Clear-cell Renal Cell CarcinomaPhase 2NCT03035630
Sunitinib Followed by Avelumab or the Reverse for Metastatic Renal Cell Carcinoma
A Phase 2 study testing Avelumab and Sunitinib in people with Clear-cell Renal Cell Carcinoma and RCC, run by Guru Sonpavde at 1 site in United States.
Trial summary
This is an open label, randomized phase II trial. Eligible subjects will be randomized in a 1:1 ratio and stratified for known prognostics variables to one of two first-line medication treatment arms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clear-cell Renal Cell Carcinoma, RCC, Kidney Cancer
- What is being tested?
- Avelumab and Sunitinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2017to Dec 2020
- Phase
- Phase 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
- Subjects must meet all of the following applicable inclusion criteria to participate in this study:
- Written informed consent and HIPAA authorization for release of personal health information prior to registration.
- Age ≥ 18 years at the time of consent.
- Karnofsky performance status ≥ 60 within 28 days prior to registration.
- Histological or cytological confirmation of ccRCC (component of clear cell histology required).
- Measurable metastatic disease according to RECIST 1.1 criteria within 28 days prior to registration.
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- Received no prior mTOR or PD1/PD-L1 inhibitors (prior IL-2 is allowed). Prior VEGF inhibitor is allowed only if >12 months prior to registration, and only if earlier if administered in the neoadjuvant or adjuvant setting
- Females of childbearing potential must have a negative serum pregnancy test within 14 days prior to registration. NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months
- Females of childbearing potential and males must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 60 days after treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method.
- As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study
Who cannot join
- Subjects meeting any of the criteria below may not participate in the study:
- Active infection requiring systemic therapy.
- Known HIV positive (HIV testing is not required for eligibility)
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- Known additional invasive malignancy that is active and/or progressive requiring treatment; exceptions include locally curable cancers, or other cancer for which the subject has been disease-free for at least three years or prostate cancer on surveillance.
- Active central nervous system (CNS) metastases (previously treated CNS metastasis are allowed if subject completed radiation ≥2 weeks earlier and off steroids, and neurologically stable or subject has been on requiring ≤10 mg of daily prednisone or prednisone equivalent dose of another corticosteroid for ≥2 weeks) is acceptable)
Show all 35Show fewer
- Treatment with any investigational agent (chemotherapy or biologic treatment) within 28 days prior to registration.
- Subjects who have not recovered from toxicities from prior systemic anti-cancer treatment or local therapies (a residual toxicity likely to be chronic but controlled and manageable is allowed, e.g. endocrine syndromes from prior interleukin-2).
- Subjects who have undergone major surgery < 4 weeks or minor surgery < 2 weeks prior to registration. Wounds must be completely healed prior to study entry and subjects must have recovered from all toxicities from surgery. NOTE: placement of a vascular access device is not considered major or minor surgery in this regard.
- Prior radiation therapy is allowed as long as irradiated area was not the sole source of measurable disease and radiotherapy was completed with recovery from toxicity, at least 2 weeks prior to registration, and subject has recovered from toxicity. If the irradiated area is the only site of disease, there must be evidence of progressive disease outside of the radiation field .
- Uncontrolled adrenal insufficiency
- Any active known or suspected autoimmune disease
- Recent or active bleeding diathesis or arterial vascular event (including embolic arterial event such as cerebrovascular accident (or transient ischemic attacks) within 6 months of registration. NOTE: subjects with deep venous thrombosis or pulmonary embolism allowed even within 6 months if controlled on anticoagulation (such as warfarin or heparin provided that their medication dose and INR/PTT are stable)
- Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter the study
- Uncontrolled hypertension (systolic pressure > 140 mm Hg or diastolic pressure > 90 mm Hg on repeated measurement) despite optimal medical management.
- Active or clinically significant cardiac disease within 6 months including:
- Symptomatic Congestive heart failure - New York Heart Association (NYHA)
- > Class II
- Symptomatic Coronary artery disease (controlled clinically on medication allowed)
- Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin. Controlled atrial fibrillation is allowed.
- Unstable angina or myocardial infarction.
- Any hemorrhage or bleeding event ≥ NCI CTCAE v4 Grade 3 within 4 weeks prior to start of study medication.
- Subjects with any previously untreated or concurrent cancer that is distinct in primary site or histology from ccRCC except cervical cancer in-situ, treated localized basal cell carcinoma, Gleason score 6 prostate cancer or superficial bladder tumor.
- Known current or chronic hepatitis B or C infection requiring treatment with antiviral therapy. (NOTE: testing not required)
- Presence of non-healing wound, non-healing ulcer or bone fracture.
- Renal failure requiring hemo- or peritoneal dialysis.
- Persistent proteinuria ≥ Grade 3 NCI-CTCAE v4 (> 3.5 g/24hrs, measured by urine protein: creatinine ratio on a random urine sample)
- Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)."
- Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
- Pleural effusion or ascites that causes respiratory compromise (≥ Grade 2 dyspnea NCI-CTCAE v4)
- History of organ allograft (including corneal transplant)
- Known or suspected allergy or hypersensitivity to any drugs, study drug classes, or excipients of the formulations given during the course of this trial.
- Any uncontrolled malabsorption condition
- Any condition which in the site investigator's opinion, makes the subject unsuitable for trial participation.
- Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama Hematology Oncology Clinic at Medical West
Birmingham, Alabama, 35294
About this study
Official title: Randomized Phase II Trial Comparing Sequential First-line Sunitinib and Second-line Avelumab vs First-line Avelumab and Second-line Sunitinib for Metastatic Renal Cell Carcinoma: SUAVE Trial. Hoosier Cancer Research Network GU15-223
This is an open label, randomized phase II trial. Eligible subjects will be randomized in a 1:1 ratio and stratified for known prognostics variables to one of two first-line medication treatment arms. Once disease progression has been documented, and following a required inter-line washout period, subjects will receive either second-line medication treatment or discontinue treatment, per discretion of treating investigator.
Read the detailed description
OUTLINE: This is a multi-center trial. Eligible subjects will be randomized and stratified to one of two arms:
FIRST-LINE INVESTIGATIONAL TREATMENT ARM A:
- Avelumab 10mg/kg intravenously (IV) on Day 1 (D1) and Day 15 (D15) of every 28 day cycle until documented disease progression per Immune-related Response Evaluation Criteria In Solid Tumors (irRECIST) 1.1
SECOND-LINE INVESTIGATIONAL TREATMENT ARM A:
- Following completion of an inter-line washout period of a minimum of 2 weeks up to a maximum of 60 days (or at the discretion of treating investigator) subjects will receive:
- Sunitinib 50 mg by mouth (po) once daily from D1 to D14 of every 21 day cycle until documented disease progression per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 OR
- Discontinue treatment
FIRST-LINE INVESTIGATIONAL TREATMENT ARM B:
- Sunitinib 50 mg po once daily from D1 to D14 of every 21 day cycle until documented disease progression per RECIST 1.1
SECOND-LINE INVESTIGATIONAL TREATMENT ARM B:
- Following completion of an inter-line washout period of a minimum of 2 weeks up to a maximum of 60 days (or at the discretion of treating investigator) subjects will receive:
- Avelumab 10mg/kg IV on D1 and D15 every 28 day cycle until documented disease progression per irRECIST 1.1 OR
- Discontinue treatment
NOTE:
Subjects who do not experience disease progression at end of first-line treatment and are removed from first-line treatment due to toxicities or personal decision, may also either receive second-line therapy or be monitored during the inter-line period until progression (which may be longer than 60 days) per discretion of treating investigator.
Radiological disease evaluation assessments will be completed every 12 weeks.
To demonstrate adequate organ function, all screening labs must be obtained within 14 days prior to registration:
Hematological:
- Absolute Neutrophil Count (ANC) ≥ 1.5 K/mm3
- Hemoglobin (Hgb) ≥ 9 g/dL
- Platelets ≥ 100 K/ mm3
Renal:
- Calculated creatinine clearance by Cockcroft-Gault formula ≥ 40 ml/min
Hepatic:
- Bilirubin ≤ 1.5 × upper limit of normal (ULN)
- Aspartate aminotransferase (AST) ≤ 2.5 × ULN
- Alanine aminotransferase (ALT) ≤ 2.5 × ULN
Miscellaneous:
- Urine/serum pregnancy test - Negative
- Keywords
- Avelumab, Sunitinib, MSB0010718C, Sutent, IgG1 antibody, Anti-PD-L1, Tyrosine kinase inhibitor
- 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.
AvelumabDrug
Also called MSB0010718C
Avelumab 10mg/kg IV over 60 minutes on D1 and D15 of every 28 day cycle
SunitinibDrug
Also called Sutent
Sunitinib 50 mg once daily from D1 to D14 of every 21 day cycle
| Study group | Role | What they receive |
|---|---|---|
| Avelumab then Sunitinib for Investigational Arm A | Experimental | First-Line Medication:
* Avelumab 10mg/kg IV on D1 and D15 of every 28 day cycle, until irRECIST 1.1 disease progression criteria is documented.
* Subjects will have a mandatory an inter-line washout period (14-60 days) before receiving first dose of second-line medication.
Second-Line Medication:
* Sunitinib 50 mg po once daily from D1 to D14 of every 21 day cycle until RECIST 1.1 disease progression criteria is documented.
Subjects who do not have disease progression at end of first-line treatment and are removed due to toxicities or personal decision, may switch to either the second-line therapy or be monitored during the inter-line period until progression, which may be longer than 60 days. Receives: Drug: Avelumab; Drug: Sunitinib |
| Sunitinib then Avelumab for Investigational Arm B | Experimental | First-Line Medication:
* Sunitinib 50 mg po once daily from D1 to D14 of every 21 day cycle until RECIST 1.1 disease progression criteria is documented.
* Subjects will have a mandatory inter-line washout period (14-60 days) before receiving first dose of second-line medication.
Second-Line Medication:
* Avelumab 10mg/kg IV on D1 and D15 of every 28 day cycle, until irRECIST 1.1 disease progression criteria is documented.
Subjects who do not have disease progression at end of first-line treatment and are removed due to toxicities or personal decision, may switch to either the second-line therapy or be monitored during the inter-line period until progression, which may be longer than 60 days. Receives: Drug: Avelumab; Drug: Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Progression-Free Survival (PFS)
Compare PFS1 + PFS2 rates for overall PFS
Measured: up to 24 months
Secondary outcomes (4)
Overall Failure-Free Survival (FFS)
Compare FFS1 rates for first-line therapy on each arm
Measured: up to 24 months
Overall Survival (OS)
Compare OS rates for subjects on each arm
Measured: up to 36 months
Overall Response Rate (RR)
Compare RR and PFS1 of sunitinib vs. avelumab as first-line therapy and PFS2 as second-line therapy
Measured: 2 years
Overall Toxicities
Describe toxicities of sunitinib and avelumab
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start23 May 2017
- Primary completionDec 2018 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: Principal investigator left lead institution and efforts to open the protocol at another institution were not successful.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clear-cell Renal Cell CarcinomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guru Sonpavde
- Sponsor type
- University, hospital or other
- Collaborators
- Hoosier Cancer Research Network, Pfizer
- Responsible party
- Sponsor-investigator, Guru Sonpavde, Hoosier Cancer Research Network
- Investigators
- Guru Sonpavde, M.D., Study chair, Hoosier Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035630
- Sponsor's protocol ID
- HCRN GU15-223
- Status last verified
- Feb 2022
- First submitted
- 24 Jan 2017
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial Comparing Sequential First-line Sunitinib and Second-line Avelumab vs First-line Avelumab and Second-line Sunitinib for Metastatic Renal Cell Carcinoma: SUAVE Trial. Hoosier Cancer Research Network GU15-223
- ClinicalTrials.gov ID
- NCT03035630
- Acronym / sponsor ID
- HCRN GU15-223
- Keywords
- Avelumab, Sunitinib, MSB0010718C, Sutent, IgG1 antibody, Anti-PD-L1, Tyrosine kinase inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal investigator left lead institution and efforts to open the protocol at another institution were not successful.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Guru SonpavdeUniversity, hospital or other
- Collaborators
- Hoosier Cancer Research Network, Pfizer
- Study start
- 23 May 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 30 Jan 2017 (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 is an open label, randomized phase II trial. Eligible subjects will be randomized in a 1:1 ratio and stratified for known prognostics variables to one of two first-line medication treatment arms. Once disease progression has been documented, and following a required inter-line washout period, subjects will receive either second-line medication treatment or discontinue treatment, per discretion of treating investigator.
Detailed description
OUTLINE: This is a multi-center trial. Eligible subjects will be randomized and stratified to one of two arms:
FIRST-LINE INVESTIGATIONAL TREATMENT ARM A:
- Avelumab 10mg/kg intravenously (IV) on Day 1 (D1) and Day 15 (D15) of every 28 day cycle until documented disease progression per Immune-related Response Evaluation Criteria In Solid Tumors (irRECIST) 1.1
SECOND-LINE INVESTIGATIONAL TREATMENT ARM A:
- Following completion of an inter-line washout period of a minimum of 2 weeks up to a maximum of 60 days (or at the discretion of treating investigator) subjects will receive:
- Sunitinib 50 mg by mouth (po) once daily from D1 to D14 of every 21 day cycle until documented disease progression per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 OR
- Discontinue treatment
FIRST-LINE INVESTIGATIONAL TREATMENT ARM B:
- Sunitinib 50 mg po once daily from D1 to D14 of every 21 day cycle until documented disease progression per RECIST 1.1
SECOND-LINE INVESTIGATIONAL TREATMENT ARM B:
- Following completion of an inter-line washout period of a minimum of 2 weeks up to a maximum of 60 days (or at the discretion of treating investigator) subjects will receive:
- Avelumab 10mg/kg IV on D1 and D15 every 28 day cycle until documented disease progression per irRECIST 1.1 OR
- Discontinue treatment
NOTE:
Subjects who do not experience disease progression at end of first-line treatment and are removed from first-line treatment due to toxicities or personal decision, may also either receive second-line therapy or be monitored during the inter-line period until progression (which may be longer than 60 days) per discretion of treating investigator.
Radiological disease evaluation assessments will be completed every 12 weeks.
To demonstrate adequate organ function, all screening labs must be obtained within 14 days prior to registration:
Hematological:
- Absolute Neutrophil Count (ANC) ≥ 1.5 K/mm3
- Hemoglobin (Hgb) ≥ 9 g/dL
- Platelets ≥ 100 K/ mm3
Renal:
- Calculated creatinine clearance by Cockcroft-Gault formula ≥ 40 ml/min
Hepatic:
- Bilirubin ≤ 1.5 × upper limit of normal (ULN)
- Aspartate aminotransferase (AST) ≤ 2.5 × ULN
- Alanine aminotransferase (ALT) ≤ 2.5 × ULN
Miscellaneous:
- Urine/serum pregnancy test - Negative
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Avelumab then Sunitinib for Investigational Arm A | Experimental | Drug: Avelumab, Drug: SunitinibFirst-Line Medication: * Avelumab 10mg/kg IV on D1 and D15 of every 28 day cycle, until irRECIST 1.1 disease progression criteria is documented. * Subjects will have a mandatory an inter-line washout period (14-60 days) before receiving first dose of second-line medication. Second-Line Medication: * Sunitinib 50 mg po once daily from D1 to D14 of every 21 day cycle until RECIST 1.1 disease progression criteria is documented. Subjects who do not have disease progression at end of first-line treatment and are removed due to toxicities or personal decision, may switch to either the second-line therapy or be monitored during the inter-line period until progression, which may be longer than 60 days. |
| Sunitinib then Avelumab for Investigational Arm B | Experimental | Drug: Avelumab, Drug: SunitinibFirst-Line Medication: * Sunitinib 50 mg po once daily from D1 to D14 of every 21 day cycle until RECIST 1.1 disease progression criteria is documented. * Subjects will have a mandatory inter-line washout period (14-60 days) before receiving first dose of second-line medication. Second-Line Medication: * Avelumab 10mg/kg IV on D1 and D15 of every 28 day cycle, until irRECIST 1.1 disease progression criteria is documented. Subjects who do not have disease progression at end of first-line treatment and are removed due to toxicities or personal decision, may switch to either the second-line therapy or be monitored during the inter-line period until progression, which may be longer than 60 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects must meet all of the following applicable inclusion criteria to participate in this study:
- Written informed consent and HIPAA authorization for release of personal health information prior to registration.
- Age ≥ 18 years at the time of consent.
- Karnofsky performance status ≥ 60 within 28 days prior to registration.
- Histological or cytological confirmation of ccRCC (component of clear cell histology required).
Key exclusion criteria (35 listed)
- Active infection requiring systemic therapy.
- Known HIV positive (HIV testing is not required for eligibility)
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- Known additional invasive malignancy that is active and/or progressive requiring treatment; exceptions include locally curable cancers, or other cancer for which the subject has been disease-free for at least three years or prostate cancer on surveillance.
- Active central nervous system (CNS) metastases (previously treated CNS metastasis are allowed if subject completed radiation ≥2 weeks earlier and off steroids, and neurologically stable or subject has been on requiring ≤10 mg of daily prednisone or prednisone equivalent dose of another corticosteroid for ≥2 weeks) is acceptable)
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 |
|---|---|---|
| AvelumabAlso: MSB0010718CAvelumab 10mg/kg IV over 60 minutes on D1 and D15 of every 28 day cycle | Drug | Avelumab then Sunitinib for Investigational Arm A, Sunitinib then Avelumab for Investigational Arm B |
| SunitinibAlso: SutentSunitinib 50 mg once daily from D1 to D14 of every 21 day cycle | Drug | Avelumab then Sunitinib for Investigational Arm A, Sunitinib then Avelumab for Investigational Arm B |
Primary outcome
Overall Progression-Free Survival (PFS)
Time frame: up to 24 months
Compare PFS1 + PFS2 rates for overall PFS
4 secondary outcomes
Overall Failure-Free Survival (FFS)
Time frame: up to 24 months
Overall Survival (OS)
Time frame: up to 36 months
Overall Response Rate (RR)
Time frame: 2 years
Overall Toxicities
Time frame: up to 36 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Hoosier Cancer Research Network WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Guru Sonpavde, M.D. study chair
Hoosier Cancer Research Network
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 Avelumab and Sunitinib in people with Clear-cell Renal Cell Carcinoma and RCC, run by Guru Sonpavde 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 10 inclusion and 35 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: withdrawn, as of the sponsor's last update on 15 Feb 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Overall Progression-Free Survival (PFS) (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.