A Phase II Study of Nivolumab Immunotherapy plus FOLFOX and Regorafenib in People with HER2-Negative Metastatic Esophagogastric Cancer

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Full Title

A Phase II Study of Nivolumab in Combination with FOLFOX and Regorafenib in Patients with Metastatic Esophagogastric Cancer

Purpose

The purpose of this study is to assess the safety and effectiveness of combining nivolumab immunotherapy with regorafenib and standard FOLFOX chemotherapy in patients with metastatic esophagogastric cancer that is negative for a protein called HER2. (HER2 is a target of other treatments, but they cannot be used in these patients.) Nivolumab helps the immune system detect and attack cancer cells. Regorafenib blocks the proteins that cancer cells need to grow and survive. FOLFOX is a combination of the chemotherapy drugs fluorouracil, leucovorin, and oxaliplatin.

Researchers think that this combination of drugs may be a better treatment for HER2-negative metastatic esophagogastric cancer than standard chemotherapy alone. FOLFOX is already used as a treatment for this cancer; combining it with nivolumab and regorafenib is considered investigational. Regorafenib is taken orally (by mouth) and FOLFOX and nivolumab 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 HER2-negative metastatic esophagogastric cancer.
  • Patients may not have received prior chemotherapy for metastatic disease, nor previous immunotherapy or regorafenib.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and 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 aged 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Yelena Janjigian at 646-888-4186.

Protocol

20-540

Phase

II

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators