A Trial of Atezolizumab and Vigil in Patients With Advanced Gynecological Cancers

PHASE2CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

May 31, 2017

Primary Completion Date

May 22, 2019

Study Completion Date

May 18, 2022

Conditions
Advanced Gynecological CancersOvarian CancerCervical CancerUterine Cancer
Interventions
BIOLOGICAL

Vigil

The Vigil vaccine is made up of irradiated autologous tumor cells which have been electroporated ex vivo with the Vigil plasmid designed to suppress expression of both the TGFβ1 and TGFβ2 proteins while simultaneously expressing rhGMCSF protein.

DRUG

Atezolizumab

"Atezolizumab was prepared and administered at the FDA approved dose and schedule as described in the U.S. Package Insert (USPI). The initial dose was administered over one hour and if well tolerated, subsequent infusions may have been administered over 30 minutes.~Atezolizumab in formulation F03 (1200 mg per vial) was administered in 250 mL 0.9% NaCl IV infusion bags and infusion lines equipped with 0.2 μm in-line filters."

Trial Locations (6)

29605

Prisma Health Cancer Institute, Greenville

30912

Georgia Cancer Center at Augusta University, Augusta

36604

University of South Alabama Mitchell Cancer Institute, Mobile

48202

Henry Ford Hospital, Detroit

59101

Billings Clinic, Billings

03756

Dartmouth-Hitchcock Medical Center/ Norris Cotton Cancer Center, Lebanon

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Roche-Genentech

INDUSTRY

lead

Gradalis, Inc.

INDUSTRY