A Phase II Study of Adaptive Nivolumab and Ipilimumab Immunotherapy in Patients with Melanoma


Full Title

A Phase II Study to Evaluate Adaptive Dosing of Ipilimumab and Nivolumab Combination Immunotherapy


Nivolumab and ipilimumab are immunotherapy drugs that can be used together to treat melanoma. The typical dosage is four doses of each drug, but this treatment often causes side effects. Some patients benefit after only one or two doses. The purpose of this study is to see if doctors can give one or two doses of these medications to patients with stage III and IV melanoma and achieve the same benefit, increasing the number of doses to four only in those patients who don’t adequately respond to the reduced dosage.

Nivolumab and ipilimumab work by boosting the ability of the immune system to recognize and destroy cancer cells. They work by inhibiting proteins that put the brakes on the immune response: nivolumab blocks PD-1 activity and ipilimumab inhibits CTLA-4. After ipilimumab treatment is stopped, patients will continue to receive nivolumab every four weeks instead of the usual every two weeks; studies indicate that the blood level of nivolumab remains sufficiently elevated with this approach. Both drugs are given intravenously (by vein).


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

  • Patients must have inoperable stage III or IV melanoma.
  • Patients may not have previously received inhibitors of PD-1 or CTLA-4 for the treatment of metastatic or inoperable disease.
  • 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 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Michael Postow at 646-888-4589.