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



Status:Recruiting
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/15/2019
Start Date:May 24, 2018
End Date:September 2020
Contact:Inovio Call Center
Email:clinical.trials@inovio.com
Phone:267-440-4237

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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

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.


Inclusion Criteria:

- Sign an Informed Consent Form (ICF);

- Have histologically or cytologically documented locally advanced unresectable or
metastatic/recurrent urothelial carcinoma (including renal pelvis, ureters, urinary
bladder, and urethra);

- For Cohort A: Subjects who have radiographically confirmed disease progression during
or following treatment with an anti-PD-1/PD-L1 based therapy;

- For Cohort B: No prior chemotherapy for inoperable locally advanced or metastatic or
recurrent UCa and ineligible ("unfit") for cisplatin-based chemotherapy;

- Have measurable disease, as defined by RECIST version 1.1;

- Have a performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG)
Performance Scale;

- Have life expectancy of >/= 3 months;

- Be willing to provide a tissue sample for pre-treatment intra-tumoral assessment of
proinflammatory and immunosuppressive factors;

- Have electrocardiogram (ECG) with no clinically significant findings as assessed by
the investigator performed within 28 days prior to first dose;

- Demonstrate adequate hematological, renal, hepatic, and coagulation function;

- For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use contraceptive methods that result in a failure rate
of < 1% per year during the treatment period and for at least 5 months after the last
dose of study treatment;

- For male subjects: agreement not to father a child. Participants must be surgically
sterile (e.g, vasectomy) or use contraceptive methods that result in a failure rate of
< 1% per year during the treatment period and for at least 5 months after the last
dose of study treatment.

Exclusion Criteria:

- Any approved anti-cancer therapy including chemotherapy, targeted small molecule
therapy or radiation therapy within 2 weeks prior to trial Day 0 as well as current
participation or recipient of treatment on a clinical trial within 28 days prior to
Day 0;

- Documented active or untreated central nervous system (CNS) metastases and/or
carcinomatous meningitis;

- Malignancies other than UCa within 3 years prior to Day 0, with the exception of those
with negligible risk of metastasis or death treated with expected curative outcome;

- Prior treatment with CD137 agonists or immune checkpoint blockade therapies;

- Treatment with systemic immunostimulatory agents;

- Treatment with systemic immunosuppressive medication;

- History of severe allergic, anaphylactic, or other hypersensitivity reactions to
chimeric or humanized antibodies or fusion proteins;

- Known hypersensitivity allergy or contraindication to biopharmaceuticals produced in
Chinese hamster ovary cells or any component of the PD-1/PD-L1 inhibitor formulation;

- Active or history of autoimmune disease or immune deficiency;

- History or any evidence of interstitial lung disease;

- History of human immunodeficiency virus (HIV);

- Active hepatitis B or active hepatitis C;

- Severe infections within 4 weeks prior to enrollment;

- Received therapeutic oral or IV antibiotics within 2 weeks prior to Day 0;

- History or current evidence of any condition, therapy or laboratory abnormality that
might confound the results of the trial; interfere with the subject's participation
for the full duration of the trial, or is negatively impacted by EP treatment, or is
not in the best interest of the subject to participate in the opinion of the treating
investigator;

- Prior allogeneic stem cell or solid organ transplant;

- Uncontrolled tumor-related pain; pleural effusion, pericardial effusion, or ascites
requiring recurrent drainage procedures; or, hypercalcemia or symptomatic
hypercalcemia requiring continued use of bisphosphonate therapy or denosumab.
We found this trial at
15
sites
200 Lothrop St
Pittsburgh, Pennsylvania 15213
Phone: 412-235-1319
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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333 South Columbia Street
Chapel Hill, North Carolina 27599
Phone: 919-445-4185
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
Phone: 813-745-2169
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Anchorage, Alaska 99508
Phone: 907-276-1455
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733 North Broadway
Baltimore, Maryland 21205
(410) 955-3182
Phone: 410-502-8610
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
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89 Carrer de Sant Quintí
Barcelona, 08025
Phone: 34-93-556-5651
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Detroit, Michigan 48201
Phone: 313-576-9703
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8505 Arlington Boulevard
Fairfax, Virginia 22031
Phone: 703-970-6447
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701 Grove Rd
Greenville, South Carolina 29605
(864) 455-7000
Phone: 864-241-6251
Greenville Memorial Hospital Greenville Memorial Medical Campus is a regional referral center for the diagnosis...
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Indianapolis, Indiana 46202
Phone: 317-274-5830
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New York, New York 10032
Phone: 212-304-5543
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333 East 38th Street
New York, New York 10016
Phone: 212-731-5820
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New York, New York 10021
Phone: 646-962-2072
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Phoenix, Arizona 85054
Phone: 855-776-0015
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660 South Euclid Avenue
Saint Louis, Missouri 63110
Phone: 314-747-1343
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