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In-home Intravesical Chemotherapy for the Treatment of Bladder Cancer, INVITE Trial

NCT06704191 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-03-30

No results posted yet for this study

Summary

This phase Ib/II trial compares the safety, tolerability and acceptability of intravesical chemotherapy given at home to in-clinic administration in patients with non-muscle invasive bladder cancer. Chemotherapy drugs, such as bacillus Calmette-Guerin (BCG), gemcitabine, docetaxel, and mitomycin C, 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. Standard of care chemotherapy for non-invasive bladder cancer is usually given directly into the bladder through a catheter (intravesical). This process requires numerous visits and can be disruptive to the lives of patients and caregivers. Bringing cancer care to the patients with in-home intravesical therapy may help reduce the disruption to daily lives. In-home intravesical chemotherapy may be safe and tolerable and may also be preferable to in-clinic administration in patients with non-muscle invasive bladder cancer.

Conditions

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

Interventions

BIOLOGICAL

BCG Solution

Given intravesically

PROCEDURE

Cystoscopy

Undergo cystoscopy

DRUG

Docetaxel

Given intravesically

DRUG

Gemcitabine

Given intravesically

OTHER

Home Health Encounter

Receive access to CCBW home health visits

DRUG

Mitomycin

Given intravesically

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Timothy D. Lyon, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-21
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT06704191 on ClinicalTrials.gov