Metastatic MelanomaPhase 2NCT03850691
Radiation and Combination Immunotherapy for Melanoma
A Phase 2 study testing Aldesleukin: All Patients, Nivolumab: Cohort 1 (Cutaneous) and Nivolumab: Cohort 2 (Ocular) in people with Metastatic Melanoma, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
This is a Phase 2 study designed to evaluate the combination of checkpoint blockade and aldesleukin (IL-2) therapy after a course of standard of care palliative radiation in the management of unresectable metastatic melanoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- Aldesleukin: All Patients, Nivolumab: Cohort 1 (Cutaneous) and Nivolumab: Cohort 2 (Ocular)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2019to 12 Dec 2022
- Phase
- Phase 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-proven unresectable, metastatic melanoma refractory to standard immunotherapy drugs or regimens, including prior treatment with Aldesleukin (IL-2), GM-CSF, Ipilimumab, Nivolumab, Pembrolizumab, and/or Imlygic (T- VEC).
- Prior clinical trial participation or treatment with molecularly targeted agents (i.e. Vemurafenib/Cobimetinib, Dabrafenib/Trametinib) or chemotherapy (i.e. Temozolomide, Dacarbazine, Platinum, or Taxanes) is permitted.
- Patients with ocular melanoma may enroll (Cohort 2) without prior therapy as there is no standard 1st line therapy for this subset of melanoma.
- Must have a minimum of 3 radiographically distinct (>1.5 cm) lesions measurable by RECIST 1.1 at time of study enrollment (>5 preferred).
- A maximum of 2 metastases per treated organ may be targeted for palliative radiation, but must be separated by more than 5 cm of normal tissue
- At least 2 non-irradiated lesions are required for systemic response assessments
Show all 22Show fewer
- Pulmonary metastases: Pulmonary metastasis permissible. Appropriate candidates with lung lesions may be considered for ablative hypofractionation using SBRT.
- Hepatic metastases: Hepatic metastasis permissible. Appropriate candidates with metastasis to liver may be considered for ablative hypofractionation using SBRT .
- Brain metastases: Brain metastases may be treated using Gamma Knife Radiosurgery (GKR) or whole brain radiation therapy (WBRT) per the treating radiation oncologist. Total radiation dose and number of fractions will be determined by the treating radiation oncologist based on anatomic and dosing constraints. MRI of the vertebral column is required for all patients with suspected epidural tumor extension.
- Must have sufficient archival tissue block material (1.5 x 1.5 x 1.5 cm) and/or newly obtained core or excisional biopsy of tumor tissue; minimum of 2 cores.
- ECOG performance status 0 or 1 (Appendix 2)
- Age 18 through 80 years of age; > 80 years of age must be approved by Principal Investigator.
- Adequate organ function within 14 days of enrollment (30 days for pulmonary and cardiac assessments) defined as:
- Hematologic: leukocytes ≥ 2,000/mcL, ANC ≥ 1,000/mcL, hemoglobin ≥ 9.0 g/dL, platelets ≥ 100,000/mcL unsupported by transfusions
- Renal: Serum creatinine ≤ 1.8 mg/dL; for patients with a creatinine > 1.5 mg/dL or a history of renal dysfunction, an estimated glomerular filtration rate ≥ 35 mL/min/1.73 m2 is required
- Hepatic: AST, ALT, and alkaline phosphatase ≤ 5 x upper limit of normal and total bilirubin ≤ 2.0 mg/dL
- Pulmonary: oxygen saturation ≥90% on room air; corrected DLCO and FEV1, ≥ 60% predicted
- Cardiac: Absence of clinical decompensated congestive heart failure or uncontrolled arrhythmia; left ventricular ejection fraction (echocardiogram within 6 months permitted) ≥ 40%. QTc must be < 450 ms in males and < 470 ms in females.
- A minimum of 1 week between last anti-tumor treatment if given, and 1st dose of radiation therapy (not applicable for patients enrolling after palliative radiation therapy).
- Recovery from previous cancer treatment if applicable defined as ≤ Grade 1 (by CTCAE 5.0 criteria) at enrollment
- Women of childbearing potential and males with partners of childbearing potential must agree to the use of barrier methods of contraception, hormonal contraceptives, or abstain from heterosexual activity for the duration of study treatment and for 3 months after the last dose of study drug.
- Ability to understand and provide voluntary written consent
Who cannot join
- Pregnant or breast feeding. The agents used in this study have the potential to harm a fetus. Radiation is a known teratogen. There is insufficient information regarding potential for fetal harm during immunotherapy at this time. Biological females of childbearing potential must have a negative pregnancy test within 14 days of enrollment.
- Concurrent use of high dose steroids; chronic steroid use of < 2 mg dexamethasone or equivalent per day is permissible
- Concurrent malignancy requiring active treatment, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ
- Severe and active autoimmune diseases requiring systemic immunosuppression
- Prior organ allograft or allogeneic transplantation
- Other contraindication to IL-2, nivolumab, ipilimumab, or combination immunotherapy per treating medical oncologist
- Live vaccines within 30 days prior to the first dose of IL-2 and while participating in the trial. Examples of live vaccines include, but are not limited to, measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid (oral) vaccine. Seasonal influenza vaccines for injection are generally inactivated virus vaccines and are allowed. Intranasal influenza vaccine (eg, Flu - Mist®) is a live attenuated vaccine, and is not allowed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Masonic Cancer Center
Burnsville, Minnesota, 55337
About this study
Official title: A Phase 2 Study of Palliative Radiation and Combination Sequential Immunotherapy for Metastatic Cutaneous Melanoma and Ocular Melanoma
This is a Phase 2 study designed to evaluate the combination of checkpoint blockade and aldesleukin (IL-2) therapy after a course of standard of care palliative radiation in the management of unresectable metastatic melanoma. To be eligible, a patient must have a minimum of 3 (preferably >5) radiographically distinct, measurable (>1.5 cm) lesions based on RECIST 1.1. Metastatic cutaneous melanoma must be refractory to standard immunotherapy drugs, molecular targeted agents and/or chemotherapy. Patients with ocular melanoma subtypes may enroll in this study without prior therapy, as there is no standard front-line therapy for this subset of patients.
- Conditions
- Metastatic Melanoma
- Being tested
- Aldesleukin: All Patients, Nivolumab: Cohort 1 (Cutaneous), Nivolumab: Cohort 2 (Ocular), Ipilimumab: Cohort 2 (Ocular)
- Keywords
- MM
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aldesleukin: All PatientsDrug
Also called IL-2
Cycle 1:
(600,000 U/kg/dose) given as a bolus infusion once every 8 to 12 hours over 5 days or until no longer tolerated (to a maximum of 10 doses). Administered as an inpatient.
Days 1-5 and Days 15-19 (all patients)
Nivolumab: Cohort 1 (Cutaneous)Drug
Cycle 1: 6 Week Duration Nivolumab 240 mg IV
Cycle 2: 6 Week Duration Nivolumab 240 mg IV on Day 1, 15 and 29
Cycle 3: 4 Week Duration Nivolumab 240 mg IV on Day 1 and 15
Patients may continue maintenance nivolumab 240 mg IV every 2 weeks OR nivolumab 480 mg IV every 4 weeks per 2018 FDA approval at discretion of the treating physician and independent of this study
Nivolumab: Cohort 2 (Ocular)Drug
Cycle 1: 6 Week Duration Nivolumab 3 mg/kg IV on Day 29
OR for a high risk patient with an excellent performance status, the following regimen may be given at the discretion of the treating investigator:
Nivolumab 1 mg/kg IV on Day 29
Cycle 2: 6 Week Duration Nivolumab on Day 8 and on Day 29 using the same dose regimen as used Cycle 1 Day 29
Cycle 3: 4 Week Duration Nivolumab on Day 8 using the same dose regimen as used Cycle 1 Day 29.
Patients may continue maintenance nivolumab 240 mg IV every 2 weeks OR nivolumab 480 mg IV every 4 weeks per 2018 FDA approval at discretion of the treating physician and independent of this study
Ipilimumab: Cohort 2 (Ocular)Drug
Cycle 1: 6 Week Duration Ipilimumab 1 mg/kg IV on Day 29
OR for a high risk patient with an excellent performance status, the following regimen may be given at the discretion of the treating investigator:
Ipilimumab 3 mg/kg IV on Day 29
Cycle 2: 6 Week Duration Ipilimumab on Day 8 and on Day 29 using the same dose regimen as used Cycle 1 Day 29
Cycle 3: 4 Week Duration Ipilimumab on Day 8 using the same dose regimen as used Cycle 1 Day 29
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Nivolumab | Experimental | Not described Receives: Drug: Aldesleukin: All Patients; Drug: Nivolumab: Cohort 1 (Cutaneous) |
| Cohort 2: Nivolumab & Ipilimumab | Experimental | Not described Receives: Drug: Aldesleukin: All Patients; Drug: Nivolumab: Cohort 2 (Ocular); Drug: Ipilimumab: Cohort 2 (Ocular) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Determine the objective response rate (ORR). The ORR will be presented as the proportion of patients who achieved complete response (CR) or partial response (PR). In general, categorical data measurements will be summarized as counts and percentages (or proportions). The disease control rate (DCR) will be presented as the proportion of patients with CR, PR, or stable disease. The best overall response (BOR) will be measured as the maximum change from baseline in the sum of the longest diameter for each of the target lesions over the full 2 year follow-up period.
Measured: up to approximately 2 Years
Safety and Tolerability of Sequential Combination Immunotherapy (Incidence of Adverse Events)
This will be achieved by the number of adverse event (AE) reports. AEs, SAEs, deaths, and abnormal laboratory values will be summarized by the proportion of patients who experience them. Descriptive statistics of safety will be presented using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. All on-study AEs, Grade 3-4 AEs, treatment-related AEs, Grade 3-4 treatment-related AEs, SAEs, treatment-related SAEs, and AEs leading to discontinuation will be tabulated using the worst grade per NCI CTCAE v 5.0 criteria by system organ class.
Measured: Approximately up to 2 Years
Safety and Tolerability of Sequential Combination Immunotherapy (Incidence of Stopping Rule Events)
This will be measured by the number of participants who are suspended from the trial as noted by a stopping rule event. These events are determined after serious adverse events are graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The following events count toward an early stopping rule event: 1) Any Grade 2 or greater drug-related uveitis, eye pain, or blurred vision that does not respond to topical therapy and does not improve to Grade 1 severity within 7 days of checkpoint inhibitor OR requires systemic treatment with corticosteroids, 2) Any Grade 3 or greater non-skin, drug-related adverse event lasting > 7 days, including uveitis, pneumonitis, bronchospasm, diarrhea, colitis, neurologic toxicity, hypersensitivity reactions, and infusion reactions. In addition, the trial would be stopped and re-evaluated if there is ≥ 1 treatment-related mortality event.
Measured: Approximately up to 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start28 May 2019
- Primary completion4 May 2021
- Study completion12 Dec 2022
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 Metastatic MelanomaStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evidio Domingo-Musibay, MD, Principal investigator, Division of Hematology, Oncology and Transplantation, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03850691
- Sponsor's protocol ID
- 2018LS110
- Status last verified
- Dec 2023
- First submitted
- 20 Feb 2019
- Last updated
- 17 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Palliative Radiation and Combination Sequential Immunotherapy for Metastatic Cutaneous Melanoma and Ocular Melanoma
- ClinicalTrials.gov ID
- NCT03850691
- Acronym / sponsor ID
- 2018LS110
- Conditions
- Metastatic Melanoma
- Keywords
- MM
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 28 May 2019 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 22 Feb 2019 (actual)
- Results
- Posted 3 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2 study designed to evaluate the combination of checkpoint blockade and aldesleukin (IL-2) therapy after a course of standard of care palliative radiation in the management of unresectable metastatic melanoma. To be eligible, a patient must have a minimum of 3 (preferably >5) radiographically distinct, measurable (>1.5 cm) lesions based on RECIST 1.1. Metastatic cutaneous melanoma must be refractory to standard immunotherapy drugs, molecular targeted agents and/or chemotherapy. Patients with ocular melanoma subtypes may enroll in this study without prior therapy, as there is no standard front-line therapy for this subset of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Nivolumab | Experimental | Drug: Aldesleukin: All Patients, Drug: Nivolumab: Cohort 1 (Cutaneous) |
| Cohort 2: Nivolumab & Ipilimumab | Experimental | Drug: Aldesleukin: All Patients, Drug: Nivolumab: Cohort 2 (Ocular), Drug: Ipilimumab: Cohort 2 (Ocular) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Biopsy-proven unresectable, metastatic melanoma refractory to standard immunotherapy drugs or regimens, including prior treatment with Aldesleukin (IL-2), GM-CSF, Ipilimumab, Nivolumab, Pembrolizumab, and/or Imlygic (T- VEC).
- Must have a minimum of 3 radiographically distinct (>1.5 cm) lesions measurable by RECIST 1.1 at time of study enrollment (>5 preferred).
- Pulmonary metastases: Pulmonary metastasis permissible. Appropriate candidates with lung lesions may be considered for ablative hypofractionation using SBRT.
- Hepatic metastases: Hepatic metastasis permissible. Appropriate candidates with metastasis to liver may be considered for ablative hypofractionation using SBRT .
- Brain metastases: Brain metastases may be treated using Gamma Knife Radiosurgery (GKR) or whole brain radiation therapy (WBRT) per the treating radiation oncologist. Total radiation dose and number of fractions will be determined by the treating radiation oncologist based on anatomic and dosing constraints. MRI of the vertebral column is required for all patients with suspected epidural tumor extension.
Key exclusion criteria (7 listed)
- Pregnant or breast feeding. The agents used in this study have the potential to harm a fetus. Radiation is a known teratogen. There is insufficient information regarding potential for fetal harm during immunotherapy at this time. Biological females of childbearing potential must have a negative pregnancy test within 14 days of enrollment.
- Concurrent use of high dose steroids; chronic steroid use of < 2 mg dexamethasone or equivalent per day is permissible
- Concurrent malignancy requiring active treatment, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ
- Severe and active autoimmune diseases requiring systemic immunosuppression
- Prior organ allograft or allogeneic transplantation
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 |
|---|---|---|
| Aldesleukin: All PatientsAlso: IL-2Cycle 1: (600,000 U/kg/dose) given as a bolus infusion once every 8 to 12 hours over 5 days or until no longer tolerated (to a maximum of 10 doses). Administered as an inpatient. Days 1-5 and Days 15-19 (all patients) | Drug | Cohort 1: Nivolumab, Cohort 2: Nivolumab & Ipilimumab |
| Nivolumab: Cohort 1 (Cutaneous)Cycle 1: 6 Week Duration Nivolumab 240 mg IV Cycle 2: 6 Week Duration Nivolumab 240 mg IV on Day 1, 15 and 29 Cycle 3: 4 Week Duration Nivolumab 240 mg IV on Day 1 and 15 Patients may continue maintenance nivolumab 240 mg IV every 2 weeks OR nivolumab 480 mg IV every 4 weeks per 2018 FDA approval at discretion of the treating physician and independent of this study | Drug | Cohort 1: Nivolumab |
| Nivolumab: Cohort 2 (Ocular)Cycle 1: 6 Week Duration Nivolumab 3 mg/kg IV on Day 29 OR for a high risk patient with an excellent performance status, the following regimen may be given at the discretion of the treating investigator: Nivolumab 1 mg/kg IV on Day 29 Cycle 2: 6 Week Duration Nivolumab on Day 8 and on Day 29 using the same dose regimen as used Cycle 1 Day 29 Cycle 3: 4 Week Duration Nivolumab on Day 8 using the same dose regimen as used Cycle 1 Day 29. Patients may continue maintenance nivolumab 240 mg IV every 2 weeks OR nivolumab 480 mg IV every 4 weeks per 2018 FDA approval at discretion of the treating physician and independent of this study | Drug | Cohort 2: Nivolumab & Ipilimumab |
| Ipilimumab: Cohort 2 (Ocular)Cycle 1: 6 Week Duration Ipilimumab 1 mg/kg IV on Day 29 OR for a high risk patient with an excellent performance status, the following regimen may be given at the discretion of the treating investigator: Ipilimumab 3 mg/kg IV on Day 29 Cycle 2: 6 Week Duration Ipilimumab on Day 8 and on Day 29 using the same dose regimen as used Cycle 1 Day 29 Cycle 3: 4 Week Duration Ipilimumab on Day 8 using the same dose regimen as used Cycle 1 Day 29 | Drug | Cohort 2: Nivolumab & Ipilimumab |
Primary outcome
Objective Response Rate (ORR)
Time frame: up to approximately 2 Years
Determine the objective response rate (ORR). The ORR will be presented as the proportion of patients who achieved complete response (CR) or partial response (PR). In general, categorical data measurements will be summarized as counts and percentages (or proportions). The disease control rate (DCR) will be presented as the proportion of patients with CR, PR, or stable disease. The best overall response (BOR) will be measured as the maximum change from baseline in the sum of the longest diameter for each of the target lesions over the full 2 year follow-up period.
Safety and Tolerability of Sequential Combination Immunotherapy (Incidence of Adverse Events)
Time frame: Approximately up to 2 Years
This will be achieved by the number of adverse event (AE) reports. AEs, SAEs, deaths, and abnormal laboratory values will be summarized by the proportion of patients who experience them. Descriptive statistics of safety will be presented using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. All on-study AEs, Grade 3-4 AEs, treatment-related AEs, Grade 3-4 treatment-related AEs, SAEs, treatment-related SAEs, and AEs leading to discontinuation will be tabulated using the worst grade per NCI CTCAE v 5.0 criteria by system organ class.
Safety and Tolerability of Sequential Combination Immunotherapy (Incidence of Stopping Rule Events)
Time frame: Approximately up to 2 Years
This will be measured by the number of participants who are suspended from the trial as noted by a stopping rule event. These events are determined after serious adverse events are graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The following events count toward an early stopping rule event: 1) Any Grade 2 or greater drug-related uveitis, eye pain, or blurred vision that does not respond to topical therapy and does not improve to Grade 1 severity within 7 days of checkpoint inhibitor OR requires systemic treatment with corticosteroids, 2) Any Grade 3 or greater non-skin, drug-related adverse event lasting > 7 days, including uveitis, pneumonitis, bronchospasm, diarrhea, colitis, neurologic toxicity, hypersensitivity reactions, and infusion reactions. In addition, the trial would be stopped and re-evaluated if there is ≥ 1 treatment-related mortality event.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Evidio Domingo-Musibay, MD principal investigator
Division of Hematology, Oncology and Transplantation, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aldesleukin: All Patients, Nivolumab: Cohort 1 (Cutaneous) and Nivolumab: Cohort 2 (Ocular) in people with Metastatic Melanoma, run by Masonic Cancer Center, University of Minnesota 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 22 inclusion and 7 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 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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 3 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: up to approximately 2 Years). The study lists 3 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 17 Jan 2024.