Full TitleA Phase 1b/2 Study of MEDI4736 in Combination with Tremelimumab, MEDI4736 Monotherapy, and Tremelimumab Monotherapy in Subjects with Metastatic or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma (Version date 11-JAN-2016)
The purpose of this study is to assess the safety and effectiveness of the immunotherapy drugs durvalumab (MEDI4736) and tremelimumab when given together in patients with recurrent or metastatic cancer of the stomach or the junction between the stomach and the esophagus (gastroesophageal junction).
Durvalumab is designed to boost the body’s immune system by targeting a protein on tumor cells called PD-L1. PD-L1 normally maintains the balance of the immune system. In cancer, PD-L1 helps tumors escape detection and destruction by the immune system. Durvalumab may increase the immune system’s ability to identify and destroy cancer cells. It is used to treat bladder cancer; its use in this study is investigational.
Tremelimumab is an investigational drug that blocks CTLA4, a protein found on cells of the immune system. CTLA4 puts the brakes on the immune response and may prevent immune cells from attacking cancer cells. Tremelimumab prevents this from happening, potentially enhancing the immune response against the cancer.
Both drugs are given intravenously.
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have recurrent or metastatic gastric or gastroesophageal cancer that continues to grow despite one or two prior regimens of chemotherapy.
- Patients’ tumors must express an “interferon-gamma gene signature” (which will be tested for as part of the study).
- At least 4 weeks must pass between the completion of prior treatment and receipt of the study drugs.
- 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.