A Phase II Study of Combination Immunotherapy in Patients with Advanced Stomach Cancer


Full Title

CA018003: A Phase 2, Fast Real-time Assessment of Combination Therapies in Immuno-ONcology Study in Participants with Advanced Gastric Cancer (FRACTION-Gastric Cancer)


In this study, researchers are assessing the safety and effectiveness of different immunotherapy combinations in patients with advanced stomach (gastric) cancer that has come back or continued to grow despite prior treatment. Some patients will receive nivolumab plus ipilimumab, followed by nivolumab alone. Others will receive nivolumab with the investigational drug BMS-986016.

Nivolumab is a form of immunotherapy. It boosts the body’s immune system by targeting 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 shut-down mechanism by activating PD-1, enabling them to escape attack by the immune system. Nivolumab binds to and inactivates PD-1, enhancing the body’s ability to detect and destroy cancer cells.

BMS-986016 is an investigational drug also designed to provoke an immune response against cancer cells. While nivolumab targets PD-1, BMS-986016 targets a protein called LAG-3. Ipilimumab is a third immunotherapy drug; it enhances the anticancer immune response by blocking the CTLA-4 protein.

All three drugs are 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 gastric or gastroesophageal cancer that has come back or continued to grow despite prior therapy.
  • At least 4 weeks must pass between the completion of previous treatment 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. Geoffrey Ku at 646-888-4588.