A Phase IB Study of Atezolizumab Immunotherapy plus Radium-223 Dichloride in Men with Metastatic Prostate Cancer

Full Title

BO30013: A Phase IB, Open-Label Study of the Safety and Tolerability of Atezolizumab in Combination with Radium-223 Dichloride in Patients with Castrate-Resistant Prostate Cancer Who Have Progressed Following Treatment with An Androgen Pathway Inhibitor

Purpose

Prostate cancers initially need the male hormone testosterone for growth. Hormone therapies that lower the level of testosterone are among the most effective treatments for prostate cancers that have spread to other organs (metastasized). The benefits of hormone treatments do not last, however. Over time, many prostate cancers continue to grow despite hormonal therapies (and are called “castration-resistant” prostate cancer, or CRPC). Additional hormonal therapies (enzalutamide and abiraterone) and chemotherapy drugs (docetaxel and cabazitaxel) are treatments for CRPC, but the cancer often eventually grows despite these therapies as well.

In this study, researchers are evaluating a combination of two treatments in men with CRPC. One is atezolizumab, a immune therapy currently approved for bladder and lung cancers that enhances the immune system’s ability to recognize and kill cancer cells. The other is radium-223 dichloride, which is approved for metastatic CRPC and is taken up by metastatic prostate cancer in the bones. Their use together in this study is considered investigational.

Patients in this study will be randomly assigned to different treatment groups in which the two drugs are given at the same time, or separately at various intervals. Atezolizumab is given intravenously (by vein), and radium-223 dichloride is given by injection.

Eligibility

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

  • Patients must have metastatic CRPC that continues to grow despite prior treatment with an androgen pathway inhibitor (hormonal therapy) and has spread to at least two sites in the bones, as well as other sites in the soft tissues (except the liver).
  • At least 3 weeks must pass since the completion of prior systemic therapies and 1 week since any radiation therapy for symptom relief 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 men age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Michael Morris at 646-422-4469.

Protocol

17-110

Phase

I

Investigator

Co-Investigators