A Randomized Phase II Study of Ipilimumab at 3 mg/kg or 10 mg/kg Alone or in Combination with High Dose Interferon-? in Advanced Melanoma
Investigating Treatments for Advanced Metastatic Melanoma
Brief description of study.
The purpose of this study is to compare the effects, good and/or bad, of ipilimumab (given at 2 different doses, 10 mg/kg or 3 mg/kg) either alone or in combination with interferon alfa-2b melanoma to find out which treatment is safer and better.
Detailed description of study
The purpose of this study is to test the hypothesis that the combination of ipilimumab and high-dose interferon (HDI [recombinant interferon alfa-2b]) will improve progression free survival (PFS) of patients with advanced metastatic melanoma as compared to ipilimumab alone (across ipilimumab treatment status).
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Melanoma
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Age: 18 years - 100 years
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Gender: All
The purpose of this study is to compare the effects of an investigational medication, given at two different doses, either alone or in combination with another investigational medication for advanced metastatic melanoma. Melanoma is a type of skin cancer that can spread to other parts of the body. This study investigates which treatment option is safer and more effective in improving progression-free survival, which is the length of time during and after treatment that a patient lives with the disease without it getting worse.
Participants in the study will receive either the investigational medication alone or in combination with another investigational medication. The study procedures will involve regular monitoring to assess the effects of the treatments on progression-free survival.
- Who can participate: This study is for patients diagnosed with advanced metastatic melanoma. Participants must meet specific health criteria to be eligible, including age requirements.
- Study details: Participants will receive either ipilimumab alone or in combination with interferon alfa-2b. The study will involve regular health assessments to monitor the effects of the treatment. If applicable, participants may receive a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine.
Interested in the study?
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