A Phase I Study of a Personalized Cancer Vaccine plus Atezolizumab Immunotherapy in Patients with Locally Advanced or Metastatic Cancer

Full Title

GO39733: A Phase IA/IB Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of RO7198457 as a Single Agent and in Combination with Atezolizumab in Patients with Locally Advanced or Metastatic Tumors

Purpose

In this study, researchers are evaluating a personalized cancer vaccine in patients with inoperable or metastatic cancers that cannot be cured with standard therapies. The vaccine is made to resemble features of a patient’s own cancer, to stimulate the patient’s immune system to attack the tumor. Patients will receive escalating doses of the vaccine to determine the highest dose that can be given safely.

Some patients will also receive atezolizumab in addition to the personalized vaccine. Atezolizumab is designed to improve the immune system’s ability to recognize and destroy cancer cells by blocking PD-L1, a protein made by some cancers. Atezolizumab is approved for treating advanced bladder cancer and lung cancer; its use in this study is considered investigational.

The personal cancer vaccine and atezolizumab are given intravenously (by vein). The vaccine usually requires a tissue biopsy and several weeks to be manufactured, so immediate treatment may not be feasible.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have recurrent, inoperable, or metastatic cancer that cannot be successfully treated with standard therapies. This includes patients with non-small cell lung cancer, triple-negative breast cancer, colorectal cancer, head and neck cancer, bladder cancer, and kidney cancer.
  • At least 3 weeks must pass between the completion of prior therapies and entry into the study.
  • 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. Matthew Hellmann at 646-888-4863.

Protocol

17-573

Phase

I

Investigator

Co-Investigators