following indications:
- Advanced melanoma
- Stage III unresectable melanoma
- Stage IV metastatic melanoma
- Advanced melanoma
- Stage III unresectable melanoma
- Stage IV metastatic melanoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor