A Phase IB/II Study Assessing Multiple Immunotherapy Treatments in Patients with Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Cancers

Share
Print

Full Title

YO39609: A Phase Ib/II, Open-Label, Multicenter, Randomized, Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients with Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer (Morpheus-Gastric Cancer)

Purpose

The purpose of this study is to compare standard chemotherapy with immunotherapy-based combination treatments in patients with inoperable or metastatic cancer of the stomach (gastric cancer) or the junction between the stomach and esophagus (gastroesophageal junction or GEJ). Immunotherapy drugs such as atezolizumab work by boosting the power of the immune system to detect and destroy cancer cells.

Patients in this study will be randomly assigned to receive standard chemotherapy (ramucirumab plus paclitaxel) or one of these investigational treatments, which includes an immunotherapy drug:

  • Atezolizumab plus PEGPH20, an enzyme which breaks down hyaluronan, a substance produced in large amounts by many gastric cancers; PEGPH20 may help atezolizumab to work better
  • Atezolizumab plus BL-8040, which alters immune cell movement and may increase the body’s immune response against cancer
  • Atezolizumab plus linagliptin, which enhances the flow of immune cells to a tumor by blocking a protein called DPP-4

Atezolizumab and PEGPH20 are given intravenously (by vein), BL-8040 is given by subcutaneous (under the skin) injection, and linagliptin is taken orally (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 or metastatic gastric or GEJ cancer that continues to grow despite prior therapy.
  • Patients must recover from the serious side effects of prior treatments before entering the study.
  • Patients may not have previously received 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 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

18-531

Phase

I/II

Investigator

Co-Investigators