A Phase II Study of Ipilimumab versus Standard Chemotherapy after Initial Therapy in Patients with Inoperable or Advanced Gastric or Gastroesophageal Cancer

Protocol
12-277
Full Title
A Randomized, Open-label, Two-Arm Phase II Trial Comparing the Efficacy of Sequential Ipilimumab Versus Best Supportive Care Following First-line Chemotherapy in Subjects with Unresectable Locally Advanced/Metastatic Gastric or Gastro-Esophageal Junction Cancer
Phase
II
Purpose

Ipilimumab is a drug approved for treating melanoma. It is an antibody against CTLA-4, a molecule that controls a part of the immune system by shutting it down. Researchers believe that an antibody against CTLA-4 could stop it from turning off the immune system, and allow an immune response that may help the body to destroy cancer cells. They believe this immune reaction can also work against stomach and esophageal cancers.

In this study, investigators want to determine if giving ipilimumab after initial standard therapy for inoperable or metastatic gastric (stomach) cancer or cancer of the junction between the esophagus and the stomach (gastroesophageal cancer) is more effective than continuing with standard therapy. Initial therapy includes the drugs oxaliplatin and either 5-fluorouracil (FOLXFOX therapy) or capecitabine (Capeox therapy).

All patients will have had and responded to three to four months of FOLFOX or Capeox therapy. Patients will then be randomly assigned to one of two groups: those who receive ipilimumab, or those who continue with 5-fluorouracil or capecitabine.

Eligibility

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 previously been treated with FOLFOX or Capeox therapy.
  • Patients whose tumors are positive for the HER2 protein are not eligible for this study. (There is a different drug used to treat these tumors.)
  • Patients may not have had prior 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 open to 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.

Disease(s)
Upper Gastrointestinal: Esophageal Cancer
Upper Gastrointestinal: Gastric Cancer
Locations
Related Diseases