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A Multicenter Treatment Protocol for Compassionate Use of Ipilimumab Monotherapy in Patients with Unresectable Stage III or Stage IV Melanoma

[Protocol 07-156]


Full Title :
A MULTICENTER TREATMENT PROTOCOL FOR COMPASSIONATE USE OF IPILIMUMAB (BMS-734016) MONOTHERAPY IN SUBJECTS WITH UNRESECTABLE STAGE III OR STAGE IV MELANOMA (CA184045)
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.

Some patients with melanoma have experienced good responses to treatment with ipilimumab in prior clinical trials. The purpose of this study is to evaluate the effectiveness of ipilimumab in people being treated for stage III or IV melanoma who could not tolerate previous treatment (due to bad side effects) or whose disease did not respond to previous treatment.

Eligibility :

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have stage III or IV melanoma that persists despite at least one prior regimen of systemic therapy, or patients must have been unable to tolerate at least one prior regimen of systemic therapy.
  • At least 4 weeks must have passed since completion of prior treatment and entry into the study.
  • Patients must not be confined to a bed or chair for more than half of their normal waking hours.
  • 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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