Urothelial CarcinomaVESUVIONCT06113367
Immunotherapy in Upper Tract Urothelial Carcinoma
An observational study of Urothelial Carcinoma, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Upper-tract urothelial carcinoma (UTUC) is a rare tumor. Standard treatment of localized disease is most often radical nephroureterectomy. In advanced/metastatic disease, treatments follow the standards for urothelial carcinoma including platinum-based chemotherapy and anti-PD(L)1 (Programmed death (ligand) 1)… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Urothelial Carcinoma
- What is being tested?
- Evaluation of anti-PD-(L)1 immunotherapy efficacy
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 28 Feb 2024
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced/metastatic UTUC treated with second-line anti-PD-(L)1 immunotherapy
Who may be able to join
- Age 18 and more
- Diagnosis of urothelial carcinoma (with or without variant histology)
- Advanced/metastatic disease not amenable to local treatment with curative intent
- Treatment with an anti-PD-(L)1 monoclonal antibody initiated between 2016 and 2022
Who cannot join
- Patient's opposition to this research
- Urothelial carcinoma of bladder or urethral primary site
- Non-urothelial tumor
- Maintenance immunotherapy initiated without disease progression
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Carcinomes urothéliaux Des Voies excrétrices supérieures traitées en Vie réelle Par immunothérapie (VESUVIO) : étude rétrospective Nationale
Upper-tract urothelial carcinoma (UTUC) is a rare tumor. Standard treatment of localized disease is most often radical nephroureterectomy.
In advanced/metastatic disease, treatments follow the standards for urothelial carcinoma including platinum-based chemotherapy and anti-PD(L)1 (Programmed death (ligand) 1) immunotherapy, with no regard as to the primary disease site (bladder or upper tract). Given the rarity of UTUC, efficacy data in the UTUC subgroup of advanced urothelial carcinoma is scarce.
UTUC show distinct pahological and molecular features, including higher prevalence of microsatellite instability and of abnormalities in the FGFR (fibroblast growth factor receptors) gene family. These specific features may impact outcomes of immunotherapy in advanced/metastatic UTUC.
- Conditions
- Urothelial Carcinoma
- Being tested
- Evaluation of anti-PD-(L)1 immunotherapy efficacy
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of anti-PD-(L)1 immunotherapy efficacyOther
Non Applicable, research on data
| Study group | Role | What they receive |
|---|---|---|
| Patients with advanced/metastatic UTUC treated with second-line anti-PD-(L)1 immunotherapy | Not described Receives: Other: Evaluation of anti-PD-(L)1 immunotherapy efficacy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival on anti-PD-(L)1 immunotherapy
Measured: 2 years after immunotherapy initiation
Secondary outcomes (9)
Best Objective Radiologic Response
Evaluated by RECIST v1.1 The Response Evaluation Criteria in Solid Tumors (RECIST) is a standard system to measure how cancer responds to different treatments.It permits to evaluate the response according to the evolution of the lesions.
Measured: Up to 7 years maximum
Overall survival
Measured: 5 years after immunotherapy initiation
Progression free survival
Measured: 6 months after immunotherapy initiation
Progression free survival
Measured: 1 year after immunotherapy initiation
Progression free survival
Measured: 2 years after immunotherapy initiation
Progression free survival
Measured: 3 years after immunotherapy initiation
Duration of immunotherapy treatment
Treatment tolerability
Measured: Up to 7 years after immunotherapy initiation
Reasons for treatment discontinuation
Measured: Up to 7 years after immunotherapy initiation
Translational study of predictive biomarkers of efficacy
Measured: Up to 7 years after immunotherapy initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Nov 2023 (estimated)
- Primary completion28 Feb 2024 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113367
- Sponsor's protocol ID
- APHP230738
- Acronym
- VESUVIO
- Status last verified
- Oct 2023
- First submitted
- 27 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carcinomes urothéliaux Des Voies excrétrices supérieures traitées en Vie réelle Par immunothérapie (VESUVIO) : étude rétrospective Nationale
- ClinicalTrials.gov ID
- NCT06113367
- Acronym / sponsor ID
- VESUVIO / APHP230738
- Conditions
- Urothelial Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 2 Nov 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.
Upper-tract urothelial carcinoma (UTUC) is a rare tumor. Standard treatment of localized disease is most often radical nephroureterectomy.
In advanced/metastatic disease, treatments follow the standards for urothelial carcinoma including platinum-based chemotherapy and anti-PD(L)1 (Programmed death (ligand) 1) immunotherapy, with no regard as to the primary disease site (bladder or upper tract). Given the rarity of UTUC, efficacy data in the UTUC subgroup of advanced urothelial carcinoma is scarce.
UTUC show distinct pahological and molecular features, including higher prevalence of microsatellite instability and of abnormalities in the FGFR (fibroblast growth factor receptors) gene family. These specific features may impact outcomes of immunotherapy in advanced/metastatic UTUC.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with advanced/metastatic UTUC treated with second-line anti-PD-(L)1 immunotherapy | – | Other: Evaluation of anti-PD-(L)1 immunotherapy efficacy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced/metastatic UTUC treated with second-line anti-PD-(L)1 immunotherapy
Key inclusion criteria (4 listed)
- Age 18 and more
- Diagnosis of urothelial carcinoma (with or without variant histology)
- Advanced/metastatic disease not amenable to local treatment with curative intent
- Treatment with an anti-PD-(L)1 monoclonal antibody initiated between 2016 and 2022
Key exclusion criteria (4 listed)
- Patient's opposition to this research
- Urothelial carcinoma of bladder or urethral primary site
- Non-urothelial tumor
- Maintenance immunotherapy initiated without disease progression
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 |
|---|---|---|
| Evaluation of anti-PD-(L)1 immunotherapy efficacyNon Applicable, research on data | Other | Patients with advanced/metastatic UTUC treated with second-line anti-PD-(L)1 immunotherapy |
Primary outcome
Overall survival on anti-PD-(L)1 immunotherapy
Time frame: 2 years after immunotherapy initiation
9 secondary outcomes
Best Objective Radiologic Response
Time frame: Up to 7 years maximum
Overall survival
Time frame: 5 years after immunotherapy initiation
Progression free survival
Time frame: 6 months after immunotherapy initiation
Progression free survival
Time frame: 1 year after immunotherapy initiation
Progression free survival
Time frame: 2 years after immunotherapy initiation
Progression free survival
Time frame: 3 years after immunotherapy initiation
Duration of immunotherapy treatment
Time frame: Up to 7 years after immunotherapy initiation
Reasons for treatment discontinuation
Time frame: Up to 7 years after immunotherapy initiation
Translational study of predictive biomarkers of efficacy
Time frame: Up to 7 years after immunotherapy initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Urothelial Carcinoma, run by Assistance Publique - Hôpitaux de Paris.
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 4 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: status not confirmed, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clément Dumont, Dr (+142494217, clement.dumont@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival on anti-PD-(L)1 immunotherapy (time frame: 2 years after immunotherapy initiation). 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 2 Nov 2023.