A Phase II Study Assessing Mediators of Response to Nivolumab and Ipilimumab Immunotherapy in Patients with Advanced Melanoma or Bladder Cancer

Full Title

A Prospectively Designed Study to Assess the Relationship between Tumor Mutation Burden and Predicted Neo-antigen Burden in Patients with Advanced Melanoma or Bladder Cancer Treated with Nivolumab or Nivolumab plus Ipilimumab (CA209-260)


The purpose of this study is to understand why some patients with advanced melanoma and bladder cancer respond to the immunotherapy while others do not. The immunotherapy drugs being assessed in this study are nivolumab and ipilimumab.

Nivolumab is approved for treating several types of cancer, including melanoma. Ipilimumab is approved for treating melanoma, but its use for treating bladder cancer is considered investigational. Both drugs are given intravenously (by vein).

All patients will be required to have a biopsy of their tumor before starting treatment, for research purposes.


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

  • Patients with melanoma may have had prior therapy or no previous treatment. Patients with bladder cancer must have experienced a recurrence or persistent growth of their cancer despite prior treatment that included a platinum-containing drug.
  • At least 4 weeks must pass between 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.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Margaret Callahan at 646-888-3579.