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

NCT02514213 | Completed Phase 1

• 1 other identifier: PCa-001
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Prostate Cancer

Keywords

PSA

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability of INO-5150 alone or with INO-9012 delivered via IM EP ( Incidence of adverse events, Injection site reactions, Changes in safety laboratory parameters)

  1. Incidence of adverse events (all, severe, \[NCI CTCAE v4.03\] and serious) classified by system organ class (SOC), preferred term, severity, and relationship to study medication and schedule 2. Injection site reactions 3. Changes in safety laboratory parameters .

  72 weeks

• Antigen specific immune response of INO-5150 alone or with INO-9012 delivered via IM EP

  Antigen specific cellular immune responses

  72 weeks

Secondary Outcomes (1)

• PSA response rate by PSA testing

  72 weeks

Study Arms (4)

Arm A

EXPERIMENTAL

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

Biological: 2mg INO-5150 and electroporation device CELLECTRA®-5P; Device: Electroporation using CELLECTRA®-5P

Arm B

EXPERIMENTAL

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

Biological: 8.5mg INO-5150 and electroporation device CELLECTRA®-5P; Device: Electroporation using CELLECTRA®-5P

Arm C

EXPERIMENTAL

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

Biological: 2mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P; Device: Electroporation using CELLECTRA®-5P

Arm D

EXPERIMENTAL

8.5mg 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; Device: Electroporation using CELLECTRA®-5P

Interventions

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

2mg INO-5150 delivered IM followed by electroporation using CELLECTRA®-5P

Arm A

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

8.5 mg INO-5150 delivered IM followed by electroporation using CELLECTRA®-5P

Arm B

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

2mg INO-5150 plus 1 mg INO9012 delivered IM followed by electroporation using CELLECTRA®-5P

Arm C

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

8.5mg INO-5150 plus 1 mg INO9012 delivered IM followed by electroporation using CELLECTRA®-5P

Arm D

Electroporation using CELLECTRA®-5P DEVICE

Electroporation device CELLECTRA®-5P

Arm A; Arm B; Arm C; Arm D

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men aged 18 to 90 years with a histologic diagnosis of prostate cancer;
• 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.;
• 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
• ii) Subjects with a history of androgen deprivation therapy (either in adjuvant or biochemical relapse setting):
• The two most recent measurements of serum testosterone prior to enrollment must fulfill the following criteria:
• Both measurements are greater than 150 ng/dL or 5.2 nmol/L;
• The two measurements are spaced at least 14 days apart;
• Both must be measured within 3 months of enrollment;

You may not qualify if:

• 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);
• 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;
• Receipt of investigational therapy in a clinical trial setting within 30 days of enrollment;
• Any pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome;
• Prior major surgery or radiation therapy within 4 weeks of enrollment;
• Any prior chemotherapy, except short-course neo-adjuvant or adjuvant chemotherapy that had been stopped for at least 6 weeks prior to Study enrollment;
• Active AIDS / HIV infection, clinically uncontrolled immune deficiency disorders;
• Clinically uncontrolled autoimmune disorders, transplant recipients who depend on immunosuppressive therapy, other immunosuppressive conditions including any concurrent condition requiring immunosuppressive/immunomodulating agents;
• Recipient of any blood product and immunotherapy (such as anti-PD1, anti-PDL-1 and anti-CTLA4) within 3 months of enrollment;

Sponsors & Collaborators

• Inovio Pharmaceuticals: lead

Study Sites (10)

Chesapeake Urology Research Associates

Baltimore, Maryland, 21204, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

GU Research Network, LLC/ Urology Cancer Center

Omaha, Nebraska, 68130, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

University of North Carolina Lineberger Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44915, United States

Location

Sidney Kimmel Cancer Center - Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

UPMC

Pittsburgh, Pennsylvania, 15232, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

rocakinogene sifuplasmid

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Ildi Csiki, MD, PH.D.

  Inovio Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: August 3, 2015
• Study Start: July 1, 2015
• Primary Completion: December 12, 2017
• Study Completion: December 12, 2017
• Last Updated: December 26, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)