Oral Squamous Cell Carcinoma (OSCC)Phase 2NOCANONCT07514767
Evaluation of the Efficacy and Safety of Nivolumab Neoadjuvant Treatment of Patients With Locally Advanced Oral Squamous Cell Carcinoma
A Phase 2 study testing Nivolumab (240 mg) in people with Oral Squamous Cell Carcinoma (OSCC), run by Prof. Lars Olaf Cardell at 1 site in Sweden.
Trial summary
This is a Phase II, single-centre, non-randomized, single-arm clinical trial to investigate the efficacy and safety of neoadjuvant nivolumab therapy in adult participants with resectable, locoregionally advanced Oral Squamous Cell Carcinoma (OSCC) tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Squamous Cell Carcinoma (OSCC)
- What is being tested?
- Nivolumab (240 mg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 1 May 2026to Sep 2033
- Phase
- Phase 2
- 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
- The subject is willing to participate and has given their written and dated consent to participate in the trial.
- Naïve to immunotherapy.
- ≥ 18 years of age at the time of signing the informed consent.
- Primary histologically or cytologically confirmed Oral Squamous Cell Carcinoma classified according to the ICD-10 classification.
- Stage T2-4 N0-3 M0.
- The subject is planned for curative surgery as the primary treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Who cannot join
- Distant metastases (pathologically proven, radiologic or clinical evidence of distant metastatic disease). This includes all diseases below the clavicles, as well as disease metastatic to the bone, brain, or in the spinal canal.
- Active malignancy requiring concurrent treatment or history of another primary malignancy.
- History of radio- and/or chemotherapy.
- Pregnant, breastfeeding, planning pregnancy or refusal to use highly effective contraception method during the treatment period and for at least 5 months after the last dose.
- History of systemic treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
- Prior organ transplantation.
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- Treatment with a live (attenuated) vaccine within 4 weeks before Screening visit.
- Initiation of allergen immunotherapy within 3 months prior Screening visit or a plan to begin therapy during the trial.
- Known or suspected systemic hypersensitivity to the active substance nivolumab including any of the OPDIVO™ excipients.
- History of systemic hypersensitivity or anaphylaxis to other monoclonal antibodies including any excipient.
- Active, known, or suspected autoimmune disease or inflammatory disease (e.g. lupus, inflammatory bowel disease [e.g. colitis or Crohn's disease]), diverticulitis, rheumatoid arthritis, Sarcoidosis, Wegener syndrome, Grave's disease, uveitis, etc.) that has required systemic treatment with immune modifying agents in the last 2 years (e.g. replacement therapy such as thyroxine, insulin or physiological corticosteroids is not an exclusion criteria).*The subject may enroll if they have vitiligo, alopecia, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
- Presence of condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisolone equivalents) or other immunosuppressive medication within 14 days before the start of nivolumab therapy.
- Severe asthma exacerbation requiring the admission to hospital with systemic corticosteroids within 4 weeks before Screening visit.
- Known significant respiratory disease, including, but not limited to, pneumonitis, interstitial lung disease (ILD), chronic obstructive pulmonary disease, cystic fibrosis.
- Prior history or evidence of active ILD or non-infectious pneumonitis that required steroids
- Known or suspected condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome.
- Recent history of myocardial infarction, cardiac arrhythmia, unstable angina pectoris, transient ischemic attack, or a known history of a hypercoagulable disease.
- Known hepatitis B virus (HBV) and/or hepatitis C virus (HCV) acute or chronic infection. If suspected, tests for hepatitis B surface antigen (HBs Ag) and/or HCV antibody (HCV Ab) confirmed by HCV ribonucleic acid (RNA) are required.
- Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS) or positive HIV 1/2 serology test result if suspected.
- Active tuberculosis (TB), non-tuberculous mycobacterial infection, a history of incompletely treated TB. TB test if suspected.
- Known or suspected immunodeficiency, including history of invasive opportunistic infections (e.g. TB, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis or aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency or prolonged duration suggesting a compromised immune system status, as judged by the Investigator.
- Uncontrolled concurrent medical disorder affecting organ function and in the opinion of the Investigator may increase the risk for the subject or may interfere with the treatment and thus affect the study results or assessment.
- Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
- Known or suspected heavy drinking and/or drug use.
- In the opinion of the Investigator, the subject is unfit or unsuitable to receive neoadjuvant nivolumab, whatever the reason, including medical or clinical condition.
- Any mental inability (e.g. dementia), reluctance or language difficulties that result in difficulty understanding the meaning of participation in the clinical trial and following the study protocol and instructions.
- Lack of adherence to the study protocol and instructions given by the Investigator.
- Premature withdrawal by the Investigator/Sponsor due to safety or any other reason.
- Revoked consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hanna Carstens, MD contact
Sweden1 site
Karolinska University Hospital, Head-, neck-, lung- and skin cancer, Theme Cancer
Stockholm
Hanna Dr Carstens
About this study
Official title: NOCANO: Nivolumab as Neoadjuvant Immunotherapy for Patients With Oral CANcer and Identification of Response-predictive Biomarkers in Tumour Draining Lymph NOdes
This is a Phase II, single-centre, non-randomized, single-arm clinical trial to investigate the efficacy and safety of neoadjuvant nivolumab therapy in adult participants with resectable, locoregionally advanced Oral Squamous Cell Carcinoma (OSCC) tumors. Identification of predictive molecular biomarkers of tumor response to treatment will also be performed.
Read the detailed description
Patients 18 years old and above, any gender, naïve to immunotherapy, and with histologically confirmed T2-4 N0-3 M0 resectable Oral Squamous Cell Carcinoma tumors will be eligible for this clinical trial. Enrolled patients must be fit and eligible for the primary treatment of curative surgery at the primary tumor site with sentinel node identification and removal. Total 60 patients fulfilling eligibility criteria will be included during the period of three years and will receive a total of 2 doses (240 mg per dose) of nivolumab at day 1 and day 15 prior to the curative standard of care surgery. After the study treatment and standard of care surgery, the study participants will be offered evidence-based adjuvant therapy, such as radiotherapy, chemoradiotherapy and checkpoint inhibitors or combination treatments, according to the existing evidence.
The study duration per participant after inclusion is approximately 27 weeks including two study-related follow-up visits at 3 and 6 months after the second nivolumab dose. Survival status and disease status of every participant will be also reviewed in medical records at 1, 2, 3 and 5 years after the second nivolumab dose.
- Conditions
- Oral Squamous Cell Carcinoma (OSCC)
- Being tested
- Nivolumab (240 mg)
- Keywords
- neoadjuvant, Nivolumab, anti-PD-1
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab (240 mg)Drug
Nivolumab at day 1 and day 15 prior to the curative standard of care surgery.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant treatment | Experimental | Drug:Nivolumab Receives: Drug: Nivolumab (240 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of response
Frequency of tumor response measured as Objective Response Rate (ORR) based on the standard RECIST v1.1 criteria, assessed using radiographic images.
Measured: From start of neoadjuvant treatment to end of neoadjuvant treatment (before surgery), up to approximately 4 weeks
Frequency of pathological response
Tumour pathological response, defined as percentage residual tumour cells after treatment, measured as Pathologic Complete Response, pCR (no residual tumour cells in tumor bed or lymph nodes), Major Pathological Response, MPR (≤10% residual viable tumour), Pathological Partial Response, pPR (≤50% residual viable tumour).
Measured: From start of neoadjuvant treatment to end of neoadjuvant treatment (before surgery), up to approximately 4 weeks
Frequency of volumetric tumour response
Volumetric tumour response, measured by radiographic images and/or physical measurements and assessments.
Measured: From start of neoadjuvant treatment to end of neoadjuvant treatment (before surgery), up to approximately 4 weeks
Secondary outcomes (17)
Incidence of treatment-related Adverse events (TRAEs)
Incidence of treatment related adverse events classified according to the definitions in NCI CTCAE version 5.0.
Measured: From start of neoadjuvant treatment up to and including 6 months.
Incidence of Serious adverse events (SAE)
Incidence of serious adverse events
Measured: From start of neoadjuvant treatment up to and including 6 months.
Change from baseline in hematology parameters
Change from baseline in white blood cells (WBC), white blood cell differentiation, absolute neutrophil count (ANC), thrombocytes/platelets, erythrocytes (haematocrit), (B)Erc-MCH, (B)Erc-MCV, haemoglobin (Hb).
Measured: From screening visit, assessed at regular intervals up to 6 months after first neoadjuvant treatment
Change from baseline in clinical chemistry parameters
Change from baseline in Electrolyte status: sodium (Na), potassium (K), calcium (Ca), creatinine, Liver status: albumin, bilirubin, alkaline phosphatase (ALP), alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), lactate dehydrogenase (LD), gamma-glutamyl transferase (GGT), Amylase, glucose, and c-reactive protein (CRP).
Measured: From screening visit, assessed at regular intervals up to 6 months after first neoadjuvant treatment
Change from baseline in vital signs
Change in vital signs including heart rate, systolic and diastolic blood pressure, body temperature, respiratory rate.
Measured: From screening visit up to 6 months after first neoadjuvant treatment
Change from baseline in Electrocardiogram (ECG) values
Change from baseline in ECG values, including ECG QT interval, heart rhythm and rate, ST segment and T wave
Measured: From screening visit up to 6 months after first neoadjuvant treatment
Rate of postoperative complications
Rate of postoperative complications
Measured: From surgery to date of any postoperative complication, assessed up to 5 months post surgery
Incidence of surgery delays or surgery cancelation
Incidence of surgery delays/cancellations due to disease progression or treatment related adverse reactions during the neoadjuvant treatment period.
Measured: From start of neoadjuvant treatment to date of surgery, assessed up to 6 months
Incidence of reduced extent of surgical intervention
Incidence of reduced extent of surgical intervention with achieved negative/clear surgical margins (SM) or spared from surgery due to complete response to neoadjuvant therapy.
Measured: At surgery, 3 weeks after start of neoadjuvant treatment
Incidence of immunogenicity
Incidence of immunogenicity as measured by the presence of antidrug antibody (ADA) and neutralizing antibodies (NAb) to nivolumab
Measured: From pre-screening to 5 months after surgery
Proportion of participants with progression-free survival (PFS) and event-free survival (EFS) at distinct timepoints
Number of patients that had not experienced disease progression (PFS) or any event (EFS) such as recurrence, treatment-related complications, or death at distinct time points.
Measured: From second dose of neoadjuvant treatment, assessed one, two, three, four and five years after the second dose of neoadjuvant treatment
Rate of overall survival at distinct timepoints up to 5-year follow-up
Number of patients that survived at distinct time points up to 5-year follow-up
Measured: From second dose of neoadjuvant treatment, assessed one, two, three, four and five years after second dose of neoadjuvant treatment.
Effect of neoadjuvant nivolumab treatment on a quality of life (QOL)
Time to clinically relevant changes defined as ≥10-point change for all scales in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck 35 (EORTC QLQ-H\&N35).
Measured: From screening visit assessed up to 6 months
Incidence of HPV status in tumour
HPV status assessment of tumor and incidence reporting during pre-screening.
Measured: At pre-screening visit, 1-5 weeks before first neoadjuvant treatment
Correlation of HPV status and response to neoadjuvant therapy
Correlation of HPV status and response to neoadjuvant therapy as defined RECIST 1.1
Measured: From pre-screening visit to end of neoadjuvant treatment, up to 8 weeks
Proportion of patients with response at lymph nodes
Lymph node response, according to the RECIST v1.1 criteria
Measured: From pre-screening to surgery, up to 8 weeks
Change in the number of metastatic lymph nodes
Number of metastatic lymph nodes, defined according to the RECIST v1.1 criteria.
Measured: From prescreening to surgery, up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Squamous Cell Carcinoma (OSCC)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Lars Olaf Cardell
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Lars Olaf Cardell, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514767
- Sponsor's protocol ID
- NOCANO_SWE
- Other IDs
- 2025-521006-18-00, 2025
- Acronym
- NOCANO
- Status last verified
- Apr 2026
- First submitted
- 27 Feb 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NOCANO: Nivolumab as Neoadjuvant Immunotherapy for Patients With Oral CANcer and Identification of Response-predictive Biomarkers in Tumour Draining Lymph NOdes
- ClinicalTrials.gov ID
- NCT07514767
- Acronym / sponsor ID
- NOCANO / NOCANO_SWE
- Conditions
- Oral Squamous Cell Carcinoma (OSCC)
- Keywords
- neoadjuvant, Nivolumab, anti-PD-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Prof. Lars Olaf CardellUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2033 (estimated)
- First posted
- 7 Apr 2026 (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 a Phase II, single-centre, non-randomized, single-arm clinical trial to investigate the efficacy and safety of neoadjuvant nivolumab therapy in adult participants with resectable, locoregionally advanced Oral Squamous Cell Carcinoma (OSCC) tumors. Identification of predictive molecular biomarkers of tumor response to treatment will also be performed.
Detailed description
Patients 18 years old and above, any gender, naïve to immunotherapy, and with histologically confirmed T2-4 N0-3 M0 resectable Oral Squamous Cell Carcinoma tumors will be eligible for this clinical trial. Enrolled patients must be fit and eligible for the primary treatment of curative surgery at the primary tumor site with sentinel node identification and removal. Total 60 patients fulfilling eligibility criteria will be included during the period of three years and will receive a total of 2 doses (240 mg per dose) of nivolumab at day 1 and day 15 prior to the curative standard of care surgery. After the study treatment and standard of care surgery, the study participants will be offered evidence-based adjuvant therapy, such as radiotherapy, chemoradiotherapy and checkpoint inhibitors or combination treatments, according to the existing evidence.
The study duration per participant after inclusion is approximately 27 weeks including two study-related follow-up visits at 3 and 6 months after the second nivolumab dose. Survival status and disease status of every participant will be also reviewed in medical records at 1, 2, 3 and 5 years after the second nivolumab dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant treatment | Experimental | Drug: Nivolumab (240 mg)Drug:Nivolumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The subject is willing to participate and has given their written and dated consent to participate in the trial.
- Naïve to immunotherapy.
- ≥ 18 years of age at the time of signing the informed consent.
- Primary histologically or cytologically confirmed Oral Squamous Cell Carcinoma classified according to the ICD-10 classification.
- Stage T2-4 N0-3 M0.
Key exclusion criteria (29 listed)
- Distant metastases (pathologically proven, radiologic or clinical evidence of distant metastatic disease). This includes all diseases below the clavicles, as well as disease metastatic to the bone, brain, or in the spinal canal.
- Active malignancy requiring concurrent treatment or history of another primary malignancy.
- History of radio- and/or chemotherapy.
- Pregnant, breastfeeding, planning pregnancy or refusal to use highly effective contraception method during the treatment period and for at least 5 months after the last dose.
- History of systemic treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
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 |
|---|---|---|
| Nivolumab (240 mg)Nivolumab at day 1 and day 15 prior to the curative standard of care surgery. | Drug | Neoadjuvant treatment |
Primary outcome
Frequency of response
Time frame: From start of neoadjuvant treatment to end of neoadjuvant treatment (before surgery), up to approximately 4 weeks
Frequency of tumor response measured as Objective Response Rate (ORR) based on the standard RECIST v1.1 criteria, assessed using radiographic images.
Frequency of pathological response
Time frame: From start of neoadjuvant treatment to end of neoadjuvant treatment (before surgery), up to approximately 4 weeks
Tumour pathological response, defined as percentage residual tumour cells after treatment, measured as Pathologic Complete Response, pCR (no residual tumour cells in tumor bed or lymph nodes), Major Pathological Response, MPR (≤10% residual viable tumour), Pathological Partial Response, pPR (≤50% residual viable tumour).
Frequency of volumetric tumour response
Time frame: From start of neoadjuvant treatment to end of neoadjuvant treatment (before surgery), up to approximately 4 weeks
Volumetric tumour response, measured by radiographic images and/or physical measurements and assessments.
17 secondary outcomes
Incidence of treatment-related Adverse events (TRAEs)
Time frame: From start of neoadjuvant treatment up to and including 6 months.
Incidence of Serious adverse events (SAE)
Time frame: From start of neoadjuvant treatment up to and including 6 months.
Change from baseline in hematology parameters
Time frame: From screening visit, assessed at regular intervals up to 6 months after first neoadjuvant treatment
Change from baseline in clinical chemistry parameters
Time frame: From screening visit, assessed at regular intervals up to 6 months after first neoadjuvant treatment
Change from baseline in vital signs
Time frame: From screening visit up to 6 months after first neoadjuvant treatment
Change from baseline in Electrocardiogram (ECG) values
Time frame: From screening visit up to 6 months after first neoadjuvant treatment
Rate of postoperative complications
Time frame: From surgery to date of any postoperative complication, assessed up to 5 months post surgery
Incidence of surgery delays or surgery cancelation
Time frame: From start of neoadjuvant treatment to date of surgery, assessed up to 6 months
Incidence of reduced extent of surgical intervention
Time frame: At surgery, 3 weeks after start of neoadjuvant treatment
Incidence of immunogenicity
Time frame: From pre-screening to 5 months after surgery
Proportion of participants with progression-free survival (PFS) and event-free survival (EFS) at distinct timepoints
Time frame: From second dose of neoadjuvant treatment, assessed one, two, three, four and five years after the second dose of neoadjuvant treatment
Rate of overall survival at distinct timepoints up to 5-year follow-up
Time frame: From second dose of neoadjuvant treatment, assessed one, two, three, four and five years after second dose of neoadjuvant treatment.
Effect of neoadjuvant nivolumab treatment on a quality of life (QOL)
Time frame: From screening visit assessed up to 6 months
Incidence of HPV status in tumour
Time frame: At pre-screening visit, 1-5 weeks before first neoadjuvant treatment
Correlation of HPV status and response to neoadjuvant therapy
Time frame: From pre-screening visit to end of neoadjuvant treatment, up to 8 weeks
Proportion of patients with response at lymph nodes
Time frame: From pre-screening to surgery, up to 8 weeks
Change in the number of metastatic lymph nodes
Time frame: From prescreening to surgery, up to 8 weeks
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 7 Apr 2026.
- 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.
Hanna Carstens, MD contact
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 Nivolumab (240 mg) in people with Oral Squamous Cell Carcinoma (OSCC), run by Prof. Lars Olaf Cardell at 1 site in Sweden.
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 7 inclusion and 29 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: opening soon, as of the sponsor's last update on 7 Apr 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 Sweden. 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?
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 Lars Olaf Cardell, MD, PhD (+468-123 70 000, lars-olaf.cardell@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of response (time frame: From start of neoadjuvant treatment to end of neoadjuvant treatment (before surgery), up to approximately 4 weeks). 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 7 Apr 2026.