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Cancer Vaccine

Cancer Vaccine for BRCA Gene Mutation

Phase 1
Recruiting
Led By Susan Domchek, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Normal bone marrow, hepatic, and renal function
Minimum of 2 clear sites on the skin to allow for injection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for 2 years after last dose of study treatment
Awards & highlights

Study Summary

This trial is testing a new cancer vaccine for people with BRCA1 or BRCA2 mutations. They want to see if it's safe and if it activates the immune system.

Who is the study for?
This trial is for adults over 18 with BRCA1 or BRCA2 mutations who've had breast, ovarian, pancreatic (excluding neuroendocrine), or prostate cancer but are now free of disease. Participants must have completed adjuvant therapy and be post-menopausal if female. They should not have significant heart issues, bleeding disorders, active infections like HIV or hepatitis B/C, recent major surgery, or require steroids/immunosuppressants.Check my eligibility
What is being tested?
The study tests an experimental vaccine called INO-5401 to prevent cancer in individuals with BRCA gene mutations. It examines the vaccine's safety and immune system activation using a new delivery method involving Cellectra 2000 alongside another agent named INO-9012.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site such as pain and swelling, flu-like symptoms including fever and fatigue, muscle aches, possible impacts on blood cells leading to increased infection risk. The full extent of side effects will be studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver, kidneys, and bone marrow are functioning normally.
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I have at least 2 clear areas on my skin suitable for injections.
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I carry a BRCA1 or BRCA2 mutation.
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I am fully active and can carry on all my pre-disease activities without restriction.
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I am a woman and have gone through menopause.
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I have had breast, ovarian, pancreatic (not neuroendocrine), or prostate cancer and completed treatment with no signs of the disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for 2 years after last dose of study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and for 2 years after last dose of study treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Limiting Toxicities
Secondary outcome measures
Antigen-specific immune response

Side effects data

From 2021 Phase 1 & 2 trial • 56 Patients • NCT03606213
100%
Injection site reaction
9%
Bipolar depression with hypomania
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort B - Arm 1
Cohort A - Arm 2
Cohort A - Arm 3
Cohort A - Arm 1

Trial Design

2Treatment groups
Experimental Treatment
Group I: INO-5401 and INO-9012Experimental Treatment3 Interventions
Participants receive INO-5401 and INO-09012 vaccine, followed by electroporation, on Day 1, Week 4, Week 8, and Week 12
Group II: INO-5401Experimental Treatment2 Interventions
Participants receive INO-5401 vaccine, followed by electroporation, on Day 1, Week 4, Week 8, and Week 12
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cellectra 2000
2019
Completed Phase 1
~50
INO-9012
2014
Completed Phase 2
~150

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Inovio PharmaceuticalsIndustry Sponsor
53 Previous Clinical Trials
4,795 Total Patients Enrolled
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,189 Total Patients Enrolled
Susan Domchek, MDPrincipal InvestigatorAbramson Cancer Center at Penn Medicine
5 Previous Clinical Trials
2,020 Total Patients Enrolled

Media Library

INO-5401 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04367675 — Phase 1
BRCA Gene Mutation Research Study Groups: INO-5401 and INO-9012, INO-5401
BRCA Gene Mutation Clinical Trial 2023: INO-5401 Highlights & Side Effects. Trial Name: NCT04367675 — Phase 1
INO-5401 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04367675 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could individuals currently participate in this clinical examination?

"Affirmative. According to clinicaltrials.gov, this medical experiment is currently recruiting patients who fit the criteria. This research program was initially published on April 20th 2021 and its most recent update came Nov 22nd 2022 - with 44 individuals being sought from 1 site of operation."

Answered by AI

Are there any prior clinical studies that have made use of INO-9012?

"As of now, 7 clinical trials assessing the effectiveness of INO-9012 are currently in progress with none being at Phase 3. Philadelphia, Pennsylvania is hosting a considerable portion of these tests; however, there are 60 sites across the country conducting such studies."

Answered by AI

What is the aggregate population size for this particular research endeavor?

"Affirmative. According to the data hosted on clinicaltrials.gov, this medical study is currently searching for patients and was initially posted on April 20th 2021. The research team seeks 44 participants recruited from a single site and last updated its records in November 22nd 2022."

Answered by AI

Is INO-9012 an innocuous medication for people?

"As this is an initial Phase 1 trial, the safety of INO-9012 was evaluated as a 1 due to its limited prior data concerning efficacy and safety."

Answered by AI

Does this trial represent a pioneering effort in its field?

"Since 2016, Inovio Pharmaceuticals has been researching INO-9012. The first trial was launched that same year and involved 33 participants. Following the initial study's completion in 2016, a Phase 1 drug approval was granted to INO-9012. Currently 7 studies are being conducted across 4 countries involving 33 cities."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
INO 5401 Vaccination in BRCA1/2 Mutation Carriers
2021. "INO 5401 Vaccination in BRCA1/2 Mutation Carriers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04367675.
~15 spots leftby Dec 2025
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