A Phase I/II Study of Nivolumab Immunotherapy plus Chemoradiation Before Surgery for Esophageal Cancer

Full Title

s16-00971/CA209-791: A Phase I/II Open Label Multi-Center Study of Immune Checkpoint Therapy with Nivolumab for Patients with Locally Advanced Esophageal Squamous Cell Carcinoma

Purpose

This study is evaluating the safety and effectiveness of nivolumab immunotherapy when given with chemotherapy (carboplatin and paclitaxel) and radiation therapy in patients with previously untreated squamous cell cancer of the esophagus. Patients are able to have surgery after chemoradiation, based on their response to treatment, their preference, and their doctors¿ recommendation.

Nivolumab inhibits a protein that normally puts the brakes on the immune response, enhancing the power of the immune system to find and destroy cancer cells. It is used to treat several types of cancer; its use in this study is considered investigational. Carboplatin and paclitaxel are standard chemotherapy drugs. Nivolumab, carboplatin, and paclitaxel are given intravenously (by vein).

Eligibility

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

  • Patients must have previously untreated stage II/III esophageal squamous cell cancer.
  • Patients may not have previously received 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 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Geoffrey Ku at 646-888-4588.

Protocol

18-050

Phase

I/II

Investigator