A Phase Ib Study of RO5509554 (Emactuzumab) and MPDL3280A (Atezolizumab) Immunotherapy Given Together in Patients with Advanced Solid Tumors

Full Title

Open-label, Multicenter, Dose Escalation Phase Ib Study with Expansion Phase to Evaluate the Safety, Pharmacokinetics, and Activity of RO5509554 (EMACTUZUMAB) and MPDL3280A (ATEZOLIZUMAB) Administered in Patients with Advanced Solid Tumors

Purpose

The purpose of this study is to find the optimal doses of two investigational drugs, RO5509554 (emactuzumab) and MPDL3280A (atezolizumab), when they are given together in patients with solid tumors that are continuing to grow despite standard treatments or for which there are no standard treatments. Researchers believe that combining these two drugs may be more effective for treating cancer than using either drug alone. Once they identify the optimal doses of this drug combination, they'll also assess its safety and preliminary effectiveness.

RO5509554 blocks a protein called CSF1-R on white blood cells called M2 macrophages, which cause cancer cells to grow. It is hoped by blocking CSF1-R, RO5509554 may stop cancers from growing. Atezolizumab is a form of immunotherapy. It 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. It is approved for treating bladder cancer; its use in this study is considered investigational.

Both drugs are given intravenously (by vein).

Eligibility

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

  • Patients must have advanced triple-negative breast cancer, non-small cell lung cancer, ovarian cancer, bladder cancer, gastric (stomach) cancer, colorectal cancer, soft-tissue sarcoma, or any cancer that has metastasized to the liver and has continued to grow despite standard treatment or for which no standard treatment exists.
  • Patients must recover from the serious side effects of previous therapies before entering 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.
  • Patients must be able to attend all of the required appointments, which are very frequent during the first 12 weeks of the study.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact the Immunotherapeutics Clinic at 646-888-3359.

Protocol

15-144

Phase

I

Investigator

Co-Investigators

Locations