Clinical Trial ECOG 1609
- A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon a-2b for Resected High-Risk Melanoma
- Principal Investigator
- Sunandana Chandra
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.ECOG 1609
- The purpose of this study is to compare the effects of ipilimumab with interferon alfa-2b on patients with melanoma to find out which is better.
- Participants in this study have skin cancer (melanoma) which, although it has been successfully treated with surgery, has a high probability of coming back. Participants will get either ipilimumab or the interferon alfa-2b, not both. High doses of interferon alfa-2b can reduce the risk of melanoma returning, but only some patients benefit from interferon. Ipilimumab is a drug that has been shown to have anti-tumor activity in advanced melanoma. Ipilimumab is investigational which means that it has not been approved by the FDA.
Some of the eligibility criteria include:
- Participants must be at least 18 years of age.
- Participants must have skin cancer (melanoma), which has been successfully treated with surgery, but has a high probability of coming back.
- Participants must not have received any previous treatment (chemotherapy, biotherapy, etc.).
- Description of Treatment
- Participants will be placed randomly into one of the study groups described below. Neither participant nor doctor can choose the group. Participants will have an equal chance of being placed in any group. Participants in group 1 will receive ipilimumab that will be given through the vein. Participants in group 2 will be given interferon Alfa-2b through the vein. These will be administered in 2 stages called induction phase and maintenance phase. The dose and frequency of each dose will vary depending on which phase of the study the participant is in. During the maintenance phase for group 2, participants will be taught how to self administer the injection of the drug.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- Randomized Phase II/III Study of Nivolumab plus Ipilimumab plus Sargramostim versus Nivolumab plus Ipilimumab in Patients with Unresectable Stage III or Stage IV melanoma
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last updated: 21-Oct-16 08:46 PM
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