A Phase Ib Study of Immunotherapy with RO6895882 plus Atezolizumab in Patients with Locally Advanced or Metastatic Solid Tumors

Full Title

A Phase 1b, Open-Label, Multi-Center, Dose-Escalation Study of the Safety, Pharmacokinetics, and Therapeutic Activity of RO6895882, an Immunocytokine, which Consists of a Variant of Interleukin-2 (IL-2v), that Targets Carcinoembryonic Antigen (CEA),and Atezolizumab,an Antibody that Targets Programmed Death-Ligand 1 (PD-L1), Administered in Combination Intravenously, in Patients with Locally Advanced and/or Metastatic Solid Tumors

Purpose

The purpose of this study is to assess the safety and preliminary effectiveness of combining two immunotherapy drugs to treat patients with locally advanced or metastatic solid tumors: RO6895882 and atezolizumab.

RO6895882 is an antibody. One end attaches to a protein on cancer cells called CEA. The other end is attached to a protein designed to stimulate the immune system to fight cancer cells. 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. It is approved for treating bladder cancer; its use in this study is considered investigational.

It is hoped that these two drugs used together will trigger an immune response against cancer. 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 a locally advanced or metastatic solid tumor that has continued to grow despite standard therapy or cannot be treated with standard therapy.
  • Patients' tumor tissue must express CEA.
  • Patients must recover from the serious side effects of prior 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.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact the office of Dr. Neil H. Segal at 646-888-4187.

Protocol

15-176

Phase

I/II

Investigator

Co-Investigators

Locations