Breast CancerPhase 1TRT-001NCT02960594

hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of Relapse

A Phase 1 study testing INO-1400, INO-9012 and INO-1401 in people with Breast Cancer and Lung Cancer, run by Inovio Pharmaceuticals at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Breast Cancer, Lung Cancer, Pancreatic Cancer
What is being tested?: INO-1400, INO-9012 and INO-1401
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 93 participants
Where: 6 sitesUnited States
Study dates: Dec 2014to 9 Nov 2018
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1. Signed and dated written IRB approved informed consent;
2. Males or females aged ≥18 years;
3. Subjects with breast, lung or pancreatic carcinoma who are at high risk of relapse post definitive therapy at least 4 and no more than 24 weeks from completion of definitive therapy at the time of signing informed consent as described below for each indication:
Breast carcinoma:
Lung carcinoma:
Pancreatic carcinoma:

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Head and neck squamous cell carcinoma:
Ovarian cancer:
Colorectal cancer
Gastric and esophageal cancer
Hepatocellular carcinoma

Who cannot join

1. Previous treatment wth any TERT or IL-12 containing therapy, or any other DNA immunotherapy;
2. Any concurrent condition requiring the continued or anticipated use of systemic steroids (excluding non-systemic inhaled, topical skin and/or eye drop-containing corticosteroids) or immunosuppressive therapy (excludes low dose methotrexate). All other systemic corticosteroids must be discontinued at least 4 weeks prior to first Study Treatment;
3. Administration of any vaccine within 4 weeks of the first study treatment

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

University of North Carolina
Chapel Hill, North Carolina, 27599
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
University of Pittsburgh
Pittsburgh, Pennsylvania, 15232
Mayo Clinic
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Multi-center Study of hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of Relapse Post Definitive Surgery and Standard Therapy

This is a Phase I, open label study to evaluate the safety, tolerability, and immunogenicity of INO-1400 or INO-1401 alone or in combination with INO-9012, delivered by electroporation in subjects with high-risk solid tumor cancer with no evidence of disease after surgery and standard therapy. Subjects will be enrolled into one of ten treatment arms. Subjects will be assessed according to standard of care. Restaging and imaging studies will be performed to assess disease relapse per NCCN guidelines. RECIST will be used to validate the findings in cases of relapse.

Conditions: Breast Cancer, Lung Cancer, Pancreatic Cancer, Head and Neck Cancer, Ovarian Cancer, ColoRectal Cancer
Being tested: INO-1400, INO-9012, INO-1401
Keywords: Immunotherapy, Human Telomerase Reverse Transcriptase (hTERT), Breast Neoplasms, Lung Neoplasms, Pancreatic Neoplasms, High Risk of Relapse, Post Definitive Surgery, Post Adjuvant Therapy, No Evidence of Disease
Medical subject headings: Breast Neoplasms, Lung Neoplasms, Pancreatic Neoplasms, Head and Neck Neoplasms, Ovarian Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

INO-1400Biological
Also called hTERT
INO-9012Biological
Also called IL-12
INO-1401Biological
Also called SynCon TERT

Study groups in NCT02960594
Study group	Role	What they receive
Arm 1	Experimental	2 mg INO-1400 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12 Receives: Biological: INO-1400
Arm 2	Experimental	8 mg INO-1400 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12 Receives: Biological: INO-1400
Arm 3	Experimental	2 mg INO-1400 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12 Receives: Biological: INO-1400; Biological: INO-9012
Arm 4	Experimental	2 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12 Receives: Biological: INO-1400; Biological: INO-9012
Arm 5	Experimental	8 mg INO-1400 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12 Receives: Biological: INO-1400; Biological: INO-9012
Arm 6	Experimental	8 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12 Receives: Biological: INO-1400; Biological: INO-9012
Arm 7	Experimental	2 mg INO-1401 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12 Receives: Biological: INO-1401
Arm 8	Experimental	8 mg INO-1401 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12 Receives: Biological: INO-1401
Arm 9	Experimental	8 mg INO-1401 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12 Receives: Biological: INO-9012; Biological: INO-1401
Arm 10	Experimental	8 mg INO-1401 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12 Receives: Biological: INO-9012; Biological: INO-1401

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse events graded in accordance with "Common Terminology Criteria for Adverse Events (CTCAE)", NCI version 4.03
Measured: Up to 2 years from first study treatment
Injection site reactions including, but not necessarily limited to, local skin erythema, induration, pain and tenderness at administration site
Measured: Up to 14 weeks
Changes in safety laboratory parameters
Measured: Up to 2 years from first study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 20149 Nov 2018

First posted9 Nov 2016 (estimated)
Study startDec 2014
Primary completion9 Nov 2018
Study completion9 Nov 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Breast 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: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 93 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02960594
Sponsor's protocol ID: TRT-001
Acronym: TRT-001
Status last verified: Nov 2018
First submitted: 4 Nov 2016
Last updated: 19 Nov 2018
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center Study of hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of Relapse Post Definitive Surgery and Standard Therapy
ClinicalTrials.gov ID: NCT02960594
Acronym / sponsor ID: TRT-001 / TRT-001
Conditions: Breast Cancer, Lung Cancer, Pancreatic Cancer, Head and Neck Cancer, Ovarian Cancer, ColoRectal Cancer
Keywords: Immunotherapy, Human Telomerase Reverse Transcriptase (hTERT), Breast Neoplasms, Lung Neoplasms, Pancreatic Neoplasms, High Risk of Relapse, Post Definitive Surgery, Post Adjuvant Therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 93 participants (actual)
Lead sponsor: Inovio PharmaceuticalsIndustry (pharma, biotech, devices)
Collaborators: University of Pennsylvania, University of North Carolina, Thomas Jefferson University, University of Pittsburgh, Barbara Ann Karmanos Cancer Institute, Mayo Clinic
Study start: Dec 2014
Primary completion: 9 Nov 2018 (actual)
Study completion: 9 Nov 2018 (actual)
First posted: 9 Nov 2016 (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.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 10

Arm	Type	Receives
Arm 1	Experimental	Biological: INO-14002 mg INO-1400 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 2	Experimental	Biological: INO-14008 mg INO-1400 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 3	Experimental	Biological: INO-1400, Biological: INO-90122 mg INO-1400 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 4	Experimental	Biological: INO-1400, Biological: INO-90122 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 5	Experimental	Biological: INO-1400, Biological: INO-90128 mg INO-1400 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 6	Experimental	Biological: INO-1400, Biological: INO-90128 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 7	Experimental	Biological: INO-14012 mg INO-1401 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 8	Experimental	Biological: INO-14018 mg INO-1401 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 9	Experimental	Biological: INO-9012, Biological: INO-14018 mg INO-1401 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 10	Experimental	Biological: INO-9012, Biological: INO-14018 mg INO-1401 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

1. Signed and dated written IRB approved informed consent;
2. Males or females aged ≥18 years;
3. Subjects with breast, lung or pancreatic carcinoma who are at high risk of relapse post definitive therapy at least 4 and no more than 24 weeks from completion of definitive therapy at the time of signing informed consent as described below for each indication:

Key exclusion criteria (3 listed)

1. Previous treatment wth any TERT or IL-12 containing therapy, or any other DNA immunotherapy;
2. Any concurrent condition requiring the continued or anticipated use of systemic steroids (excluding non-systemic inhaled, topical skin and/or eye drop-containing corticosteroids) or immunosuppressive therapy (excludes low dose methotrexate). All other systemic corticosteroids must be discontinued at least 4 weeks prior to first Study Treatment;
3. Administration of any vaccine within 4 weeks of the first study treatment

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
INO-1400Also: hTERT	Biological	Arm 1, Arm 2, Arm 3, Arm 4, Arm 5, Arm 6
INO-9012Also: IL-12	Biological	Arm 10, Arm 3, Arm 4, Arm 5, Arm 6, Arm 9
INO-1401Also: SynCon TERT	Biological	Arm 10, Arm 7, Arm 8, Arm 9

Primary outcome

Adverse events graded in accordance with "Common Terminology Criteria for Adverse Events (CTCAE)", NCI version 4.03
Time frame: Up to 2 years from first study treatment
Injection site reactions including, but not necessarily limited to, local skin erythema, induration, pain and tenderness at administration site
Time frame: Up to 14 weeks
Changes in safety laboratory parameters
Time frame: Up to 2 years from first study treatment

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 19 Nov 2018.
Sponsor's WebsiteLink provided by the sponsor.
Individual participant dataSharing planned: No

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Not yet recruitingObservational study
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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.

Robert Vonderheide, MD, PhD principal investigator

University of Pennsylvania

Autumn McRee, MD principal investigator

University of North Carolina

Jennifer Johnson, MD principal investigator

Thomas Jefferson University Hospitial

6 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 INO-1400, INO-9012 and INO-1401 in people with Breast Cancer and Lung Cancer, run by Inovio Pharmaceuticals at 6 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 11 inclusion and 3 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 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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?

Adverse events graded in accordance with "Common Terminology Criteria for Adverse Events (CTCAE)", NCI version 4.03 (time frame: Up to 2 years from first study treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02960594.

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 19 Nov 2018.