A Phase IB Study of Immunotherapy with Atezolizumab and GDC-0919 in Patients with Metastatic Solid Tumors

Full Title

A Phase IB, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of GDC-0919 Administered with Atezolizumab in Patients with Locally Advanced or Metastatic Solid Tumors

Purpose

Atezolizumab and GDC-0919 are immunotherapy drugs designed to boost the power of the immune system against cancer. Atezolizumab works by blocking a protein called PD-L1, while GDC-0919 blocks an enzyme called IDO1. Both drugs have been assessed before in patients, but their use together is novel. Atezolizumab is approved for treating bladder cancer; its use in this study is considered investigational.

In this study, researchers want to find the highest dose of this drug combination that can be given safely to patients with metastatic solid tumors. Atezolizumab is given intravenously (by vein), while GDC-0919 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 an inoperable, recurrent, or metastatic solid tumor that has continued to grow despite standard therapy or for which no standard therapy is available. Examples include non-small cell lung cancer, gastric cancer, triple-negative breast cancer, and melanoma.
  • At least 3 weeks must pass between the completion of prior therapy and entry into the study.
  • Participants must have tumor tissue available for testing for PD-L1 status.
  • 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 people age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Matthew Hellmann at 646-888-4863.

Protocol

15-197

Phase

I

Investigator

Co-Investigators

Locations