INO-5401 + INO-9012 in Combination With Atezolizumab in Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

May 24, 2018

Primary Completion Date

May 9, 2025

Study Completion Date

May 9, 2025

Conditions
Urothelial Carcinoma
Interventions
BIOLOGICAL

INO-5401

INO-5401 (9 milligram \[mg\] dose IM): mixture of 3 synthetic plasmids that target Wilms' tumor gene-1 (WT1) antigen, prostate-specific membrane antigen (PSMA) and human telomerase reverse transcriptase (hTERT) antigen.

BIOLOGICAL

INO-9012

"INO-9012 (1 mg dose IM): A synthetic plasmid that expresses human interleukin-12 (IL-12).~INO-5401 + INO-9012 will be administered IM followed by EP with CELLECTRA™ 2000 device every 3 weeks for 4 doses then every 6 weeks for 6 additional doses, thereafter every 12 weeks until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator."

DRUG

Atezolizumab

Atezolizumab will be administered by intravenous (IV) infusion every 3 weeks until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.

DEVICE

CELLECTRA™ 2000

IM injection of INO-5401 and INO-9012 is followed by EP with the CELLECTRA™ 2000 device.

Trial Locations (11)

10016

New York University Langone Medical Center - Perlmutter Cancer Center, New York

10032

Columbia University, Herbert Irving Comprehensive Cancer Center, New York

15232

University of Pittsburgh Medical Center, Pittsburgh

21287

Johns Hopkins University School of Medicine, Baltimore

22031

Inova Melanoma and Skin Cancer Center, Fairfax

27599

University of North Carolina School of Medicine, Chapel Hill

29615

Greenville Memorial Hospital, Greenville

33612

H. Lee Moffitt Cancer Center & Research Institute, Inc., Tampa

48201

Karmanos Cancer Institute, Detroit

63110

Washington University School of Medicine in St. Louis, St Louis

85054

Mayo Clinic Cancer Center, Phoenix

Sponsors
All Listed Sponsors
lead

Inovio Pharmaceuticals

INDUSTRY

NCT03502785 - INO-5401 + INO-9012 in Combination With Atezolizumab in Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma | Biotech Hunter | Biotech Hunter