OncoMatch

OncoMatch/Clinical Trials/NCT05644041

Intravesical Gem/Doce in Patients With NMIBC

Is NCT05644041 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies gemcitabine + docetaxel for urinary bladder cancer.

Phase 2RecruitingUniversity of ArizonaNCT05644041Data as of May 2026

Treatment: gemcitabine + docetaxelIntravesical 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.

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Extracted eligibility criteria

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

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