Study on Ipilimumab With or Without High-Dose Interferon for Treating Advanced Melanoma That Cannot Be Surgically Removed

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT01708941

Provider View

This clinical trial is exploring whether the drug ipilimumab, used alone or with high-dose interferon, can help treat advanced melanoma that cannot be removed by surgery. The study aims to find out which treatment option is more effective in controlling the cancer.

Patient Parameters

Program Overview

The purpose of this study is to determine if ipilimumab, a type of monoclonal antibody, is more effective in treating advanced melanoma when used alone or in combination with high-dose interferon alfa-2b. Ipilimumab works by targeting specific cells to block tumor growth, while interferon alfa-2b may interfere with the growth of tumor cells. The study will compare the effectiveness of these treatments in patients with stage III-IV melanoma that cannot be surgically removed.

Description

The study is divided into two main objectives: primary and secondary.

Primary Objective:

  • To test if combining ipilimumab with high-dose interferon improves the time patients live without the cancer getting worse, compared to using ipilimumab alone.

Secondary Objectives:

  • To see if the combination of ipilimumab and high-dose interferon is safe and tolerable.
  • To explore if higher doses of ipilimumab improve outcomes compared to lower doses.
  • To assess if the combination treatment improves overall survival compared to ipilimumab alone.

Participants will be randomly assigned to one of four treatment groups:

  • Group A: Higher dose ipilimumab with high-dose interferon.
  • Group B: Higher dose ipilimumab alone.
  • Group C: Lower dose ipilimumab with high-dose interferon.
  • Group D: Lower dose ipilimumab alone.

Each group will receive treatment in two phases: an induction phase and a maintenance phase. Treatment will continue as long as the cancer does not progress and side effects are manageable. After treatment, patients will have follow-up visits every 3 months for 2 years, every 6 months for 3 years, and then annually for up to 5 years.

Eligibility Criteria

Inclusion Criteria

  • Have stage III or IV melanoma that cannot be removed by surgery, either newly diagnosed or recurrent, and confirmed by lab tests.
  • Have had no more than one previous treatment for advanced melanoma, excluding certain therapies.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • No significant medical, surgical, or psychiatric conditions that could interfere with the study.
  • No history of inflammatory bowel disease or diverticulitis.
  • No other current cancers, unless disease-free for over 5 years or treated with curative intent and disease-free for over 3 years.
  • No autoimmune disorders or conditions requiring ongoing treatment with systemic steroids or immunosuppressants.
  • No recent vaccinations for infectious diseases within 4 weeks before starting the study.
  • Women must not be pregnant or breastfeeding and must use effective contraception.
  • Meet specific blood count and organ function criteria.
  • No active infections with HIV, hepatitis B, or hepatitis C.
  • No active brain metastases, confirmed by recent scans.
  • Have measurable disease as defined by standard criteria.

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