Testing a new method to predict response to immunotherapy in bladder cancer patients
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.
Centre Hospitalier Universitaire de Nīmes · NCT06738797
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 |
|---|---|
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nīmes (other) |
| Drugs / interventions | immunotherapy, pembrolizumab, avelumab, Nivolumab, Enfortumab, chemotherapy |
| Locations | 5 sites (Montpellier and 4 other locations) |
| Trial ID | NCT06738797 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically proven advanced or metastatic urothelial carcinoma who are eligible for immunotherapy.
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.
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 performed: Other studies have shown promise in using biomarkers to predict responses to immunotherapy, but this specific approach with SPHERTEST is novel.
Eligibility criteria
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 this trial is running
Montpellier and 4 other locations
- 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)
- CHU de Nimes — Nîmes, France (RECRUITING)
- Iuct Oncopole — Toulouse, France (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Urogenital Neoplasms