Unresectable or Metastatic MelanomaPhase 1NCT01810016
NY-ESO-1 Vaccine in Combination With Ipilimumab in Patients With Unresectable or Metastatic Melanoma
A Phase 1 study testing Ipilimumab, NY-ESO-1 Protein Vaccine and NY-ESO-1 OLP4 Vaccine with Poly-ICLC and Montanide in people with Unresectable or Metastatic Melanoma, run by Ludwig Institute for Cancer Research at 5 sites in 2 countries.
Trial summary
This was a Phase 1, open-label, non-randomized study of the combination of NY-ESO-1 plus ipilimumab in patients with unresectable or metastatic melanoma for whom treatment with ipilimumab was indicated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable or Metastatic Melanoma
- What is being tested?
- Ipilimumab, NY-ESO-1 Protein Vaccine and NY-ESO-1 OLP4 Vaccine with Poly-ICLC and Montanide
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 24 Jan 2014to 17 May 2016
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with unresectable or metastatic melanoma, for whom treatment with ipilimumab was indicated as per ipilimumab/Yervoy® package insert (applicable for United States [US] sites) or product information (applicable for Australia site).
- Radiologically measurable disease by irRC.
- Tumor expression of NY-ESO-1 or LAGE-1 antigen by immunohistochemistry or reverse transcriptase-polymerase chain reaction (RT-PCR), or evidence of seropositivity to NY-ESO-1 or LAGE-1.
- Willingness to provide at least one pre-and post-vaccination tumor biopsy sample.
- Expected survival of at least 4 months.
- At the time of Day 1 of the study, patients must have been at least 3 weeks since surgery.
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- At the time of Day 1 of the study, patients with brain metastases must have been asymptomatic and:
- at least 8 weeks without tumor progression after any whole brain radiotherapy;
- at least 4 weeks since craniotomy and resection or stereotactic radiosurgery;
- at least 3 weeks without new brain metastases as evidenced by magnetic resonance imaging (MRI).
- Eastern Cooperative Oncology Group performance status of 0 to 2.
- Laboratory parameters for vital functions must have been in the normal range. Laboratory abnormalities that were not clinically significant were generally permitted, except for the following laboratory parameters, which must have been within the ranges specified:
- hemoglobin: ≥ 10 g/dL;
- neutrophil count: ≥ 1.5 x 10^9/L;
- lymphocyte count: ≥ lower limit of normal (LLN);
- platelet count: ≥ 80 x 10^9/L;
- serum creatinine: ≤ 2 mg/dL;
- serum bilirubin: ≤ 2 x upper limit of normal (ULN);
- aspartate aminotransferase (AST)/alanine aminotransferase (ALT): ≤ 2 x ULN.
- Had been informed of other treatment options.
- Age ≥ 18 years.
- Able and willing to give valid written informed consent.
Who cannot join
- Any contraindications for ipilimumab/Yervoy® as per package insert (applicable for US sites) or product information (applicable for Australia site).
- Prior exposure to NY-ESO-1 vaccine.
- Active autoimmune disease, symptoms or conditions except for vitiligo, type I diabetes, treated thyroiditis, asymptomatic laboratory evidence of autoimmune disease (e.g., +antinuclear antibody [ANA], +rheumatoid factor [RF], antithyroglobulin antibodies), or mild arthritis requiring no therapy or manageable with nonsteroidal anti-inflammatory drugs (NSAIDs).
- Unresolved immune-related adverse events following prior biological therapy.
- Systemic treatment with high-dose corticosteroids (greater than prednisone 10 mg daily or equivalent).
- Treatment with protocol-specified non-permitted concomitant therapies.
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- Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may have been available.
- Myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, chest pain or shortness of breath with activity, or other heart conditions being treated by a doctor.
- Other malignancy within 3 years prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ.
- Known immunodeficiency or human immunodeficiency virus positivity, active Hepatitis B or active Hepatitis C.
- History of severe allergic reactions to vaccines or unknown allergens.
- Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders).
- Participation in any other clinical trial involving another investigational agent within 4 weeks prior to Day 1 of the study.
- Mental impairment that may have compromised the ability to give informed consent and comply with the requirements of the study.
- Lack of availability for immunological and clinical follow-up assessments.
- Women who were breast feeding or pregnant as evidenced by positive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) done within 14 days prior to first dosing and urine test within 72 hours prior to first dosing.
- Women of childbearing potential not using a medically acceptable means of contraception for the duration of the study.
- Any condition that, in the clinical judgment of the treating physician, was likely to prevent the patient from complying with any aspect of the protocol or that may have put the patient at unacceptable risk.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
Mount Sinai Medical Center
New York, New York, 10029
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
University of Pittsburgh Cancer Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Phase I Study of NY-ESO-1 Vaccine in Combination With Ipilimumab in Patients With Unresectable or Metastatic Melanoma, for Whom Treatment With Ipilimumab is Indicated
This was a Phase 1, open-label, non-randomized study of the combination of NY-ESO-1 plus ipilimumab in patients with unresectable or metastatic melanoma for whom treatment with ipilimumab was indicated. Patients must have had evidence of NY-ESO-1 or LAGE-1 tumor positivity and radiologically measurable disease by the immune-related Response Criteria (irRC). Primary study objectives were to determine the safety and tolerability of the combination and to evaluate humoral and cellular immune response. Secondary objectives were to evaluate tumor response and immunological changes in the tumor microenvironment.
Read the detailed description
Patients were enrolled sequentially, alternating among 3 treatment arms. Study treatment comprised ipilimumab 3 mg/kg administered intravenously (IV) over 90 minutes every 3 weeks for 4 doses followed by the NY-ESO-1 vaccine administered subcutaneously (SC). Arm A received the NY-ESO-1 recombinant protein mixed with polyinosinic-polycytidylic acid-poly-L-lysine carboxymethylcellulose (Poly-ICLC) and Montanide; Arm B received NY-ESO-1 overlapping long peptides 4 (OLP4) mixed with Poly-ICLC and Montanide; and Arm C received NY-ESO-1 OLP4 mixed with Poly-ICLC (without Montanide). The vaccine was administered immediately following the ipilimumab infusion, and patients were observed for 1 hour following administration. No dose adjustments or delays were permitted.
Because the study treatment regimens had not been previously investigated in humans, the first patient in each treatment arm was followed for 28 days and evaluated for any regimen-limiting toxicity (RLT), defined as any dose-limiting toxicity (DLT) that could not be attributed solely to either the vaccine or ipilimumab and was therefore considered to be related to the combination. If an RLT was observed in the first patient, the second patient was to be evaluated for 28 days before the third patient was enrolled. If at any point ≥ 2 RLTs were observed in a treatment arm, accrual to that arm was to be terminated and the combination in that arm was to be declared unsafe.
Patients were monitored for safety, immune and tumor response, and immunological changes in the tumor microenvironment for the duration of study participation, which may have been up to 6 months.
- Conditions
- Unresectable or Metastatic Melanoma
- Being tested
- Ipilimumab, NY-ESO-1 Protein Vaccine, NY-ESO-1 OLP4 Vaccine with Poly-ICLC and Montanide, NY-ESO-1 OLP4 Vaccine with Poly-ICLC
- Keywords
- NY-ESO-1, Metastatic Melanoma, Ipilimumab, Phase I, Adjuvant, Immunologic, Vaccination, Immunotherapy, Neoplasm
- Medical subject headings
- Melanoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpilimumabBiological
Also called Yervoy
Ipilimumab was administered IV over 90 minutes at a dose of 3 mg/kg directly preceding the NY-ESO-1 injection every 3 weeks for 4 doses.
NY-ESO-1 Protein VaccineBiological
NY-ESO-1 recombinant protein (250 µg) was mixed with Poly-ICLC (1 mg) and Montanide ISA-51 VG (1 mL) and administered SC directly following the ipilimumab infusion every 3 weeks for 4 doses.
NY-ESO-1 OLP4 Vaccine with Poly-ICLC and MontanideBiological
NY-ESO-1 OLP4 (1 mg) was mixed in 5% dextrose solution in water with Poly-ICLC (1 mg) and Montanide ISA-51 VG (1 mL) and administered SC directly following the ipilimumab infusion every 3 weeks for 4 doses.
NY-ESO-1 OLP4 Vaccine with Poly-ICLCBiological
NY-ESO-1 OLP4 (1 mg) was mixed in 5% dextrose solution in water with Poly-ICLC (1 mg) and administered SC directly following the ipilimumab infusion every 3 weeks for 4 doses.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Ipilimumab (IV) followed by NY-ESO-1 recombinant protein mixed with Poly-ICLC and Montanide (SC) every 3 weeks for 4 doses. Receives: Biological: Ipilimumab; Biological: NY-ESO-1 Protein Vaccine |
| Arm B | Experimental | Ipilimumab (IV) followed by NY-ESO-1 OLP4 mixed with Poly-ICLC and Montanide (SC) every 3 weeks for 4 doses. Receives: Biological: Ipilimumab; Biological: NY-ESO-1 OLP4 Vaccine with Poly-ICLC and Montanide |
| Arm C | Experimental | Ipilimumab (IV) followed by NY-ESO-1 OLP4 mixed with Poly-ICLC (SC) every 3 weeks for 4 doses. Receives: Biological: Ipilimumab; Biological: NY-ESO-1 OLP4 Vaccine with Poly-ICLC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Treatment-emergent Adverse Events
Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through the study period. Dose-limiting toxicity (DLT) was defined as any ≥ Grade 3 hematologic or non-hematologic toxicity that was definitely, probably, or possibly related to the administration of the NY-ESO-1 vaccine or as any toxicity that was definitely, probably, or possibly related to ipilimumab and required permanent discontinuation of ipilimumab in accordance with local prescribing information. DLT assessments were based on the combination of all vaccine components, not on the components individually.
Measured: Continuously for up to 6 months
Secondary outcomes (1)
Number of Patients With Immune-related Tumor Response at the Last Assessment
Immune-related tumor response was evaluated using the imaging techniques considered appropriate by the Investigators at Baseline, Week 13, and at the end of the study (Week 20 ± 1 week). Tumor response was designated according to the immune-related Response Criteria (irRC) (Wolchok et al. Clin Cancer Res 2009;15:7412-20) into the following categories: immune-related complete response (irCR) requires disappearance of all lesions in two consecutive observations not less than 4 weeks apart; immune-related partial response (irPR) requires ≥ 50% decrease in tumor burden compared with baseline in two observations at least 4 weeks apart; immune-related stable disease (irSD) is assigned when neither a 50% decrease from baseline tumor burden nor a 25% increase in tumor burden from nadir can be established; immune-related progressive disease (irPD) requires a ≥ 25% increase from nadir in tumor burden at any single time point in two consecutive observations at least 4 weeks apart.
Measured: Up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study start24 Jan 2014
- Primary completion17 May 2016
- Study completion17 May 2016
Why it stopped: Low recruitment due to change in standard of care
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 Unresectable or Metastatic 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig Institute for Cancer Research
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research Institute, NY, USA
- Responsible party
- Sponsor
- Investigators
- Michael A Postow, MD, Study chair, Memorial Sloan Kettering Cancer CenterHassane M Zarour, MD, Principal investigator, University of PittsburghCraig L Slingluff, MD, Principal investigator, University of VirginiaJonathan Cebon, MBBS, FRACP, PhD, Principal investigator, Austin Health, Ludwig Oncology UnitPhilip Friedlander, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810016
- Sponsor's protocol ID
- LUD2012-004
- Status last verified
- Oct 2022
- First submitted
- 8 Mar 2013
- Last updated
- 12 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of NY-ESO-1 Vaccine in Combination With Ipilimumab in Patients With Unresectable or Metastatic Melanoma, for Whom Treatment With Ipilimumab is Indicated
- ClinicalTrials.gov ID
- NCT01810016
- Acronym / sponsor ID
- LUD2012-004
- Conditions
- Unresectable or Metastatic Melanoma
- Keywords
- NY-ESO-1, Metastatic Melanoma, Ipilimumab, Phase I, Adjuvant, Immunologic, Vaccination, Immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment due to change in standard of care
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Ludwig Institute for Cancer ResearchUniversity, hospital or other
- Collaborators
- Cancer Research Institute, NY, USA
- Study start
- 24 Jan 2014 (actual)
- Primary completion
- 17 May 2016 (actual)
- Study completion
- 17 May 2016 (actual)
- First posted
- 13 Mar 2013 (estimated)
- Results
- Posted 30 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a Phase 1, open-label, non-randomized study of the combination of NY-ESO-1 plus ipilimumab in patients with unresectable or metastatic melanoma for whom treatment with ipilimumab was indicated. Patients must have had evidence of NY-ESO-1 or LAGE-1 tumor positivity and radiologically measurable disease by the immune-related Response Criteria (irRC). Primary study objectives were to determine the safety and tolerability of the combination and to evaluate humoral and cellular immune response. Secondary objectives were to evaluate tumor response and immunological changes in the tumor microenvironment.
Detailed description
Patients were enrolled sequentially, alternating among 3 treatment arms. Study treatment comprised ipilimumab 3 mg/kg administered intravenously (IV) over 90 minutes every 3 weeks for 4 doses followed by the NY-ESO-1 vaccine administered subcutaneously (SC). Arm A received the NY-ESO-1 recombinant protein mixed with polyinosinic-polycytidylic acid-poly-L-lysine carboxymethylcellulose (Poly-ICLC) and Montanide; Arm B received NY-ESO-1 overlapping long peptides 4 (OLP4) mixed with Poly-ICLC and Montanide; and Arm C received NY-ESO-1 OLP4 mixed with Poly-ICLC (without Montanide). The vaccine was administered immediately following the ipilimumab infusion, and patients were observed for 1 hour following administration. No dose adjustments or delays were permitted.
Because the study treatment regimens had not been previously investigated in humans, the first patient in each treatment arm was followed for 28 days and evaluated for any regimen-limiting toxicity (RLT), defined as any dose-limiting toxicity (DLT) that could not be attributed solely to either the vaccine or ipilimumab and was therefore considered to be related to the combination. If an RLT was observed in the first patient, the second patient was to be evaluated for 28 days before the third patient was enrolled. If at any point ≥ 2 RLTs were observed in a treatment arm, accrual to that arm was to be terminated and the combination in that arm was to be declared unsafe.
Patients were monitored for safety, immune and tumor response, and immunological changes in the tumor microenvironment for the duration of study participation, which may have been up to 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Biological: Ipilimumab, Biological: NY-ESO-1 Protein VaccineIpilimumab (IV) followed by NY-ESO-1 recombinant protein mixed with Poly-ICLC and Montanide (SC) every 3 weeks for 4 doses. |
| Arm B | Experimental | Biological: Ipilimumab, Biological: NY-ESO-1 OLP4 Vaccine with Poly-ICLC and MontanideIpilimumab (IV) followed by NY-ESO-1 OLP4 mixed with Poly-ICLC and Montanide (SC) every 3 weeks for 4 doses. |
| Arm C | Experimental | Biological: Ipilimumab, Biological: NY-ESO-1 OLP4 Vaccine with Poly-ICLCIpilimumab (IV) followed by NY-ESO-1 OLP4 mixed with Poly-ICLC (SC) every 3 weeks for 4 doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Patients with unresectable or metastatic melanoma, for whom treatment with ipilimumab was indicated as per ipilimumab/Yervoy® package insert (applicable for United States [US] sites) or product information (applicable for Australia site).
- Radiologically measurable disease by irRC.
- Tumor expression of NY-ESO-1 or LAGE-1 antigen by immunohistochemistry or reverse transcriptase-polymerase chain reaction (RT-PCR), or evidence of seropositivity to NY-ESO-1 or LAGE-1.
- Willingness to provide at least one pre-and post-vaccination tumor biopsy sample.
- Expected survival of at least 4 months.
Key exclusion criteria (18 listed)
- Any contraindications for ipilimumab/Yervoy® as per package insert (applicable for US sites) or product information (applicable for Australia site).
- Prior exposure to NY-ESO-1 vaccine.
- Active autoimmune disease, symptoms or conditions except for vitiligo, type I diabetes, treated thyroiditis, asymptomatic laboratory evidence of autoimmune disease (e.g., +antinuclear antibody [ANA], +rheumatoid factor [RF], antithyroglobulin antibodies), or mild arthritis requiring no therapy or manageable with nonsteroidal anti-inflammatory drugs (NSAIDs).
- Unresolved immune-related adverse events following prior biological therapy.
- Systemic treatment with high-dose corticosteroids (greater than prednisone 10 mg daily or equivalent).
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 |
|---|---|---|
| IpilimumabAlso: YervoyIpilimumab was administered IV over 90 minutes at a dose of 3 mg/kg directly preceding the NY-ESO-1 injection every 3 weeks for 4 doses. | Biological | Arm A, Arm B, Arm C |
| NY-ESO-1 Protein VaccineNY-ESO-1 recombinant protein (250 µg) was mixed with Poly-ICLC (1 mg) and Montanide ISA-51 VG (1 mL) and administered SC directly following the ipilimumab infusion every 3 weeks for 4 doses. | Biological | Arm A |
| NY-ESO-1 OLP4 Vaccine with Poly-ICLC and MontanideNY-ESO-1 OLP4 (1 mg) was mixed in 5% dextrose solution in water with Poly-ICLC (1 mg) and Montanide ISA-51 VG (1 mL) and administered SC directly following the ipilimumab infusion every 3 weeks for 4 doses. | Biological | Arm B |
| NY-ESO-1 OLP4 Vaccine with Poly-ICLCNY-ESO-1 OLP4 (1 mg) was mixed in 5% dextrose solution in water with Poly-ICLC (1 mg) and administered SC directly following the ipilimumab infusion every 3 weeks for 4 doses. | Biological | Arm C |
Primary outcome
Number of Patients With Treatment-emergent Adverse Events
Time frame: Continuously for up to 6 months
Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through the study period. Dose-limiting toxicity (DLT) was defined as any ≥ Grade 3 hematologic or non-hematologic toxicity that was definitely, probably, or possibly related to the administration of the NY-ESO-1 vaccine or as any toxicity that was definitely, probably, or possibly related to ipilimumab and required permanent discontinuation of ipilimumab in accordance with local prescribing information. DLT assessments were based on the combination of all vaccine components, not on the components individually.
1 secondary outcome
Number of Patients With Immune-related Tumor Response at the Last Assessment
Time frame: Up to 5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- 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.
Michael A Postow, MD study chair
Memorial Sloan Kettering Cancer Center
Hassane M Zarour, MD principal investigator
University of Pittsburgh
Craig L Slingluff, MD principal investigator
University of Virginia
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ipilimumab, NY-ESO-1 Protein Vaccine and NY-ESO-1 OLP4 Vaccine with Poly-ICLC and Montanide in people with Unresectable or Metastatic Melanoma, run by Ludwig Institute for Cancer Research at 5 sites in 2 countries.
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 22 inclusion and 18 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 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Australia. 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 30 Nov 2018). 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?
Number of Patients With Treatment-emergent Adverse Events (time frame: Continuously for up to 6 months). 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 12 Oct 2022.