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Neoantigen DNA vaccine for Breast Cancer

Phase 1

Waitlist Available

Led By William Gillanders, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days after completion of treatment (approximately day 259)

Awards & highlights

Study Summary

This trial is testing a neoantigen DNA vaccine in patients with triple negative breast cancer. The vaccine will be given either alone or with the drug durvalumab.

Eligible Conditions

Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days after completion of treatment (approximately day 259)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days after completion of treatment (approximately day 259)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days after completion of treatment (approximately day 259) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient

Secondary outcome measures

Immune Response to Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by ELISPOT

Immune Response to Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Luminex Assay

Immune Response to Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Multiparametric Flow Cytometry

Side effects data

From 2022 Phase 3 trial • 867 Patients • NCT03084471

26%

Asthenia

20%

Anaemia

20%

Constipation

17%

Decreased appetite

16%

Diarrhoea

15%

Nausea

13%

Pruritus

10%

Urinary tract infection

10%

Cough

10%

Fatigue

Vomiting

Dyspnoea

Back pain

Oedema peripheral

Pyrexia

Haematuria

Abdominal pain

Arthralgia

Hypothyroidism

Blood creatinine increased

Weight decreased

Sepsis

Pneumonia

Tumour hyperprogression

General physical health deterioration

Death

Acute kidney injury

Pyelonephritis

Device related infection

Urosepsis

Pulmonary embolism

100%

80%

60%

40%

20%

Study treatment Arm

Durvalumab

Trial Design

2Treatment groups

Experimental Treatment

Group I: Neoantigen DNA vaccine + DurvalumabExperimental Treatment4 Interventions

The first neoantigen DNA vaccine injection will take place following the completion of standard of care therapy. The day of the first vaccine injection will be referred to as Day 1 The schedule of vaccination is Day 1, Day 29 ± 7, Day 57 ± 7, Day 85 ± 7, Day 113 ± 7, and Day 141 ± 7 with at least 21 days between injection days For patients who are randomized to the neoantigen DNA vaccine plus durvalumab arm, the neoantigen-specific T cell response will be assessed prior to Day 85. If a neoantigen-specific T cell response is present, durvalumab will be started on Day 85, and will be administered Q4W at a dose of 1500 mg over the course of 60 minutes. If a neoantigen-specific T cell response is not present, these patients will be replaced but may continue to receive the neoantigen DNA vaccine on study. They will not be transferred to the vaccine-only arm.

Group II: Neoantigen DNA vaccineExperimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3870

Neoantigen DNA vaccine

2018

Completed Phase 1

~20

Peripheral blood draw

2017

Completed Phase 2

~80

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,705 Previous Clinical Trials

7,507,268 Total Patients Enrolled

50 Trials studying Breast Cancer

110,785 Patients Enrolled for Breast Cancer

MedImmune LLCIndustry Sponsor

347 Previous Clinical Trials

793,891 Total Patients Enrolled

3 Trials studying Breast Cancer

218 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,687 Previous Clinical Trials

40,930,353 Total Patients Enrolled

941 Trials studying Breast Cancer

1,543,396 Patients Enrolled for Breast Cancer

Frequently Asked Questions

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

Are there available slots for participants in this experiment?

"Online records on clinicaltrials.gov demonstrate that this particular medical trial, which was created back in August 2019 and last updated only recently, is no longer actively enrolling patients. However, there are over two thousand six hundred eighty-four other studies searching for participants right now."

Answered by AI

How many participants are being monitored as part of this therapeutic experiment?

"At the moment, this medical trial is not actively seeking patients. It was initially published on August 8th 2019 and last updated on August 24th 2022. However, 2351 clinical trials are currently recruiting for those with Triple Negative Breast Neoplasms while 333 tests require participants to receive a Neoantigen DNA Vaccine."

Answered by AI

Is Neoantigen DNA vaccine usage associated with any potential risks for individuals?

"Limited clinical evidence exists to support the effectiveness and safety of Neoantigen DNA vaccine, thus it has been given a score of 1."

Answered by AI

How has the Neoantigen DNA vaccine been employed to address certain medical conditions?

"Neoantigen DNA vaccines are widely used to treat unresectable stage iii non-small cell lung cancer. Furthermore, they can also be deployed against previously untreated metastatic urothelial carcinoma and advance directives."

Answered by AI

Could you provide more details regarding the research conducted with Neoantigen DNA vaccine?

"At present, 333 Neoantigen DNA vaccine trials are in progress. Out of these, 52 have reached Phase 3. These studies mainly take place at Cordoba, Texas but there are 12952 sites globally running clinical research for this therapy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neoantigen DNA Vaccine Alone vs. Neoantigen DNA Vaccine Plus Durvalumab in Triple Negative Breast Cancer Patients Following Standard of Care Therapy

2019. "Neoantigen DNA Vaccine Alone vs. Neoantigen DNA Vaccine Plus Durvalumab in Triple Negative Breast Cancer Patients Following Standard of Care Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03199040.