Oropharyngeal Squamous Cell CarcinomaNCT06771674
Real-world Study of First Line Pembrolizumab- or Nivolumab-treated HPV-positive Recurrent/Metastatic Oropharyngeal Squamous Cell Carcinoma
An observational study of Oropharyngeal Squamous Cell Carcinoma, run by Hookipa Biotech GmbH at 1 site in United States.
Trial summary
Pembrolizumab and nivolumab (with or without chemotherapy) are used to treat head and neck cancer. The middle part of the throat (oropharynx) is a common location for head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Squamous Cell Carcinoma
- What is being tested?
- Pembrolizumab and Nivolumab
- How many people
- 662 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2024to 28 Feb 2025
- Phase
- Observational
- 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
Study population: Real-world patients with HPV+ R/M OPSCC who received 1L pembrolizumab monotherapy, or nivolumab with or without chemotherapy will be evaluated. The ECAs derived from this real-world study are matched to respective study populations from interventional clinical studies. Propensity score matching will be used to generate the ECAs. The baseline characteristics used for matching will encompass key demographic and clinical factors potentially associated with treatment outcomes and may include: * Type of disease (only recurrent/metastatic including any recurrent) * Smoking history * Sex at birth * Race/Ethnicity * Hemoglobin
Who may be able to join
- Confirmed diagnosis of HPV+ R/M OPSCC (base and posterior one-third of tongue, the tonsils, soft palate, and lateral pharyngeal walls).
- Initiated and treated with pembrolizumab monotherapy, or nivolumab (monotherapy or in combination with chemotherapy) as 1L therapy for HPV+ R/M OPSCC on or after 05 June 2024 (may have had curative intent treatment including surgery, chemotherapy, and/or radiotherapy for non-metastatic/non-recurrent disease).
- Have access to baseline assessment scan within 30 days prior to initiating 1L therapy for HPV+ R/M OPSCC and response assessment confirmed by objective measurements within 26 weeks of initiation of 1L therapy.
- Must have been followed for 6 months or more since initiation of 1L therapy for R/M OPSCC.
Who cannot join
- Participation in a controlled clinical trial for 1L R/M OPSCC.
- Central nervous system involvement or other concurrent malignancy at the time of 1L initiation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-world Study of Patients With Human Papillomavirus-positive Recurrent/ Metastatic Oropharyngeal Squamous Cell Carcinoma Treated With First Line Pembrolizumab or Nivolumab With or Without Chemotherapy
Pembrolizumab and nivolumab (with or without chemotherapy) are used to treat head and neck cancer. The middle part of the throat (oropharynx) is a common location for head and neck cancer. This cancer is known as oropharyngeal squamous cell carcinoma (OPSCC) and is most often caused by human papillomavirus (HPV) infection. This real-world evidence study carried out in the United States (US) will assess patient demographic and clinical characteristics, treatment patterns, and effectiveness of pembrolizumab and nivolumab (with or without chemotherapy) in patients with HPV positive (HPV+) OPSCC after their cancer spread (metastatic) and/or returned (recurrent). The collected real-world data can be compared with data derived from matched study populations in clinical studies that test new therapies in patients with HPV+ OPSCC. This will allow a more reliable evaluation of the clinical benefits and better-informed design of future clinical studies in this patient population.
Read the detailed description
This non-interventional study will be conducted as a single-phase, multicenter medical chart review of US patients with HPV+ recurrent and/or metastatic (R/M) OPSCC treated with first-line (1L) pembrolizumab or nivolumab (with or without chemotherapy). Participating physicians (Cardinal Health's Oncology Provider Extended Network) and clinical sites (Practice Research Network) will be asked to submit data on patient demographics, clinical characteristics, treatment patterns, and 1L treatment outcomes during a 10-week data collection period. The networks do not overlap, eliminating the chance of duplicate patient records. The completion of data collection defines the study completion date. The data collection period will be followed by a data validation period based on responses of the participating physicians and clinical sites to follow-up questions.
The data obtained in this study will create external control arms (ECAs) comprised of patients with HPV+ R/M OPSCC initiating 1L therapy with pembrolizumab monotherapy, or nivolumab with or without chemotherapy. The use of these ECAs will allow for a more accurate estimation of the effectiveness of therapies currently assessed in interventional clinical studies versus pembrolizumab or nivolumab (with or without chemotherapy) as assessed in this observational study in a non-randomized setting. This information will serve to increase the reliability of the study data from interventional clinical studies investigating therapies in matching indications and patient populations and improve the accuracy of the clinical data to inform future clinical trials.
- Conditions
- Oropharyngeal Squamous Cell Carcinoma
- Being tested
- Pembrolizumab, Nivolumab
- Keywords
- oropharyngeal squamous cell carcinoma, throat, head and neck cancer, squamous cell cancer, OPSCC, HNSCC, human papillomavirus, HPV, immunotherapy, real-world study, PD-L1 therapy, checkpoint inhibitor, pembrolizumab, nivolumab
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms, Neoplasms, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called Keytruda
Given as monotherapy.
NivolumabDrug
Also called Opdivo
Given in combination with chemotherapy.
NivolumabDrug
Also called Opdivo
Given without chemotherapy.
PembrolizumabDrug
Also called Keytruda
Given in combination with chemotherapy.
PembrolizumabDrug
Given without chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| ECA 1 | A representative sample of real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab monotherapy. Receives: Drug: Pembrolizumab | |
| ECA 3 | A representative sample of real-world patients with HPV+ R/M OPSCC and high CPS (at least 20 or more) treated with 1L pembrolizumab monotherapy. Receives: Drug: Pembrolizumab | |
| ECA 2 | A representative sample of real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab or nivolumab with chemotherapy. Receives: Drug: Nivolumab; Drug: Pembrolizumab | |
| ECA 4 | A representative sample of real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab or nivolumab with or without chemotherapy. Receives: Drug: Nivolumab; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient demographics with ECA 1
Patient demographics among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab monotherapy.
Measured: Whole study period (05 June 2024 through 30 April 2025)
Clinical characteristics with ECA 1
Clinical characteristics among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab monotherapy.
Measured: Whole study period (05 June 2024 through 30 April 2025)
Treatment patterns with ECA 1
Treatment patterns among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab monotherapy.
Measured: Whole study period (05 June 2024 through 30 April 2025)
1L treatment outcomes with ECA 1
1L treatment outcomes among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab monotherapy.
Measured: Whole study period (05 June 2024 through 30 April 2025)
Patient demographics with ECA 2
Patient demographics among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab or nivolumab with chemotherapy.
Measured: Whole study period (05 June 2024 through 30 April 2025)
Clinical characteristics with ECA 2
Describe the clinical characteristics among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab or nivolumab with chemotherapy.
Measured: Whole study period (05 June 2024 through 30 April 2025)
1L treatment outcomes with ECA 2
1L treatment outcomes among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab or nivolumab with chemotherapy.
Measured: Whole study period (05 June 2024 through 30 April 2025)
Treatment patterns with ECA 2
Treatment patterns among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab or nivolumab with chemotherapy.
Measured: Whole study period (05 June 2024 through 30 April 2025)
Patient demographics with ECA3
Patient demographics among real-world patients with HPV+ R/M OPSCC and with a CPS of at least 20 or more treated with 1L pembrolizumab monotherapy.
Measured: Whole study period (05 June 2024 through 30 April 2025)
Clinical characteristics with ECA3
Clinical characteristics among real-world patients with HPV+ R/M OPSCC and with a CPS of at least 20 or more treated with 1L pembrolizumab monotherapy.
Measured: Whole study period (05 June 2024 through 30 April 2025)
Treatment patterns with ECA3
Treatment patterns among real-world patients with HPV+ R/M OPSCC and with a CPS of at least 20 or more treated with 1L pembrolizumab monotherapy.
Measured: Whole study period (05 June 2024 through 30 April 2025)
1L treatment outcomes with ECA3
1L treatment outcomes among real-world patients with HPV+ R/M OPSCC and with a CPS of at least 20 or more treated with 1L pembrolizumab monotherapy.
Measured: Whole study period (05 June 2024 through 30 April 2025)
Patient demographics with ECA 4
Patient demographics among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab or nivolumab with or without chemotherapy.
Measured: Whole study period (05 June 2024 through 30 April 2025)
Clinical characteristics with ECA 4
Describe the clinical characteristics among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab or nivolumab with or without chemotherapy.
Measured: Whole study period (05 June 2024 through 30 April 2025)
Treatment patterns with ECA 4
Treatment patterns among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab or nivolumab with or without chemotherapy.
Measured: Whole study period (05 June 2024 through 30 April 2025)
1L treatment outcomes with ECA 4
1L treatment outcomes among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab or nivolumab with or without chemotherapy.
Measured: Whole study period (05 June 2024 through 30 April 2025)
Secondary outcomes (4)
Real-world ECA 1 population versus a population from an interventional clinical study
Compare clinical outcomes of a matched patient population from an interventional clinical study with those of the representative ECA 1 real-world population with HPV+ R/M OPSCC treated with 1L pembrolizumab monotherapy from this study.
Measured: Whole study period (05 June 2024 through 30 April 2025)
Real-world ECA 2 population versus a population from an interventional clinical study
Compare clinical outcomes of a matched patient population from an interventional clinical study with those of the representative ECA 2 real-world population with HPV+ R/M OPSCC treated with pembrolizumab or nivolumab with chemotherapy from this study.
Measured: Whole study period (05 June 2024 through 30 April 2025)
Real-world ECA 3 population versus a population from an interventional clinical study
Compare clinical outcomes of a matched patient population from an interventional clinical study with those of the representative ECA 3 real-world population with HPV+ R/M OPSCC and with CPS of at least 20 or more treated with pembrolizumab monotherapy from this study.
Measured: Whole study period (05 June 2024 through 30 April 2025)
Real-world ECA 4 population versus a population from an interventional clinical study
Compare clinical outcomes of a matched patient population from an interventional clinical study with those of the representative ECA 4 real-world population with HPV+ R/M OPSCC treated with pembrolizumab or nivolumab with or without chemotherapy from this study.
Measured: Whole study period (05 June 2024 through 30 April 2025)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start5 Jun 2024
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal Squamous 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 662 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hookipa Biotech GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cardinal Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771674
- Sponsor's protocol ID
- H-RWE-001
- Status last verified
- Sep 2025
- First submitted
- 8 Jan 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Study of Patients With Human Papillomavirus-positive Recurrent/ Metastatic Oropharyngeal Squamous Cell Carcinoma Treated With First Line Pembrolizumab or Nivolumab With or Without Chemotherapy
- ClinicalTrials.gov ID
- NCT06771674
- Acronym / sponsor ID
- H-RWE-001
- Conditions
- Oropharyngeal Squamous Cell Carcinoma
- Keywords
- oropharyngeal squamous cell carcinoma, throat, head and neck cancer, squamous cell cancer, OPSCC, HNSCC, human papillomavirus, HPV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 662 participants (actual)
- Lead sponsor
- Hookipa Biotech GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Cardinal Health
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 13 Jan 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.
Pembrolizumab and nivolumab (with or without chemotherapy) are used to treat head and neck cancer. The middle part of the throat (oropharynx) is a common location for head and neck cancer. This cancer is known as oropharyngeal squamous cell carcinoma (OPSCC) and is most often caused by human papillomavirus (HPV) infection. This real-world evidence study carried out in the United States (US) will assess patient demographic and clinical characteristics, treatment patterns, and effectiveness of pembrolizumab and nivolumab (with or without chemotherapy) in patients with HPV positive (HPV+) OPSCC after their cancer spread (metastatic) and/or returned (recurrent). The collected real-world data can be compared with data derived from matched study populations in clinical studies that test new therapies in patients with HPV+ OPSCC. This will allow a more reliable evaluation of the clinical benefits and better-informed design of future clinical studies in this patient population.
Detailed description
This non-interventional study will be conducted as a single-phase, multicenter medical chart review of US patients with HPV+ recurrent and/or metastatic (R/M) OPSCC treated with first-line (1L) pembrolizumab or nivolumab (with or without chemotherapy). Participating physicians (Cardinal Health's Oncology Provider Extended Network) and clinical sites (Practice Research Network) will be asked to submit data on patient demographics, clinical characteristics, treatment patterns, and 1L treatment outcomes during a 10-week data collection period. The networks do not overlap, eliminating the chance of duplicate patient records. The completion of data collection defines the study completion date. The data collection period will be followed by a data validation period based on responses of the participating physicians and clinical sites to follow-up questions.
The data obtained in this study will create external control arms (ECAs) comprised of patients with HPV+ R/M OPSCC initiating 1L therapy with pembrolizumab monotherapy, or nivolumab with or without chemotherapy. The use of these ECAs will allow for a more accurate estimation of the effectiveness of therapies currently assessed in interventional clinical studies versus pembrolizumab or nivolumab (with or without chemotherapy) as assessed in this observational study in a non-randomized setting. This information will serve to increase the reliability of the study data from interventional clinical studies investigating therapies in matching indications and patient populations and improve the accuracy of the clinical data to inform future clinical trials.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ECA 1 | – | Drug: PembrolizumabA representative sample of real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab monotherapy. |
| ECA 3 | – | Drug: PembrolizumabA representative sample of real-world patients with HPV+ R/M OPSCC and high CPS (at least 20 or more) treated with 1L pembrolizumab monotherapy. |
| ECA 2 | – | Drug: Nivolumab, Drug: PembrolizumabA representative sample of real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab or nivolumab with chemotherapy. |
| ECA 4 | – | Drug: Nivolumab, Drug: PembrolizumabA representative sample of real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab or nivolumab with or without chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Real-world patients with HPV+ R/M OPSCC who received 1L pembrolizumab monotherapy, or nivolumab with or without chemotherapy will be evaluated. The ECAs derived from this real-world study are matched to respective study populations from interventional clinical studies. Propensity score matching will be used to generate the ECAs. The baseline characteristics used for matching will encompass key demographic and clinical factors potentially associated with treatment outcomes and may include: * Type of disease (only recurrent/metastatic including any recurrent) * Smoking history * Sex at birth * Race/Ethnicity * Hemoglobin
Key inclusion criteria (4 listed)
- Confirmed diagnosis of HPV+ R/M OPSCC (base and posterior one-third of tongue, the tonsils, soft palate, and lateral pharyngeal walls).
- Initiated and treated with pembrolizumab monotherapy, or nivolumab (monotherapy or in combination with chemotherapy) as 1L therapy for HPV+ R/M OPSCC on or after 05 June 2024 (may have had curative intent treatment including surgery, chemotherapy, and/or radiotherapy for non-metastatic/non-recurrent disease).
- Have access to baseline assessment scan within 30 days prior to initiating 1L therapy for HPV+ R/M OPSCC and response assessment confirmed by objective measurements within 26 weeks of initiation of 1L therapy.
- Must have been followed for 6 months or more since initiation of 1L therapy for R/M OPSCC.
Key exclusion criteria (2 listed)
- Participation in a controlled clinical trial for 1L R/M OPSCC.
- Central nervous system involvement or other concurrent malignancy at the time of 1L initiation.
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 |
|---|---|---|
| PembrolizumabAlso: KeytrudaGiven as monotherapy. | Drug | ECA 1, ECA 3 |
| NivolumabAlso: OpdivoGiven in combination with chemotherapy. | Drug | ECA 2, ECA 4 |
| NivolumabAlso: OpdivoGiven without chemotherapy. | Drug | ECA 4 |
| PembrolizumabAlso: KeytrudaGiven in combination with chemotherapy. | Drug | ECA 2, ECA 4 |
| PembrolizumabGiven without chemotherapy. | Drug | ECA 4 |
Primary outcome
Patient demographics with ECA 1
Time frame: Whole study period (05 June 2024 through 30 April 2025)
Patient demographics among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab monotherapy.
Clinical characteristics with ECA 1
Time frame: Whole study period (05 June 2024 through 30 April 2025)
Clinical characteristics among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab monotherapy.
Treatment patterns with ECA 1
Time frame: Whole study period (05 June 2024 through 30 April 2025)
Treatment patterns among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab monotherapy.
1L treatment outcomes with ECA 1
Time frame: Whole study period (05 June 2024 through 30 April 2025)
1L treatment outcomes among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab monotherapy.
Patient demographics with ECA 2
Time frame: Whole study period (05 June 2024 through 30 April 2025)
Patient demographics among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab or nivolumab with chemotherapy.
Clinical characteristics with ECA 2
Time frame: Whole study period (05 June 2024 through 30 April 2025)
Describe the clinical characteristics among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab or nivolumab with chemotherapy.
1L treatment outcomes with ECA 2
Time frame: Whole study period (05 June 2024 through 30 April 2025)
1L treatment outcomes among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab or nivolumab with chemotherapy.
Treatment patterns with ECA 2
Time frame: Whole study period (05 June 2024 through 30 April 2025)
Treatment patterns among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab or nivolumab with chemotherapy.
Patient demographics with ECA3
Time frame: Whole study period (05 June 2024 through 30 April 2025)
Patient demographics among real-world patients with HPV+ R/M OPSCC and with a CPS of at least 20 or more treated with 1L pembrolizumab monotherapy.
Clinical characteristics with ECA3
Time frame: Whole study period (05 June 2024 through 30 April 2025)
Clinical characteristics among real-world patients with HPV+ R/M OPSCC and with a CPS of at least 20 or more treated with 1L pembrolizumab monotherapy.
Treatment patterns with ECA3
Time frame: Whole study period (05 June 2024 through 30 April 2025)
Treatment patterns among real-world patients with HPV+ R/M OPSCC and with a CPS of at least 20 or more treated with 1L pembrolizumab monotherapy.
1L treatment outcomes with ECA3
Time frame: Whole study period (05 June 2024 through 30 April 2025)
1L treatment outcomes among real-world patients with HPV+ R/M OPSCC and with a CPS of at least 20 or more treated with 1L pembrolizumab monotherapy.
Patient demographics with ECA 4
Time frame: Whole study period (05 June 2024 through 30 April 2025)
Patient demographics among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab or nivolumab with or without chemotherapy.
Clinical characteristics with ECA 4
Time frame: Whole study period (05 June 2024 through 30 April 2025)
Describe the clinical characteristics among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab or nivolumab with or without chemotherapy.
Treatment patterns with ECA 4
Time frame: Whole study period (05 June 2024 through 30 April 2025)
Treatment patterns among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab or nivolumab with or without chemotherapy.
1L treatment outcomes with ECA 4
Time frame: Whole study period (05 June 2024 through 30 April 2025)
1L treatment outcomes among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab or nivolumab with or without chemotherapy.
4 secondary outcomes
Real-world ECA 1 population versus a population from an interventional clinical study
Time frame: Whole study period (05 June 2024 through 30 April 2025)
Real-world ECA 2 population versus a population from an interventional clinical study
Time frame: Whole study period (05 June 2024 through 30 April 2025)
Real-world ECA 3 population versus a population from an interventional clinical study
Time frame: Whole study period (05 June 2024 through 30 April 2025)
Real-world ECA 4 population versus a population from an interventional clinical study
Time frame: Whole study period (05 June 2024 through 30 April 2025)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oropharyngeal Squamous Cell Carcinoma, run by Hookipa Biotech GmbH 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 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 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 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient demographics with ECA 1 (time frame: Whole study period (05 June 2024 through 30 April 2025)). The study lists 16 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 9 Sep 2025.