2024-517106-28-00RecruitingPhase 2
COBRA - Chemoablation for Low Grade Bladder Cancer: A single arm, prospective, open-label, investigator-initiated Phase 2 study
Source: EU CTIS (euclinicaltrials.eu) · Last updated 30 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To assess efficacy of intravesical gemcitabine in patients with TaLG bladder cancer
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 47 (estimated)
- First submitted
- 24 Sept 2024
- Start date
- 27 Dec 2023
- Lead sponsor
- Medical University Of Vienna
- Diseases
- Bladder cancer
- EU CT number
- 2024-517106-28-00
- EudraCT number
- 2023-000212-22
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 47
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a low-grade, non-invasive bladder cancer (TaLG) that has come back or is newly found. It tests gemcitabine placed in the bladder.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- TaLG bladder cancer confirmed by a biopsy. Largest tumour 15 mm or smaller. No more than 5 tumours. No spread to lymph nodes or other organs.
- Earlier treatment
- No treatment placed inside the bladder within the last 1 year.
- Biomarker or test result
- Urine cell test negative for high-grade disease within 8 weeks before screening.
Main reasons for not taking part
- High-grade bladder cancer in the last 3 years
- Muscle-invasive or spread bladder cancer
- Past cancer of the upper urinary tract
- Positive HIV test
- Pregnant or breastfeeding
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Evidence of active urinary tract infection (UTI) that in the Investigator's opinion cannot be treated and resolved prior to biopsy and/or administration of study treatment
- Any previous intravesical therapy within 1 year
- Previous HG NMIBC (within the last 3 years). It is allowed to include patients who had history of HG disease longer than 3 years ago
Other illness
- History of neurogenic bladder; active urinary retention; any other condition that would prohibit normal voiding
- Positive human immunodeficiency virus (HIV) test
- Past or current muscle invasive bladder cancer (i.e., T2, T3, T4) or metastatic UC
- History of upper tract urothelial carcinoma (UTUC)
Other
- Tumors that clinicians suspect to be HG
- Patient refused to participate
- Female patients who are pregnant/breastfeeding
- Female patients of childbearing potential not using adequate contraception
- Positive HG cytology according to Paris criteria
- Diameter of tumor >15 mm
- Number of lesions >5
- Clinically significant urethral stricture that would preclude passage of a urethral catheter
Who the study is looking for
- Diagnosis of a recurrent tumor and a history of TaLG BCa or diagnosis of primary TaLG BCa histologically confirmed by cold cup biopsy at screening or within 8 weeks before screening
- Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment. Female patients of childbearing potential must use adequate contraception during study period
- Willing and able to provide informed consent
- On screening cystoscopy: Diameter of the largest lesion ≤15mm
- Number of lesions ≤5
- Cystoscopy with bladder diagram including number, site, size and appearance of the tumors with photo documentation
- Patient who has recurrence of and not other than TaLG NMIBC (low or intermediate EAU risk)
- NMIBC requiring treatment with transurethral resection of bladder tumors (TURBT)
- Negative voiding cytology for high grade (HG) disease within 8 weeks before Screening
- No lymph node metastasis or distant metastasi
- Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Vienna | Vienna | Austria | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.