A Phase I/II Study of SGI-110 Given with Atezolizumab Immunotherapy and the CDX-1401 Vaccine to Treat Relapsed Ovarian Cancer

Full Title

A Randomized Phase 2 Trial of Atezolizumab (MPDL3280A), SGI-110 and CDX-1401 Vaccine in Recurrent Ovarian Cancer (NCI 10017) (CIRB)

Purpose

In this study, researchers are assessing the safety and effectiveness of combining the investigational drug SGI-110 with atezolizumab immunotherapy and the CDX-1401 vaccine in women whose ovarian cancer came back after treatment. In the Phase I part of the study, they will determine the highest dose of SGI-110 that can be given safely with atezolizumab. In the Phase II portion, patients will be randomly assigned to one of three treatments:

  • Atezolizumab alone
  • Atezolizumab plus SGI-110
  • Atezolizumab plus SGI-110 and CDX-1401 with polyICLC

SGI-110 works by blocking DNA production in cancer cells. Atezolizumab boosts the power of the immune system to find and kill cancer cells by blocking PD-L1, a protein which may help cancer cells escape detection by the immune system. CDX-1401 with polyICLC is a vaccine combined with a vaccine-stimulating protein that enhances the immune response against tumors.

Atezolizumab is given intravenously (by vein) while SGI-110 and CDX-1401/polyICLC are given through a subcutaneous (under the skin) injection. The use of these drugs in this study is considered investigational.

Eligibility

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

  • Patients must have ovarian cancer that has come back within 6 months of platinum-based chemotherapy.
  • Prior immunotherapy is not permitted.
  • At least 4 weeks must pass since the last treatment and entry into the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Chrisann Kyi at 646-888-4221.

Protocol

18-194

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators