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A Study Comparing Standard Treatments in People With Non-Muscle Invasive Bladder Cancer (NMIBC)

NCT06929286 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2026-05-11

No results posted yet for this study

Summary

The purpose of this study is to compare the effectiveness of different FDA-approved/NCCN-recommended drug treatments for NMIBC. In particular, the FDA-approved drug nadofaragene firadenovec will be compared to usual care with other NCCN-recommended standard treatments for NMIBC (gemcitabine with or without docetaxel, mitomycin, re-treatment with BCG, or pembrolizumab).

Conditions

Interventions

DRUG

Nadofaragene Firadenovec

For patients randomized to receive nadofaragene firadenovec, the patient will receive nadofaragene firadenovec as of normal saline instilled intravesically every 3 months for up to 12 months.

DRUG

Gemcitabine

gemcitabine instilled intravesically for 1 h, then drained completely out of the bladder

DRUG

Docetaxel

followed by docetaxel instilled intravesically for 1 h. This is given once weekly for 6 weeks for induction. Those who have a complete response typically proceed with once-monthly instillations of GemDoce for up to 24 months as maintenance therapy

Sponsors & Collaborators

Principal Investigators

  • Eugene Pietzak, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-11
Primary Completion
2028-04-30
Completion
2028-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT06929286 on ClinicalTrials.gov