Who is sponsoring NCT04179162?

NCT04179162 is sponsored by Memorial Sloan Kettering Cancer Center.

What condition does NCT04179162 study?

NCT04179162 studies Non-Muscle Invasive Bladder Cancer (NMIBC).

What drugs are being tested in NCT04179162?

Interventions: Bacillus Calmette-Guérin (BCG), Gemcitabine.

What is the status of NCT04179162?

NCT04179162 is currently ACTIVE_NOT_RECRUITING.

Last reviewed 2025-06-12 · How we verify

Phase I/II Trial of Bacillus Calmette-Guérin (BCG) and Intravesical Gemcitabine for Patients With BCG-Relapsing High-Grade Non-Muscle Invasive Bladder Cancer

NCT04179162 Phase 1/Phase 2 ACTIVE_NOT_RECRUITING

This study will test the safety of BCG and gemcitabine in people who have BCG-relapsing Non-Muscle Invasive Bladder Cancer (NMIBC). The researchers will test increasing doses of gemcitabine to find the highest dose that causes few or mild side effects when combined with BCG. The study will also look at whether this combination of drugs is effective in treating BCG-relapsing NMIBC.

Details

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 1/Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	54
Start date	2019-11-22
Completion	2026-11

Conditions

Non-Muscle Invasive Bladder Cancer (NMIBC)

Interventions

Bacillus Calmette-Guérin (BCG)
Gemcitabine

Primary outcomes

evaluate the MTD (Phase I) — 1 year
Describe the toxicities by frequency and by grade.This study will use CTCAE version 5.0 for toxicity and serious adverse event reporting.
proportion of patients who are disease free — 6 months after the start of treatment
Will be assessed by both urine cytology and cystoscopy at 6 months after initiation of therapy. Disease free (i.e., complete treatment response) is defined as no evidence of disease (negative cytology and cystoscopy).

Countries

United States