A Phase I/II Study of Varlilumab plus Atezolizumab Immunotherapy in Patients with Advanced Kidney or Bladder Cancer

Full Title

A Phase I/II, Open-label, Dose-escalation Study of Varlilumab (CDX-1127) in Combination with Atezolizumab (MPDL3280A, Anti-PD-L1) in Patients with Advanced Cancer (CDX1127-06)

Purpose

Advanced cancers of the kidney or bladder can be challenging to treat successfully using standard therapies. The purpose of this study is to assess the safety and preliminary effectiveness of two drugs in patients with these cancers. The drugs are called varlilumab and atezolizumab. Researchers want to find the optimal dose of varlilumab that can be given when the drug is combined with atezolizumab.

Both of these drugs are called monoclonal antibodies. They find and attach to specific proteins on human immune cells and cancer cells, and are designed to stimulate an immune response against these cancer cells. Varlilumab binds to a protein on immune cells called CD27, which makes the immune system stronger.

Atezolizumab is designed to improve the immune system's ability to recognize and destroy cancer cells by blocking a protein called PD-L1, which can be found on cancer cells. It is approved for treating bladder cancer; its use in this study is considered investigational.

Doctors believe these two drugs used together will be more effective in activating the patient's immune system against cancer than either one alone. Varlilumab and atezolizumab are both 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 stage III or IV inoperable kidney or bladder cancer that has continued to grow despite at least one prior regimen of systemic therapy.
  • Patients must recover from the serious side effects of prior therapies before entering the study.
  • Patients may not have received PD-1, PD-L1, or PD-L2 inhibitors, nor varlilumab or other antibodies that target the CD27 protein.
  • 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. Martin Voss at 646-422-4631.

Protocol

15-288

Phase

I/II

Investigator

Co-Investigators

Locations