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A Phase III Study of Immunotherapy with Nivolumab Given Alone or with Ipilimumab after Surgery in Patients with Advanced Melanoma

Full Title

A Phase 3, Randomized Study of Adjuvant Immunotherapy with Nivolumab Combined with Ipilimumab Versus Nivolumab Monotherapy after Complete Resection of Stage IIIb/c/d or Stage IV Melanoma


This study is comparing two immunotherapy treatments in patients with stage III or IV melanoma that has been surgically removed but has a chance of coming back. Patients will be randomly assigned to receive nivolumab alone or in combination with ipilimumab. Both drugs are given intravenously and are already used to treat inoperable and metastatic melanoma.

Nivolumab targets 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 mechanism by expressing PD-L1, enabling them to escape attack by the body’s white blood cells. Nivolumab blocks PD-1, enhancing the body’s ability to detect and destroy cancer cells. Ipilimumab has a similar effect on boosting the immune response, but does so by blocking CTLA-4, a molecule that controls a part of the immune system by shutting it down at the right time.


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

  • Patients must have stage IIIB, IIIC, IIID, or IV melanoma that was surgically removed within 12 weeks of entering the study.
  • Patients may not have had prior chemotherapy or immunotherapy.
  • 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 for patients age 15 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Alexander Shoushtari at 646-888-4161.