Prostate CancerPhase 1NCT02514213
Trial to Evaluate Safety and Immunogenicity of INO-5150 Alone or With INO-9012 in Men With Prostate Cancer
A Phase 1 study testing 2mg INO-5150 and electroporation device CELLECTRA®-5P, 8.5mg INO-5150 and electroporation device CELLECTRA®-5P and 2mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P in people with Prostate Cancer, run by Inovio Pharmaceuticals at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 2mg INO-5150 and electroporation device CELLECTRA®-5P, 8.5mg INO-5150 and electroporation device CELLECTRA®-5P and 2mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 10 sitesUnited States
- Study dates
- Jul 2015to 12 Dec 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 21Show fewer
- 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:
- 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
- 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;
- Normal electro cardio gram (ECG) or ECG with no clinically significant findings;
- Adequate bone marrow, hepatic, and renal function tests within 30 days prior to enrollment:
- CBC (except platelets and hemoglobin), serum chemistry, liver panel, and CPK values ≤ Grade 1 abnormality as defined in CTCAE v 4.03 dated June 14, 2010
- Platelets ≥ 75,000 /mL;
- Hemoglobin ≥ 9.0 g/dL;
- No desire or plans to father new children during the study and/or have a prior vasectomy
Who cannot join
- 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;
Show all 9Show fewer
- 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;
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Chesapeake Urology Research Associates
Baltimore, Maryland, 21204
University of North Carolina Lineberger Cancer Center
Chapel Hill, North Carolina, 27599
Cleveland Clinic
Cleveland, Ohio, 44915
Karmanos Cancer Institute
Detroit, Michigan, 48201
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Weill Cornell Medical College
New York, New York, 10065
GU Research Network, LLC/ Urology Cancer Center
Omaha, Nebraska, 68130
Sidney Kimmel Cancer Center - Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
UPMC
Pittsburgh, Pennsylvania, 15232
Seattle Cancer Care Alliance
Seattle, Washington, 98109
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- 2mg INO-5150 and electroporation device CELLECTRA®-5P, 8.5mg INO-5150 and electroporation device CELLECTRA®-5P, 2mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P, 8.5mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P, Electroporation using CELLECTRA®-5P
- Keywords
- PSA
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2mg INO-5150 and electroporation device CELLECTRA®-5PBiological
2mg INO-5150 delivered IM followed by electroporation using CELLECTRA®-5P
8.5mg INO-5150 and electroporation device CELLECTRA®-5PBiological
8.5 mg INO-5150 delivered IM followed by electroporation using CELLECTRA®-5P
2mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5PBiological
2mg INO-5150 plus 1 mg INO9012 delivered IM followed by electroporation using CELLECTRA®-5P
8.5mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5PBiological
8.5mg INO-5150 plus 1 mg INO9012 delivered IM followed by electroporation using CELLECTRA®-5P
Electroporation using CELLECTRA®-5PDevice
Electroporation device CELLECTRA®-5P
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | 2mg INO-5150 and electroporation device CELLECTRA®-5P Receives: 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 Receives: 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 Receives: 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 Receives: Biological: 8.5mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P; Device: Electroporation using CELLECTRA®-5P |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
- 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
- Injection site reactions
- Changes in safety laboratory parameters .
Measured: 72 weeks
Antigen specific immune response of INO-5150 alone or with INO-9012 delivered via IM EP
Antigen specific cellular immune responses
Measured: 72 weeks
Secondary outcomes (1)
PSA response rate by PSA testing
PSA response
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study startJul 2015
- Primary completion12 Dec 2017
- Study completion12 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inovio Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ildi Csiki, MD, PH.D., Study director, Inovio Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514213
- Sponsor's protocol ID
- PCa-001
- Status last verified
- Dec 2017
- First submitted
- 29 Jul 2015
- Last updated
- 26 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: combined results when available will be made available
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02514213
- Acronym / sponsor ID
- PCa-001
- Conditions
- Prostate Cancer
- Keywords
- PSA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Inovio PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- 12 Dec 2017 (actual)
- Study completion
- 12 Dec 2017 (actual)
- First posted
- 3 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Biological: 2mg INO-5150 and electroporation device CELLECTRA®-5P, Device: Electroporation using CELLECTRA®-5P2mg INO-5150 and electroporation device CELLECTRA®-5P |
| Arm B | Experimental | Biological: 8.5mg INO-5150 and electroporation device CELLECTRA®-5P, Device: Electroporation using CELLECTRA®-5P8.5mg INO-5150 and electroporation device CELLECTRA®-5P |
| Arm C | Experimental | Biological: 2mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P, Device: Electroporation using CELLECTRA®-5P2mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P |
| Arm D | Experimental | Biological: 8.5mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P, Device: Electroporation using CELLECTRA®-5P8.5mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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:
- Serum testosterone level:
- Normal electro cardio gram (ECG) or ECG with no clinically significant findings;
- Adequate bone marrow, hepatic, and renal function tests within 30 days prior to enrollment:
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2mg INO-5150 and electroporation device CELLECTRA®-5P2mg INO-5150 delivered IM followed by electroporation using CELLECTRA®-5P | Biological | Arm A |
| 8.5mg INO-5150 and electroporation device CELLECTRA®-5P8.5 mg INO-5150 delivered IM followed by electroporation using CELLECTRA®-5P | Biological | Arm B |
| 2mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P2mg INO-5150 plus 1 mg INO9012 delivered IM followed by electroporation using CELLECTRA®-5P | Biological | Arm C |
| 8.5mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P8.5mg INO-5150 plus 1 mg INO9012 delivered IM followed by electroporation using CELLECTRA®-5P | Biological | Arm D |
| Electroporation using CELLECTRA®-5PElectroporation device CELLECTRA®-5P | Device | Arm A, Arm B, Arm C, Arm D |
Primary outcome
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)
Time frame: 72 weeks
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 .
Antigen specific immune response of INO-5150 alone or with INO-9012 delivered via IM EP
Time frame: 72 weeks
Antigen specific cellular immune responses
1 secondary outcome
PSA response rate by PSA testing
Time frame: 72 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
- Individual participant dataSharing planned: No. combined results when available will be made available
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ildi Csiki, MD, PH.D. study director
Inovio Pharmaceuticals
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 2mg INO-5150 and electroporation device CELLECTRA®-5P, 8.5mg INO-5150 and electroporation device CELLECTRA®-5P and 2mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P in people with Prostate Cancer, run by Inovio Pharmaceuticals at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 72 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2017.