Triple Negative Breast CancerPhase 1NCT03199040

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

A Phase 1 study testing Durvalumab, Neoantigen DNA vaccine and TDS-IM system (Inchor Medical Systems) in people with Triple Negative Breast Cancer and Triple Negative Breast Neoplasms, run by Washington University School of Medicine at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Triple Negative Breast Cancer, Triple Negative Breast Neoplasms, TNBC - Triple-Negative Breast Cancer
What is being tested?: Durvalumab, Neoantigen DNA vaccine and TDS-IM system (Inchor Medical Systems)
Type of treatment: Vaccines, Injection or infusion, Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 23 Jul 2019to 1 May 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically confirmed diagnosis of invasive breast cancer.
ER and PR less than Allred score of 3 or less than 1% positive staining cells in the invasive component of the tumor. Patients not meeting this pathology criteria, but have been clinically treated as having TNBC, may be enrolled at treating physician's discretion.
HER2 negative by FISH or IHC staining 0 or 1+.
Consented for genome sequencing
Clinical stage T1c-T4c, any N, M0 primary tumor by AJCC 7th edition clinical staging prior to neoadjuvant chemotherapy, with residual invasive breast cancer after neoadjuvant therapy.
At least 18 years of age.

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Eastern Cooperative Oncology Group (ECOG) performance status ≥1.
Adequate organ and marrow function no more than 14 days prior to registration as defined below:
absolute neutrophil count ≥1,500/μL
platelets ≥100,000/μL
hemoglobin ≥ 9.0 g/dL
total bilirubin ≤ 1.5 X institutional upper limit of normal
AST/ALT ≤2.5 X institutional upper limit of normal
serum creatinine clearance >40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance
Body weight > 30 kg.
Evidence of post-menopausal status or negative urine or serum pregnancy test for female pre-menopausal subjects. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
Women < 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
Women ≥ 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses > 1 year ago, had chemotherapy-induced menopause with last menses > 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
Able to understand and willing to sign an IRB-approved written informed consent document.

Who cannot join

Received chemotherapy, radiotherapy (to more than 30% of the bone marrow or with a wide field of radiation), or biologic therapy within the last 30 days.
Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
Receiving any other investigational agent(s) or has received an investigational agent within the last 30 days.
Receipt of live attenuated vaccination within 6 months prior to study entry or within 30 days of receiving durvalumab.
Major surgical procedure within 28 days prior to the first dose of durvalumab. Local surgery of isolated lesions for palliative intent is acceptable.
Current use or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal, inhaled, and intra-articular corticosteroids or systemic corticosteroids at physiological doses which are not to exceed 10 mg/day of prednisone or an equivalent corticosteroid.

Show all 39Show fewer

Known metastatic disease.
Invasive cancer in the contralateral breast.
Known allergy, or history of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty.
History of hypersensitivity to durvalumab or any excipient.
Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms calculated from 3 electrocardiograms (ECGs) (within 15 minutes at 5 minutes apart).
Any unresolved toxicity NCI CTCAE grade ≥ 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria. Subjects with grade ≥ 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician. Subjects with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the study physician.
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, evidence of any acute or chronic viral illness or disease, or psychiatric illness/social situation that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent.
Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion:
Subjects with vitiligo or alopecia
Subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
Any chronic skin condition that does not require systemic therapy
Subjects without active disease in the last 5 years may be included but only after consultation with the study physician
Subjects with celiac disease controlled by diet alone
History of pneumonitis or interstitial lung disease.
History of active primary immunodeficiency.
Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination, and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody (anti-HBc) and absence of HBsAg) are eligible. Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
History of allogeneic organ transplantation.
Pregnant or breastfeeding. A negative serum pregnancy test is required no more than 7 days before study entry.
Subjects of reproductive potential who are not willing to employ effective birth control from screening to 1 year after the last dose of durvalumab.
History of another primary malignancy except for:
Malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose of study treatment and low potential for risk of recurrence
Adequately treated non-melanoma skin cancer of lentigo maligna without evidence of disease
Adequately treated carcinoma in situ without evidence of disease
History of leptomeningeal carcinomatosis.
Patient must have no active major medical or psychosocial problems that could be complicated by study participation.
Subjects with a strong likelihood of non-adherence such as difficulties in adhering to follow-up schedule due to geographic distance from the Siteman Cancer Center should not knowingly be registered.
Individuals in whom a skinfold measurement of the cutaneous and subcutaneous tissue for eligible injection sites (left and right medial deltoid region) exceeds 40 mm.
Individuals in whom the ability to observe possible local reactions at the eligible injection sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art.
Therapeutic or traumatic metal implant in the skin or muscle of either deltoid region.
Acute or chronic, clinically significant hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the investigator based on medical history, physical examination, EKG, and/or laboratory screening test
Any chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child, or chronic seizure disorder which is well controlled by medication with no seizures within the last 2 years
Syncopal episode within 12 months of screening
Current use of any electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators.

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Randomized Phase 1 Trial of Neoantigen DNA Vaccine Alone vs. Neoantigen DNA Vaccine Plus Durvalumab in Triple Negative Breast Cancer Patients Following Standard of Care Therapy

This is a single institution, open-label randomized phase 1 trial of neoantigen DNA vaccine alone vs. neoantigen DNA vaccine plus durvalumab in triple negative breast cancer (TNBC) patients following standard of care therapy. Patients with newly diagnosed clinical stage II-III TNBC are eligible for enrollment. Patients will receive standard of care therapy including chemotherapy, surgery and radiation therapy as clinically indicated. Following standard of care therapy, patients will be randomized to receive either a neoantigen DNA vaccine alone, or a neoantigen DNA vaccine + durvalumab.

Conditions: Triple Negative Breast Cancer, Triple Negative Breast Neoplasms, TNBC - Triple-Negative Breast Cancer, Triple-negative Breast Carcinoma
Being tested: Durvalumab, Neoantigen DNA vaccine, TDS-IM system (Inchor Medical Systems), Peripheral blood draw
Medical subject headings: Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DurvalumabDrug
Also called Imfinzi
-Human monoclonal antibody
Neoantigen DNA vaccineBiological
-The vaccine will be given by the TDS-IM system
TDS-IM system (Inchor Medical Systems)Device
Also called Integrated electroporation administration system
-At each vaccination time point, patients will receive two injections at separate sites.
Peripheral blood drawProcedure or surgery
-Baseline, following completion of standard of care therapy, Day 1, Day 57, Day 113, Day 159, and 1 year after initiation of neoantigen DNA vaccine therapy

Study groups in NCT03199040
Study group	Role	What they receive
Neoantigen DNA vaccine + Durvalumab	Experimental	* 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. Receives: Drug: Durvalumab; Biological: Neoantigen DNA vaccine; Device: TDS-IM system (Inchor Medical Systems); Procedure: Peripheral blood draw
Neoantigen DNA vaccine	Experimental	* 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 Receives: Biological: Neoantigen DNA vaccine; Device: TDS-IM system (Inchor Medical Systems); Procedure: Peripheral blood draw

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient
- Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03.
- Assessment of the safety of neoantigen DNA vaccines will include both clinical observation and laboratory evaluation. Safety will be closely monitored after injection with eight or more clinical and laboratory assessments in the first 24 weeks of the trial
Measured: 90 days after completion of treatment (approximately day 259)

Secondary outcomes (4)

Immune Response to Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Luminex Assay
-Peripheral blood will be collected at multiple time points before and after vaccination
Measured: Up to 1 year after completion of treatment (approximately 1 year and 141 days)
Number of Participants With an Immune Response to Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Interferon-gamma ELISPOT Assay
The ELISpot assay was performed after in vitro culture of patient PBMC with neoantigen peptide for ~12 days. The number of spot-forming T cells, a surrogate for the number of neoantigen-specific T cells, was determined after neoantigen peptide re-stimulation for the duration of the assay (48 hours) and compared to that of control cells that were not re-stimulated with neoantigen during the assay. One-way anova analysis was performed on replicate assessments.
Measured: Up to 1 year after completion of treatment (approximately 1 year and 141 days)
Number of Participants With Immune Response to Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Multiparametric Flow Cytometry - CD4
Multiparametric flow cytometry was performed as a second readout to assess neoantigen-specific T cell reactivity. Markers included CD4, CD8, IFNγ, and a viability marker. After culture, as described above, T cells were stimulated for 6 hours with/without neoantigen and stained with fluorescent antibodies specific for the various markers. Data were analyzed by comparing the percentage IFNγ+ CD4/CD8 cells between neoantigen-stimulated vs unstimulated T cells; a >2-fold increase in percentage positive cells after neoantigen stimulation was considered positive.
Measured: Up to 1 year after completion of treatment (approximately 1 year and 141 days)
Number of Participants With Immune Response to Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Multiparametric Flow Cytometry - CD8
Multiparametric flow cytometry was performed as a second readout to assess neoantigen-specific T cell reactivity. Markers included CD4, CD8, IFNγ, and a viability marker. After culture, as described above, T cells were stimulated for 6 hours with/without neoantigen and stained with fluorescent antibodies specific for the various markers. Data were analyzed by comparing the percentage IFNγ+ CD4/CD8 cells between neoantigen-stimulated vs unstimulated T cells; a >2-fold increase in percentage positive cells after neoantigen stimulation was considered positive.
Measured: Up to 1 year after completion of treatment (approximately 1 year and 141 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jul 20191 May 2023

First posted26 Jun 2017
Study start23 Jul 2019
Primary completion21 Nov 2022
Study completion1 May 2023

Why it stopped: Drugs/equipment unavailable and insufficient funding

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03199040
Sponsor's protocol ID: 201710109
Other IDs: 1R01CA240983-01
Status last verified: Apr 2024
First submitted: 22 Jun 2017
Last updated: 28 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Phase 1 Trial of Neoantigen DNA Vaccine Alone vs. Neoantigen DNA Vaccine Plus Durvalumab in Triple Negative Breast Cancer Patients Following Standard of Care Therapy
ClinicalTrials.gov ID: NCT03199040
Acronym / sponsor ID: 201710109
Conditions: Triple Negative Breast Cancer, Triple Negative Breast Neoplasms, TNBC - Triple-Negative Breast Cancer, Triple-negative Breast Carcinoma
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Drugs/equipment unavailable and insufficient funding
Enrolment: 18 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: MedImmune LLC, National Cancer Institute (NCI), National Institutes of Health (NIH)
Study start: 23 Jul 2019 (actual)
Primary completion: 21 Nov 2022 (actual)
Study completion: 1 May 2023 (actual)
First posted: 26 Jun 2017 (actual)
Results: Posted 14 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Neoantigen DNA vaccine + Durvalumab	Experimental	Drug: Durvalumab, Biological: Neoantigen DNA vaccine, Device: TDS-IM system (Inchor Medical Systems), Procedure: Peripheral blood draw* 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.
Neoantigen DNA vaccine	Experimental	Biological: Neoantigen DNA vaccine, Device: TDS-IM system (Inchor Medical Systems), Procedure: Peripheral blood draw* 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

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (19 listed)

Histologically confirmed diagnosis of invasive breast cancer.
ER and PR less than Allred score of 3 or less than 1% positive staining cells in the invasive component of the tumor. Patients not meeting this pathology criteria, but have been clinically treated as having TNBC, may be enrolled at treating physician's discretion.
HER2 negative by FISH or IHC staining 0 or 1+.
Consented for genome sequencing
Clinical stage T1c-T4c, any N, M0 primary tumor by AJCC 7th edition clinical staging prior to neoadjuvant chemotherapy, with residual invasive breast cancer after neoadjuvant therapy.

Key exclusion criteria (39 listed)

Received chemotherapy, radiotherapy (to more than 30% of the bone marrow or with a wide field of radiation), or biologic therapy within the last 30 days.
Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
Receiving any other investigational agent(s) or has received an investigational agent within the last 30 days.
Receipt of live attenuated vaccination within 6 months prior to study entry or within 30 days of receiving durvalumab.
Major surgical procedure within 28 days prior to the first dose of durvalumab. Local surgery of isolated lesions for palliative intent is acceptable.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DurvalumabAlso: Imfinzi-Human monoclonal antibody	Drug	Neoantigen DNA vaccine + Durvalumab
Neoantigen DNA vaccine-The vaccine will be given by the TDS-IM system	Biological	Neoantigen DNA vaccine, Neoantigen DNA vaccine + Durvalumab
TDS-IM system (Inchor Medical Systems)Also: Integrated electroporation administration system-At each vaccination time point, patients will receive two injections at separate sites.	Device	Neoantigen DNA vaccine, Neoantigen DNA vaccine + Durvalumab
Peripheral blood draw-Baseline, following completion of standard of care therapy, Day 1, Day 57, Day 113, Day 159, and 1 year after initiation of neoantigen DNA vaccine therapy	Procedure or surgery	Neoantigen DNA vaccine, Neoantigen DNA vaccine + Durvalumab

Primary outcome

Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient
Time frame: 90 days after completion of treatment (approximately day 259)
* Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03. * Assessment of the safety of neoantigen DNA vaccines will include both clinical observation and laboratory evaluation. Safety will be closely monitored after injection with eight or more clinical and laboratory assessments in the first 24 weeks of the trial

4 secondary outcomes

Immune Response to Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Luminex Assay
Time frame: Up to 1 year after completion of treatment (approximately 1 year and 141 days)
Number of Participants With an Immune Response to Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Interferon-gamma ELISPOT Assay
Time frame: Up to 1 year after completion of treatment (approximately 1 year and 141 days)
Number of Participants With Immune Response to Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Multiparametric Flow Cytometry - CD4
Time frame: Up to 1 year after completion of treatment (approximately 1 year and 141 days)
Number of Participants With Immune Response to Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Multiparametric Flow Cytometry - CD8
Time frame: Up to 1 year after completion of treatment (approximately 1 year and 141 days)

Results and safety

Results posted to the registry on 14 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Neoantigen DNA Vaccine + Durvalumab	9	5
Neoantigen DNA Vaccine	9	7

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

Time frame: 90 days after completion of treatment (approximately day 259). Count of participants. Unit: Participants

Measure	Neoantigen DNA Vaccine + Durvalumab n = 9	Neoantigen DNA Vaccine n = 9
Grade 1-2 anemia	3	1
Grade 1-2 chest pain-cardiac	0	1
Grade 1-2 palpitations	1	0
Grade 1-2 hypothyroidism	1	0
Grade 1-2 visual migraine	0	1
Grade 1-2 abdominal cramps	1	0
Grade 1-2 constipation	0	1
Grade 1-2 diarrhea	0	1

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Neoantigen DNA Vaccine + Durvalumab	0 of 9 (0%)	9 of 9 (100%)	1 of 9
Neoantigen DNA Vaccine	0 of 9 (0%)	9 of 9 (100%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

William Gillanders, M.D. principal investigator

Washington University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient (time frame: 90 days after completion of treatment (approximately day 259)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03199040.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.