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Cancer Vaccine
AE37 Vaccine + Pembrolizumab for Breast Cancer (NSABP FB-14 Trial)
Phase 2
Waitlist Available
Led By Norman Wolmark, MD
Research Sponsored by NuGenerex Immuno-Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a performance status of 0 or 1 on the ECOG Performance Scale
At least 1 of the tumor sites must be amenable to core needle biopsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, within 72 hours of vaccination (48-72 hours), and as adverse events occur in each cycle (21 days) of study therapy (first 13 patients).
Awards & highlights
NSABP FB-14 Trial Summary
This trial will study the safety and efficacy of a new cancer vaccine in patients with advanced triple-negative breast cancer.
Who is the study for?
This trial is for adults with advanced triple-negative breast cancer who have measurable metastatic disease, are in good physical condition (ECOG 0 or 1), and whose organs function well. They must not be pregnant, breastfeeding, or planning to conceive soon. Participants should not have severe allergies to pembrolizumab, active infections like Hepatitis B/C or HIV, certain psychiatric conditions, other cancers needing treatment, recent vaccinations or therapies that could affect the study.Check my eligibility
What is being tested?
The trial is testing the AE37 Peptide vaccine combined with Pembrolizumab to boost immune response against advanced triple-negative breast cancer. It has two stages: first determining a safe dose of AE37 (13 patients) and then expanding this cohort (16 patients) using the established safe dose from Stage 1.See study design
What are the potential side effects?
Potential side effects include reactions at the injection site from the vaccine and typical immune-related adverse effects from Pembrolizumab such as fatigue, skin issues, inflammation of organs like lungs (pneumonitis), hormonal gland problems which can alter hormone levels.
NSABP FB-14 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
One of my tumors can be biopsied with a needle.
Select...
My brain metastasis is treated, stable, and I don't need ongoing steroids.
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My cancer is triple-negative.
Select...
My breast cancer has spread and can be measured.
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My breast cancer has been confirmed by lab tests.
NSABP FB-14 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1, within 72 hours of vaccination (48-72 hours), and as adverse events occur in each cycle (21 days) of study therapy (first 13 patients).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, within 72 hours of vaccination (48-72 hours), and as adverse events occur in each cycle (21 days) of study therapy (first 13 patients).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate
Recommended dose
Secondary outcome measures
Clinical benefit rate
Overall Survival
Overall Toxicity
+1 moreNSABP FB-14 Trial Design
1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment2 Interventions
AE37 peptide vaccine every 21 days for 5 doses + Pembrolizumab every 21 days for 2 years (Maximum 35 cycles)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Find a Location
Who is running the clinical trial?
NuGenerex Immuno-OncologyLead Sponsor
1 Previous Clinical Trials
456 Total Patients Enrolled
1 Trials studying Breast Cancer
456 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,055,054 Total Patients Enrolled
59 Trials studying Breast Cancer
7,534 Patients Enrolled for Breast Cancer
NSABP Foundation IncNETWORK
86 Previous Clinical Trials
136,959 Total Patients Enrolled
45 Trials studying Breast Cancer
100,530 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a severe allergic reaction to pembrolizumab or its ingredients.I am fully active or restricted in physically strenuous activity but can do light work.I have had pneumonitis treated with steroids or have it now.I have not received a live vaccine in the last 30 days.My side effects from the last chemotherapy are mild.I have been diagnosed with HIV.One of my tumors can be biopsied with a needle.My brain metastasis is treated, stable, and I don't need ongoing steroids.I haven't taken cancer antibody treatments in the last 4 weeks or still have side effects from them.I have not taken more than 10mg of steroids daily in the week before starting the trial.I haven't had cancer treatment or recovered from its side effects in the last 2 weeks.My cancer is triple-negative.My breast cancer has spread and can be measured.I have another cancer that is getting worse or needs treatment.I haven't received blood products or colony stimulating factors in the last 4 weeks.My breast cancer has been confirmed by lab tests.I have received more than one treatment for my cancer that has spread.I have been treated for an autoimmune disease in the last 2 years.I am a woman who can have children and have a negative pregnancy test taken within the last 3 days.I have previously been treated with specific antibodies.My organs are functioning well.I have an active Hepatitis B or C infection.I am currently on medication for an infection.I have active brain metastases or cancer in the lining of my brain.
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the AE37 Peptide vaccine typically used as a therapy for?
"AE37 Peptide vaccine is a commonly used medication for malignant neoplasms. It has also been shown to be helpful for patients with unresectable melanoma, microsatellite instability high, and disease progression after chemotherapy."
Answered by AI
What are the investigators of this trial looking to discover?
"The primary goal of this trial, which will last no longer than two years or until the disease progresses or the patient experiences intolerable toxicity, is to assess the Recommended dose. Secondary outcomes that will be measured include the Overall Survival rate, the Clinical Benefit rate, and the Overall Toxicity."
Answered by AI
Is there a danger to patients from the AE37 Peptide vaccine?
"The AE37 Peptide vaccine is currently in Phase 2 of clinical trials. This means that while there is some data supporting the safety of the vaccine, there is none yet to suggest that it is effective."
Answered by AI
From how many places is this research project being directed?
"There are six sites currently running this trial, with three in Cleveland, Illinois, and Effingham respectively. The other six centres are located elsewhere."
Answered by AI
Are there any more places open in this research project for participants?
"This clinical study is not enrolling patients at the moment. The listing was first published on May 3rd, 2019 and was last edited on May 28th, 2021. For patients looking for other trials, there are 2430 active studies for patients with triple-negative breast cancer and 1000 studies for the AE37 Peptide vaccine."
Answered by AI
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