A Phase III Study of Nivolumab and Ipilimumab, Together and Individually, in Patients Newly Diagnosed with Advanced Melanoma

Protocol
13-075
Full Title
A Phase 3, Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined with Ipilimumab Versus Ipilimumab Monotherapy in Subjects with Previously Untreated Unresectable or Metastatic Melanoma
Phase
III
Purpose

The purpose of this study is to compare the effectiveness of the drugs nivolumab and ipilimumab given together with each drug given with a placebo in patients with previously untreated inoperable or metastatic melanoma. Ipilimumab is already approved for treating melanoma. Nivolumab (also called BMS-936558) is investigational. Prior research has shown that the combination of these two drugs can be very effective for shrinking melanoma tumors.

Nivolumab boosts the body’s immune system by targeting a protein on white blood cells called PD-1. PD-1 normally maintains the balance of the immune system by shutting it down at the right time. Some cancers take advantage of this shut-down mechanism by activating PD-1, enabling them to escape attack by the body’s white blood cells. Nivolumab binds to and inactivates PD-1, enhancing the body’s ability to detect and destroy cancer cells.

Ipilimumab is an antibody against CTLA-4, a molecule that controls a part of the immune system by shutting it down. Researchers believe that an antibody against CTLA-4 could stop it from turning off the immune system, and allow an immune response that may help the body to destroy cancer cells.

Patients in this study will be randomly assigned to receive one of three treatments: nivolumab and ipilimumab, nivolumab and a placebo, or ipilimumab plus a placebo. All treatments are given intravenously (by vein).

Eligibility

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

  • Patients must have previously untreated inoperable stage III or IV 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.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Jedd Wolchok at 646-888-2395.

Disease(s)
Melanoma
Locations
Related Diseases