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Urogenital NeoplasmsPROMES-URONCT06738797

Association Between the SPHERTEST in Vitro Test and Response to Checkpoint Inhibitor Treatments in Patients With Advanced or Metastatic Urothelial Carcinoma

An observational study of Urogenital Neoplasms, run by Centre Hospitalier Universitaire de Nīmes at 5 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

First-line systemic treatments for bladder cancer are based on a combination of cytotoxic and immunotherapy, sequentially or concomitantly. Immune checkpoint inhibition (ICPI) is a powerful treatment for patients with metastatic urothelial carcinoma (UC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urogenital Neoplasms
What is being tested?
SPHERTEST test
How many people
32 participants
Where
5 sitesFrance
Study dates
12 Dec 2024to Jun 2029
Phase
Observational
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

Study population: The study population consists of patients with advanced or metastatic urothelial carcinoma with an indication for treatment with an immune checkpoint inhibitor treated in the onco-urology departments of the Nîmes University Hospitals, the Antoine Lacassagne Center, the IUCT Toulouse and the Montpellier Regional Cancer Institute.

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Nadine Houede contact

04.66.68.33.01

nadine.houede@chu-nimes.fr

5 sites in 1 country

France5 sites, 5 recruiting

  • Institut du Cancer de Montpellier

    Montpellier

    Diego TOSI, 04.67.6.31.12, diego.tosi@icm.unicancer.fr

    Not yet recruiting

  • Institut Régional du Cancer de Montpellier

    Montpellier

    Céline GONGORA, 04.11.28.31.09, celine.gongora@inserm.fr

    Not yet recruiting

  • Centre Antoine Lacassagne

    Nice

    Delphine BORCHIELLINI, 04 92 03 10 00, delphine.borchiellini@nice.unicancer.fr

    Not yet recruiting

  • CHU de Nimes

    Nîmes

    Anissa MEGZARI, 04.66.68.42.36, drc@chu-nimes.fr

    Recruiting

  • Iuct Oncopole

    Toulouse

    Damien POUESSEL, 05.31.15.50.50, pouessel.damien@iuct-oncopole.fr

    Recruiting

Other trials in France

About this study

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.

First-line systemic treatments for bladder cancer are based on a combination of cytotoxic and immunotherapy, sequentially or concomitantly. Immune checkpoint inhibition (ICPI) is a powerful treatment for patients with metastatic urothelial carcinoma (UC). Since 2017, pembrolizumab (anti-PD1) can be offered as a second-line treatment after failure of platinum agents. In patients responding to platinum salts in first-line treatment, it is possible to maintain efficacy with maintenance treatment with another ICPI, avelumab (anti-PDL1). The phase III JAVELIN BLADDER 100 study compared avelumab to supportive care alone after successful platinum-based chemotherapy. At 30 months, 19.3% of patients were still in response compared to only 6.3% in the supportive care arm. However, biomarker analysis on tumor tissue did not show a robust signature on an individual scale. Recently, two phase 3 trials in first-line were presented at the ESMO 2023 congress. The first, in patients who could receive cisplatin-based chemotherapy, found a benefit on overall survival of adding Nivolumab in combination and then maintaining it for two years. The second proposed combined Enfortumab Vedotin and Pembrolizumab versus standard chemotherapy, with an overall survival for the study arm of more than 31 months. These trials confirm the essential role of immunotherapy in urothelial carcinomas. This progress is tempered by toxicity, cost and the lack of data on patient selection and treatment sequence. Although "prognostic" biomarkers have been identified, they cannot guide the choice of therapy, but only predict the expected outcomes, regardless of the treatment; biomarkers capable of predicting clinical benefit ("predictive") are urgently needed. It is therefore essential to identify a predictive signature at the individual level. The study authors have validated an in vitro model of heterotypic spheroids (SPHERTEST) composed of commercial urothelial carcinoma tumor cells and PBMCs from healthy donors. The aim of the study is to validate this model with PBMCs from UC patients to evaluate the effects of immunotherapy on the immune response and on tumor cell survival in vitro.

The study hypothesis is that the outcome of the pre-therapeutic test based on a heterotypic spheroid model with PBMC from patients with advanced or metastatic urothelial carcinoma (SPHERTEST) is related to the response to checkpoint inhibitor (CI) treatment.

Being tested
SPHERTEST test
Medical subject headings
Urogenital Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPHERTEST testDiagnostic test

    The SPHERETEST is an in vitro model of heterotypic spheroids composed of commercial urothelial carcinoma tumor cells and leukocyte mononuclear cells from healthy donors.

Study groups in NCT06738797
Study groupRoleWhat they receive
Patients with urothelial carcinomaNot described
Receives: Diagnostic Test: SPHERTEST test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SPHERTEST measurement of potential therapeutic efficacy

    Yes/No. Differential in spheroid size before and after treatment according to the formula: R=M1-M0. R = test results, M0 = average spheroid size without immunotherapy treatment, M1 = average spheroid size with immunotherapy treatment. When R is ≤ 0, SPHERTEST = "yes" or "potential therapeutic efficacy". When R is > 0, SPHERTEST = "no" or "absence of potential therapeutic efficacy"

    Measured: Day 0

  2. Progression-free survival

    Yes/No according to RECIST criteria

    Measured: Month 12

Secondary outcomes (30)

  1. Histology of cells

    Pure transitional cells vs predominantly transitional cells

    Measured: Inclusion

  2. Presence of an aggressive minority component

    Yes/no

    Measured: Inclusion

  3. Type of other component

    Micropapillary, microcystic, trophoblastic differentiation, epidermoid differentiation, nested, plasmacytoid, sarcomatoid, rhabdoid, lymphoepitheliomatoid, large cell, undifferentiated or neuroendocrine

    Measured: Inclusion

  4. Tumor grade

    WHO grading

    Measured: Inclusion

  5. PD1/PDL1 status

    Yes/no

    Measured: Inclusion

  6. PDL1 score

    positive/negative

    Measured: Inclusion

  7. Type of metastatic involvement

    Locally advanced (= local recurrence, or pelvic lymph node involvement) or Metastatic sites: liver, bone, lung, brain, extrapelvic lymph node, other

    Measured: Inclusion

  8. Primary tumor site

    Bladder/Urethra/upper urinary tract/Urethra

    Measured: Inclusion

  9. Hemoglobin level

    g/dL

    Measured: Inclusion

  10. Hemoglobin level

    g/dL

    Measured: Cycle 2 visit

  11. Lactate dehydrogenase level

    UI/L

    Measured: Inclusion

  12. Lactate dehydrogenase level

    UI/L

    Measured: Cycle 2 visit

  13. C-reactive protein level

    mg/L

    Measured: Inclusion

  14. C-reactive protein level

    mg/L

    Measured: Cycle 2 visit

  15. Neutrophil count

    G/L

    Measured: Inclusion

  16. Neutrophil count

    G/L

    Measured: Cycle 2 visit (cycles are spaced 3 weeks (pembrolizumab) or 2 weeks (avelumab) apart)

  17. Lymphocyte count

    G/L

    Measured: Inclusion

  18. Lymphocyte count

    G/L

    Measured: Cycle 2 visit (cycles are spaced 3 weeks (pembrolizumab) or 2 weeks (avelumab) apart)

  19. Number of lines of systemic treatment received in the metastatic phase

    0, 1, 2, ≥3

    Measured: Inclusion

  20. Type of platinum salt received prior to immunotherapy

    Cisplatin or carboplatin

    Measured: Inclusion

  21. Treatment regimen prior to anti-PD1 therapy

    Neoadjuvant with progression within 12 months / Adjuvant with progression within 12 months / Initially locally advanced/metastatic

    Measured: Inclusion

  22. Current treatment: whether treatment is combined with another molecule

    Cisplatin / entoftumab-vedotin

    Measured: Inclusion

  23. Antibiotics in the previous month

    Duration (days)

    Measured: Inclusion

  24. Corticosteroid therapy > 10 mg prednisolone equivalent at immunotherapy initiation

    Yes/no

    Measured: Inclusion

  25. Taking an immunosuppressant other than corticosteroid therapy at immunotherapy initiation

    Yes/no

    Measured: Inclusion

  26. Any comedication at immunotherapy initiation

    Protein pump inhibitors / beta blockers / metformin / statin

    Measured: Inclusion

  27. Patient functioning level

    ECOG Performance Status Scale (1-5)

    Measured: Inclusion

  28. BCG vaccine

    Yes/no

    Measured: Inclusion

  29. Mitomycin therapy

    Yes/no

    Measured: Inclusion

  30. History of auto-immune disease

    Yes/no

    Measured: Inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2024
  2. Study start12 Dec 2024
  3. Primary completionJun 2029 (estimated)
  4. Study completionJun 2029 (estimated)

Resources

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
Case only
Time perspective
Prospective
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06738797
Sponsor's protocol ID
NIMAO/2023-2/NH01
Acronym
PROMES-URO
Status last verified
Jan 2026
First submitted
10 Dec 2024
Last updated
28 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Urogenital Neoplasms, run by Centre Hospitalier Universitaire de Nīmes at 5 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 3 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 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 Nadine Houede (04.66.68.33.01, nadine.houede@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SPHERTEST measurement of potential therapeutic efficacy (time frame: Day 0). The study lists 2 primary outcomes in all. 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 NCT06738797.

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 28 Jan 2026.

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