Last updated on March 2017

A Personalized Cancer Vaccine (NEO-PV-01) w/ Nivolumab for Patients With Melanoma Lung Cancer or Bladder Cancer


Brief description of study

The purpose of this study is to evaluate f the treatment with NEO-PV-01 + adjuvant in combination with nivolumab is safe and useful for patients with certain types of cancer. The study also will investigate if NEO-PV-01 + adjuvant with nivolumab may represent a substantial improvement over other available therapies such as nivolumab alone. All eligible patients will receive NEO-PV-01 + adjuvant and nivolumab while on this trial.

Detailed Study Description

This clinical trial will enroll patients with metastatic or advanced melanoma, lung, or bladder cancer. The three agents being used in this study are: - A new, investigational, personalized cancer vaccine called "NEO-PV-01" - Poly-ICLC (Hiltonol), an investigational adjuvant that is used to help stimulate the immune system - A cancer drug called nivolumab (OPDIVO®) These agents are considered immunotherapy and work by stimulating the immune system to fight cancer. NEO-PV-01 is a truly personalized vaccine therapy in that it is custom designed and manufactured to include targets for the immune system that are present uniquely on an individual's cancer. Poly-ICLC is an adjuvant that helps stimulate the immune system and make the vaccine, NEO-PV-01 more effective. Nivolumab helps T-cells, a certain type of immune cell, that recognize these targets to reach and attack the tumor. Nivolumab is in clinical development for treatment of bladder cancer and is approved by the FDA (the U.S. Food and Drug Administration) for the treatment of some lung, skin, kidney, and blood cancers. The purpose of this study is to find out if treatment with NEO-PV-01 + adjuvant in combination with nivolumab is safe and effective for patients with melanoma, lung, or bladder cancer. The study also will see if NEO-PV-01 vaccine + adjuvant with nivolumab can improve responses compared to available therapies such as nivolumab monotherapy The side effects of NEO-PV-01 + adjuvant and nivolumab will be monitored and additional research tests will be done to assess the immune response against each individual's cancer.

Clinical Study Identifier: NCT02897765

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Sumanta Pal, MD

City of Hope
Duarte, CA United States
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Siwen Hu-Lieskovan, MD, PhD

UCLA Medical Center
Los Angeles, CA United States
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Patrick Ott, MD, PhD

Dana Farber Cancer Center
Boston, MA United States
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Ramaswamy Govindan, MD

Washington University in St. Louis
Saint Louis, MO United States
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Aung Naing, MD

MD Anderson Cancer Center
Houston, TX United States
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