Phase 2 Bladder Cancer Trial, Recruiting NCT07019220 Sponsor: Ekaterina Laukhtina Condition: Bladder Cancer
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Phase 2 Bladder Cancer Trial, Recruiting

NCT07019220
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 or older who have given written consent to participate
  • People who have been diagnosed with a specific low-grade, early-stage bladder cancer (called TaLG bladder cancer), either as a first-time diagnosis or as a return of a previously treated cancer, confirmed by a tissue sample taken at or within 8 weeks before the screening visit
  • People whose largest bladder tumor measures 15mm or less in diameter, as seen on a bladder camera examination (cystoscopy)
  • People with no more than 5 bladder tumors present
  • People who have had a bladder camera examination with a detailed diagram recording the number, location, size, and appearance of tumors, including photos
  • People whose cancer has returned but remains only low- or intermediate-risk early-stage bladder cancer, with no other cancer types present
  • People whose condition requires a surgical procedure to remove bladder tumors (called TURBT)
  • People whose urine cell test (cytology) showed no sign of high-grade disease within 8 weeks before the screening visit
  • People with no cancer spread to lymph nodes or other parts of the body
  • People who are willing and able to use effective contraception throughout the study and for at least 6 months after treatment ends
  • Women who could become pregnant must have a negative blood pregnancy test within 2 weeks before enrolling, and must use adequate contraception throughout the study
  • People who are willing and able to give informed consent

Who may not be able to join:

  • People whose tumors are suspected by their doctor to be high-grade (more aggressive) cancer
  • People whose urine cell test showed high-grade cancer cells, based on recognised testing standards
  • People whose largest tumor is greater than 15mm in diameter
  • People with more than 5 bladder tumors
  • People who have had any treatment placed directly into the bladder within the past year
  • People who have had high-grade early-stage bladder cancer within the last 3 years (a history of high-grade disease more than 3 years ago may still be considered — confirm with trial site)
  • People who have had, or currently have, bladder cancer that has grown into the bladder muscle or spread to other parts of the body
  • People with a history of cancer in the upper urinary tract (the kidneys or tubes leading to the bladder)
  • People with a significant narrowing of the urethra that would prevent a catheter from being inserted
  • People with a history of nerve-related bladder problems, active inability to urinate, or any other condition that prevents normal urination
  • People with an active urinary tract infection that, in the treating doctor's opinion, cannot be treated and cleared before the biopsy or study treatment
  • People who do not wish to participate
  • People who have a known positive HIV test result
  • Women who are pregnant or breastfeeding
  • Women of childbearing potential who are not using adequate contraception

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Shahrokh F. Shariat Prof. Dr., Professor, Department of Urology, Medical University of Viernna

Phone: +43 (0)1 40400-26315

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Ekaterina Laukhtina
Registry
ClinicalTrials.gov
Start date
27 December 2023
Est. completion
1 November 2027

Where this trial is recruiting

🇦🇹 Austria

Primary endpoints

Clinical complete response (cCR)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov