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A Phase III Study of Ipilimumab versus Placebo after Complete Resection of High-Risk Stage III Melanoma
[Protocol 08-085]
- Full Title :
- ADJUVANT IMMUNOTHERAPY WITH ANTI-CTLA-4 MONOCLONAL ANTIBODY (IPILIMUMAB) VERSUS PLACEBO AFTER COMPLETE RESECTION OF HIGH-RISK STAGE III MELANOMA: A RANDOMIZED, DOUBLE-BLIND PHASE 3 TRIAL OF THE EORTC MELANOMA GROUP (CA184-029/EORTC 18071)
- Purpose :
Ipilimumab (also known as MDX-010 or BMS-734016) is an antibody against CTLA-4, a molecule that controls a part of the immune system by shutting it down. Researchers believe that one way cancers can escape the immune system could be through this shut-down mechanism. An antibody against CTLA-4 could stop it from turning off the immune system, and allow an immune reaction to continue. This immune reaction may help the body to destroy cancer cells.
The purpose of this study is to evaluate the effectiveness of ipilimumab in patients with surgically removed stage III melanoma that has a high risk of recurring. Researchers will assess the drug's ability to delay disease relapse after surgery. Patients will be randomly assigned to receive ipilimumab or a placebo.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have stage III melanoma that has been surgically removed.
- Patients may not have had prior systemic treatment or radiation therapy for melanoma.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- Patients must be age 18 or older.
For more information and to see if you are eligible for this study, please contact Dr. Jedd Wolchok at 646-888-2395.
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