Solid Tumor, AdultPhase 1/2TEMPLENCT05276284
Thiopurine Enhanced Mutations for PD-1/Ligand-1 Efficacy
A Phase 1/2 study testing Atezolizumab, 6-mercaptopurine, 6-thioguanine in people with Solid Tumor, Adult and Metastatic Cancer, run by Kristoffer Rohrberg at 1 site in Denmark.
Trial summary
The TEMPLE study is a single-center prospective phase Ib and II trial to determine the safety, tolerability and efficacy of Atezolizumab given in combination with thiopurine therapy (6-mercaptopurine and 6-thioguanine) in patients with advanced and/or metastatic solid tumors with an intermediate tumor mutational… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult, Metastatic Cancer
- What is being tested?
- Atezolizumab, 6-mercaptopurine, 6-thioguanine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2022to 1 Sep 2025
- Phase
- Phase 1/2
- 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
Who may be able to join
- The patient MUST MEET ALL the following criteria to be enrolled in the study:
- Signed written informed consent.
- Age ≥ 18 years.
- Performance status (WHO) of 0-1.
- Histologically confirmed advanced and/or metastatic solid tumors for which standard curative measures do not exist.
- Radiologically measurable disease according to RECIST v1.1.
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- Life expectancy estimated by the Investigator to be ≥12 weeks.
- Metastatic Lesion(s) or primary tumour accessible for biopsy
- Intermediate tumor mutational burden of 5-10 mutations/mb
- Adequate organ function assessed by screening laboratory values:
- Absolute lymphocyte count ≥ 0.5 x 109/L
- Neutrophils ≥ 1.5 x 109/L
- Platelets ≥ 100 x 109/L. For patients with primary hepatocellular carcinoma platelet counts ≥65 x 109/L is allowed.
- Hemoglobin ≥ 90 g/L (5.6 mmol/L) and at least 4 weeks since blood transfusion
- Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or calculated by Cockroft-Gault formula or directly measured creatinine clearance ≥ 50 mL/min at screening
- AST ≤ 3 x ULN without, and ≤ 5 x ULN with hepatic metastasis
- Bilirubin ≤ 1.5 x ULN (except patients with Gilbert's syndrome, who must have total bilirubin < 3.0 mg/dL)
- Ability to take oral medications.
- Woman of childbearing potential must have been tested negative in a serum pregnancy test within 5 days prior to study drug initiation.
- Male and female patients who have the potential to reproduce must agree to use a highly effective method of birth control (i.e., pregnancy rate of less than 1 % per year) during the study and for 5 months after the discontinuation of study medication. Women must refrain from donating eggs and men must refrain from donating sperm during this same period.
Who cannot join
- Any of the following :
- Pregnancy, lactation, or breastfeeding.
- History or clinical evidence of central nervous system (CNS) primary tumors or metastases including leptomeningeal metastases, unless they have been previously treated, are asymptomatic, and have had no requirement for steroids or anticonvulsants in the last 14 days prior to Screening.
- Deficiency in thiopurine methyltransferase (TPMT) or NUDT15.
- Use, or have used, any concomitant anti-cancer medications within the previous 30 days or 5 half-lives of the medication (whichever is shortest) prior to first dose (bisphosphonates, denosumab and androgen deprivation therapies such as LHRH (GnRH) agonists are allowed if patient is on stable treatment for at least 4 weeks prior to first dose). Limited field radiotherapy for palliative purpose is allowed at any time.
- Participants with immune-related adverse events attributed to prior immunomodulatory therapy must have resolved to Grade ≤ 1 (according to NCI CTCAE v 5.0) or baseline other than adverse events that are clinically non-significant and/or stable on supportive therapy, and are not expected to interfere with treatment in the study such as:
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- Grade ≤ 2 alopecia, asthenia, dermatologic events.
- Grade ≤ 2 anemia if hemoglobin ≥ 90 g/L (5.6 mmol/L)
- Grade 2 (> 1.5-2.0 x ULN) asymptomatic amylase and/or lipase elevation with no abdominal pain and no characteristic CT findings. However, weekly monitoring of amylase and lipase is required in this case.
- Be an organ transplant recipient.
- Have a history of prior other malignancy (with the exception of localized prostate cancer, adequately treated basal skin cancer or carcinoma in-situ of the cervix) within 2 years prior to first dose.
- Have a severe autoimmune disorder requiring treatment during the last 12 months prior to first dose. Diabetes on stable anti-diabetic medication, hypothyroidism and adrenocortical deficiency on stable substitution therapy are allowed.
- Be on chronic therapy with systemic immunosuppressant medication (inhaled, intra articular and low dose systemic corticosteroids, e.g. 7.5 mg or less prednisolone per day is allowed, provided that treatment has been unchanged for at least 4 weeks prior to first dose of IMP).
- Known HIV, active hepatitis B or hepatitis C infection.
- Participants with a history of severe allergic anaphylactic reactions to chimeric or humanized antibodies or known hypersensitivity to Chinese hamster ovary cell products or to any component of the Atezolizumab formulation
- Any condition that, in the opinion of the Investigator, would place the patient at increased risk or preclude the patient's compliance with the study.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University Hospital of Copenhagen, Rigshospitalet
Copenhagen, 2100
About this study
Official title: TEMPLE - Thiopurine Enhanced Mutations for PD-1/Ligand-1 Efficacy
The TEMPLE study is a single-center prospective phase Ib and II trial to determine the safety, tolerability and efficacy of Atezolizumab given in combination with thiopurine therapy (6-mercaptopurine and 6-thioguanine) in patients with advanced and/or metastatic solid tumors with an intermediate tumor mutational burden.
Maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) will be determined in a single armed, open label phase Ib trial with a fixed dose of Atezolizumab in combination with thiopurine therapy with a dose-limiting toxicity (DLT) period of 4 weeks. A total of 27-39 patients will be enrolled in the TEMPLE study. Phase Ib will enroll 3-18 patients depending on the number of DLTs and need for dose de-escalation. Data from patients treated in the phase Ib study at RP2D will be included when assessing endpoints in the phase II part of the study. Phase II will enroll a total of 27 patients (including 3-6 patients treated at RP2D in the phase I part of the trial) in a Simon's 2 stage design (13 in stage 1 and 14 in stage 2).
Read the detailed description
INTRODUCTION:
Immune checkpoint inhibitors (ICI) have revolutionized treatment of several cancer types. However, many patients fail to respond. A prerequisite for response is the presence of neoepitopes on cancer cells that trigger the immune system, and the likelihood hereof increases with the number of mutations in the cancer. The thiopurines 6-mercaptopurine (6MP) and 6-thioguanine (6TG) are prodrugs that are converted into cytotoxic metabolites that are incorporated into DNA (DNA-TG) and cause DNA-damage through futile DNA mismatch repair attempts. 6MP and 6TG have been used for more than 50 years for long-term treatment of hematological cancers. In leukemia, high levels of DNA-TG are associated with higher cure rates. A recent pilot study has shown that combination therapy with 6MP and 6TG significantly increases DNA-TG levels and that the drug combination is safe and tolerable. The higher DNA-TG levels most likely increase the mutational burden and thus presence of neoepitopes that activate cytotoxic T-cell responses.
The TEMPLE project will apply the innovative thiopurine combination strategy to increase the mutational burden, presence of neoepitopes and thus proportion of patients with incurable solid cancers that respond to treatment with ICIs.
STUDY DESIGN:
The TEMPLE study is a single-center prospective phase Ib and II trial to determine the safety, tolerability and efficacy of Atezolizumab given in combination with thiopurine therapy in patients with advanced and/or metastatic solid tumors with an intermediate tumor mutational burden. Maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) will be determined in a single armed, open label phase Ib trial with a fixed dose of Atezolizumab in combination with thiopurine therapy. In the phase Ib part of the study, patients will start treatment with investigational medicinal products:
- 6-mercaptopurine (6MP) 50 mg/m2 orally taken once a day,
- 6-thioguanine (6TG) 12.5 mg/m2 orally taken once a day, and
- Atezolizumab 1200 mg every 3 weeks
The combination of thiopurines and Atezolizumab will be administered in 21-day cycles. The DLT evaluation period will be four weeks. Patients will be included in a modified 3+3 design. 3-18 patients are expected to be enrolled in the phase Ib study, depending on observed DLTs. Phase II be an open label, single arm phase II trial enrolling additional patients up to a total of 27 patients treated at RP2D in a Simon's 2 stage design (13 in stage 1 and 14 in stage 2).
All three study drugs are already approved for within hospital use in Denmark and the Summary of Product Characteristics (SmPCs) will be used in assessment of possible undesirable effects during the study. Patients will be monitored closely for adverse events using the NCI CTCAE v 5.0. If patients develop toxicity, the dose may be modified or discontinued. All dosing interruptions and modifications should be based on the worst preceding toxicity. Patients will be monitored continuously, and dose modifications or interruptions will occur based on the observed toxicity. For Atezolizumab, no dose reduction is permitted, but infusions may be omitted. Dose modifications may be implemented to manage toxicities for 6MP and 6TG.
Patients will continue treatment until progression disease, death, development of unacceptable toxicity or withdrawal of consent. Patients can be treated for a maximum of 2 years with option to re-challenge upon progression or relapse for those responding.
- Conditions
- Solid Tumor, Adult, Metastatic Cancer
- Being tested
- Atezolizumab, 6-mercaptopurine, 6-thioguanine
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atezolizumab, 6-mercaptopurine, 6-thioguanineCombination product
Combination therapy with Atezolizumab, 6-mercaptopurine and 6-thioguanine
| Study group | Role | What they receive |
|---|---|---|
| TEMPLE | Experimental | Study drugs: Atezolizumab, 6-mercaptopurine and 6-thioguanine Receives: Combination Product: Atezolizumab, 6-mercaptopurine, 6-thioguanine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Type and number of adverse events
Measured: 3-6 months
Dose limiting toxicities
Dose limiting toxicities (DLTs) and the MTD for determination of RP2D of Atezolizumab, 6TG and 6MP
Measured: 28 days
Best overall response
Complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), unconfirmed (iUPD) and confirmed PD (iCPD), assessed according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1
Measured: One year
Secondary outcomes (3)
Progression Free Survival
Survival time without progression
Measured: Two years
Overall Survival
Survival time of participants
Measured: Two years
Duration of response
Time from initial time of response according to RECIST 1.1 until progression, censoring or death.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start1 Sep 2022
- Primary completion31 Dec 2024
- Study completion1 Sep 2025
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 Solid Tumor, AdultStudies 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
- Model description
- The TEMPLE study is a single-center prospective phase Ib and II trial to determine the safety, tolerability and efficacy of Atezolizumab given in combination with thiopurine therapy in patients with advanced and/or metastatic solid tumors with an intermediate tumor mutational burden.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kristoffer Rohrberg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kristoffer Rohrberg, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Kristoffer S Rohrberg, MD PhD, Principal investigator, MD, Phd, Consultant, Head of Phase 1 Unit, Department of Oncology, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276284
- Sponsor's protocol ID
- TEMPLE01
- Acronym
- TEMPLE
- Status last verified
- Jan 2026
- First submitted
- 4 Feb 2022
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nazerai L, Willis SC, Yankilevich P, Di Leo L, Bosisio FM, Frias A, Bertolotto C, Nersting J, Thastrup M, Buus S, Thomsen AR, Nielsen M, Rohrberg KS, Schmiegelow K, De Zio D. Thiopurine 6TG treatment increases tumor immunogenicity and response to immune checkpoint blockade. Oncoimmunology. 2022 Dec 17;12(1):2158610. doi: 10.1080/2162402X.2022.2158610. eCollection 2023.
PubMed 36545256
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TEMPLE - Thiopurine Enhanced Mutations for PD-1/Ligand-1 Efficacy
- ClinicalTrials.gov ID
- NCT05276284
- Acronym / sponsor ID
- TEMPLE / TEMPLE01
- Conditions
- Solid Tumor, Adult, Metastatic Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Kristoffer RohrbergUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 11 Mar 2022 (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.
The TEMPLE study is a single-center prospective phase Ib and II trial to determine the safety, tolerability and efficacy of Atezolizumab given in combination with thiopurine therapy (6-mercaptopurine and 6-thioguanine) in patients with advanced and/or metastatic solid tumors with an intermediate tumor mutational burden.
Maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) will be determined in a single armed, open label phase Ib trial with a fixed dose of Atezolizumab in combination with thiopurine therapy with a dose-limiting toxicity (DLT) period of 4 weeks. A total of 27-39 patients will be enrolled in the TEMPLE study. Phase Ib will enroll 3-18 patients depending on the number of DLTs and need for dose de-escalation. Data from patients treated in the phase Ib study at RP2D will be included when assessing endpoints in the phase II part of the study. Phase II will enroll a total of 27 patients (including 3-6 patients treated at RP2D in the phase I part of the trial) in a Simon's 2 stage design (13 in stage 1 and 14 in stage 2).
Detailed description
INTRODUCTION:
Immune checkpoint inhibitors (ICI) have revolutionized treatment of several cancer types. However, many patients fail to respond. A prerequisite for response is the presence of neoepitopes on cancer cells that trigger the immune system, and the likelihood hereof increases with the number of mutations in the cancer. The thiopurines 6-mercaptopurine (6MP) and 6-thioguanine (6TG) are prodrugs that are converted into cytotoxic metabolites that are incorporated into DNA (DNA-TG) and cause DNA-damage through futile DNA mismatch repair attempts. 6MP and 6TG have been used for more than 50 years for long-term treatment of hematological cancers. In leukemia, high levels of DNA-TG are associated with higher cure rates. A recent pilot study has shown that combination therapy with 6MP and 6TG significantly increases DNA-TG levels and that the drug combination is safe and tolerable. The higher DNA-TG levels most likely increase the mutational burden and thus presence of neoepitopes that activate cytotoxic T-cell responses.
The TEMPLE project will apply the innovative thiopurine combination strategy to increase the mutational burden, presence of neoepitopes and thus proportion of patients with incurable solid cancers that respond to treatment with ICIs.
STUDY DESIGN:
The TEMPLE study is a single-center prospective phase Ib and II trial to determine the safety, tolerability and efficacy of Atezolizumab given in combination with thiopurine therapy in patients with advanced and/or metastatic solid tumors with an intermediate tumor mutational burden. Maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) will be determined in a single armed, open label phase Ib trial with a fixed dose of Atezolizumab in combination with thiopurine therapy. In the phase Ib part of the study, patients will start treatment with investigational medicinal products:
- 6-mercaptopurine (6MP) 50 mg/m2 orally taken once a day,
- 6-thioguanine (6TG) 12.5 mg/m2 orally taken once a day, and
- Atezolizumab 1200 mg every 3 weeks
The combination of thiopurines and Atezolizumab will be administered in 21-day cycles. The DLT evaluation period will be four weeks. Patients will be included in a modified 3+3 design. 3-18 patients are expected to be enrolled in the phase Ib study, depending on observed DLTs. Phase II be an open label, single arm phase II trial enrolling additional patients up to a total of 27 patients treated at RP2D in a Simon's 2 stage design (13 in stage 1 and 14 in stage 2).
All three study drugs are already approved for within hospital use in Denmark and the Summary of Product Characteristics (SmPCs) will be used in assessment of possible undesirable effects during the study. Patients will be monitored closely for adverse events using the NCI CTCAE v 5.0. If patients develop toxicity, the dose may be modified or discontinued. All dosing interruptions and modifications should be based on the worst preceding toxicity. Patients will be monitored continuously, and dose modifications or interruptions will occur based on the observed toxicity. For Atezolizumab, no dose reduction is permitted, but infusions may be omitted. Dose modifications may be implemented to manage toxicities for 6MP and 6TG.
Patients will continue treatment until progression disease, death, development of unacceptable toxicity or withdrawal of consent. Patients can be treated for a maximum of 2 years with option to re-challenge upon progression or relapse for those responding.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The TEMPLE study is a single-center prospective phase Ib and II trial to determine the safety, tolerability and efficacy of Atezolizumab given in combination with thiopurine therapy in patients with advanced and/or metastatic solid tumors with an intermediate tumor mutational burden.
| Arm | Type | Receives |
|---|---|---|
| TEMPLE | Experimental | Combination Product: Atezolizumab, 6-mercaptopurine, 6-thioguanineStudy drugs: Atezolizumab, 6-mercaptopurine and 6-thioguanine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Signed written informed consent.
- Age ≥ 18 years.
- Performance status (WHO) of 0-1.
- Histologically confirmed advanced and/or metastatic solid tumors for which standard curative measures do not exist.
- Radiologically measurable disease according to RECIST v1.1.
Key exclusion criteria (16 listed)
- Pregnancy, lactation, or breastfeeding.
- History or clinical evidence of central nervous system (CNS) primary tumors or metastases including leptomeningeal metastases, unless they have been previously treated, are asymptomatic, and have had no requirement for steroids or anticonvulsants in the last 14 days prior to Screening.
- Deficiency in thiopurine methyltransferase (TPMT) or NUDT15.
- Use, or have used, any concomitant anti-cancer medications within the previous 30 days or 5 half-lives of the medication (whichever is shortest) prior to first dose (bisphosphonates, denosumab and androgen deprivation therapies such as LHRH (GnRH) agonists are allowed if patient is on stable treatment for at least 4 weeks prior to first dose). Limited field radiotherapy for palliative purpose is allowed at any time.
- Participants with immune-related adverse events attributed to prior immunomodulatory therapy must have resolved to Grade ≤ 1 (according to NCI CTCAE v 5.0) or baseline other than adverse events that are clinically non-significant and/or stable on supportive therapy, and are not expected to interfere with treatment in the study such as:
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 |
|---|---|---|
| Atezolizumab, 6-mercaptopurine, 6-thioguanineCombination therapy with Atezolizumab, 6-mercaptopurine and 6-thioguanine | Combination product | TEMPLE |
Primary outcome
Adverse events
Time frame: 3-6 months
Type and number of adverse events
Dose limiting toxicities
Time frame: 28 days
Dose limiting toxicities (DLTs) and the MTD for determination of RP2D of Atezolizumab, 6TG and 6MP
Best overall response
Time frame: One year
Complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), unconfirmed (iUPD) and confirmed PD (iCPD), assessed according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1
3 secondary outcomes
Progression Free Survival
Time frame: Two years
Overall Survival
Time frame: Two years
Duration of response
Time frame: Two years
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 14 Jan 2026.
- Derived from this study: PubMed 36545256Nazerai L, Willis SC, Yankilevich P, Di Leo L, Bosisio FM, Frias A, Bertolotto C, Nersting J, Thastrup M, Buus S, Thomsen AR, Nielsen M, Rohrberg KS, Schmiegelow K, De Zio D. Thiopurine 6TG treatment increases tumor immunogenicity and response to immune checkpoint blockade. Oncoimmunology. 2022 Dec 17;12(1):2158610. doi: 10.1080/2162402X.2022.2158610. eCollection 2023.
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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.
Kristoffer S Rohrberg, MD PhD principal investigator
MD, Phd, Consultant, Head of Phase 1 Unit, Department of Oncology, Rigshospitalet
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 Atezolizumab, 6-mercaptopurine, 6-thioguanine in people with Solid Tumor, Adult and Metastatic Cancer, run by Kristoffer Rohrberg at 1 site in Denmark.
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 20 inclusion and 16 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 14 Jan 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 Denmark. 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?
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?
Adverse events (time frame: 3-6 months). 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?
On the ClinicalTrials.gov record for NCT05276284, 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 14 Jan 2026.