A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon a-2b for Resected High-Risk Melanoma (ECOG E1609)
What is the purpose of this trial?
This trial is divided into 2 Arms. You will be randomly assigned to either Arm A or Arm B. Randomization means that you are put into a group by chance. A computer program will place you in one of the study groups. Neither you nor your doctor can choose the group you will be in. You will have an equal chance of being placed in any group. If you are in group 1 (often called "Arm A") you will receive ipilimumab that will be given in 2 stages called induction phase and maintenance phase. In the induction phase, you will receive iplimumab every 3 weeks for a maximum of 4 doses. In the maintenance phase,you will receive iplimumab every 12 weeks (3 months), beginning at week 24, for a maximum of 4 doses (weeks 24, 36, 48, 60). Ipilimumab will be administered by intravenous infusion, a method of putting the drug directly into the bloodstream through a vein. The infusion will take about 90 minutes and will take place at an outpatient facility.
Prior to the infusion, you will have your vital signs measured. During the infusion your vital signs will be measured every 30 minutes and one hour after the infusion has stopped, your vital signs will be measured one more time. If you are in group 2 (often called "Arm B") you will receive interferon Alfa-2b (IFN) that will begiven in 2 stages called induction phase and maintenance phase.
In the induction phase, you will receive interferon Alfa-2b given 5 consecutive days (Monday to Friday)for four weeks by intravenous infusions over 20 minutes. These infusions will be given in the outpatient setting.
In the maintenance phase, you will receive interferon Alfa-2b three times weekly,every other day (Monday, Wednesday, Friday) for 48 weeks by subcutaneous (under the skin) injections. You will be taught how to self administer the IFN subcutaneous injections. You will be asked to keep track of your injections with a written interferon calendar which will be reviewed during visits to your doctor’s office or clinic.
- Eastern Cooperative Oncology Group
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