A Phase IB Study of a Personalized Cancer Vaccine plus Nivolumab Immunotherapy in Patients with Melanoma, Lung Cancer, and Bladder Cancer

Full Title

An Open-label, Phase IB study of NEO-PV-01 + Adjuvant with Nivolumab in Patients with Melanoma, Non-Small Cell Lung Carcinoma or Transitional Cell Carcinoma of the Bladder


The purpose of this study is to assess the safety of combining a customized anticancer vaccine with nivolumab immunotherapy in patients with melanoma, non-small cell lung cancer (NSCLC), and bladder cancer. The vaccine, called NEO-PV-01, is custom-made made from proteins in the patient’s tumor. These proteins aim to improve the immune system’s ability to recognize and target the cancer.

It is hoped that giving the vaccine with an immunotherapy such as nivolumab will make the immune system even better able to find and destroy cancer cells. Nivolumab works by taking the brakes off the immune response, boosting the power of the immune system to kill cancer cells. It is approved for several cancers, including melanoma, NSCLC, and bladder cancer, and is 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 or metastatic melanoma, smoking-related NSCLC, or bladder cancer.
  • Patients may not have received more than one prior regimen of treatment for advanced cancer.
  • At least 30 days must pass since completion of prior chemotherapy and 4 weeks since previous 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 for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Matthew Hellmann at 646-888-4863.