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Testing the Addition of an Anti-Cancer Drug, Gemcitabine, to Usual Treatment (BCG Alone) in People Whose Non-Muscle Invasive Bladder Cancer (NMIBC) Came Back After Prior BCG Therapy

NCT07000084 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2026-04-07

No results posted yet for this study

Summary

This phase III trial compares the effect of adding gemcitabine to intravesical Bacillus Calmette Guerin (BCG) versus intravesical BCG alone in patients with non-muscle invasive bladder cancer that has come back after a period of improvement (recurrent). Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Intravesical BCG is a solution containing the live BCG bacteria that is placed in the bladder via a catheter (intravesical). When the solution comes into direct contact with the bladder wall, it stimulates the body's immune system which kills tumor cells. Giving gemcitabine with intravesical BCG may kill more tumor cells in patients with recurrent non-muscle invasive bladder cancer.

Conditions

  • Recurrent Non-Muscle Invasive Bladder Carcinoma
  • Stage 0a Bladder Cancer AJCC v8
  • Stage I Bladder Cancer AJCC v8

Interventions

BIOLOGICAL

BCG Solution

Given intravesically

PROCEDURE

Biopsy of Bladder

Undergo bladder biopsy

PROCEDURE

Cystoscopy

Undergo cystoscopy

PROCEDURE

Computed Tomography

Undergo CT Scan

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Biospecimen Collection

Undergo blood and urine sample collection

PROCEDURE

Transurethral Resection of Bladder Tumor

Undergo TURBT

DRUG

Gemcitabine

Given intravesically

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Alliance for Clinical Trials in Oncology

    lead OTHER

Principal Investigators

  • Eugene Pietzak, MD · Alliance for Clinical Trials in Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-17
Primary Completion
2028-06-05
Completion
2028-12-05

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07000084 on ClinicalTrials.gov