A Phase Ib Study of MDX-1106 (BMS-936558 or Nivolumab) in Combination with Ipilimumab (BMS-734016) in Patients with Unresectable Stage III or Stage IV Malignant Melanoma

Protocol
09-155
Full Title
A Phase Ib, Open Label, Multicenter, Multidose, Dose-Escalation Study of MDX-1106 in Combination with Ipilimumab in Subjects with Unresectable Stage III or Stage IV Malignant Melanoma
Phase
I
Purpose

The purpose of the study is to test the safety of two drugs called MDX-1106 (BMS-936558 or nivolumab, which is investigational) and ipilimumab in patients with stage III or IV malignant melanoma. Both drugs are antibodies which bind to cells involved in the immune system.

The antibodies in this study bind to substances on the cell which control different parts 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.

Both drugs have been assessed alone and are being evaluated when given together in patients with melanoma that is resistant to or has come back following other treatments. Laboratory research has shown that MDX-1106 and ipilimumab given together may work better than each one alone, and may kill melanoma cells or cause them to slow down or to stop growing completely.

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 malignant melanoma that cannot be treated with surgery and has continued to grow despite prior therapy.
  • Patients may have had up to three prior regimens of systemic therapy.
  • At least 4 weeks must have passed since completion of prior therapies and entry into the study.
  • 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 inquire about eligibility for this study, please contact Dr. Jedd Wolchok at 646-888-2395.

Disease(s)
Melanoma
Locations
Related Diseases