Head and Neck Squamous Cell Carcinoma (HNSCC)Phase 2NCT07465276
Neoadjuvant Ficerafusp Alfa With Pembrolizumab in Resectable SCC
A Phase 2 study testing Ficerafusp alfa and Pembrolizumab in people with Head and Neck Squamous Cell Carcinoma (HNSCC) and Squamous Cell Carcinoma of the Head and Neck, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
This trial is to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab prior to surgical resection in participants with resectable, high-risk, locoregionally advanced, PD-L1-positive squamous cell carcinoma of the head and neck (HNSCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma (HNSCC), Squamous Cell Carcinoma of the Head and Neck
- What is being tested?
- Ficerafusp alfa and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Mar 2026to 30 Apr 2030
- 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
- Participants must have histologically or cytologically confirmed, untreated and newly diagnosed, locoregionally advanced head and neck squamous cell carcinoma (HNSCC) arising from oral cavity, oropharynx (with documented HPV-negative disease if presenting with oropharyngeal SCC), larynx, or hypopharynx.
- Participants should have resectable disease at baseline per the discretion of the treating surgical oncologist.
- Participants must have clinical stage disease as defined below using the 8th (2017) edition of the tumor, node, metastasis (TNM) staging system by the American Joint Committee on Cancer (AJCC) and the Union for International Cancer Control (UICC):
- T1-2, N1-3: III
- T3, any N: III, IVA, IVB
- T4, any N: IVA, IVB
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- Tumor must be PD-L1 positive with a CPS score equal to 1 or greater (by any approved assay or scoring method).
- Participants must be willing to provide blood and tissue pre-treatment and at the time of surgery for pathologic and correlative analyses. Specifically, willingness to provide a newly obtained core or excisional biopsy of a tumor lesion from the primary tumor site.
- Age 18 years or older at the time of informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Participants must have adequate organ and marrow function as defined below:
- absolute neutrophil count ≥1500/mcL
- platelets ≥100 x 109/L
- total serum bilirubin ≤1.5X upper limit of normal (ULN) (except for subjects with documented Gilbert syndrome) and AST (SGOT) and ALT (SGPT) ≤2.5X ULN
- AST(SGOT) / ALT (SGPT) ≤3X ULN
- Creatinine ≤institutional ULN or GFR of ≥30 mL/min/1.73 m2
- Coagulation PT/INR or activated partial thromboplastin time (aPTT) ≤1.5X ULN unless subject is receiving anticoagulant therapy
- Female participants of childbearing potential should have a negative urine or serum pregnancy test within 7 days of study registration. Female subjects of childbearing potential should have a negative urine or serum pregnancy test repeated within 72 hours prior to receiving the first dose of study medication.
- Female participants of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 120 days after the last dose of study drugs.
- Unsterilized male patient having sex with a female partner of childbearing potential must agree to use an effective method of contraception from the beginning of screening until day 60 after the last dose of study drugs.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Recurrent or metastatic (M1 or IVC disease by AJCC 2017 8th edition staging) HNSCC or very early-stage HNSCC (stage I or II by AJCC 2017 8th edition staging); or head and neck cancer arising at other primary subsites such as the skin, paranasal sinuses, nasal cavity, or salivary glands.
- HPV-associated oropharyngeal cancer (as determined by p16 positivity by immunohistochemistry and/or confirmatory HPV RNA ISH or PCR testing, or by plasma HPV DNA testing results).
- Inoperable or surgically unresectable at baseline per the treating investigator(s).
- ECOG performance status of 2 or greater.
- Prior exposure to anti-EGFR antibody or anti-PD-1 immunotherapy.
- Significant bleeding risk peri-operatively at the judgment of the treating investigator(s); such as those with a known bleeding diathesis or experiencing a major bleeding episode within 4 weeks of enrolling to the study.
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- Active autoimmune disease requiring systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Active systemic infection requiring either hospitalization or parenteral anti-infective therapy within 2 weeks before first dose of study treatment.
- Known psychiatric, behavioral, or substance abuse disorders that would interfere with cooperation of the study requirements.
- Subjects with chronic hepatitis B virus (HBV) infection with active disease who meet the criteria for anti-HBV therapy and are not on a suppressive antiviral therapy prior to initiation of study treatment. Subjects who are hepatitis B surface antigen positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization. Note: Subjects should remain on antiviral therapy throughout the study treatment period and follow local guidelines for HBV antiviral therapy post completion of study treatment.
- Subjects with a known history of hepatitis C virus (HCV) who have not completed curative antiviral treatment or have an HCV viral load above the limit of quantification at Screening. Note: subjects must have completed curative antiviral therapy at least 4 weeks prior to treatment.
- Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies). HIV testing is not required unless mandated by local health authority.
- Receipt of any organ transplantation, including autologous and allogeneic stem cell transplantation, except for transplants that do not require immunosuppression.
- Known to be diagnosed and/or treated for any other additional malignancy within 2 years prior to registration with the exception of the following: curatively treated basal cell carcinoma or squamous cell carcinoma of the skin, and curatively resected in situ cervical cancer, and curatively resected in situ breast cancer, and low-risk early stage prostate cancer defined as follows: Stage T1c or T2a with a Gleason score ≤6 and prostatic-specific antigen <10 ng/mL either treated with definitive intent or untreated in active surveillance that has been stable. Other exceptions may be considered with the input of the Sponsor-Investigator.
- Any condition requiring systemic treatment with either corticosteroids (>10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 7 days prior to the first dose of study treatment, except for topical, intranasal, intrabronchial, or ocular steroids. Corticosteroid use as premedication for allergic reactions (e.g., intravenous contrast), or as a prophylactic management of AEs related to the therapies specified in the protocol is allowed. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor-Investigator.
- Use of a live or live attenuated vaccine within 4 weeks prior to Screening. Note: Administration of killed, recombinant, or inactivated vaccines is allowed.
- Active pregnancy or breastfeeding.
- Unwilling to provide tumor or blood samples for research.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Glenn Hanna contact
United States2 sites, 2 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02215
Glenn Hanna, 617-632-3779, Gjhanna@partners.org
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Glenn Hanna, 617-632-3779, Gjhanna@partners.org
Glenn Hanna
About this study
Official title: Neoadjuvant Ficerafusp Alfa With Pembrolizumab in Resectable Squamous Cell Carcinoma of the Head and Neck: a Phase 2 Trial
This trial is to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab prior to surgical resection in participants with resectable, high-risk, locoregionally advanced, PD-L1-positive squamous cell carcinoma of the head and neck (HNSCC).
The names of the study drugs used in this research study are:
- ficerafusp alfa (a type of bifunctional antibody and recombinant fusion protein)
- pembrolizumab (a type of monoclonal antibody)
Read the detailed description
This open-label, non-randomized, phase 2 clinical trial is to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab prior to surgical resection in participants with resectable, high-risk, locoregionally advanced, PD-L1-positive squamous cell carcinoma of the head and neck.
The U.S. Food and Drug Administration (FDA) has not approved ficerafusp alfa as treatment for resectable, high-risk, locoregionally advanced, PD-L1-positive squamous cell carcinoma of the head and neck.
The FDA has approved pembrolizumab as treatment for resectable, high-risk, locoregionally advanced, PD-L1-positive squamous cell carcinoma of the head and neck.
The research study procedures include screening for eligibility, in-clinic visits, blood tests, urine tests, tumor biopsies, and Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, or Positron Emission (PET) scans.
It is expected that about 32 people will take part in this research study. Bicara Therapeutics is supporting this research study by providing an investigational supply of Ficerafusp alfa.
- Conditions
- Head and Neck Squamous Cell Carcinoma (HNSCC), Squamous Cell Carcinoma of the Head and Neck
- Being tested
- Ficerafusp alfa, Pembrolizumab
- 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.
Ficerafusp alfaDrug
Also called FmAb2, BCA101
Bifunctional antibody and recombinant fusion protein, single-use vial, via intravenous (into the vein) infusion per protocol.
PembrolizumabDrug
Also called Keytruda
Monoclonal antibody, single-dose vial, via intravenous infusion per protocol.
| Study group | Role | What they receive |
|---|---|---|
| Ficerafusp Alfa plus Pembrolizumab | Experimental | 32 participants will be enrolled and will complete:
* Baseline visit
* Cycle 1 (21 day cycle):
* Day 1: predetermined dose of Prembrolizumab 1x daily.
* Days 1, 8, and 15: predetermined dose of Ficerafusp Alfa 1x daily.
* Cycle 2 (21 day cycle):
* Day 1: predetermined dose of Prembrolizumab 1x daily.
* Day 1: predetermined dose of Ficerafusp Alfa 1x daily.
* Standard of care surgery
* End of treatment visit
* Follow up for up to 2 years Receives: Drug: Ficerafusp alfa; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Treatment Response-2 (pTR-2) Rate
pTR-2 rate is defined as ≥50% pathological response of the primary tumor using the surgical specimen following neoadjuvant therapy as established by 2 independent pathologists.
Measured: Assessed at time of surgical resection, between days 30 and 42 from start of neoadjuvant treatment.
Secondary outcomes (5)
Median Event-free survival (EFS)
EFS is defined as the time from date of surgery to first invasive local, regional, distant recurrence, or death due to any cause. Participants alive without disease are censored at date of last disease evaluation. Median EFS is estimated based on the Kaplan-Meier method. Disease recurrence is established by 2 independent pathologists.
Measured: Disease assessed every 3 months up to 24 months from date of surgery (+42 days from start of neoadjuvant therapy).
Median Overall Survival
OS is defined as the time from study registration until death due to any cause, or censored at the date last known alive. Median OS is estimated based on the Kaplan-Meier method.
Measured: Survival assessed every 3 months up to 24 months from date of surgery (+42 days from start of neoadjuvant therapy).
Pathologic Response Rate by PD-LI Combined positive score (CPS) Subgroup
Pathologic response rate is defined as ≥50% pathological response of the primary tumor using the surgical specimen following neoadjuvant therapy as established by 2 independent pathologists. PD-LI expression will be evaluated per established methods and PD-LI CPS ranges from 0-100.
Measured: Assessed at time of surgical resection, between days 30 and 42 from start of neoadjuvant treatment.
Major Pathologic Response Rate
MPR rate is defined as the percentage of participants with ≥90% pathological response of the primary tumor and lymph nodes using the surgical specimen following neoadjuvant therapy as established by 2 independent pathologists.
Measured: Assessed at time of surgical resection, between days 30 and 42 from start of neoadjuvant treatment.
Pre-Operative Objective Response Rate (ORR)
Pre-operative ORR is the percentage of participants achieving complete or partial response on neoadjuvant treatment based on RECIST v1.1 criteria (Eisenhauer et al Eur J Ca 45:228-247, 2009).
Measured: Assessed over 2 cycles of neoadjuvant treatment (cycle duration=21 days), up to day 42.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start26 Mar 2026
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell Carcinoma (HNSCC)Studies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Bicara Therapeutics
- Responsible party
- Principal investigator, Glenn J. Hanna, Dana-Farber Cancer Institute
- Investigators
- Glenn Hanna, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465276
- Sponsor's protocol ID
- 25-829
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Ficerafusp Alfa With Pembrolizumab in Resectable Squamous Cell Carcinoma of the Head and Neck: a Phase 2 Trial
- ClinicalTrials.gov ID
- NCT07465276
- Acronym / sponsor ID
- 25-829
- Conditions
- Head and Neck Squamous Cell Carcinoma (HNSCC), Squamous Cell Carcinoma of the Head and Neck
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Bicara Therapeutics
- Study start
- 26 Mar 2026 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 11 Mar 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 trial is to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab prior to surgical resection in participants with resectable, high-risk, locoregionally advanced, PD-L1-positive squamous cell carcinoma of the head and neck (HNSCC).
The names of the study drugs used in this research study are:
- ficerafusp alfa (a type of bifunctional antibody and recombinant fusion protein)
- pembrolizumab (a type of monoclonal antibody)
Detailed description
This open-label, non-randomized, phase 2 clinical trial is to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab prior to surgical resection in participants with resectable, high-risk, locoregionally advanced, PD-L1-positive squamous cell carcinoma of the head and neck.
The U.S. Food and Drug Administration (FDA) has not approved ficerafusp alfa as treatment for resectable, high-risk, locoregionally advanced, PD-L1-positive squamous cell carcinoma of the head and neck.
The FDA has approved pembrolizumab as treatment for resectable, high-risk, locoregionally advanced, PD-L1-positive squamous cell carcinoma of the head and neck.
The research study procedures include screening for eligibility, in-clinic visits, blood tests, urine tests, tumor biopsies, and Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, or Positron Emission (PET) scans.
It is expected that about 32 people will take part in this research study. Bicara Therapeutics is supporting this research study by providing an investigational supply of Ficerafusp alfa.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ficerafusp Alfa plus Pembrolizumab | Experimental | Drug: Ficerafusp alfa, Drug: Pembrolizumab32 participants will be enrolled and will complete: * Baseline visit * Cycle 1 (21 day cycle): * Day 1: predetermined dose of Prembrolizumab 1x daily. * Days 1, 8, and 15: predetermined dose of Ficerafusp Alfa 1x daily. * Cycle 2 (21 day cycle): * Day 1: predetermined dose of Prembrolizumab 1x daily. * Day 1: predetermined dose of Ficerafusp Alfa 1x daily. * Standard of care surgery * End of treatment visit * Follow up for up to 2 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Participants must have histologically or cytologically confirmed, untreated and newly diagnosed, locoregionally advanced head and neck squamous cell carcinoma (HNSCC) arising from oral cavity, oropharynx (with documented HPV-negative disease if presenting with oropharyngeal SCC), larynx, or hypopharynx.
- Participants should have resectable disease at baseline per the discretion of the treating surgical oncologist.
- Participants must have clinical stage disease as defined below using the 8th (2017) edition of the tumor, node, metastasis (TNM) staging system by the American Joint Committee on Cancer (AJCC) and the Union for International Cancer Control (UICC):
- Tumor must be PD-L1 positive with a CPS score equal to 1 or greater (by any approved assay or scoring method).
- Participants must be willing to provide blood and tissue pre-treatment and at the time of surgery for pathologic and correlative analyses. Specifically, willingness to provide a newly obtained core or excisional biopsy of a tumor lesion from the primary tumor site.
Key exclusion criteria (18 listed)
- Recurrent or metastatic (M1 or IVC disease by AJCC 2017 8th edition staging) HNSCC or very early-stage HNSCC (stage I or II by AJCC 2017 8th edition staging); or head and neck cancer arising at other primary subsites such as the skin, paranasal sinuses, nasal cavity, or salivary glands.
- HPV-associated oropharyngeal cancer (as determined by p16 positivity by immunohistochemistry and/or confirmatory HPV RNA ISH or PCR testing, or by plasma HPV DNA testing results).
- Inoperable or surgically unresectable at baseline per the treating investigator(s).
- ECOG performance status of 2 or greater.
- Prior exposure to anti-EGFR antibody or anti-PD-1 immunotherapy.
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 |
|---|---|---|
| Ficerafusp alfaAlso: FmAb2, BCA101Bifunctional antibody and recombinant fusion protein, single-use vial, via intravenous (into the vein) infusion per protocol. | Drug | Ficerafusp Alfa plus Pembrolizumab |
| PembrolizumabAlso: KeytrudaMonoclonal antibody, single-dose vial, via intravenous infusion per protocol. | Drug | Ficerafusp Alfa plus Pembrolizumab |
Primary outcome
Pathologic Treatment Response-2 (pTR-2) Rate
Time frame: Assessed at time of surgical resection, between days 30 and 42 from start of neoadjuvant treatment.
pTR-2 rate is defined as ≥50% pathological response of the primary tumor using the surgical specimen following neoadjuvant therapy as established by 2 independent pathologists.
5 secondary outcomes
Median Event-free survival (EFS)
Time frame: Disease assessed every 3 months up to 24 months from date of surgery (+42 days from start of neoadjuvant therapy).
Median Overall Survival
Time frame: Survival assessed every 3 months up to 24 months from date of surgery (+42 days from start of neoadjuvant therapy).
Pathologic Response Rate by PD-LI Combined positive score (CPS) Subgroup
Time frame: Assessed at time of surgical resection, between days 30 and 42 from start of neoadjuvant treatment.
Major Pathologic Response Rate
Time frame: Assessed at time of surgical resection, between days 30 and 42 from start of neoadjuvant treatment.
Pre-Operative Objective Response Rate (ORR)
Time frame: Assessed over 2 cycles of neoadjuvant treatment (cycle duration=21 days), up to day 42.
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 27 Mar 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Glenn Hanna contact
Glenn Hanna principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ficerafusp alfa and Pembrolizumab in people with Head and Neck Squamous Cell Carcinoma (HNSCC) and Squamous Cell Carcinoma of the Head and Neck, run by Dana-Farber Cancer Institute at 2 sites 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 21 inclusion and 18 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 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 Glenn Hanna (617-632-3779, Gjhanna@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Treatment Response-2 (pTR-2) Rate (time frame: Assessed at time of surgical resection, between days 30 and 42 from start of neoadjuvant treatment.). 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 27 Mar 2026.