A Phase III Study of BMS-936558 (Nivolumab) versus Standard Chemotherapy in Patients with Advanced Melanoma that Progressed Despite Anti-CTLA-4 Therapy

Protocol
12-254
Full Title
A Randomized, Open-Label Phase III Trial of BMS-936558 (Nivolumab) Versus Investigator's Choice in Advanced (Unresectable or Metastatic) Melanoma Patients Progressing Post Anti-CTLA-4 Therapy
Phase
III
Purpose

The purpose of this study is to compare the investigational drug BMS-936558 (nivolumab) with standard chemotherapy in patients with inoperable or metastatic melanoma that has continued to grow despite anti-CTLA-4 therapy and (if a patient’s tumor has a BRAF mutation) prior vemurafenib therapy.

BMS-936558 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. BMS-936558 binds to and inactivates PD-1, enhancing the body’s ability to detect and destroy cancer cells.

In this study, patients will be randomly assigned to receive BMS-936558 or standard chemotherapy (dacarbazine or paclitaxel plus carboplatin).

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 continued to grow despite one or two prior regimens of therapy that included an anti-CTLA-4 drug (such as ipilimumab) and (if the patient’s tumor has a BRAF mutation) prior vemurafenib therapy.
  • At least 6 weeks must have passed since completion of anti-CTLA-4 therapy, 4 weeks since other chemotherapy or immunotherapy, and 2 weeks since radiation therapy 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.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Sandra D’Angelo at 646-888-4159.

Disease(s)
Melanoma
Locations
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