COBRA - Chemoablation for Low Grade Bladder Cancer: A single arm, prospective, open-label, investigator-initiated Phase 2 study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Vienna

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

27 Dec 2023 → ongoing

Decision date (initial)

2024-10-30

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-517106-28-00

EudraCT number

2023-000212-22

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To assess efficacy of intravesical gemcitabine in patients with TaLG bladder cancer

Secondary objectives 1

1. To assess safety and tolerability of intravesical gemcitabine in patients with TaLG bladder cancer

Conditions and MedDRA coding

Bladder cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. 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
2. On screening cystoscopy: Diameter of the largest lesion ≤15mm
3. Number of lesions ≤5
4. Cystoscopy with bladder diagram including number, site, size and appearance of the tumors with photo documentation
5. Patient who has recurrence of and not other than TaLG NMIBC (low or intermediate EAU risk)
6. NMIBC requiring treatment with transurethral resection of bladder tumors (TURBT)
7. Negative voiding cytology for high grade (HG) disease within 8 weeks before Screening
8. No lymph node metastasis or distant metastasi
9. Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment
10. 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
11. Willing and able to provide informed consent

Exclusion criteria 15

1. Tumors that clinicians suspect to be HG
2. Positive HG cytology according to Paris criteria
3. Diameter of tumor >15 mm
4. Number of lesions >5
5. Any previous intravesical therapy within 1 year
6. 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
7. Past or current muscle invasive bladder cancer (i.e., T2, T3, T4) or metastatic UC
8. History of upper tract urothelial carcinoma (UTUC)
9. Clinically significant urethral stricture that would preclude passage of a urethral catheter
10. History of neurogenic bladder; active urinary retention; any other condition that would prohibit normal voiding
11. 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
12. Patient refused to participate
13. Positive human immunodeficiency virus (HIV) test
14. Female patients who are pregnant/breastfeeding
15. Female patients of childbearing potential not using adequate contraception

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Clinical complete response (cCR, absence of the macroscopic tumor after chemoablation)

Secondary endpoints 5

1. Pathological complete response (pCR)
2. Overall response (cCR + pCR)
3. Treatment-related adverse events evaluated using the National Cancer Institute’s Common Terminology Criteria for Adverse Events (version 5.0)
4. Rate of treatment discontinuation (at least 5 from 6 instillations within 8 weeks)
5. Health-related quality of life

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Vienna

Sponsor organisation

Medical University Of Vienna

Address

Spitalgasse 23, Alsergrund Alsergrund

City

Vienna

Postcode

1090

Country

Austria

Scientific contact point

Organisation

Medical University Of Vienna

Contact name

Department of Urology

Public contact point

Organisation

Medical University Of Vienna

Contact name

Department of Urology

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications