Testing a new method to predict response to immunotherapy in bladder cancer patients
Official title: Evaluation de l'Association Entre Les résultats d'un Test in Vitro en Cours de développement (SPHERTEST) et la réponse Aux Traitements Par Inhibiteur du Point de contrôle Chez Des Patients Atteints de Carcinome urothélial de Stade avancé ou métastatique.
Run by Centre Hospitalier Universitaire de Nīmes · NCT06738797 · Data updated 2026-11-12
This study is testing a new test called SPHERTEST to see if it can help doctors figure out which bladder cancer patients are likely to respond well to immunotherapy after chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 32 (estimated) |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Drugs / interventions | immunotherapy, pembrolizumab, avelumab, Nivolumab, Enfortumab, chemotherapy |
| Locations | 5 sites (Montpellier and 4 other locations) |
| Status | Recruiting |
| Started | December 12, 2024 |
| Main results expected | June 2029 |
| Study ends | June 2029 |
| Registry record updated | January 28, 2026 |
| Trial ID | NCT06738797 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with histologically proven advanced or metastatic urothelial carcinoma who are eligible for immunotherapy.
✕Probably not a fit
Patients who have received anti-PD1, anti-PDL1, or anti-CTLA4 treatments within the past year may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the association between the SPHERTEST in vitro test and the response to checkpoint inhibitor treatments in patients with advanced or metastatic urothelial carcinoma. It aims to identify biomarkers that can predict which patients are likely to benefit from immunotherapy following platinum-based chemotherapy. The study will include patients who have consented and meet specific eligibility criteria, focusing on those with histologically confirmed urothelial carcinoma. The SPHERTEST will be utilized to assess the potential effectiveness of immunotherapy in these patients.
Why it matters
Potential benefit: If successful, this study could help tailor immunotherapy treatments to individual patients, improving outcomes for those with advanced bladder cancer.
How similar studies have gone: Other studies have shown promise in using biomarkers to predict responses to immunotherapy, but this specific approach with SPHERTEST is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with histologically proven urothelial carcinoma, in a locally advanced or metastatic situation with indication for immunotherapy. * The patient must have given their free and informed consent and signed the consent form * The patient must be a member or beneficiary of a health insurance plan Exclusion Criteria: * The subject is participating in a category 1 or drug monotherapy interventional study, or is in a period of exclusion determined by a previous study * It is impossible to give the subject informed information * The patient is under safeguard of justice or state guardianship * History of treatment with anti-PD1 or anti-PDL1 or anti-CTLA4 within the year. * Pregnant, parturient or breastfeeding patient.
Where it's running
-
CHU de Nimes
Nîmes, France Recruiting -
Iuct Oncopole
Toulouse, France Recruiting -
Institut du Cancer de Montpellier
Montpellier, France Not yet recruiting -
Institut Régional du Cancer de Montpellier
Montpellier, France Not yet recruiting -
Centre Antoine Lacassagne
Nice, France Not yet recruiting
Study contacts
- Principal investigator: Nadine Houede — CHU de Nimes
- Study coordinator: Nadine Houede
- Email: nadine.houede@chu-nimes.fr
- Phone: 04.66.68.33.01
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.