Squamous Cell Carcinoma of the OropharynxiMonitORLNCT06061705
Identification of Individual Histological and Blood Markers in Patients With Recurrent or Metastatic Upper Aerodigestive Tract Squamous Cell Carcinoma in Response to Immunotherapies
A study testing Tumor Biopsy in people with Squamous Cell Carcinoma of the Oropharynx, run by Fondation Hôpital Saint-Joseph at 3 sites in France.
Trial summary
Epidermoid Carcinoma of the Upper Aerodigestive Tract (CEVADS) is the 6th most common cancer worldwide. Despite current therapies (radiotherapy, surgery and chemotherapy), cancers of the Upper Aerodigestive Tract (UAT) have a poor prognosis, with a 10-year survival rate of no more than 20%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Oropharynx
- What is being tested?
- Tumor Biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesFrance
- Study dates
- 29 Jan 2024to 30 Jun 2026
- Phase
- Interventional
- 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
- Patients aged ≥ 18 years
- Patients with histologically confirmed CEVADS involving the oral cavity, oropharynx, hypopharynx or larynx
- Pre-treated patients with a first recurrence (locoregional or metastatic) who are candidates for immunotherapy
- Patient affiliated to a health insurance plan
- French-speaking patient
- Patient with free, informed and written consent
Who cannot join
- Patients with a contraindication to immunotherapy (transplant patients)
- Pregnant or breast-feeding patients
- Patient under guardianship or curatorship
- Patient under court protection
- Patient deprived of liberty
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Helene BEAUSSIER, PharmD, PhD contact
France3 sites, 3 recruiting
- Recruiting
Hôpital Saint-Joseph
Paris, 75014
Eric RAYMOND, MD, PhD
- Recruiting
Hôpital Bichat
Paris
Diane EVRARD, MD
- Not yet recruiting
Hôpital Saint-Louis
Paris
Sandrine FAIVRE, MD, PhD
About this study
Epidermoid Carcinoma of the Upper Aerodigestive Tract (CEVADS) is the 6th most common cancer worldwide. Despite current therapies (radiotherapy, surgery and chemotherapy), cancers of the Upper Aerodigestive Tract (UAT) have a poor prognosis, with a 10-year survival rate of no more than 20%.
For recurrent or metastatic CEVADS, the therapeutic arsenal, based for many years on chemotherapy and anti-EGFR (Epidermal Growth Factor Receptor) agents, has been enriched by a new therapeutic class: PD-1 inhibitors. For CEVADS, PD-1 inhibitors have been approved for second-line treatment of nivolumab for over a year, and are now used in first-line treatment of pembrolizumab.
Read more
The results of this therapeutic class in CEVADS are not as spectacular as for melanoma or bronchial cancer. Indeed, only 20% of patients have a favorable response, compared with half who experience disease progression. This low proportion of responders can be explained by tumor heterogeneity within CEVADS and poor patient selection.
The only marker used to select patients is PD-L1 expression detected by ImmunoHistochemistry (IHC). However, it seems that this marker, described as imperfect, is still little explored in ENT. It needs to be compared with the expression of other cell lines in the tumor microenvironment, which could play an important role in resistance to PD-1 inhibitors.
IHC identifies all macrophages using the CD68 marker, while the CD163 marker is specific to M2 macrophages.
Other targets in the microenvironment are also being investigated, with the discovery of a Tertiary Lymphocyte Structure (TLS) in melanoma treated with immunotherapy.
It therefore seems necessary to gain a better understanding of the mechanisms of tumor progression under immunotherapy in order to develop strategies to optimize response to treatment. This would enable better selection of patients likely to benefit from immunotherapy, and open up prospects for therapeutic combinations.
The hypothesis is that macrophages, but also other cells and factors in the CEVADS microenvironment, play a decisive role in resistance to PD-1 inhibitors. The aim is therefore to continue these macrophage analyses, extend them to other cells in the microenvironment and link them to other prognostic factors under investigation.
A prospective study will analyze tumor tissue during treatment with PD-1 inhibitors, in order to correlate all the factors studied with response or resistance to immunotherapies.
In addition, the oral microbiota, in the lineage of the intestinal microbiota, has been shown to be highly stable over time and to play a role in the oncogenesis of certain cancers, notably CEVADS. Like the intestinal microbiota, it could also represent a prognostic factor in the response to immunotherapies.
Of all the bacteria in this oral microbiota, one has been shown to play a major role: Fusobacterium nucleatum (F. nucleatum). However, little is known about the mechanism of action of intratumoral F. nucleatum on the development of CEVADS. In particular, it is thought to play a role in local cancer immunity, via macrophages, regulatory T cells (Tregs) and TLRs. Finally, it appears that specific antimicrobial T-cell responses may cross-react with tumor antigens, hence the importance of also analyzing the metabolome of commensal bacteria.The aim of this study was to evaluate the evolution of the presence of this bacterium in saliva, as well as the specific immune response to F. nucleatum in patients with CEVADS during immunotherapy treatment.
- Being tested
- Tumor Biopsy
- 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.
Tumor BiopsyProcedure or surgery
Following the start of immunotherapy, an ENT surgeon will perform a cervico-facial tumor biopsy between D30 and D180. This will only be carried out if the tumour tissue is externalized and therefore accessible, and if the biopsy can be performed under local anaesthetic without any constraints for the patient (pain, risk of bleeding).
It consists of a superficial sampling of the externalized tumour lesion under local anaesthetic (xylocaine spray 5%, or xylocaine injectable 1%).
Biopsy of cervico-facial lesions under local anaesthetic is a commonly performed procedure. The main risk of this procedure is bleeding, which is very rare.
The biopsy will not be performed if the surgeon considers that the risk of bleeding is too great. Given the externalized nature of the lesion, biopsy does not entail any risk of tumour dissemination (possible for deep biopsies).
- Four 10-mL blood samples from two heparinized tubes
- Four 5-mL unstimulated saliva samples: non-invasive examination.
| Study group | Role | What they receive |
|---|---|---|
| procedure/surgery: Tumor biopsy | Experimental | Following the start of immunotherapy, an ENT surgeon will perform a cervico-facial tumor biopsy between D30 and D180. Receives: Procedure: Tumor Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological markers linked to the clinical benefit of immunotherapies
This outcome corresponds to the number of patients presenting a clinical benefit: objective response or stable disease according to RECIST v1.1 dimensional criteria, and the number of patients presenting tumor progression as the best response to immunotherapy.
Measured: Month 6
Secondary outcomes (4)
Histological markers linked to survival
This outcome corresponds to the time elapsed between initiation of immunotherapy and death, all causes combined.
Measured: Month 6
Expression of histological markers with PD-L1 expression
This outcome corresponds to the quantitative or semi-quantitative evolution of each marker including incidence of macrophages, lymphocytes, epithelial-mesenchymal transition markers) and blood (including Squamous Cell Carcinoma (SCC), neutrophil/lymphocyte ratio, circulating macrophages and lymphocytes), compared with the quantitative evolution of PD-L1 expression.
Measured: Month 6
Presence of Fusobacterium nucleatum in the oral microbiota
This outcome corresponds to the presence of Fusobacterium nucleatum in the oral microbiota by microbial DNA detection.
Measured: Month 6
Presence of an IgG or IgA anti-Fusobacterium nucleatum humoral response
This outcome corresponds to the presence of an anti-F. nuc IgG or IgA humoral response in patients' serum before and after immunotherapy treatment.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start29 Jan 2024
- Primary completion29 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Squamous Cell Carcinoma of the OropharynxStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Raymond, MD, PhD, Study director, Hôpital Paris Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061705
- Sponsor's protocol ID
- iMonitORL
- Acronym
- iMonitORL
- Status last verified
- Jun 2025
- First submitted
- 11 Sep 2023
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
PubMed 25651787Vermorken JB, Mesia R, Rivera F, Remenar E, Kawecki A, Rottey S, Erfan J, Zabolotnyy D, Kienzer HR, Cupissol D, Peyrade F, Benasso M, Vynnychenko I, De Raucourt D, Bokemeyer C, Schueler A, Amellal N, Hitt R. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med. 2008 Sep 11;359(11):1116-27. doi: 10.1056/NEJMoa0802656.
PubMed 18784101Ferris RL, Blumenschein G Jr, Fayette J, Guigay J, Colevas AD, Licitra L, Harrington K, Kasper S, Vokes EE, Even C, Worden F, Saba NF, Iglesias Docampo LC, Haddad R, Rordorf T, Kiyota N, Tahara M, Monga M, Lynch M, Geese WJ, Kopit J, Shaw JW, Gillison ML. Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck. N Engl J Med. 2016 Nov 10;375(19):1856-1867. doi: 10.1056/NEJMoa1602252. Epub 2016 Oct 8.
PubMed 27718784Cohen EEW, Soulieres D, Le Tourneau C, Dinis J, Licitra L, Ahn MJ, Soria A, Machiels JP, Mach N, Mehra R, Burtness B, Zhang P, Cheng J, Swaby RF, Harrington KJ; KEYNOTE-040 investigators. Pembrolizumab versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head-and-neck squamous cell carcinoma (KEYNOTE-040): a randomised, open-label, phase 3 study. Lancet. 2019 Jan 12;393(10167):156-167. doi: 10.1016/S0140-6736(18)31999-8. Epub 2018 Nov 30.
PubMed 30509740Leemans CR, Snijders PJF, Brakenhoff RH. The molecular landscape of head and neck cancer. Nat Rev Cancer. 2018 May;18(5):269-282. doi: 10.1038/nrc.2018.11. Epub 2018 Mar 2.
PubMed 29497144Evrard D, Hourseau M, Couvelard A, Paradis V, Gauthier H, Raymond E, Halimi C, Barry B, Faivre S. PD-L1 expression in the microenvironment and the response to checkpoint inhibitors in head and neck squamous cell carcinoma. Oncoimmunology. 2020 Nov 19;9(1):1844403. doi: 10.1080/2162402X.2020.1844403.
PubMed 33299655Wondergem NE, Nauta IH, Muijlwijk T, Leemans CR, van de Ven R. The Immune Microenvironment in Head and Neck Squamous Cell Carcinoma: on Subsets and Subsites. Curr Oncol Rep. 2020 Jun 29;22(8):81. doi: 10.1007/s11912-020-00938-3.
PubMed 32602047
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Individual Histological and Blood Markers in Patients With Recurrent or Metastatic Upper Aerodigestive Tract Squamous Cell Carcinoma in Response to Immunotherapies
- ClinicalTrials.gov ID
- NCT06061705
- Acronym / sponsor ID
- iMonitORL / iMonitORL
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 29 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 29 Sep 2023 (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.
Epidermoid Carcinoma of the Upper Aerodigestive Tract (CEVADS) is the 6th most common cancer worldwide. Despite current therapies (radiotherapy, surgery and chemotherapy), cancers of the Upper Aerodigestive Tract (UAT) have a poor prognosis, with a 10-year survival rate of no more than 20%.
For recurrent or metastatic CEVADS, the therapeutic arsenal, based for many years on chemotherapy and anti-EGFR (Epidermal Growth Factor Receptor) agents, has been enriched by a new therapeutic class: PD-1 inhibitors. For CEVADS, PD-1 inhibitors have been approved for second-line treatment of nivolumab for over a year, and are now used in first-line treatment of pembrolizumab.
The results of this therapeutic class in CEVADS are not as spectacular as for melanoma or bronchial cancer. Indeed, only 20% of patients have a favorable response, compared with half who experience disease progression. This low proportion of responders can be explained by tumor heterogeneity within CEVADS and poor patient selection.
The only marker used to select patients is PD-L1 expression detected by ImmunoHistochemistry (IHC). However, it seems that this marker, described as imperfect, is still little explored in ENT. It needs to be compared with the expression of other cell lines in the tumor microenvironment, which could play an important role in resistance to PD-1 inhibitors.
IHC identifies all macrophages using the CD68 marker, while the CD163 marker is specific to M2 macrophages.
Other targets in the microenvironment are also being investigated, with the discovery of a Tertiary Lymphocyte Structure (TLS) in melanoma treated with immunotherapy.
It therefore seems necessary to gain a better understanding of the mechanisms of tumor progression under immunotherapy in order to develop strategies to optimize response to treatment. This would enable better selection of patients likely to benefit from immunotherapy, and open up prospects for therapeutic combinations.
The hypothesis is that macrophages, but also other cells and factors in the CEVADS microenvironment, play a decisive role in resistance to PD-1 inhibitors. The aim is therefore to continue these macrophage analyses, extend them to other cells in the microenvironment and link them to other prognostic factors under investigation.
A prospective study will analyze tumor tissue during treatment with PD-1 inhibitors, in order to correlate all the factors studied with response or resistance to immunotherapies.
In addition, the oral microbiota, in the lineage of the intestinal microbiota, has been shown to be highly stable over time and to play a role in the oncogenesis of certain cancers, notably CEVADS. Like the intestinal microbiota, it could also represent a prognostic factor in the response to immunotherapies.
Of all the bacteria in this oral microbiota, one has been shown to play a major role: Fusobacterium nucleatum (F. nucleatum). However, little is known about the mechanism of action of intratumoral F. nucleatum on the development of CEVADS. In particular, it is thought to play a role in local cancer immunity, via macrophages, regulatory T cells (Tregs) and TLRs. Finally, it appears that specific antimicrobial T-cell responses may cross-react with tumor antigens, hence the importance of also analyzing the metabolome of commensal bacteria.The aim of this study was to evaluate the evolution of the presence of this bacterium in saliva, as well as the specific immune response to F. nucleatum in patients with CEVADS during immunotherapy treatment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| procedure/surgery: Tumor biopsy | Experimental | Procedure: Tumor BiopsyFollowing the start of immunotherapy, an ENT surgeon will perform a cervico-facial tumor biopsy between D30 and D180. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged ≥ 18 years
- Patients with histologically confirmed CEVADS involving the oral cavity, oropharynx, hypopharynx or larynx
- Pre-treated patients with a first recurrence (locoregional or metastatic) who are candidates for immunotherapy
- Patient affiliated to a health insurance plan
- French-speaking patient
Key exclusion criteria (5 listed)
- Patients with a contraindication to immunotherapy (transplant patients)
- Pregnant or breast-feeding patients
- Patient under guardianship or curatorship
- Patient under court protection
- Patient deprived of liberty
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 |
|---|---|---|
| Tumor BiopsyFollowing the start of immunotherapy, an ENT surgeon will perform a cervico-facial tumor biopsy between D30 and D180. This will only be carried out if the tumour tissue is externalized and therefore accessible, and if the biopsy can be performed under local anaesthetic without any constraints for the patient (pain, risk of bleeding). It consists of a superficial sampling of the externalized tumour lesion under local anaesthetic (xylocaine spray 5%, or xylocaine injectable 1%). Biopsy of cervico-facial lesions under local anaesthetic is a commonly performed procedure. The main risk of this procedure is bleeding, which is very rare. The biopsy will not be performed if the surgeon considers that the risk of bleeding is too great. Given the externalized nature of the lesion, biopsy does not entail any risk of tumour dissemination (possible for deep biopsies). * Four 10-mL blood samples from two heparinized tubes * Four 5-mL unstimulated saliva samples: non-invasive examination. | Procedure or surgery | procedure/surgery: Tumor biopsy |
Primary outcome
Histological markers linked to the clinical benefit of immunotherapies
Time frame: Month 6
This outcome corresponds to the number of patients presenting a clinical benefit: objective response or stable disease according to RECIST v1.1 dimensional criteria, and the number of patients presenting tumor progression as the best response to immunotherapy.
4 secondary outcomes
Histological markers linked to survival
Time frame: Month 6
Expression of histological markers with PD-L1 expression
Time frame: Month 6
Presence of Fusobacterium nucleatum in the oral microbiota
Time frame: Month 6
Presence of an IgG or IgA anti-Fusobacterium nucleatum humoral response
Time frame: Month 6
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 24 Jun 2025.
- Background: PubMed 25651787Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
- Background: PubMed 18784101Vermorken JB, Mesia R, Rivera F, Remenar E, Kawecki A, Rottey S, Erfan J, Zabolotnyy D, Kienzer HR, Cupissol D, Peyrade F, Benasso M, Vynnychenko I, De Raucourt D, Bokemeyer C, Schueler A, Amellal N, Hitt R. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med. 2008 Sep 11;359(11):1116-27. doi: 10.1056/NEJMoa0802656.
- Background: PubMed 27718784Ferris RL, Blumenschein G Jr, Fayette J, Guigay J, Colevas AD, Licitra L, Harrington K, Kasper S, Vokes EE, Even C, Worden F, Saba NF, Iglesias Docampo LC, Haddad R, Rordorf T, Kiyota N, Tahara M, Monga M, Lynch M, Geese WJ, Kopit J, Shaw JW, Gillison ML. Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck. N Engl J Med. 2016 Nov 10;375(19):1856-1867. doi: 10.1056/NEJMoa1602252. Epub 2016 Oct 8.
- Background: PubMed 30509740Cohen EEW, Soulieres D, Le Tourneau C, Dinis J, Licitra L, Ahn MJ, Soria A, Machiels JP, Mach N, Mehra R, Burtness B, Zhang P, Cheng J, Swaby RF, Harrington KJ; KEYNOTE-040 investigators. Pembrolizumab versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head-and-neck squamous cell carcinoma (KEYNOTE-040): a randomised, open-label, phase 3 study. Lancet. 2019 Jan 12;393(10167):156-167. doi: 10.1016/S0140-6736(18)31999-8. Epub 2018 Nov 30.
- Background: PubMed 29497144Leemans CR, Snijders PJF, Brakenhoff RH. The molecular landscape of head and neck cancer. Nat Rev Cancer. 2018 May;18(5):269-282. doi: 10.1038/nrc.2018.11. Epub 2018 Mar 2.
- Background: PubMed 33299655Evrard D, Hourseau M, Couvelard A, Paradis V, Gauthier H, Raymond E, Halimi C, Barry B, Faivre S. PD-L1 expression in the microenvironment and the response to checkpoint inhibitors in head and neck squamous cell carcinoma. Oncoimmunology. 2020 Nov 19;9(1):1844403. doi: 10.1080/2162402X.2020.1844403.
- Background: PubMed 32602047Wondergem NE, Nauta IH, Muijlwijk T, Leemans CR, van de Ven R. The Immune Microenvironment in Head and Neck Squamous Cell Carcinoma: on Subsets and Subsites. Curr Oncol Rep. 2020 Jun 29;22(8):81. doi: 10.1007/s11912-020-00938-3.
- SEER Cancer Statistics Review (CSR) 1975-2014Link provided by the sponsor.
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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.
Helene BEAUSSIER, PharmD, PhD contact
Eric Raymond, MD, PhD study director
Hôpital Paris Saint-Joseph
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tumor Biopsy in people with Squamous Cell Carcinoma of the Oropharynx, run by Fondation Hôpital Saint-Joseph at 3 sites in France.
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 6 inclusion and 5 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 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
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 Eric Raymond, MD, PhD (144127883 ext. +33, eraymond@ghpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histological markers linked to the clinical benefit of immunotherapies (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06061705, which also lists 7 linked publications.
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 24 Jun 2025; AzTrials last refreshed its copy on 8 Nov 2026.