Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)Phase 1/2NCT03767582

Trial of Neoadjuvant and Adjuvant Nivolumab and BMS-813160 With or Without GVAX for Locally Advanced Pancreatic Ductal Adenocarcinomas.

A Phase 1/2 study testing Stereotactic Body Radiation (SBRT), Nivolumab and CCR2/CCR5 dual antagonist in people with Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) and Pancreatic Ductal Adenocarcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate if the combination of nivolumab and a CCR2/CCR5 dual antagonist (BMS-813160) with GVAX is safe in patients with locally advanced pancreatic cancer (LAPC) who have received chemotherapy and radiotherapy, and to see if this combination therapy enhances the infiltration of… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC), Pancreatic Ductal Adenocarcinoma
What is being tested?: Stereotactic Body Radiation (SBRT), Nivolumab and CCR2/CCR5 dual antagonist
Type of treatment: Vaccines, Pill or oral medicine, Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteUnited States
Study dates: 12 Dec 2019to 1 Feb 2025
Phase: Phase 1/2
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
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥18 years.
Patients with histologically- or cytologically-proven, surgically unresectable, locally advanced pancreatic adenocarcinoma.
If the patient does not have a diagnostic biopsy that is adequate for review at our institution, the patient must agree to a research core biopsy to be performed at Johns Hopkins.
If the patient's available imaging is not adequate for review by our institution, the patient must agree to a repeat imaging to be performed at Johns Hopkins.
ECOG performance status 0 or 1
Life expectancy greater than 3 months.

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Able to swallow pills or capsules.
Patient must have adequate organ function defined by the study-specified laboratory tests.
Patients must be eligible to receive FOLFIRINOX-based chemotherapy.
Patients must be willing to be treated with stereotactic body radiation therapy (SBRT) only at Johns Hopkins Hospital.
Patients must be willing to undergo a core biopsy of the pancreatic cancer.
Patients must be willing to undergo a biopsy of the pancreatic cancer if the patient is not deemed a surgical candidate during the pre-surgical evaluation.
Must use acceptable form of birth control while on study.
Ability to understand and willingness to sign a written informed consent document.

Who cannot join

Patients cannot have had any prior therapy for the locally advanced pancreatic adenocarcinoma.
Have received any anti-neoplastic biologics, vaccines or hormonal treatment, including investigational drugs, within 28 days of the first dose of study.
History of past treatment with immunotherapy agents prior to initial enrollment into this study (including, but not limited to: IL-2, interferon, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40, anti-CTLA-4 or anti-CCR2/5 drugs).
Have had prior organ or tissue allograft or allogeneic bone marrow transplantation, including corneal transplants.
Is currently participating or has participated in a study of an investigational agent or using an investigational device for the treatment of cancer.
Current use of immunosuppressive medications within 14 days prior to study medications.

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Have received any vaccine within 14 days prior to study medications.
Receiving growth factors including, but not limited to, granulocyte-colony stimulating factor (G-CSF), GM-CSF, erythropoietin, within 14 days of the first dose of study medication.
History of any autoimmune disease. Patients with thyroid disease will be allowed.
Has a history of (non-infectious) pneumonitis or current pneumonitis.
Has a pulse oximetry < 92% on room air.
Requires the use of home oxygen.
Patients with uncontrolled intercurrent illness including, but not limited to, myocardial infarction or stroke/transient ischemic attack within the past 6 months, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
12-lead electrocardiogram with QRS ≥ 120 msec, except right bundle branch block ; QTcF (QT corrected for heart rate using Fridericia's method) ≥ 480 msec, except right bundle branch block
Has an active infection requiring systemic therapy.
Infection with HIV or hepatitis B or C.
Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, early stage prostate cancer, or carcinoma in situ of the cervix.
Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could impact the absorption of study treatment.
Any gastrointestinal surgery that is likely impact upon the absorption of study treatment.
Inability to tolerate oral medication.
Unable to have blood drawn.
Have had surgery within 28 days of the first dose of study medication.
Prior use of strong/moderate CYP3A4 inhibitors or inducers within 28 days of the first dose of BMS-813160.
Prior use of Class I antiarrhythmics within 28 days of first dose of study medication.
Has ascites requiring medical management.
Presence of duodenal or gastric invasion by the tumor.
Hypersensitivity reaction to any monoclonal antibody.
Known allergy or hypersensitivity to study drugs or any of their components of the study arm that participant is enrolling.
Woman who are pregnant or breastfeeding.
Patient is unwilling or unable to follow the study schedule for any reason.

Trial locations and contacts

1 site in 1 country.

United States1 site

Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231

Other trials in United States

About this study

Official title: A Phase I/II Trial of Combination Immunotherapy With Nivolumab and a CCR2/CCR5 Dual Antagonist (BMS-813160) With or Without GVAX Following Chemotherapy and Radiotherapy for Locally Advanced Pancreatic Ductal Adenocarcinomas (PDACs).

Conditions: Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC), Pancreatic Ductal Adenocarcinoma
Being tested: Stereotactic Body Radiation (SBRT), Nivolumab, CCR2/CCR5 dual antagonist, GVAX
Keywords: GVAX, Nivolumab, CCR2/CCR5 dual antagonist, Anti-PD-1, Cancer vaccine, Monoclonal antibody, Checkpoint inhibitor, Myeloid modulating agent, Immunotherapy, Neoadjuvant chemotherapy, Stereotactic body radiation therapy, SBRT, Pancreatic cancer, Pancreatic Ductal Adenocarcinoma, PDAC, Locally advanced pancreatic ductal adenocarcinoma, LAPC
Medical subject headings: Pancreatic Neoplasms

What participants receive

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

Stereotactic Body Radiation (SBRT)Radiation
SBRT (6.6 Gy over 5 days) will be administered between 2 to 4 weeks after chemotherapy. (Prior to surgery)
NivolumabDrug
Also called OPDIVO
Nivolumab (480 mg) will be administered IV over 30 minutes, on day 1 of cycle 1 (within 1 to 2 weeks after SBRT prior to surgery). Post - surgery Nivolumab will be given on Day 1 of cycles 2-5. Cycles are 4 weeks long.
CCR2/CCR5 dual antagonistDrug
Also called BMS-813160
CCR2/CCR5 dual antagonist (150 mg capsules) will be administered orally twice a day, on days 1-28 of cycle 1 (within 1 to 2 weeks after SBRT prior to surgery). Post - surgery CCR2/CCR5 dual antagonist will be given daily on cycles 2-5. Cycles are 4 weeks long.
GVAXDrug
Also called PANC 10.05 pcDNA-1/GM-Neo vaccine, PANC 6.03 pcDNA-1/GM-Neo vaccine
Vaccine (5x10^8 cells) will be administered on day 2 of cycle 1 (within 1 to 2 weeks after SBRT prior to surgery). Post - surgery GVAX will be given on Day 2 of cycles 2-5. Cycles are 4 weeks long. Six intradermal injections every 4 weeks.

Study groups in NCT03767582
Study group	Role	What they receive
Phase I - GVAX/Nivolumab/CCR2/CCR5 dual antagonist	Experimental	Not described Receives: Radiation: Stereotactic Body Radiation (SBRT); Drug: Nivolumab; Drug: CCR2/CCR5 dual antagonist; Drug: GVAX
Phase II - Arm A: Nivolumab/CCR2/CCR5 dual antagonist	Experimental	Not described Receives: Radiation: Stereotactic Body Radiation (SBRT); Drug: Nivolumab; Drug: CCR2/CCR5 dual antagonist
Phase II - Arm B: Nivolumab/GVAX/CCR2/CCR5 dual antagonist	Experimental	Not described Receives: Radiation: Stereotactic Body Radiation (SBRT); Drug: Nivolumab; Drug: CCR2/CCR5 dual antagonist; Drug: GVAX

What is being measured

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

Study Drug-related Adverse Events
Number of participants who experienced study drug-related toxicities as defined by CTCAE v5.0
Measured: Up to 18 months
Tumor Immune Response (CD8+ CD137+ Tumor Infiltration)
Number of participants who had >80% increase of infiltration of CD8+CD137+ T cells into their tumors after treatment with SBRT and immunotherapy. Baseline biopsies were collected at time of fiducial placement for SBRT (after completion of chemotherapy) and post-treatment tumor was collected at time of surgical resection
Measured: 7 months

Secondary outcomes (5)

Overall Survival (OS)
Number of months from start of immunotherapy until death from any cause
Measured: 3 years
Metastasis Free Survival (MFS)
Number of months from the start of immunotherapy until first documented distant metastases on radiographic imaging or death from any cause, whichever occurs first.
Measured: 3 years
Local Progression Free Survival (LPFS)
Number of months from the start of immunotherapy until first documented local progression on radiographic imaging or death from any cause, whichever occurs first. Local progression is defined as appearance of new lesions in the pancreas or surgical resection bed (for surgically resected patients) or clinically meaningful tumor growth in the primary pancreas tumor (for patients that were not surgically resectable).
Measured: 3 years
Surgical Resectability Rate
Number of participants who are able to undergo successful tumor resection (as defined by R0 and R1 resection).
Measured: 7 months
Pathological Response Rate
Number of participants who with a moderate, marked, or complete pathologic response after chemotherapy, SBRT, and one cycle of immunotherapy as determined by surgical margins and residual disease.
Tumor response grading Complete response (grade 0): no viable residual cancer cells Marked response (grade 1): single cells or rare small groups of cancer cells Moderate response (grade 2): residual cancer outgrown by fibrosis Poor or no response (grade 3): extensive residual cancer
Measured: 7 months

Timeline

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

12 Dec 20191 Feb 2025

First posted6 Dec 2018
Study start12 Dec 2019
Primary completion1 Feb 2025
Study completion1 Feb 2025

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 Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)Studies of the same condition, open and under way.
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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03767582
Sponsor's protocol ID: J18163
Other IDs: IRB00190660
Status last verified: Apr 2026
First submitted: 5 Dec 2018
Last updated: 11 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II Trial of Combination Immunotherapy With Nivolumab and a CCR2/CCR5 Dual Antagonist (BMS-813160) With or Without GVAX Following Chemotherapy and Radiotherapy for Locally Advanced Pancreatic Ductal Adenocarcinomas (PDACs).
ClinicalTrials.gov ID: NCT03767582
Acronym / sponsor ID: J18163
Conditions: Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC), Pancreatic Ductal Adenocarcinoma
Keywords: GVAX, Nivolumab, CCR2/CCR5 dual antagonist, Anti-PD-1, Cancer vaccine, Monoclonal antibody, Checkpoint inhibitor, Myeloid modulating agent
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
Collaborators: Bristol-Myers Squibb
Study start: 12 Dec 2019 (actual)
Primary completion: 1 Feb 2025 (actual)
Study completion: 1 Feb 2025 (actual)
First posted: 6 Dec 2018 (actual)
Results: Posted 11 May 2026

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: Sequential
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Phase I - GVAX/Nivolumab/CCR2/CCR5 dual antagonist	Experimental	Radiation: Stereotactic Body Radiation (SBRT), Drug: Nivolumab, Drug: CCR2/CCR5 dual antagonist, Drug: GVAX
Phase II - Arm A: Nivolumab/CCR2/CCR5 dual antagonist	Experimental	Radiation: Stereotactic Body Radiation (SBRT), Drug: Nivolumab, Drug: CCR2/CCR5 dual antagonist
Phase II - Arm B: Nivolumab/GVAX/CCR2/CCR5 dual antagonist	Experimental	Radiation: Stereotactic Body Radiation (SBRT), Drug: Nivolumab, Drug: CCR2/CCR5 dual antagonist, Drug: GVAX

Who may qualify

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

Key inclusion criteria (14 listed)

Age ≥18 years.
Patients with histologically- or cytologically-proven, surgically unresectable, locally advanced pancreatic adenocarcinoma.
If the patient does not have a diagnostic biopsy that is adequate for review at our institution, the patient must agree to a research core biopsy to be performed at Johns Hopkins.
If the patient's available imaging is not adequate for review by our institution, the patient must agree to a repeat imaging to be performed at Johns Hopkins.
ECOG performance status 0 or 1

Key exclusion criteria (30 listed)

Patients cannot have had any prior therapy for the locally advanced pancreatic adenocarcinoma.
Have received any anti-neoplastic biologics, vaccines or hormonal treatment, including investigational drugs, within 28 days of the first dose of study.
History of past treatment with immunotherapy agents prior to initial enrollment into this study (including, but not limited to: IL-2, interferon, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40, anti-CTLA-4 or anti-CCR2/5 drugs).
Have had prior organ or tissue allograft or allogeneic bone marrow transplantation, including corneal transplants.
Is currently participating or has participated in a study of an investigational agent or using an investigational device for the treatment of cancer.

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
Stereotactic Body Radiation (SBRT)SBRT (6.6 Gy over 5 days) will be administered between 2 to 4 weeks after chemotherapy. (Prior to surgery)	Radiation	Phase I - GVAX/Nivolumab/CCR2/CCR5 dual antagonist, Phase II - Arm A: Nivolumab/CCR2/CCR5 dual antagonist, Phase II - Arm B: Nivolumab/GVAX/CCR2/CCR5 dual antagonist
NivolumabAlso: OPDIVONivolumab (480 mg) will be administered IV over 30 minutes, on day 1 of cycle 1 (within 1 to 2 weeks after SBRT prior to surgery). Post - surgery Nivolumab will be given on Day 1 of cycles 2-5. Cycles are 4 weeks long.	Drug	Phase I - GVAX/Nivolumab/CCR2/CCR5 dual antagonist, Phase II - Arm A: Nivolumab/CCR2/CCR5 dual antagonist, Phase II - Arm B: Nivolumab/GVAX/CCR2/CCR5 dual antagonist
CCR2/CCR5 dual antagonistAlso: BMS-813160CCR2/CCR5 dual antagonist (150 mg capsules) will be administered orally twice a day, on days 1-28 of cycle 1 (within 1 to 2 weeks after SBRT prior to surgery). Post - surgery CCR2/CCR5 dual antagonist will be given daily on cycles 2-5. Cycles are 4 weeks long.	Drug	Phase I - GVAX/Nivolumab/CCR2/CCR5 dual antagonist, Phase II - Arm A: Nivolumab/CCR2/CCR5 dual antagonist, Phase II - Arm B: Nivolumab/GVAX/CCR2/CCR5 dual antagonist
GVAXAlso: PANC 10.05 pcDNA-1/GM-Neo vaccine, PANC 6.03 pcDNA-1/GM-Neo vaccineVaccine (5x10^8 cells) will be administered on day 2 of cycle 1 (within 1 to 2 weeks after SBRT prior to surgery). Post - surgery GVAX will be given on Day 2 of cycles 2-5. Cycles are 4 weeks long. Six intradermal injections every 4 weeks.	Drug	Phase I - GVAX/Nivolumab/CCR2/CCR5 dual antagonist, Phase II - Arm B: Nivolumab/GVAX/CCR2/CCR5 dual antagonist

Primary outcome

Study Drug-related Adverse Events
Time frame: Up to 18 months
Number of participants who experienced study drug-related toxicities as defined by CTCAE v5.0
Tumor Immune Response (CD8+ CD137+ Tumor Infiltration)
Time frame: 7 months
Number of participants who had >80% increase of infiltration of CD8+CD137+ T cells into their tumors after treatment with SBRT and immunotherapy. Baseline biopsies were collected at time of fiducial placement for SBRT (after completion of chemotherapy) and post-treatment tumor was collected at time of surgical resection

5 secondary outcomes

Overall Survival (OS)
Time frame: 3 years
Metastasis Free Survival (MFS)
Time frame: 3 years
Local Progression Free Survival (LPFS)
Time frame: 3 years
Surgical Resectability Rate
Time frame: 7 months
Pathological Response Rate
Time frame: 7 months

Results and safety

Results posted to the registry on 11 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase I - Dose Level 1	3	3
Phase I - Dose Level 2	6	5
Phase II - Arm A: Nivolumab + BMS-813160	5	3
Phase II - Arm B: Nivolumab + GVAX + BMS-813160	5	3
Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5)	3	0

Primary outcome: Study Drug-related Adverse Events

Time frame: Up to 18 months. Count of participants. Unit: Participants

Measure	Phase I - Dose Level 1 n = 3	Phase I - Dose Level 2 n = 6	Phase II - Arm A: Nivolumab + BMS-813160 n = 5	Phase II - Arm B: Nivolumab + GVAX + BMS-813160 n = 5	Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5) n = 3
Any Study Drug-Related AE	3	6	3	5	2
Hyperthyroidism	0	0	1	0	0
Diarrhea	0	0	1	3	0
Dry mouth	0	0	0	1	0
Nausea	0	1	0	2	1
Stomach pain	0	0	0	0	1
Vomiting	0	0	0	1	0
Chills	0	1	0	1	1

Primary outcome: Tumor Immune Response (CD8+ CD137+ Tumor Infiltration)

Time frame: 7 months. Count of participants. Unit: Participants

Measure	Phase I - Dose Level 1 n = 3	Phase I - Dose Level 2 n = 5	Phase II - Arm A: Nivolumab + BMS-813160 n = 3	Phase II - Arm B: Nivolumab + GVAX + BMS-813160 n = 3	Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5) n = 0
Value	2	5	3	3	–

Population analysed: Only patients who completed surgical resection or had a biopsy done at time of aborted surgery and had with matched pre- and post-treatment tumor samples were evaluable for the tumor immune response endpoint.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase I - Dose Level 1	1 of 3 (33.3%)	3 of 3 (100%)	2 of 3
Phase I - Dose Level 2	2 of 6 (33.3%)	6 of 6 (100%)	5 of 6
Phase II - Arm A: Nivolumab + BMS-813160	0 of 5 (0%)	5 of 5 (100%)	4 of 5
Phase II - Arm B: Nivolumab + GVAX + BMS-813160	2 of 5 (40%)	5 of 5 (100%)	5 of 5
Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5)	2 of 3 (66.7%)	3 of 3 (100%)	2 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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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.

Amol Narang, MD principal investigator

Johns Hopkins Medical Institution

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 14 inclusion and 30 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: finished, as of the sponsor's last update on 11 May 2026. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 11 May 2026). 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?

Study Drug-related Adverse Events (time frame: Up to 18 months). The study lists 2 primary outcomes in all. 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 NCT03767582.

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 11 May 2026.