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TERMINATED
NCT03206047
PHASE1/PHASE2

Atezolizumab, Guadecitabine, and CDX-1401 Vaccine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This randomized phase I/IIb trial studies side effects and best dose of atezolizumab when given together with guadecitabine and CDX-1401 vaccine and to see how well they work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. CDX-1401 vaccine may enhance the expression of the genes encoding tumor antigens on the surface of tumor cells and enhance the activity of tumor-killing T cells against those tumor cells. Vaccines made from monoclonal antibodies combined with tumor cells may help the body build an effective immune response to kill tumor cells. Giving atezolizumab, guadecitabine, and CDX-1401 vaccine may work better than CDX-1401 alone in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.

Official title: A Randomized Phase 2 Trial of Atezolizumab (MPDL3280A), SGI-110 and CDX-1401 Vaccine in Recurrent Ovarian Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

9

Start Date

2017-11-08

Completion Date

2020-11-10

Last Updated

2026-10-20

Healthy Volunteers

No

Interventions

DRUG

Atezolizumab

Given IV

BIOLOGICAL

DEC-205/NY-ESO-1 Fusion Protein CDX-1401

Given SC

DRUG

Guadecitabine

Given SC

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Poly ICLC

Given SC

Locations (17)

Banner University Medical Center - Tucson

Tucson, Arizona, United States

University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, United States

University of Chicago Medicine-Orland Park

Orland Park, Illinois, United States

University of Kansas Clinical Research Center

Fairway, Kansas, United States

Nebraska Medicine-Village Pointe

Omaha, Nebraska, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States