S2303: phase II/III trial of paclitaxel + ramucirumab ± nivolumab in gastric and esophageal adenocarcinoma (PARAMUNE)

Abstract

Cancer of the stomach and esophagus is aggressive with poor patient outcomes. Historically, the treatment for such patients has involved the use of combined chemotherapy. In recent years, the addition of immunotherapy to the treatment of patients with advanced cancers of the stomach and esophagus has led to patients living longer with a longer period without tumor growth. However, whether continuing the immunotherapy after the tumor has grown while on treatment is beneficial or not is a question that has not been answered. The standard treatment after patients’ tumor has grown on their initial treatment involves a drug called ramucirumab, which blocks the ability of cancer cells to create abnormal blood vessels around itself to support its own growth. Recent research suggests that drugs like ramucirumab make immunotherapy more effective. To test whether continuing immunotherapy in combination with this “second-line” treatment that includes ramucirumab, we have designed a study to compare whether one group who will receive immunotherapy will live longer versus another group who will not receive immunotherapy