MelanomaNCT02780089
Study in Patients With Unresectable And Metastatic Melanoma: The Optimize Study
An observational study of Melanoma, run by Bristol-Myers Squibb at 66 sites in United States.
Trial summary
This study evaluates the different patterns of care for patients who have unresectable or metastatic melanoma. The dosing, duration, regimen, indication, and treatments will be observed. The survival rate of these patients will also be observed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- How many people
- 408 participants
- Where
- 66 sitesUnited States
- Study dates
- 23 Oct 2015to 8 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients diagnosed with histologically-confirmed unresectable stage III or stage IV melanoma, (including mucosal, uveal, acral-lentiginous, leptomeningeal disease). Patients can be treatment-naïve or previously treated for unresectable or metastatic melanoma.
Who may be able to join
- Prospective cohort patients:
- Diagnosis date must occur on or after March 24, 2011 (date of ipilimumab approval in US)
- Diagnosis of stage III (unresectable) or stage IV melanoma (includes mucosal, uveal acral-lentiginous, leptomeningeal disease)
- Age ≥ 18 years at time of entry into study
- Patients must be actively receiving or scheduled to receive systemic treatment (any line, eg, first, second, third line [including investigational drugs]).
- For patients initiating new treatment, treatment must be started within 28 days after signing informed consent.
Show all 14Show fewer
- For patients currently receiving treatment, patients must enroll within the first 21 days of starting new treatment
- Retrospective cohort patients:
- Patients with diagnosis of confirmed unresectable stage III or stage IV melanoma (including mucosal, uveal, acral-lentiginous, leptomeningeal disease)
- Age ≥ 18 years at time of unresectable or metastatic melanoma diagnosis
- Initiated therapy for unresectable or metastatic melanoma within 4 years prior to approval of ipilimumab (first immune checkpoint inhibitor therapy approved in US)
- March 25, 2007 - March 24, 2011
- One year of follow-up data is required from date of therapy initiation, if a patient passed away within the one year of follow-up; such patients are still eligible and the date of death will be collected.
- If retrospective patients have at least one year of follow-up data and are then treated with immuno-oncology, immune checkpoint inhibitor therapy, or targeted therapy, these patients will be analyzed separately.
Who cannot join
- Prospective patients:
- Patients participating in a clinical study that does not allow enrollment into a non interventional study or clinical studies in which the investigational treatment is blinded
- Patients who started new treatment > 21 days
- Patients who enrolled in study but did not initiate treatment before 28 days
- Patients with current malignancies (except non-melanoma skin cancer and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) that requires additional systemic therapy
Trial locations and contacts
66 sites in 1 country.
66 sites in 1 country
United States66 sites
Network Office of Research & Innovation / Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
University of Colorado
Aurora, Colorado, 80045
Texas Oncology
Austin, Texas, 78731
Saint Agnes Hospital
Baltimore, Maryland, 21229
St. Charles Medical Center - Cancer Center
Bend, Oregon, 97701
St. Luke's Hospital and Health Network
Bethlehem, Pennsylvania, 18015
Central Care Cancer Center
Bolivar, Missouri, 65613
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
West Virginia University
Bridgeport, West Virginia, 26330
Rosewell Park Cancer Institute
Buffalo, New York, 14263
Hematolgoy and Oncology Associates, Inc.
Canton, Ohio, 44708
Aultman Hospital
Canton, Ohio, 44710
Center of Learning Healthcare
Durham, North Carolina, 27705
Texas Oncology
El Paso, Texas, 79902
The Regional Cancer Center
Erie, Pennsylvania, 15505
North Shore University Health System
Evanston, Illinois, 60201
Providence Regional Medical Center Everett
Everett, Washington, 98201
Inova Melanoma and Skin Cancer Center
Fairfax, Virginia, 22031
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 76520
Ingalls Cancer Research Center
Harvey, Illinois, 60426
Forrest General Cancer Center
Hattiesburg, Mississippi, 39119
The Queen's Medical Center
Honolulu, Hawaii, 96813
Genesis Cancer Center
Hot Springs, Arkansas, 71913
West Virginia University
Huntington, West Virginia, 25702
21st Century Oncology
Jacksonville, Florida, 32204
Cancer Specialits, LLC D/B/A
Jacksonville, Florida, 32256
Thompson Cancer Survival Center
Knoxville, Tennessee, 37916
Gundersen Lutheran Medical Foundations, Inc.
La Crosse, Wisconsin, 54601
Lakeland Regional Health
Lakeland, Florida, 33805
Watson Clinical Center for Research, INC
Lakeland, Florida, 33805
Lancaster General Health
Lancaster, Pennsylvania, 17604
Nebraska Hematology-Oncology, P.C.
Lincoln, Nebraska, 68506
Pacific Shores Medical Group
Long Beach, California, 90813
UF Health Cancer Center at Orlando Health
Longwood, Florida, 32750
West Virginia University Hematolgoy & Oncology
Martinsburg, West Virginia, 25401
Tri-County Hematology and Oncology Associates, Inc
Massillon, Ohio, 44646
Mount Sinai Medical Center
Miami Beach, Florida, 33140
Masonic Cancer Center
Minneapolis, Minnesota, 55455
West Virginia University
Morgantown, West Virginia, 26506
Atlantic Health, Morristown Medical Center
Morristown, New Jersey, 07960
Northwest Alabama Cancer Center
Muscle Shoals, Alabama, 35661
Meridian Health
Neptune City, New Jersey, 07753
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Oncology Specialits, S.C.
Niles, Illinois, 60714
Oncology Hematology West P.C.
Omaha, Nebraska, 68130
Mid Florida Hematology and Oncology Centers
Orange City, Florida, 32763
West Ky Hematology & Oncology
Paducah, Kentucky, 42003
Texas Oncology
Paris, Texas, 75460
Sacred Heart Medical Oncology Group
Pensacola, Florida, 32504
Jefferson Medical Oncology
Philadelphia, Pennsylvania, 19107
Allegheny Health Network
Pittsburgh, Pennsylvania, 15224
UPCI - UPMC Cancer Center
Pittsburgh, Pennsylvania, 15232
Cancer Care Associates
Redondo Beach, California, 90277
Mayo Clinic Cancer Center (MCCC)
Rochester, Minnesota, 55905
Harbin Clinic
Rome, Georgia, 30165
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, 84112
Summit Cancer Care
Savannah, Georgia, 31405
CHRISTUS Schumpert Cancer Treatment Center
Shreveport, Louisiana, 71101
Orchard Healthcare Research Inc.
Skokie, Illinois, 60077
Cancer Care Northwest
Spokane, Washington, 99216
Simmons Cancer Institute at SIU School of Medicine
Springfield, Illinois, 62702
Tallahassee Memorial Healthcare
Tallahassee, Florida, 32308
H. Lee Moffitt Cancer Center Moffitt Cancer Center
Tampa, Florida, 33612
Stormont-Vail Cancer Center
Topeka, Kansas, 66606
University of Kansas Medical Center
Westwood, Kansas, 66205
Genesis Cancer Care Center
Zanesville, Ohio, 43701
About this study
Official title: A US Multi-Site Observational Study in Patients With Unresectable And Metastatic Melanoma: The OPTIMIzE Study
This study evaluates the different patterns of care for patients who have unresectable or metastatic melanoma. The dosing, duration, regimen, indication, and treatments will be observed. The survival rate of these patients will also be observed.
Read the detailed description
This is a non-interventional, observational study with the primary objective to assess and describe "real world" patterns of care in the treatment of patients with unresectable or metastatic melanoma. A sample size of 1,600 prospective patients will provide sufficient information to explore this primary objective. There will be no forced number of patients enrolled into a specific treatment cohort. Setting or controlling specific treatment enrollment cohort counts would invalidate the results of the primary objective of the study. No primary hypothesis is being tested.
- Conditions
- Melanoma
- Keywords
- Metastatic, Unresectable
- Medical subject headings
- Melanoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Patients | There will be 1,600 prospective patients recruited over a period of two years and followed-up for a planned minimum of three years. For the prospective cohort, patients will be recruited after the course of treatment has been decided by the physician and prior to the start of treatment.Prior advanced melanoma treatment information will be collected from patient charts for pre-treated patients. Patients will be followed for a minimum of 3 years from their study index date until death, withdrawal of consent, lost to follow-up/record, or end of study, whichever comes first. Study index date will be the date when first study therapy is initiated. | |
| Treatment Group No. 1 | Immune checkpoint inhibitor patients who remain on an immune checkpoint inhibitor therapy. Defined as immune checkpoint inhibitor therapy patients who either remained on their initial (index) immune checkpoint inhibitor therapy or switched to another immune checkpoint inhibitor therapy during the study period. Patients in this group remained on an immune checkpoint inhibitor therapy and did not switch to a non-immune checkpoint inhibitor therapy anytime during the study period. | |
| Treatment Group No. 2 | Immune checkpoint inhibitor patients who switched to a non-immune checkpoint inhibitor therapy. Defined as patients who switched from their index immune checkpoint inhibitor therapy to a non-immune checkpoint inhibitor therapy anytime during the study period. | |
| Treatment Group No. 3 | Targeted therapy patients who remain on a targeted therapy. Defined as targeted therapy patients who either remained on their initial (index) targeted therapy or switched to another targeted therapy during the study period. Patients in this group remained on a targeted therapy and did not switch to a non-targeted therapy anytime during the study period. | |
| Treatment Group No. 4 | Targeted therapy patients who switched to a non-targeted therapy. Defined as patients who switched from their index targeted therapy to a non-targeted therapy anytime during the study period. | |
| Treatment Group No. 5 | Chemotherapy/other therapy patients who remain on a chemotherapy/other therapy. Defined as chemotherapy/other therapy patients who either remained on their initial (index) chemotherapy/other therapy or switched to another chemotherapy/other therapy during the study period. Patients in this group remained on a chemotherapy/other therapy and did not switch to an immune checkpoint inhibitor therapy or targeted therapy anytime during the study period. | |
| Treatment Group No. 6 | Chemotherapy/other patients who switched to an immune checkpoint inhibitor therapy or targeted therapy. Defined as patients who switched from their index chemotherapy/other therapy to an immune checkpoint inhibitor therapy or targeted therapy anytime during the study period. | |
| Retrospective Patients | Retrospective cohort of 600 patients with unresectable or metastatic melanoma, receiving therapies other than immune checkpoint inhibitor or targeted therapies during the four year period prior to the release of ipilimumab (March 25, 2007 -March 24, 2011), will be identified. The data for these 600 retrospective patients will be used as a benchmark for treatment patterns and outcomes prior to the marketed availability of immune checkpoint inhibitors or targeted therapies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patterns of Care
To assess the selection and sequencing of drugs and practice patterns used to treat unresectable and metastatic melanoma (e.g. immune checkpoint agents, targeted agents, or combination therapies) in a real-world setting. Reasons for initial treatment decisions across and between drug classes, changes in treatment, and discontinuation will be recorded (e.g. lack of benefit, safety, cost, or other barriers to care).
Measured: Up to 5 years
Demographics
Baseline characteristics (age, gender, race/ethnicity)
Measured: Up to 5 years
Overall Survival
To estimate overall survival in patients receiving therapy for unresectable or metastatic melanoma some statistical measurements and actual survival will be used.
Measured: Up to 5 years
Disease Characteristics
Disease characteristics (date of diagnosis, disease stage, performance status)
Measured: Up to 5 years
Secondary outcomes (5)
Healthcare Resource
To compare and describe healthcare utilization, imputed costs, and impact of initial treatment choice on lifetime or periodic costs. Due to potential differences between in patterns of care among various regions, region-specific analyses may be conducted for healthcare resource utilization.
Measured: up to 5 years
Functional Assessments of Cancer Therapy-Melanoma (FACT-M)
Measured: Up to 12 months
European Quality of Life-5 Dimensions (EQ-5D)
Measured: Up to 12 months
Work Productivity and Activity Impairment: General Health (WPAI:GH)
Measured: Up to 12 months
The Caregiver Quality of Life Index - Cancer (CQOLC)
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2016 (estimated)
- Study start23 Oct 2015
- Primary completion8 Sep 2020
- Study completion8 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02780089
- Sponsor's protocol ID
- CA209-357
- Status last verified
- May 2022
- First submitted
- 25 Apr 2016
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Kirkwood JM, Kottschade LA, McWilliams RR, Khushalani NI, Jang S, Hallmeyer S, McDermott DF, Tawbi H, Che M, Lee CH, Ritchings C, Le TK, Park B, Ramsey S. Real-world outcomes with immuno-oncology therapies in advanced melanoma: final results of the OPTIMIzE registry study. Immunotherapy. 2024 Jan;16(1):29-42. doi: 10.2217/imt-2022-0292. Epub 2023 Nov 8.
PubMed 37937397
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A US Multi-Site Observational Study in Patients With Unresectable And Metastatic Melanoma: The OPTIMIzE Study
- ClinicalTrials.gov ID
- NCT02780089
- Acronym / sponsor ID
- CA209-357
- Conditions
- Melanoma
- Keywords
- Metastatic, Unresectable
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2015 (actual)
- Primary completion
- 8 Sep 2020 (actual)
- Study completion
- 8 Sep 2020 (actual)
- First posted
- 23 May 2016 (estimated)
- 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 study evaluates the different patterns of care for patients who have unresectable or metastatic melanoma. The dosing, duration, regimen, indication, and treatments will be observed. The survival rate of these patients will also be observed.
Detailed description
This is a non-interventional, observational study with the primary objective to assess and describe "real world" patterns of care in the treatment of patients with unresectable or metastatic melanoma. A sample size of 1,600 prospective patients will provide sufficient information to explore this primary objective. There will be no forced number of patients enrolled into a specific treatment cohort. Setting or controlling specific treatment enrollment cohort counts would invalidate the results of the primary objective of the study. No primary hypothesis is being tested.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Prospective Patients | – | –There will be 1,600 prospective patients recruited over a period of two years and followed-up for a planned minimum of three years. For the prospective cohort, patients will be recruited after the course of treatment has been decided by the physician and prior to the start of treatment.Prior advanced melanoma treatment information will be collected from patient charts for pre-treated patients. Patients will be followed for a minimum of 3 years from their study index date until death, withdrawal of consent, lost to follow-up/record, or end of study, whichever comes first. Study index date will be the date when first study therapy is initiated. |
| Treatment Group No. 1 | – | –Immune checkpoint inhibitor patients who remain on an immune checkpoint inhibitor therapy. Defined as immune checkpoint inhibitor therapy patients who either remained on their initial (index) immune checkpoint inhibitor therapy or switched to another immune checkpoint inhibitor therapy during the study period. Patients in this group remained on an immune checkpoint inhibitor therapy and did not switch to a non-immune checkpoint inhibitor therapy anytime during the study period. |
| Treatment Group No. 2 | – | –Immune checkpoint inhibitor patients who switched to a non-immune checkpoint inhibitor therapy. Defined as patients who switched from their index immune checkpoint inhibitor therapy to a non-immune checkpoint inhibitor therapy anytime during the study period. |
| Treatment Group No. 3 | – | –Targeted therapy patients who remain on a targeted therapy. Defined as targeted therapy patients who either remained on their initial (index) targeted therapy or switched to another targeted therapy during the study period. Patients in this group remained on a targeted therapy and did not switch to a non-targeted therapy anytime during the study period. |
| Treatment Group No. 4 | – | –Targeted therapy patients who switched to a non-targeted therapy. Defined as patients who switched from their index targeted therapy to a non-targeted therapy anytime during the study period. |
| Treatment Group No. 5 | – | –Chemotherapy/other therapy patients who remain on a chemotherapy/other therapy. Defined as chemotherapy/other therapy patients who either remained on their initial (index) chemotherapy/other therapy or switched to another chemotherapy/other therapy during the study period. Patients in this group remained on a chemotherapy/other therapy and did not switch to an immune checkpoint inhibitor therapy or targeted therapy anytime during the study period. |
| Treatment Group No. 6 | – | –Chemotherapy/other patients who switched to an immune checkpoint inhibitor therapy or targeted therapy. Defined as patients who switched from their index chemotherapy/other therapy to an immune checkpoint inhibitor therapy or targeted therapy anytime during the study period. |
| Retrospective Patients | – | –Retrospective cohort of 600 patients with unresectable or metastatic melanoma, receiving therapies other than immune checkpoint inhibitor or targeted therapies during the four year period prior to the release of ipilimumab (March 25, 2007 -March 24, 2011), will be identified. The data for these 600 retrospective patients will be used as a benchmark for treatment patterns and outcomes prior to the marketed availability of immune checkpoint inhibitors or targeted therapies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with histologically-confirmed unresectable stage III or stage IV melanoma, (including mucosal, uveal, acral-lentiginous, leptomeningeal disease). Patients can be treatment-naïve or previously treated for unresectable or metastatic melanoma.
Key inclusion criteria (14 listed)
- Diagnosis date must occur on or after March 24, 2011 (date of ipilimumab approval in US)
- Diagnosis of stage III (unresectable) or stage IV melanoma (includes mucosal, uveal acral-lentiginous, leptomeningeal disease)
- Age ≥ 18 years at time of entry into study
- Patients must be actively receiving or scheduled to receive systemic treatment (any line, eg, first, second, third line [including investigational drugs]).
- Patients with diagnosis of confirmed unresectable stage III or stage IV melanoma (including mucosal, uveal, acral-lentiginous, leptomeningeal disease)
Key exclusion criteria (5 listed)
- Patients participating in a clinical study that does not allow enrollment into a non interventional study or clinical studies in which the investigational treatment is blinded
- Patients who started new treatment > 21 days
- Patients who enrolled in study but did not initiate treatment before 28 days
- Patients with current malignancies (except non-melanoma skin cancer and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) that requires additional systemic therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patterns of Care
Time frame: Up to 5 years
To assess the selection and sequencing of drugs and practice patterns used to treat unresectable and metastatic melanoma (e.g. immune checkpoint agents, targeted agents, or combination therapies) in a real-world setting. Reasons for initial treatment decisions across and between drug classes, changes in treatment, and discontinuation will be recorded (e.g. lack of benefit, safety, cost, or other barriers to care).
Demographics
Time frame: Up to 5 years
Baseline characteristics (age, gender, race/ethnicity)
Overall Survival
Time frame: Up to 5 years
To estimate overall survival in patients receiving therapy for unresectable or metastatic melanoma some statistical measurements and actual survival will be used.
Disease Characteristics
Time frame: Up to 5 years
Disease characteristics (date of diagnosis, disease stage, performance status)
5 secondary outcomes
Healthcare Resource
Time frame: up to 5 years
Functional Assessments of Cancer Therapy-Melanoma (FACT-M)
Time frame: Up to 12 months
European Quality of Life-5 Dimensions (EQ-5D)
Time frame: Up to 12 months
Work Productivity and Activity Impairment: General Health (WPAI:GH)
Time frame: Up to 12 months
The Caregiver Quality of Life Index - Cancer (CQOLC)
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Derived from this study: PubMed 37937397Kirkwood JM, Kottschade LA, McWilliams RR, Khushalani NI, Jang S, Hallmeyer S, McDermott DF, Tawbi H, Che M, Lee CH, Ritchings C, Le TK, Park B, Ramsey S. Real-world outcomes with immuno-oncology therapies in advanced melanoma: final results of the OPTIMIzE registry study. Immunotherapy. 2024 Jan;16(1):29-42. doi: 10.2217/imt-2022-0292. Epub 2023 Nov 8.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- 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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
66 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by Bristol-Myers Squibb at 66 sites 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 14 inclusion and 5 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 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patterns of Care (time frame: Up to 5 years). The study lists 4 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 NCT02780089, which also lists 1 linked publication.
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 23 May 2022.