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INO 5401 Vaccination in BRCA1/2 Mutation Carriers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04367675
Recruitment Status : Not yet recruiting
First Posted : April 29, 2020
Last Update Posted : October 14, 2020
Sponsor:
Collaborator:
Inovio Pharmaceuticals
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
The research study is being conducted to test an experimental vaccine to potentially prevent cancer for people with BRCA1 or BRCA2 mutations. This study will test if the vaccine is safe (without significant side effects) and test a new way of administering vaccines. It will also test whether the vaccine activates your immune system.

Condition or disease Intervention/treatment Phase
BRCA1/2 Mutation Drug: INO-5401 Drug: INO-9012 Device: Cellectra 2000 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Phase 1b Study of INO-5401 Alone or INO-5401 in Combination With INO-9012 Followed by Electroporation in Adult Cancer and Non-Cancer Patients With BRCA1 or BRCA2 Mutations
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Arm Intervention/treatment
Experimental: INO-5401
Participants receive INO-5401 vaccine, followed by electroporation, on Day 1, Week 4, Week 8, and Week 12
Drug: INO-5401
INO-5401 contains genes which are active in human cancers (hTERT, PMSA, and WNT1) and are felt to be good targets for the immune system both people who have had cancer or for those at increased risk of getting cancer.

Device: Cellectra 2000
The device will deliver a small electric charge through 5 needles to increase the amount of the study vaccine taken up by the muscle.

Experimental: INO-5401 and INO-9012
Participants receive INO-5401 and INO-09012 vaccine, followed by electroporation, on Day 1, Week 4, Week 8, and Week 12
Drug: INO-5401
INO-5401 contains genes which are active in human cancers (hTERT, PMSA, and WNT1) and are felt to be good targets for the immune system both people who have had cancer or for those at increased risk of getting cancer.

Drug: INO-9012
INO-9012 contains the gene for IL12, a part of your body's immune system. It is possible that adding this to INO-5401 will increase the immune response to the vaccine.

Device: Cellectra 2000
The device will deliver a small electric charge through 5 needles to increase the amount of the study vaccine taken up by the muscle.




Primary Outcome Measures :
  1. Dose Limiting Toxicities [ Time Frame: for 2 years after last dose of study treatment ]
    Dose-limiting toxicities will be classified by system organ class (SOC), preferred term (PT), severity, and relationship to Study Treatment.


Secondary Outcome Measures :
  1. Antigen-specific immune response [ Time Frame: for 2 years after last dose of study treatment ]
    Immune response will be measured at several time points



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Cohort A Inclusion Criteria:

  1. Signed and dated IRB approved informed consent.
  2. Females and males age 18+.
  3. Documented carrier of a pathogenic or likely pathogenic mutation in BRCA1 or BRCA2.
  4. Diagnosis of invasive breast cancer, invasive ovarian cancer, pancreatic cancer (apart from neuroendocrine) or prostate cancer with completion of adjuvant therapy and no clinical evidence of disease according to standard of care.
  5. Minimum of 2 clear sites on the skin to allow for injection.
  6. ECOG performance status of 0.
  7. Normal ECG or ECG without clinically significant findings and which does not require clinical action.
  8. Normal bone marrow, hepatic, and renal function.
  9. Females who are post-menopausal only.
  10. Male subjects with reproductive potential must be willing to use a condom with female partners of reproductive potential and their female sexual partners should use an additional highly effective method of birth control. This is required from screening through 24 weeks after the last dose of immunotherapy.
  11. Able and willing to comply with all study procedures.

Cohort B Inclusion Criteria

  1. Signed and dated IRB approved informed consent.
  2. Females and males age 18+.
  3. Documented carrier of a pathogenic or likely pathogenic mutation in BRCA1 or BRCA2.
  4. With or without prior prophylactic (but not therapeutic) mastectomy or salpingo-oophorectomy.
  5. Minimum of 2 clear sites on the skin to allow for injection.
  6. ECOG performance status of 0.
  7. Normal ECG or ECG without clinically significant findings and which does not require clinical action.
  8. Normal bone marrow, hepatic, and renal function.
  9. Females who are post-menopausal only.
  10. Male subjects with reproductive potential must be willing to use a condom with female partners of reproductive potential and their female sexual partners should use an additional highly effective method of birth control. This is required from screening through 24 weeks after the last dose of immunotherapy.
  11. Able and willing to comply with all study procedures.

Cohort A Exclusion Criteria

  1. Previous treatment with INO-5401 or IL-12 containing therapy, or any other DNA immunotherapy.
  2. Prior history of invasive cancer other than those listed above. History of localized superficial non-melanoma skin cancers, melanoma in situ, cervical intraepithelial neoplasia, or breast ductal carcinoma in situ is allowed.
  3. Pregnant or breast-feeding subjects.
  4. Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry and/or during study participation; continued participation in an observational study is allowed.
  5. Cardiac pre-excitation syndromes.
  6. Prior major surgery within 4 weeks of first study treatment.
  7. Presence of acute or chronic bleeding or clotting disorder that would contraindicate intramuscular injections or use of blood thinners within 2 weeks of first study treatment.
  8. Any concurrent condition requiring the continued or anticipated use of systemic steroids or immunosuppressive therapy. All systemic corticosteroids must be discontinued at least 4 weeks prior to first study treatment.
  9. History of clinically significant disease or other immunosuppressive disease.
  10. HIV infection.
  11. Known history of hepatitis B and/or hepatitis C with active viral replication.
  12. Receipt of any blood product within 2 weeks before signing ICF.
  13. Administration of any vaccine, except influenza vaccine, within 4 weeks of the first study treatment. Administration of influenza vaccine within 2 weeks of first study treatment.
  14. Presence of metal implants or implantable medical device within 5 cm of the planned site of injection/EP including a cardioverter-defibrillator (ICD) or pacemaker (to prevent a life-threatening arrhythmia) that is located ipsilateral to the intended deltoid injection site, unless deemed acceptable by a cardiologist.
  15. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
  16. Any illness or condition that in the opinion of the investigator may affect the safety of the subject or the evaluation of any study endpoint.
  17. Any other conditions judged by the investigator that would limit the evaluation of the subject.

Cohort B Exclusion Criteria

  1. Previous treatment with INO-5401 or IL-12 containing therapy, or any other DNA immunotherapy.
  2. Prior history of invasive cancer other than those listed above. History of localized superficial non-melanoma skin cancers, melanoma in situ, cervical intraepithelial neoplasia, or breast ductal carcinoma in situ is allowed.
  3. Pregnant or breast-feeding subjects.
  4. Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry and/or during study participation; continued participation in an observational study is allowed.
  5. Cardiac pre-excitation syndromes.
  6. Prior major surgery within 4 weeks of first study treatment.
  7. Presence of acute or chronic bleeding or clotting disorder that would contraindicate intramuscular injections or use of blood thinners within 2 weeks of first study treatment.
  8. Any concurrent condition requiring the continued or anticipated use of systemic steroids or immunosuppressive therapy. All systemic corticosteroids must be discontinued at least 4 weeks prior to first study treatment.
  9. History of clinically significant disease or other immunosuppressive disease.
  10. HIV infection.
  11. Known history of hepatitis B and/or hepatitis C with active viral replication.
  12. Receipt of any blood product within 2 weeks before signing ICF.
  13. Administration of any vaccine, except influenza vaccine, within 4 weeks of the first study treatment. Administration of influenza vaccine within 2 weeks of first study treatment.
  14. Presence of metal implants or implantable medical device within 5 cm of the planned site of injection/EP including a cardioverter-defibrillator (ICD) or pacemaker (to prevent a life-threatening arrhythmia) that is located ipsilateral to the intended deltoid injection site, unless deemed acceptable by a cardiologist.
  15. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
  16. Any illness or condition that in the opinion of the investigator may affect the safety of the subject or the evaluation of any study endpoint.
  17. Any other conditions judged by the investigator that would limit the evaluation of the subject.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04367675


Contacts
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Contact: Carey Kokkonen 215-439-7575 carey.kokkonen@pennmedicine.upenn.edu

Sponsors and Collaborators
University of Pennsylvania
Inovio Pharmaceuticals
Investigators
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Principal Investigator: Susan Domchek, MD Abramson Cancer Center of the University of Pennsylvania
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04367675    
Other Study ID Numbers: 842686, UPCC 06019
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes