Chemoablation for Low-Grade Bladder Cancer (COBRA)

Ekaterina Laukhtina

Status and phase

Enrolling

Phase 2

Conditions

Bladder (Urothelial, Transitional Cell) Cancer

Treatments

Drug: Gemcitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT07019220

COBRA

Details and patient eligibility

About

The goal of this single arm, prospective, open-label, investigator-initiated Phase 2 clinical trial is to evaluate the efficacy of intravesical chemoablation in patients with low grade bladder cancer.

Full description

In this study, patients with histologically confirmed Ta low-grade bladder cancer will undergo chemoablation with gemcitabine (six weekly instillations). The study aims to evaluate the efficacy, safety, and tolerability of chemoablation.

Enrollment

47 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male/female participants who are at least 18 years of age on the day of providing documented informed consent will be enrolled in this study
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
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 metastasis
Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment
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

Exclusion criteria

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