Renal Cell CancerPhase 4ITALIC-RCCNCT06903312
Primary Tumor Ablation and Outcome in Metastatic Renal Cell Carcinoma Treated With Immunotherapy Combinations.
A Phase 4 study testing Deferred Cytoreductive Nephrectomy + medical treatment, Radiotherapy + medical treatment and Medical therapy in people with Renal Cell Cancer and Kidney Neoplasm, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
This is Phase IV, randomized, multi arm, multicenter, low interventional clinical trial, aiming to evaluate if treatment of primary tumor in mRCC patients with initial benefit to anti-PD1- based therapy (SOC) can improve the overall survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Cancer, Kidney Neoplasm, Immunotherapy
- What is being tested?
- Deferred Cytoreductive Nephrectomy + medical treatment, Radiotherapy + medical treatment and Medical therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 409 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jun 2025to 1 Apr 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent obtained before any study-specific procedures. Patients must be able to understand and be willing to sign a written informed consent.
- Male or female patient ≥18 years of age.
- Histological or cytological documentation of renal cell carcinoma with predominantly clear cell histology.
- Evidence of primary renal cancer.
- Measurable or not measurable metastatic disease according to Response Evaluation Criteria in Solid Tumors criteria, version 1.1 [22].
- Eastern Cooperative Oncology Group performance status of ≤1.
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- Life expectancy of at least 9 months.
- Under treatment with one anti-PD1 based therapy (SOC) among axitinib + pembrolizumab or cabozantinib + nivolumab or lenvatinib + pembrolizumab or nivolumab alone after nivolumab + ipilimumab for at least 24 but not more than 52 weeks at the time of the signed informed consent and without evidence of progressive disease based on RECIST criteria v 1.1 [21].
- Eligible to continue the combination of therapies for mRCC (or nivolumab alone in case of nivolumab + ipilimumab).
- Women of childbearing potential and men must agree to use adequate contraception since signing of the informed consent form until at least 3 months after the last study drug administration. The investigator or a designated associate is requested to advise the subject how to achieve an adequate birth control. Adequate contraception is defined in the study as any medically recommend method (or combination of methods) as per standard of care.
- Adequate bone-marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 7 days of starting to study treatment:
- Creatinine value <2.5 mg/dl and creatinine clearance > 30 ml/min evaluated by the Cockcroft-Gault Formula.
- Total bilirubin ≤1∙5 × the upper limit of normal (ULN);
- Alanine aminotransferase and aspartate aminotransferase ≤2 × ULN (≤5 × ULN for patients with liver involvement of their cancer);
- International normalized ratio (INR) and partial thromboplastin time (PTT) ≤1∙5 × ULN. Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate if no prior evidence of an underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR and PTT are stable based on a pre-dose measurement as defined by the local standard of care;
- Platelet count ≥100 000/mm3, hemoglobin >9 g/dl, absolute neutrophil count >1,500/mm3;
- Alkaline phosphatase limit ≤2∙5 × ULN (≤5 × ULN for patients with liver involvement of their cancer).
Who cannot join
- More than one treatment for metastatic or locally advanced renal cell carcinoma.
- Solitary kidney
- Any contraindication to surgery or radiotherapy on primary renal tumor.
- Discontinuation (definitive) of one of the therapies for mRCC due to toxicity (previous discontinuation of ipilimumab in the ipilimumab + nivolumab combo is allowed).
- Concurrent or previous cancer within 3 years before enrolment EXCEPT curatively treated cervical cancer in situ, non-melanoma skin cancer and pT2 prostate cancer with PSA<0.01 or non-muscle invasive bladder cancer.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before the signed informed consent.
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- Pregnancy or breast-feeding. Women of childbearing potential must have a pregnancy test performed a maximum of 7 days before surgery or radiotherapy on primary tumor, and a negative result must be documented before start of treatment.
- Any cardiological condition among:
- Congestive heart failure of New York Heart Association class 3 or worse.
- Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). Myocardial infarction less than 6 months before start of study drug.
- Cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted).
- Uncontrolled hypertension (systolic blood pressure >150 mmHg or diastolic pressure >90 mmHg despite optimal medical management).
- Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), pulmonary embolism within the 4 months before start of study.
- Ongoing infection higher than National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0 grade 2.
- Known history of human immunodeficiency (HIV) virus infection or known history of chronic hepatitis B or C.
- Any autoimmune reaction or toxicity that contraindicates the use of anti-PD1 therapy.
- Seizure disorder requiring medication.
- Symptomatic metastatic brain or meningeal tumors unless the patient is >2 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry. Also, the patient must not be undergoing acute steroid therapy or tapering (chronic steroid therapy is acceptable provided that the dose is stable for 1 month before and after screening radiographic studies).
- History of organ allograft.
- Evidence or history of bleeding diathesis. Any hemorrhage or bleeding event of CTCAE grade 3 or higher within 4 weeks of start of study medication.
- Non-healing wound, ulcer, or bone fracture.
- Renal failure requiring hemodialysis or peritoneal dialysis.
- Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his or her compliance in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168
About this study
Official title: Clinical and Humoral Impact of Primary Tumor Ablation in Metastatic Renal Cell Carcinoma Treated With Immunotherapy. The ITALIC-RCC Randomized Study.
This is Phase IV, randomized, multi arm, multicenter, low interventional clinical trial, aiming to evaluate if treatment of primary tumor in mRCC patients with initial benefit to anti-PD1- based therapy (SOC) can improve the overall survival.
All patients eligible according to inclusion and exclusion criteria will be enrolled and randomized to different treatment options based on tumor extension of the primary kidney cancer.
Read more
Those with primary kidney cancer ≤ 4 cm will be randomized 1:1:1 to receive:
- Cytoreductive Nephrectomy + standard of care (SOC) or
- RT on primary tumor + SOC or SOC alone.
Those with primary kidney cancer > 4 cm will be randomized 1:1 to receive:
- Deferred Cytoreductive Nephrectomy + SOC or SOC alone. Patients randomized to Deferred Cytoreductive Nephrectomy can be treated with one among radical nephrectomy; partial nephrectomy or lumpectomy.
Patients randomized to RT should be treated with single shot of 25 Gy (or with multiple fractions with equivalent biological dose).
The SOC medical therapy is the continuation of the combination of medical therapy for mRCC including one of the available combination among axitinib + pembrolizumab or cabozantinib + nivolumab or lenvatinib + pembrolizumab or nivolumab alone after nivolumab + ipilimumab.
- Conditions
- Renal Cell Cancer, Kidney Neoplasm, Immunotherapy, Kidney Cancer, Surgery Programmed, Radiotherapy
- Being tested
- Deferred Cytoreductive Nephrectomy + medical treatment, Radiotherapy + medical treatment, Medical therapy
- Keywords
- renal cancer, primary tumor, cytoreductive nephrectomy, immunothreapy, radiotherapy
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deferred Cytoreductive Nephrectomy + medical treatmentProcedure or surgery
Patients randomized to Deferred Cytoreductive Nephrectomy can be treated with one among radical nephrectomy; partial nephrectomy or lumpectomy. Patients will continue to receive the ongoing medical treatment before the randomization.
Radiotherapy + medical treatmentRadiation
Patients randomized to RT should be treated with single shot of 25 Gy (or with multiple fractions with equivalent biological dose). Patients will continue to receive the ongoing medical treatment before the randomization.
Medical therapyDrug
Also called Standard of Care (SOC)
Medical therapy is the continuation of the immune-based combo for mRCC including one of the available options among axitinib + pembrolizumab or cabozantinib + nivolumab or lenvatinib + pembrolizumab or nivolumab alone after nivolumab + ipilimumab.
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy | Experimental | Patients with tumors up to 4 cm can receive RT single shot of 25 Gy (or with multiple fractions with equivalent biological dose). Receives: Radiation: Radiotherapy + medical treatment |
| Deferred Cytoreductive Nephrectomy | Experimental | Patients randomized to Deferred Cytoreductive Nephrectomy can be treated with one among radical nephrectomy; partial nephrectomy or lumpectomy. Receives: Procedure: Deferred Cytoreductive Nephrectomy + medical treatment |
| Control | Active comparator | patients in the control arm continue to receive immuno-based medical treatment for mRCC. Receives: Drug: Medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-months Overall Survival for surgery vs. control
The primary endpoint of the study is to assess the difference in 30-months overall survival (OS) between patients who receive or not the deferred citoreductive nephrectomy (CN) while on therapy with SOC for mRCC.
Measured: 30 months
Secondary outcomes (8)
Median overall survival for surgery vs. control
To assess the difference in overall survival (OS) between patients who receive or not the deferred citoreductive nephrectomy (CN) while on therapy with SOC for mRCC from the beginning of the anti-PD1-based therapy.
Measured: 30 months
Median Progression Free Survival for surgery vs. control
To assess the difference in progression-free survival (PFS) between patients who receive or not the deferred citoreductive nephrectomy (CN) while on therapy with SOC for mRCC.
Measured: 30 months
Median Overall Survival for radiotherapy vs. control
To assess the difference in overall survival (OS) between patients who receive or not the radiotherapy on primary tumor while on therapy with SOC for mRCC among those with primary tumor up to 4 cm at randomization.
Measured: 30 months
Median Progression Free Survival for radiotherapy vs. control
To assess the difference in progression-free survival (PFS) between patients who receive or not the radiotherapy on primary tumor while on therapy with SOC for mRCC among those with primary tumor up to 4 cm at randomization.
Measured: 30 months
Incidence of adverse events
To evaluate the safety of the CN and RT on primary tumor among patients receiving SOC for mRCC. Adverse events will be graded according to NCI CTCAE version 5.0.
Measured: 30 months
Difference in EQ-5D-5L quality of life test
To evaluate the quality of life before and after 8 weeks from the surgery or radiotherapy on primary tumor among patients receiving SOC for mRCC evaluated by the questionnaires EQ-5D-5L.
Measured: Baseline and 8 weeks after surgery or radiotherapy.
Difference in FKSI-19 quality of life test
To evaluate the quality of life before and after 8 weeks from the surgery or radiotherapy on primary tumor among patients receiving SOC for mRCC evaluated by the questionnaires FKSI-19.
Measured: Baseline and 8 weeks after surgery or radiotherapy.
Incidence in of surgical complications.
To evaluate the incidence of surgical complications by the Clavien- Dindo classification.
Measured: 8 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start15 Jun 2025
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
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 Renal Cell CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be valuated for local therapy (ie: surgery or radiotherapy) while they are receiving immunotherapy-based therapy.
- Masking
- None (open label)
- Enrolment
- 409 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Associazione Italiana per la Ricerca sul Cancro
- Responsible party
- Sponsor
- Investigators
- Roberto Iacovelli, M.D.; Ph.D., Principal investigator, Catholic University of Rome, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903312
- Sponsor's protocol ID
- 7056
- Acronym
- ITALIC-RCC
- Status last verified
- Jun 2025
- First submitted
- 24 Mar 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not planned at this time.
Publications
Iacovelli R, Ciccarese C, Arduini D, Tagliaferri L, Minervini A, Simone G, Ficarra V, Porta C, Calabro F, Zucali P, Troisi P, Francolini G, Morganti AG, Franzese C, Jereczek-Fossa BA, Maria Rocco BC. The ITALIC-RCC: A Randomized Trial on Clinical and Humoral Impact of Primary Tumor Ablation by Surgery or Radiotherapy in Metastatic Renal Cell Carcinoma Treated with Checkpoint Inhibitors. Eur Urol Open Sci. 2026 Jul 3;90:77-83. doi: 10.1016/j.euros.2026.06.004. eCollection 2026 Aug.
PubMed 42433301
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Humoral Impact of Primary Tumor Ablation in Metastatic Renal Cell Carcinoma Treated With Immunotherapy. The ITALIC-RCC Randomized Study.
- ClinicalTrials.gov ID
- NCT06903312
- Acronym / sponsor ID
- ITALIC-RCC / 7056
- Conditions
- Renal Cell Cancer, Kidney Neoplasm, Immunotherapy, Kidney Cancer, Surgery Programmed, Radiotherapy
- Keywords
- renal cancer, primary tumor, cytoreductive nephrectomy, immunothreapy, radiotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 409 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Collaborators
- Associazione Italiana per la Ricerca sul Cancro
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is Phase IV, randomized, multi arm, multicenter, low interventional clinical trial, aiming to evaluate if treatment of primary tumor in mRCC patients with initial benefit to anti-PD1- based therapy (SOC) can improve the overall survival.
All patients eligible according to inclusion and exclusion criteria will be enrolled and randomized to different treatment options based on tumor extension of the primary kidney cancer.
Those with primary kidney cancer ≤ 4 cm will be randomized 1:1:1 to receive:
- Cytoreductive Nephrectomy + standard of care (SOC) or
- RT on primary tumor + SOC or SOC alone.
Those with primary kidney cancer > 4 cm will be randomized 1:1 to receive:
- Deferred Cytoreductive Nephrectomy + SOC or SOC alone. Patients randomized to Deferred Cytoreductive Nephrectomy can be treated with one among radical nephrectomy; partial nephrectomy or lumpectomy.
Patients randomized to RT should be treated with single shot of 25 Gy (or with multiple fractions with equivalent biological dose).
The SOC medical therapy is the continuation of the combination of medical therapy for mRCC including one of the available combination among axitinib + pembrolizumab or cabozantinib + nivolumab or lenvatinib + pembrolizumab or nivolumab alone after nivolumab + ipilimumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients will be valuated for local therapy (ie: surgery or radiotherapy) while they are receiving immunotherapy-based therapy.
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy | Experimental | Radiation: Radiotherapy + medical treatmentPatients with tumors up to 4 cm can receive RT single shot of 25 Gy (or with multiple fractions with equivalent biological dose). |
| Deferred Cytoreductive Nephrectomy | Experimental | Procedure: Deferred Cytoreductive Nephrectomy + medical treatmentPatients randomized to Deferred Cytoreductive Nephrectomy can be treated with one among radical nephrectomy; partial nephrectomy or lumpectomy. |
| Control | Active comparator | Drug: Medical therapypatients in the control arm continue to receive immuno-based medical treatment for mRCC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Informed consent obtained before any study-specific procedures. Patients must be able to understand and be willing to sign a written informed consent.
- Male or female patient ≥18 years of age.
- Histological or cytological documentation of renal cell carcinoma with predominantly clear cell histology.
- Evidence of primary renal cancer.
- Measurable or not measurable metastatic disease according to Response Evaluation Criteria in Solid Tumors criteria, version 1.1 [22].
Key exclusion criteria (23 listed)
- More than one treatment for metastatic or locally advanced renal cell carcinoma.
- Solitary kidney
- Any contraindication to surgery or radiotherapy on primary renal tumor.
- Discontinuation (definitive) of one of the therapies for mRCC due to toxicity (previous discontinuation of ipilimumab in the ipilimumab + nivolumab combo is allowed).
- Concurrent or previous cancer within 3 years before enrolment EXCEPT curatively treated cervical cancer in situ, non-melanoma skin cancer and pT2 prostate cancer with PSA<0.01 or non-muscle invasive bladder cancer.
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 |
|---|---|---|
| Deferred Cytoreductive Nephrectomy + medical treatmentPatients randomized to Deferred Cytoreductive Nephrectomy can be treated with one among radical nephrectomy; partial nephrectomy or lumpectomy. Patients will continue to receive the ongoing medical treatment before the randomization. | Procedure or surgery | Deferred Cytoreductive Nephrectomy |
| Radiotherapy + medical treatmentPatients randomized to RT should be treated with single shot of 25 Gy (or with multiple fractions with equivalent biological dose). Patients will continue to receive the ongoing medical treatment before the randomization. | Radiation | Radiotherapy |
| Medical therapyAlso: Standard of Care (SOC)Medical therapy is the continuation of the immune-based combo for mRCC including one of the available options among axitinib + pembrolizumab or cabozantinib + nivolumab or lenvatinib + pembrolizumab or nivolumab alone after nivolumab + ipilimumab. | Drug | Control |
Primary outcome
30-months Overall Survival for surgery vs. control
Time frame: 30 months
The primary endpoint of the study is to assess the difference in 30-months overall survival (OS) between patients who receive or not the deferred citoreductive nephrectomy (CN) while on therapy with SOC for mRCC.
8 secondary outcomes
Median overall survival for surgery vs. control
Time frame: 30 months
Median Progression Free Survival for surgery vs. control
Time frame: 30 months
Median Overall Survival for radiotherapy vs. control
Time frame: 30 months
Median Progression Free Survival for radiotherapy vs. control
Time frame: 30 months
Incidence of adverse events
Time frame: 30 months
Difference in EQ-5D-5L quality of life test
Time frame: Baseline and 8 weeks after surgery or radiotherapy.
Difference in FKSI-19 quality of life test
Time frame: Baseline and 8 weeks after surgery or radiotherapy.
Incidence in of surgical complications.
Time frame: 8 weeks after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Derived from this study: PubMed 42433301Iacovelli R, Ciccarese C, Arduini D, Tagliaferri L, Minervini A, Simone G, Ficarra V, Porta C, Calabro F, Zucali P, Troisi P, Francolini G, Morganti AG, Franzese C, Jereczek-Fossa BA, Maria Rocco BC. The ITALIC-RCC: A Randomized Trial on Clinical and Humoral Impact of Primary Tumor Ablation by Surgery or Radiotherapy in Metastatic Renal Cell Carcinoma Treated with Checkpoint Inhibitors. Eur Urol Open Sci. 2026 Jul 3;90:77-83. doi: 10.1016/j.euros.2026.06.004. eCollection 2026 Aug.
- Individual participant dataSharing planned: No. Not planned at this time.
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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.
Roberto Iacovelli, M.D.; Ph.D. principal investigator
Catholic University of Rome, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Deferred Cytoreductive Nephrectomy + medical treatment, Radiotherapy + medical treatment and Medical therapy in people with Renal Cell Cancer and Kidney Neoplasm, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 17 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jul 2025. 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 Italy. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roberto Iacovelli, M.D.; Ph.D. (+390630157373, roberto.iacovelli@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-months Overall Survival for surgery vs. control (time frame: 30 months). 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 NCT06903312, 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 3 Jul 2025.