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Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer

NCT04164082 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2026-05-13

No results posted yet for this study

Summary

This phase II trial studies the effect of adding pembrolizumab to gemcitabine in treating patients with non-muscle invasive bladder cancer whose cancer does not respond to Bacillus Calmette-Guerin (BCG) treatment. Chemotherapy drugs, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the patient's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding pembrolizumab to gemcitabine may delay the return of BCG-unresponsive bladder cancer for longer period compared to gemcitabine alone.

Conditions

  • Bladder Flat Urothelial Carcinoma In Situ
  • Non-Muscle Invasive Bladder Urothelial Carcinoma
  • Stage 0a Bladder Cancer AJCC v8
  • Stage 0is Bladder Cancer AJCC v8
  • Stage I Bladder Cancer AJCC v8

Interventions

PROCEDURE

Biopsy Procedure

Undergo bladder biopsy

PROCEDURE

Biospecimen Collection

Undergo urine and blood sample collection

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Cystoscopy

Undergo cystoscopy

DRUG

Gemcitabine Hydrochloride

Given intravesically

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Pembrolizumab

Given IV

PROCEDURE

Transurethral Resection of Bladder Tumor

Undergo TURBT

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Michael E Woods · Alliance for Clinical Trials in Oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-18
Primary Completion
2026-12-09
Completion
2026-12-09
FDA Drug
Yes

Countries

  • United States
  • Guam
  • Puerto Rico

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 NCT04164082 on ClinicalTrials.gov