A Phase III Study of Nivolumab and Ipilimumab Immunotherapy versus Chemotherapy in Patients with Untreated Advanced Gastric or Gastroesophageal Junction Cancer

Full Title

A Randomized, Multicenter, Open-Label, Phase 3 Study of Nivolumab Plus Ipilimumab versus Oxaliplatin plus Fluoropyrimidine in Subjects with Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer

Purpose

Nivolumab and ipilimumab are immunotherapy drugs used in combination to treat melanoma. They work by boosting the immune response against cancer. In this study, researchers are comparing the effectiveness of nivolumab/ipilimumab therapy with standard chemotherapy in patients with previously untreated advanced or metastatic cancer of the stomach or the junction between the esophagus and stomach (gastroesophageal cancer).

Nivolumab targets a protein on white blood cells called PD-1. PD-1 normally maintains the balance of the immune system by shutting it down at the right time. Some cancers take advantage of this mechanism by expressing PD-L1, enabling them to escape attack by the body’s white blood cells. Nivolumab blocks PD-1, enhancing the body’s ability to detect and destroy cancer cells. Ipilimumab is an antibody against CTLA-4, a molecule that controls a part of the immune system by shutting it down at the right time. The use of nivolumab and ipilimumab in this study is considered investigational.

Patients in this study will be randomly assigned to receive nivolumab plus ipilimumab; standard chemotherapy with oxaliplatin and capecitabine; or standard chemotherapy with oxaliplatin, leucovorin, and fluorouracil. All medications in this study are given intravenously (by vein), except for capecitabine, which is taken by mouth.

Eligibility

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

  • Patients must have inoperable, locally advanced, or metastatic stomach or gastroesophageal junction cancer.
  • Patients may not have received treatment for advanced cancer. Past treatment with chemotherapy and/or radiation therapy is permitted as long as it was completed at least 6 months before entering the study.
  • Patients with HER2-positive cancers may not participate, since they can receive other treatment that targets the HER2 protein.
  • 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. Yelena Janjigian at 646-888-4186.

Protocol

16-1540

Phase

III

Investigator

Co-Investigators