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 for Patients with Urothelial Carcinoma that is Unresectable or Metastatic/Recurrent
Sponsor: Inovio Pharmaceuticals, Inc.
Enrolling: Male and Female Patients
IRB Number: AAAR5857
U.S. Govt. ID: NCT03502785
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: The purpose of this clinical trial is to evaluate safety of the trial treatment, its effects on the immune system and on urothelial cancer. The trial treatment includes INO-5401 + INO-9012 delivered by electroporation in combination with TECENTRIQ (Atezolizumab). INO-5401 + INO 9012 is a DNA based therapy that has been created in a lab using the DNA sequence for genes of interest. Genes are the pieces of DNA that act as instructions to make specific proteins that are important for the makeup or function of a cell. They also instruct the cells to make specific proteins that help your immune system to react against cancer cells. INO-5401 plasmids have code for three proteins which are similar to proteins commonly present on cancer cells. This may help your immune system to help fight your cancer. Atezolizumab is an antibody (a protein produced by the body's immune system) that affects the immune system by blocking the programmed deathligand 1 (PD-L1) pathway. The PD-L1 pathway is involved in regulating the bodys natural immune response, but tumors can take advantage of this regulation to partially resist or evade the immune system. By blocking the PD L1 pathway, atezolizumab may help your immune system stop or reverse the growth of tumors. All the drugs used in this trial are given to you in the hospital by trained hospital staff. CELLECTRA 2000 is a device that will deliver three small electric charges through 5 needles to help the entry of the plasmids into your muscle cells.
This study is closed
Investigator
Mark Stein, MD
Do You Qualify?
Are you 18 years of age or older? Yes No
Do you have renal, pelvis, ureters, urinary bladder, or urethra cancer? Yes No
Is your cancer either unable to be surgically cured or metastatic? Yes No
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For more information, please contact:
Research Nurse Navigator
cancerclinicaltrials@cumc.columbia.edu
212-342-5162