Full TitleAn Open-Label, Multicenter, Dose Escalation and Expansion Phase Ib Study to Evaluate the Safety, Pharmacokinetics, and Therapeutic Activity of RO6958688 in Combination with Atezolizumab in Patients with Locally Advanced and/or Metastatic CEA-Positive Solid Tumors (WP29945)(Version date 13-DEC-2016)
The purpose of this study is to find the optimal dose of two immunotherapy drugs used together in patients with metastatic solid tumors: RO6958688 and atezolizumab. RO6958688 attaches to a protein many tumor cells make called CEA, and also to a protein on immune cells called CD3. It is designed to activate immune cells to recognize and attack tumor cells with CEA.
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.
Both medications are given intravenously (by vein).
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 makes the CEA protein and cannot be successfully treated with standard therapy.
- At least 4 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 the office of Dr. Neil H. Segal at 646-888-4187.