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Bladder CancerPhase 2GAIN-INSTNCT05024734

Guiding Instillation in Non Muscle-invasive Bladder Cancer Based on Drug Screens in Patient Derived Organoids

A Phase 2 study testing Epirubicin, Mitomycin and Gemcitabine in people with Bladder Cancer and Non-muscle Invasive, run by Roland Seiler-Blarer at 1 site in Switzerland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

From patients with intermediate risk non-muscle invasive bladder cancer tumor (NMIBC) specimens will be harvested during transurethral resection. Fresh specimens will be cultured as patient derived organoids (PDO). After approx. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer, Non-muscle Invasive
What is being tested?
Epirubicin, Mitomycin and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteSwitzerland
Study dates
21 Feb 2023to 31 Dec 2028
Phase
Phase 2
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

  • Age ≥ 18 years
  • Signed Informed Consent Form
  • ECOG performance status of 0 or 1
  • Histologically confirmed intermediate risk non muscle-invasive urothelial carcinoma of the bladder (pTa low grade) Patients
  • Representative fresh tumor specimen for PDO generation and drug screen

Who cannot join

  • Known previous high grade and/or high risk non muscle-invasive bladder cancer
  • Previous Intravesical biological/immuno (BCG) therapy
  • Pregnancy or nursing
  • Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol
  • Severe infection within 4 weeks prior to cycle 1, day 1
  • Contraindication for frequent catheterization
Show all 10Show fewer
  • Voiding dysfunction
  • Pregnancy or nursing
  • Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through 6 months after the last treatment.
  • Male subject who is unwilling to use acceptable method of effective contraception during IP treatment and through 6 months after the last dose of IP.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Spitalzentrum Biel/Bienne

    Biel, 2501

Other trials in Switzerland

About this study

Official title: Guidance of Adjuvant Instillation in Intermediate Risk Non-muscle Invasive Bladder Cancer by Drug Screens in Patient Derived Organoids. A Single Center, Open-label, Phase II Trial With a Feasibility Endpoint. (GAIN-INST-TRIAL)

From patients with intermediate risk non-muscle invasive bladder cancer tumor (NMIBC) specimens will be harvested during transurethral resection. Fresh specimens will be cultured as patient derived organoids (PDO). After approx. 10 days, PDO are exposed to different drugs that are used as intravesical instillation agents in these patients (epirubicin, mitomycin, gemcitabine, docetaxel). After 2 days of exposure, PDO viability will be measured. The drug with the highest antitumor effect on PDO will be applied as weekly intravesical instillations 6 times. Thereafter, patients are followed according to the standard of care.

Being tested
Epirubicin, Mitomycin, Gemcitabine, Docetaxel
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

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

  • EpirubicinDrug

    In PDOs from patients that show highest response to Epirubicin, this drug will be instilled intravesically once weekly for 6 times.

    Epirubicin is also the default drug, in case of failure of drug prediction in the in-vitro drug screen in PDO.

    Epirubicin will be used as a concentrate for injection/instillation 2 mg/ml in total 50mg per vial. Prior to use, the concentrate for injection is diluted with 25ml of 0.9% saline solution to obtain the final Solution with 1mg/ml of Epirubicin.

  • MitomycinDrug

    In PDOs from patients that show highest response to Mitomycin, this drug will be instilled intravesically once weekly for 6 times.

    Mitomycin C will be used as 20mg dry powder. Prior to use, the powder will be dissolved in 50ml of 0.9% saline solution according to the manufacturer instructions

  • GemcitabineDrug

    In PDOs from patients that show highest response to Gemcitabine, this drug will be instilled intravesically once weekly for 6 times.

    Gemcitabine will be used as 2000 mg/50ml. For intravesical application, 1000mg of gemcitabine (corresponding to 25ml) will be diluted in 25ml 0.9% saline solution, to obtain the gemcitabine concentration of 1000mg/50ml used for instillation.

  • DocetaxelDrug

    In PDOs from patients that show highest response to Docetaxel, this drug will be instilled intravesically once weekly for 6 times.

    Docetaxel will be used as 140mg/7ml solution. For intravesical application, 48.825ml of saline will be added to 1.875ml Docetaxel solution (according 37.5mg of Docetaxel). The concentration of this solution is 0.74mg/ml by a total volume of the instillation solution of 50,7.

Study groups in NCT05024734
Study groupRoleWhat they receive
EpirubicinExperimentalPatients in that PDOs show highest response to this drug in-vitro will be treated with Epirubicin. If no significant drug selection can be performed in-vitro, Epirubicin will be the default for instillation.
Receives: Drug: Epirubicin
MitomycinExperimentalPatients in that PDOs show highest response to this drug in-vitro will be treated with Mitomycin.
Receives: Drug: Mitomycin
GemcitabineExperimentalPatients in that PDOs show highest response to this drug in-vitro will be treated with Gemcitabine.
Receives: Drug: Gemcitabine
DocetaxelExperimentalPatients in that PDOs show highest response to this drug in-vitro will be treated with Docetaxel.
Receives: Drug: Docetaxel

What is being measured

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

  1. Proportion of patients with successful drug selection

    Proportion of patients for which a specific selection of chemotherapeutic agent for intravesical instillation can be determined by using drug screens in PDOs.

    Measured: 24 months

Secondary outcomes (7)

  1. Proportion of patients for whom patient-derived organoids (PDOs) can be successfully generated (regardless of subsequent drug screen)

    Proportion of patients for whom patient-derived organoids (PDOs) can be successfully generated (regardless of subsequent drug screen)

    Measured: 24 months

  2. Rate of recurrence in the study population

    Rate of recurrence in the study population

    Measured: 24 months

  3. Recurrence free survival 24 months after TURBT

    Proportion of patients that show recurrence 24 months after TURBT

    Measured: 24 months

  4. Progression free survival 24 months after TURBT

    Proportion of patients that show progression 24 months after TURBT

    Measured: 24 months

  5. General quality of Life

    Description of the general quality of life based on the questionnaire EORTC-QLQ-C30

    Measured: 24 months

  6. Quality of Life related to the bladder cancer

    Description of the Quality of Life related to the bladder cancer based on the specific NMIBC24 module

    Measured: 24 months

  7. Safety profile of instillations

    Description of the side effects related to the chemotherapeutic intravesical instillations occuring during the treatment phase.

    Measured: 24 months

Timeline

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

  1. First posted27 Aug 2021
  2. Study start21 Feb 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05024734
Sponsor's protocol ID
SZB-URO-21-001
Acronym
GAIN-INST
Status last verified
Apr 2026
First submitted
23 Aug 2021
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Seiler R, Egger M, De Menna M, Wehrli S, Minoli M, Radic M, Lyatoshinsky P, Hosli R, Blarer J, Abt D, Kruithof-de Julio M. Guidance of adjuvant instillation in intermediate-risk non-muscle invasive bladder cancer by drug screens in patient derived organoids: a single center, open-label, phase II trial. BMC Urol. 2023 May 11;23(1):89. doi: 10.1186/s12894-023-01262-1.

    PubMed 37170307

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Epirubicin, Mitomycin and Gemcitabine in people with Bladder Cancer and Non-muscle Invasive, run by Roland Seiler-Blarer at 1 site in Switzerland.

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 5 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with successful drug selection (time frame: 24 months). 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 NCT05024734, which also lists 1 linked publication.

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 13 Jul 2026.

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