Spots Global Cancer Trial Database for INO-5401 + INO-9012 in Combination With Atezolizumab in Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma
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Trial Identification
Brief Title: INO-5401 + INO-9012 in Combination With Atezolizumab in Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma
Official Title: An Open-Label, Multi-Center Trial of INO-5401 + INO-9012 in Combination With Atezolizumab in Subjects With Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma
Study ID: NCT03502785
Conditions
Study Description
Brief Summary: This is a Phase I/IIA, open-label, multi-center trial to evaluate the safety, immunogenicity and preliminary clinical efficacy of INO-5401 + INO-9012 delivered by intramuscular (IM) injection followed by electroporation (EP), in combination with atezolizumab in participants with locally advanced unresectable or metastatic/recurrent Urothelial Carcinoma (UCa). The trial population is divided into two cohorts: Cohort A: Participants with locally advanced unresectable or metastatic/recurrent UCa, who have confirmed disease progression during or following treatment with anti-Programmed Death receptor-1/Programmed Death receptor Ligand-1 (anti-PD-1/PD-L1) therapy; Cohort B: Participants with locally advanced unresectable or metastatic/recurrent UCa, who are treatment naïve and ineligible for cisplatin-based chemotherapy. A safety run-in will be performed with up to six participants (safety analysis participants) from cohort A.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Alaska Clinical Research Center, LLC, Anchorage, Alaska, United States
Cancer Treatment Centers of America at Western Regional Medical Center, Goodyear, Arizona, United States
Mayo Clinic Cancer Center, Phoenix, Arizona, United States
Mayo Clinic Hospital, Jacksonville, Florida, United States
H. Lee Moffitt Cancer Center & Research Institute, Inc., Tampa, Florida, United States
Cancer Treatment Centers of America at Midwestern Regional Medical center, Zion, Illinois, United States
Indiana University Simon Cancer Center, Indianapolis, Indiana, United States
University of Kansas Cancer Center and Medical Pavilion, Westwood, Kansas, United States
Johns Hopkins University School of Medicine, Baltimore, Maryland, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Washington University School of Medicine in St. Louis, Saint Louis, Missouri, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
New York University Langone Medical Center - Perlmutter Cancer Center, New York, New York, United States
Weill Cornell Medical College, New York, New York, United States
Columbia University, Herbert Irving Comprehensive Cancer Center, New York, New York, United States
University of North Carolina School of Medicine, Chapel Hill, North Carolina, United States
Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Greenville Memorial Hospital, Greenville, South Carolina, United States
Inova Melanoma and Skin Cancer Center, Fairfax, Virginia, United States
Contact Details
Name: Jeffrey Skolnik, MD
Affiliation: Inovio Pharmaceuticals
Role: STUDY_DIRECTOR
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