Unresectable Cutaneous MelanomaPhase 1/2MORALE-MMNCT07631325
Axelopran and Nivolumab in PD-1-Refractory Metastatic Melanoma
A Phase 1/2 study testing Axelopran and Nivolumab in people with Unresectable Cutaneous Melanoma, run by John Kirkwood at 1 site in United States.
Trial summary
This first-in-human study will evaluate the safety, clinical activity, and immunologic effects of combining axelopran with nivolumab in patients with PD-1-refractory unresectable or metastatic cutaneous melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Cutaneous Melanoma
- What is being tested?
- Axelopran and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2026to 31 Jul 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Histologically confirmed, unresectable or metastatic cutaneous melanoma with documented PD-1-refractory disease, defined as disease progression during or after prior anti-PD-1-based therapy, meeting criteria for either primary or secondary (acquired) resistance, as follows57:
- Primary resistance: Disease progression as best response, or stable disease lasting <6 months, following at least 6 weeks (approximately two cycles) of anti-PD-1-based therapy, with progression confirmed by RECIST v1.1.
- Secondary (acquired) resistance: Disease progression occurring after an initial objective response (complete or partial response) or durable stable disease (≥6 months) per RECIST v1.1 while receiving anti-PD-1-based therapy, or within 12 weeks of discontinuation of anti-PD-1 therapy following prior clinical benefit.
- Note: Disease must have been histologically confirmed through prior pathology assessment conducted as per SOC.
- Note: Prior anti-PD-1-based therapy may have been administered as monotherapy or in combination with other agents.
- Age ≥ 18 years.
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- Eastern Cooperative Oncology Group (ECOG) Performance Scale (PS) 0-2
- Measurable disease using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Patients must have normal organ and marrow function as defined below:
- absolute neutrophil count ≥1,000/mcL
- platelets ≥75,000/mcL
- total bilirubin ≤1.5 × the institutional upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT) ≤2.5 × institutional ULN (≤5 × the institutional ULN for patients with liver metastasis)
- Creatinine clearance ≥40 mL/min/1.73 m2 for patients with a creatinine level above institutional normal.
- Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception prior to study entry, during the course of the study, and for 5 months after the last dose of treatment (whichever is later). In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods.
- Female subjects of childbearing potential must not be pregnant or breastfeeding at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met:
- Permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman > 45 years-of-age in the absence of other biological or physiological causes). Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.
- Ability to understand and the willingness to sign a written informed consent document.
- If known to have prior brain metastases, must not have evidence of active (enlarging and/or symptomatic lesions) brain disease on MRI/CT evaluation done within 28 days of start of study treatment.
Who cannot join
- Participant is not a candidate to continue anti-PD-1 therapy due to unresolved toxicities resulting from previous treatment with anti-PD-1 therapy.
- Has an active autoimmune disease requiring systemic treatment within the past 3 months, or a syndrome that requires ongoing systemic steroids or immunosuppressive agents. Subjects with vitiligo, Graves' disease, or psoriasis not requiring systemic therapy or resolved childhood asthma/atopy would be an exception to this rule.
- Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with stable hypothyroidism or Sjogren's syndrome will not be excluded from the study.
- Physiological replacement doses of steroids are permitted.
- Participant is taking a daily dose of opioids that is >30 morphine milligram equivalents (MME) i. Daily opioid doses ≤30 MME are allowed
- Has a history of non-infectious pneumonitis that required steroids, evidence of interstitial lung disease, or currently active non-infectious pneumonitis.
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- Prior malignancy within 2 years that in the investigator's opinion would be likely to affect the outcomes of the patients with unresectable melanoma.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Known HIV or active Hepatitis B or C. Checking viral serology will not be mandated.
- Patients with major gastrointestinal surgery within 12 weeks prior to the first dose of study treatment. Patients who have a colostomy will be excluded from the trial.
- Are unable to swallow pills or have known active inflammatory gastrointestinal disease, chronic diarrhea, previous gastric resection or lap band dysphagia, short-gut syndrome, gastroparesis, or other condition that limits the ingestion or gastrointestinal absorption of drugs administered orally.
- Note: Gastroesophageal reflux disease under medical treatment is allowed (assuming no drug interaction potential).
- Subjects taking moderate to strong CYP3A inhibitors or P-gp inhibitors
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Dannielle Bednarz, RN, BSN, 412-623-1191, bednarzdl@upmc.edu
Amy Rose, RN, BSN, 412-647-8587, kennaj@UPMC.EDU
About this study
Official title: A Phase II Trial of MOR Antagonism With Axelopran and Nivolumab in PD-1-Refractory Metastatic Melanoma (MORALE-MM)
This first-in-human study will evaluate the safety, clinical activity, and immunologic effects of combining axelopran with nivolumab in patients with PD-1-refractory unresectable or metastatic cutaneous melanoma. Exploratory analyses incorporating opioid exposure history and post-hoc OPRM1 genotyping will inform future precision immuno-oncology strategies.
Read the detailed description
Immune checkpoint inhibitors have substantially improved outcomes in melanoma; however, resistance to PD-1 blockade remains a major clinical limitation. Approximately 60% of patients with metastatic melanoma fail to achieve an objective response to anti-PD-1 therapy, and many initial responders ultimately develop acquired resistance. These limitations highlight the need to identify additional, biologically grounded mechanisms of immune escape that can be therapeutically targeted. Importantly, pharmacologic inhibition of MOR with axelopran, a peripherally acting MOR antagonist restores T-cell effector function and enhances antitumor responses to PD-1 inhibition in preclinical oral squamous cell carcinoma models exposed to exogenous opioids. Notably, endogenous μ-opioid signaling in melanoma suppresses antitumor immunity via MOR, providing a rationale for evaluating peripheral MOR antagonism to enhance checkpoint inhibitor efficacy in melanoma. These findings suggest that constitutive MOR signaling may represent a distinct and targetable pathway of immune resistance that has not been addressed in current immunotherapy strategies.
To date, the role of MOR antagonism has not been evaluated clinically in melanoma, and the OPRM1-MOR axis has not been studied as a mechanism of immune escape in humans. This first-in-human study will evaluate the safety, clinical activity, and immunologic effects of combining axelopran with anti-PD-1 therapy in patients with unresectable or metastatic melanoma who have progressed on prior PD-1-based treatment. Post hoc analyses incorporating exogenous opioid exposure and OPRM1 genotype will explore biologically relevant heterogeneity in treatment response and inform future precision-based approaches. Given the strong mechanistic rationale, consistent preclinical evidence of synergy, and the lack of effective options for patients with PD-1-refractory melanoma, this study addresses a critical unmet need and may establish MOR antagonism as a novel therapeutic strategy to overcome immune resistance in melanoma.
- Conditions
- Unresectable Cutaneous Melanoma
- Being tested
- Axelopran, Nivolumab
- Keywords
- anti-PD-1, immune checkpoint inhibitors (ICIs), OPRM1-mu opioid receptor (MOR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AxelopranDrug
A peripherally restricted mu-opioid receptor antagonist (PAMORA) designed to mitigate the undesirable peripheral effects of opioids without compromising their central analgesic action.
NivolumabDrug
Also called OPDIVO Qvantig
An immune checkpoint inhibitor that helps the immune system attack cancer cells by blocking PD-1 receptors.
| Study group | Role | What they receive |
|---|---|---|
| Axelopran + Nivolumab | Experimental | Run in (1 week):
Days -6 to 0, Axelopran monotherapy with dose escalating to 15mg PO daily by day 0
Combination Phase:
Axelopran: 15 mg PO daily Nivolumab: 480 mg IV q4w (until disease progression, up to 3 years) Receives: Drug: Axelopran; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events Related to Treatment
Adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation or death, and severity of AEs as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) determined to be possibly, probably or definitely related to study treatment.
Measured: Up to 30 days post end of treatment
Best objective response rate (BORR)
The proportion of subjects with a confirmed best objective response of Complete Response (CR) or Partial Response (PR) based on RECIST v1.1. CR: Disappearance of all target lesions. Pathological lymph nodes must decrease to a short axis of < 10 mm. All non-target lesions must have disappeared, and tumor markers must have normalized. PR: At least a 30% decrease in the sum of diameters of target lesions, using baseline measurements as a reference.
Measured: Up to 3 years
Secondary outcomes (7)
Duration of response (DOR)
Time from date of first documented response Complete Response (CR) or Partial Response (PR) to date of documented Progressive Disease (PD) or death from any cause, based on RECIST v1.1. CR: Disappearance of all target lesions. Pathological lymph nodes must decrease to a short axis of < 10 mm. All non-target lesions must have disappeared, and tumor markers must have normalized. PR: At least a 30% decrease in the sum of diameters of target lesions, using baseline measurements as a reference. PD: At least 20% increase in the sum of diameters of target lesions, taking the smallest sum on study (nadir) as the reference. In addition to the 20% relative increase, the sum must also show an absolute increase of at least 5 mm. The unequivocal progression of non-target lesions or the appearance of any new lesion also classifies as PD.
Measured: Up to 3 years
Best Treatment Response in Target lesions
Best treatment response in target lesions based on RECIST v1.1. CR: Disappearance of all target lesions. Pathological lymph nodes must decrease to a short axis of < 10 mm. All non-target lesions must have disappeared, and tumor markers must have normalized. PR: At least a 30% decrease in the sum of diameters of target lesions, using baseline measurements as a reference.
Measured: Up to 3 years
Progression-free Survival (PFS)
Time from date of first dose of study treatment to date of first documented Progressive Disease (PD) based on RECIST v1.1, or death from any cause, whichever occurs first. PD: At least 20% increase in the sum of diameters of target lesions, taking the smallest sum on study (nadir) as the reference. In addition to the 20% relative increase, the sum must also show an absolute increase of at least 5 mm. The unequivocal progression of non-target lesions or the appearance of any new lesion also classifies as PD. iUPD (Unconfirmed Progressive Disease) requires a follow-up scan to confirm whether it is true tumor growth or temporary.
Measured: Up to 3 years
Overall survival (OS)
Overall survival, defined as the time from date of first dose of study treatment to date of death from any cause.
Measured: Up to 4.5 years
Immune best objective response rate (iBORR)
Proportion of subjects with a confirmed best objective response to immunotherapy of CR or PR based on iRECIST . CR: Disappearance of all target lesions. Pathological lymph nodes must decrease to a short axis of < 10 mm. All non-target lesions must have disappeared, and tumor markers must have normalized. PR: At least a 30% decrease in the sum of diameters of target lesions, using baseline measurements as a reference. CR or PR iUPD (one or more instances), but not iCPD, before iCR, iPR.
Measured: Up to 3 years
Immune duration of response (iDOR)
Time from date of first documented response (CR or PR) to date of documented PD or death from any cause, based on iRECIST. CR: Disappearance of all target lesions. Pathological lymph nodes must decrease to a short axis of < 10 mm. All non-target lesions must have disappeared, and tumor markers must have normalized. PR: At least a 30% decrease in the sum of diameters of target lesions, using baseline measurements as a reference. CR or PR iUPD (one or more instances), but not iCPD, before iCR, iPR.
Measured: Up to 3 years
Immune progression-free survival (iPFS)
Time from date of first dose of study treatment to date of first documented PD based on iRECIST, or death from any cause, whichever occurs first. PD: At least 20% increase in the sum of diameters of target lesions, taking the smallest sum on study (nadir) as the reference. In addition to the 20% relative increase, the sum must also show an absolute increase of at least 5 mm. The unequivocal progression of non-target lesions or the appearance of any new lesion also classifies as PD. iUPD (Unconfirmed Progressive Disease) requires a follow-up scan to confirm whether it is true tumor growth or temporary.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start30 Nov 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Cutaneous MelanomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John Kirkwood
- Sponsor type
- University, hospital or other
- Collaborators
- Glycyx MOR Inc.
- Responsible party
- Sponsor-investigator, John Kirkwood, University of Pittsburgh
- Investigators
- John M Kirkwood, MD, Principal investigator, UPMC Hillman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631325
- Sponsor's protocol ID
- HCC 26-041
- Acronym
- MORALE-MM
- Status last verified
- Oct 2026
- First submitted
- 29 May 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- 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 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of MOR Antagonism With Axelopran and Nivolumab in PD-1-Refractory Metastatic Melanoma (MORALE-MM)
- ClinicalTrials.gov ID
- NCT07631325
- Acronym / sponsor ID
- MORALE-MM / HCC 26-041
- Conditions
- Unresectable Cutaneous Melanoma
- Keywords
- anti-PD-1, immune checkpoint inhibitors (ICIs), OPRM1-mu opioid receptor (MOR)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- John KirkwoodUniversity, hospital or other
- Collaborators
- Glycyx MOR Inc.
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This first-in-human study will evaluate the safety, clinical activity, and immunologic effects of combining axelopran with nivolumab in patients with PD-1-refractory unresectable or metastatic cutaneous melanoma. Exploratory analyses incorporating opioid exposure history and post-hoc OPRM1 genotyping will inform future precision immuno-oncology strategies.
Detailed description
Immune checkpoint inhibitors have substantially improved outcomes in melanoma; however, resistance to PD-1 blockade remains a major clinical limitation. Approximately 60% of patients with metastatic melanoma fail to achieve an objective response to anti-PD-1 therapy, and many initial responders ultimately develop acquired resistance. These limitations highlight the need to identify additional, biologically grounded mechanisms of immune escape that can be therapeutically targeted. Importantly, pharmacologic inhibition of MOR with axelopran, a peripherally acting MOR antagonist restores T-cell effector function and enhances antitumor responses to PD-1 inhibition in preclinical oral squamous cell carcinoma models exposed to exogenous opioids. Notably, endogenous μ-opioid signaling in melanoma suppresses antitumor immunity via MOR, providing a rationale for evaluating peripheral MOR antagonism to enhance checkpoint inhibitor efficacy in melanoma. These findings suggest that constitutive MOR signaling may represent a distinct and targetable pathway of immune resistance that has not been addressed in current immunotherapy strategies.
To date, the role of MOR antagonism has not been evaluated clinically in melanoma, and the OPRM1-MOR axis has not been studied as a mechanism of immune escape in humans. This first-in-human study will evaluate the safety, clinical activity, and immunologic effects of combining axelopran with anti-PD-1 therapy in patients with unresectable or metastatic melanoma who have progressed on prior PD-1-based treatment. Post hoc analyses incorporating exogenous opioid exposure and OPRM1 genotype will explore biologically relevant heterogeneity in treatment response and inform future precision-based approaches. Given the strong mechanistic rationale, consistent preclinical evidence of synergy, and the lack of effective options for patients with PD-1-refractory melanoma, this study addresses a critical unmet need and may establish MOR antagonism as a novel therapeutic strategy to overcome immune resistance in melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Axelopran + Nivolumab | Experimental | Drug: Axelopran, Drug: NivolumabRun in (1 week): Days -6 to 0, Axelopran monotherapy with dose escalating to 15mg PO daily by day 0 Combination Phase: Axelopran: 15 mg PO daily Nivolumab: 480 mg IV q4w (until disease progression, up to 3 years) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Histologically confirmed, unresectable or metastatic cutaneous melanoma with documented PD-1-refractory disease, defined as disease progression during or after prior anti-PD-1-based therapy, meeting criteria for either primary or secondary (acquired) resistance, as follows57:
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Scale (PS) 0-2
- Measurable disease using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Patients must have normal organ and marrow function as defined below:
Key exclusion criteria (13 listed)
- Participant is not a candidate to continue anti-PD-1 therapy due to unresolved toxicities resulting from previous treatment with anti-PD-1 therapy.
- Has an active autoimmune disease requiring systemic treatment within the past 3 months, or a syndrome that requires ongoing systemic steroids or immunosuppressive agents. Subjects with vitiligo, Graves' disease, or psoriasis not requiring systemic therapy or resolved childhood asthma/atopy would be an exception to this rule.
- Participant is taking a daily dose of opioids that is >30 morphine milligram equivalents (MME) i. Daily opioid doses ≤30 MME are allowed
- Has a history of non-infectious pneumonitis that required steroids, evidence of interstitial lung disease, or currently active non-infectious pneumonitis.
- Prior malignancy within 2 years that in the investigator's opinion would be likely to affect the outcomes of the patients with unresectable melanoma.
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 |
|---|---|---|
| AxelopranA peripherally restricted mu-opioid receptor antagonist (PAMORA) designed to mitigate the undesirable peripheral effects of opioids without compromising their central analgesic action. | Drug | Axelopran + Nivolumab |
| NivolumabAlso: OPDIVO QvantigAn immune checkpoint inhibitor that helps the immune system attack cancer cells by blocking PD-1 receptors. | Drug | Axelopran + Nivolumab |
Primary outcome
Adverse Events Related to Treatment
Time frame: Up to 30 days post end of treatment
Adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation or death, and severity of AEs as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) determined to be possibly, probably or definitely related to study treatment.
Best objective response rate (BORR)
Time frame: Up to 3 years
The proportion of subjects with a confirmed best objective response of Complete Response (CR) or Partial Response (PR) based on RECIST v1.1. CR: Disappearance of all target lesions. Pathological lymph nodes must decrease to a short axis of < 10 mm. All non-target lesions must have disappeared, and tumor markers must have normalized. PR: At least a 30% decrease in the sum of diameters of target lesions, using baseline measurements as a reference.
7 secondary outcomes
Duration of response (DOR)
Time frame: Up to 3 years
Best Treatment Response in Target lesions
Time frame: Up to 3 years
Progression-free Survival (PFS)
Time frame: Up to 3 years
Overall survival (OS)
Time frame: Up to 4.5 years
Immune best objective response rate (iBORR)
Time frame: Up to 3 years
Immune duration of response (iDOR)
Time frame: Up to 3 years
Immune progression-free survival (iPFS)
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- 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.
John M Kirkwood, MD principal investigator
UPMC Hillman Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Axelopran and Nivolumab in people with Unresectable Cutaneous Melanoma, run by John Kirkwood at 1 site in United States.
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 13 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: looking for participants now, as of the sponsor's last update on 19 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danielle Bednarz, RN, BSN (412-623-1191, bednarzdl@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events Related to Treatment (time frame: Up to 30 days post end of treatment). 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?
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 19 Oct 2026.