OncoMatch/Clinical Trials/NCT05644041
Intravesical Gem/Doce in Patients With NMIBC
Is NCT05644041 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies gemcitabine + docetaxel for urinary bladder cancer.
Treatment: gemcitabine + docetaxel — Intravesical immunotherapy or chemotherapy for non-muscle invasive bladder cancer (NMIBC) is a well-established treatment for preventing or delaying tumor recurrence after tumor resection. For high-risk non-muscle invasive bladder cancer, immunotherapy in the form of intravesical Bacillus Calmette-Guérin (BCG) can be effective as first-line; nevertheless, the response rate to BCG is suboptimal with many patients failing treatment. Following BCG-failure, however, very few effective therapeutic options exist besides life-changing cystectomy. Recent shortages of BCG have pushed the use of alternative intravesical therapies for non-muscle invasive bladder cancer. At the University of Arizona Cancer Center, the use of intravesical Gemcitabine + Docetaxel (Gem/Doce) is considered as standard treatment for patients with non-invasive bladder cancer who are unable to get BCG or are BCG-resistant. The role of Gemcitabine as first-line treatment for NMIBC is poorly understood. The purpose of this study is to gain a better understanding of the use of Gemcitabine + Docetaxel intravesical chemotherapy for non-muscle invasive bladder cancer.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage TIS
Excluded: Stage T2 OR HIGHER
Grade: intermediatehigh
Histologically confirmed intermediate or high-risk non-muscle invasive urothelial carcinoma of the bladder (Ta, T1, or Tis stage)... Clinical T2 or higher stage UC of the bladder [excluded].
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: transurethral resection of bladder tumor
Post-transurethral bladder tumor resection
Cannot have received: BCG
Exception: Patients with a high-grade recurrence after 24 months since last dose of BCG
no previous BCG treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Arizona Cancer Center · Tucson, Arizona
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05644041 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior BCG disqualifies patients from enrollment.
What disease stage is eligible?
Stage TIS is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages