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Neoantigen DNA vaccine for Breast Cancer

Washington University School of Medicine, Saint Louis, MO
Breast Cancer+2 More ConditionsNeoantigen DNA vaccine - Biological
Eligibility
18+
Female
What conditions do you have?
Select

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
  • Triple Negative Breast Cancer
  • Breast Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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Treprostinil Palmitil

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 1 year

Day 171
Safety of neoantigen DNA vaccines given alone or in combination with durvalumab as measured by number of adverse events experienced by patient
Up to 1 year
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

Trial Safety

Phase-Based Safety

1 of 3

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1
GnRH
1
SAD Cohorts 1 to 2: Participants receiving ECC5004
2
Treprostinil Palmitil

Side Effects for

Durvalumab
26%Asthenia
20%Anaemia
20%Constipation
17%Decreased appetite
16%Diarrhoea
15%Nausea
13%Pruritus
10%Fatigue
10%Urinary tract infection
10%Cough
9%Vomiting
9%Oedema peripheral
9%Dyspnoea
9%Back pain
9%Pyrexia
7%Abdominal pain
7%Arthralgia
7%Hypothyroidism
7%Haematuria
6%Blood creatinine increased
5%Weight decreased
2%Sepsis
1%Pyelonephritis
1%Acute kidney injury
1%General physical health deterioration
1%Device related infection
1%Death
1%Tumour hyperprogression
1%Urosepsis
1%Pneumonia
1%Pulmonary embolism
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT03084471) in the Durvalumab ARM group. Side effects include: Asthenia with 26%, Anaemia with 20%, Constipation with 20%, Decreased appetite with 17%, Diarrhoea with 16%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2 Treatment Groups

Neoantigen DNA vaccine + Durvalumab
1 of 2
Neoantigen DNA vaccine
1 of 2

Experimental Treatment

18 Total Participants · 2 Treatment Groups

Primary Treatment: Neoantigen DNA vaccine · No Placebo Group · Phase 1

Neoantigen DNA vaccine + DurvalumabExperimental Group · 4 Interventions: TDS-IM system (Inchor Medical Systems), Durvalumab, Neoantigen DNA vaccine, Peripheral blood draw · Intervention Types: Device, Drug, Biological, Procedure
Neoantigen DNA vaccineExperimental Group · 3 Interventions: TDS-IM system (Inchor Medical Systems), Neoantigen DNA vaccine, Peripheral blood draw · Intervention Types: Device, Biological, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
FDA approved
Neoantigen DNA vaccine
2018
Completed Phase 1
~20
Peripheral blood draw
2017
Completed Phase 2
~60

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 year

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,846 Previous Clinical Trials
2,280,566 Total Patients Enrolled
46 Trials studying Breast Cancer
8,330 Patients Enrolled for Breast Cancer
MedImmune LLCIndustry Sponsor
347 Previous Clinical Trials
793,838 Total Patients Enrolled
3 Trials studying Breast Cancer
218 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,268 Previous Clinical Trials
41,228,505 Total Patients Enrolled
931 Trials studying Breast Cancer
1,537,986 Patients Enrolled for Breast Cancer
National Institutes of Health (NIH)NIH
2,550 Previous Clinical Trials
24,611,127 Total Patients Enrolled
48 Trials studying Breast Cancer
108,838 Patients Enrolled for Breast Cancer
William Gillanders, M.D.Principal InvestigatorWashington University School of Medicine
3 Previous Clinical Trials
57 Total Patients Enrolled
1 Trials studying Breast Cancer
27 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · Female Participants · 19 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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