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COMPLETEDPHASE1

Trial to Evaluate Safety and Immunogenicity of INO-5150 Alone or With INO-9012 in Men With Prostate Cancer

Phase I, Open-label Trial to Evaluate the Safety and Immunogenicity of INO-5150 Alone or in Combination With INO-9012 in Men With Biochemically Relapsed (PSA) Prostate Cancer

NCT02514213•Inovio Pharmaceuticals

View on ClinicalTrials.gov

Summary

This is a phase I, open-label trial to evaluate the safety and immunogenicity of INO 5150 alone or in combination with INO-9012 when delivered intramuscularly (IM) followed by electroporation (EP) in men with biochemically relapsed prostate cancer.

Detailed Description

Phase I, open label study of INO-5150 (DNA plasmids encoding prostate specific antigen (PSA) and prostate specific membrane antigen (PSMA)) alone or co-administered with INO-9012 (IL-12 plasmid) delivered intramuscularly followed by EP using the CELLECTRA®-5P device in adult males with biochemically relapsed prostate cancer following definitive local therapy (e.g. prostatectomy, external beam radiation, or brachytherapy). Four injections will be administered to approximately 60 eligible subjects who consent to participate in the study. Subjects will be monitored for safety and immunogenicity through Week 72.

Eligibility

Age

18 - 90 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Men aged 18 to 90 years with a histologic diagnosis of prostate cancer;
•2. c. Biochemical recurrence following local therapy, either surgery or radiation. Rising PSA defined as:
•* After definitive surgery, e.g.
•* After radical prostatectomy, two PSA measurements of ≥ 1.0 ng/mL at least one week apart;
•* After cryosurgery, two PSA measurements of ≥ 2.0 ng/mL at least one week apart;
•* Other definitive surgical procedures may be permissible upon the approval of the medical monitor OR
•* After radiation therapy (e.g., external beam radiation, brachytherapy, or salvage/adjuvant radiation therapy after surgery), two post radiation PSA measurements level of nadir plus 2.0 ng/mL at least one week apart.;
•3. Serum testosterone level:
•i) Subjects with no history of androgen deprivation therapy:
•* A single measurement greater than 150 ng/dL or 5.2 nmol/L within 3 months of enrollment
+11 more criteria

Exclusion Criteria

•1. PSA doubling time (PSA-DT) of ≤ 3 months, using 2 PSA values at least 4 weeks apart, calculated according to the Memorial Sloan-Kettering Cancer Center nomogram (https://www.mskcc.org/nomograms/prostate/psa-doubling-time);
•2. Clinical or radiologic evidence of distant metastatic disease other than small volume (\<1.5 cm) nodes, this should be tested within 12 months from enrollment;
•3. Receipt of investigational therapy in a clinical trial setting within 30 days of enrollment;
•4. Any pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome;
•5. Prior major surgery or radiation therapy within 4 weeks of enrollment;
•6. Any prior chemotherapy, except short-course neo-adjuvant or adjuvant chemotherapy that had been stopped for at least 6 weeks prior to Study enrollment;
•7. Active AIDS / HIV infection, clinically uncontrolled immune deficiency disorders;
•8. Clinically uncontrolled autoimmune disorders, transplant recipients who depend on immunosuppressive therapy, other immunosuppressive conditions including any concurrent condition requiring immunosuppressive/immunomodulating agents;
•9. Recipient of any blood product and immunotherapy (such as anti-PD1, anti-PDL-1 and anti-CTLA4) within 3 months of enrollment;

Locations (10)

Chesapeake Urology Research Associates

Baltimore, Maryland, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

GU Research Network, LLC/ Urology Cancer Center

Omaha, Nebraska, United States

Weill Cornell Medical College

New York, New York, United States

University of North Carolina Lineberger Cancer Center

Chapel Hill, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Sidney Kimmel Cancer Center - Thomas Jefferson University

Philadelphia, Pennsylvania, United States

UPMC

Pittsburgh, Pennsylvania, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Seattle Cancer Care Alliance

Seattle, Washington, United States

Key Dates

Start Date

July 1, 2015

Primary Completion Date

December 12, 2017

Completion Date

December 12, 2017

Last Updated

December 26, 2017

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

2mg INO-5150 and electroporation device CELLECTRA®-5P

BIOLOGICAL

8.5mg INO-5150 and electroporation device CELLECTRA®-5P

BIOLOGICAL

2mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P

BIOLOGICAL

8.5mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P

BIOLOGICAL

Electroporation using CELLECTRA®-5P

DEVICE

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

NCT04550494

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+29 more

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RECRUITINGPHASE2

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 26, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Trial to Evaluate Safety and Immunogenicity of INO-5150 Alone or With INO-9012 in Men With Prostate Cancer

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC