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

March 24, 2026 updated by: Mayo Clinic

MC240502: Cancer CARE (Connected Access and Remote Expertise) Beyond Walls In-home iNtraVesIcal ThErapy (INVITE) Study - A Phase Ib/II, Single-Arm Trial of Delivering Intravesical Therapy for Bladder Cancer in Patients' Homes

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

PRIMARY OBJECTIVES:

I. To characterize the safety of in-home delivery of intravesical therapy. II. To assess the feasibility of in-home delivery of intravesical therapy.

SECONDARY OBJECTIVE:

I. To evaluate patient satisfaction with in-home intravesical therapy.

OTHER OBJECTIVES:

I. To assess patient-reported function and global health status/quality of life.

II. To assess patient-reported adverse events. III. To assess home days during study period. IV. To assess patient satisfaction with in-home intravesical therapy. V. To assess unplanned interactions with urological care team. VI. To describe disease-free survival rates following intervention period.

OUTLINE:

INDUCTION (PHASE IB COHORT AND PHASE II COHORT): Patients receive BCG intravesically over 1-2 hours, gemcitabine intravesically over 1-2 hours, gemcitabine intravesically over 1 hour followed by docetaxel intravesically over 1 hour or mitomycin (mitomycin C) intravesically over 1-2 hours in the urology clinic. Treatment repeats once weekly in the home for up to 5 weeks in the absence of disease progression or unacceptable toxicity.

MAINTENANCE (PHASE II COHORT ONLY): Patients receive in-home BCG intravesically over 1-2 hours once weekly for 3 weeks, gemcitabine intravesically over 1-2 hours once monthly for 3 months, gemcitabine intravesically over 1 hour followed by docetaxel intravesically over 1 hour once monthly for 3 months or mitomycin C intravesically over 1-2 hours once monthly for 3 months in the absence of disease progression or unacceptable toxicity.

Additionally, patients undergo cystoscopy at end of study and receive access to Cancer Care Beyond Walls (CCBW) home health visits throughout the study.

After completion of study treatment, patients are followed up at 12 weeks from registration and up to 1 year after registration.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224-9980
        • Recruiting
        • Mayo Clinic in Florida
        • Contact:
        • Principal Investigator:
          • Timothy D. Lyon, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • PHASE IB ONLY: Female or male patients with histologically confirmed non-muscle invasive bladder cancer (stage Ta, Tis, or T1) who are currently receiving induction therapy with one of the following eligible intravesical treatment regimens

    • Gemcitabine
    • Sequential gemcitabine/docetaxel
    • Bacillus Calmette-Guerin
    • Mitomycin C
  • PHASE II ONLY: Female or male patients with histologically confirmed non-muscle invasive bladder cancer (stage Ta, Tis or T1) who are receiving maintenance therapy with an eligible regimen
  • PHASE IB ONLY: Able to be successfully catheterized and able to tolerate first dost of intravesical therapy in the outpatient clinic
  • Residing within the area serviced by supplier network
  • Residence either has Wi-Fi or cellular data network connection for virtual telehealth visits
  • Age ≥ 18 years at time of registration
  • Signed informed consent form by patient
  • Willing and able to comply with the study protocol in the investigator's judgment
  • Ability to complete questionnaire(s) by themselves or with assistance
  • Willingness to follow birth control requirements for females and males of reproductive potential

Exclusion Criteria:

  • Receiving any other investigational or standard of care agent which would be considered as a treatment for non-muscle invasive bladder cancer and is not part of the eligible treatment regimens
  • Actively receiving any other treatment for cancer (except hormone therapy for breast or prostate cancer, or treatment for non-invasive skin cancer)
  • Requiring 24/7 assistance with activities of daily living (ADLs)
  • Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

  • Uncontrolled intercurrent illness including, but not limited to:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Myocardial infarction ≤ 6 months
    • Wound healing disorder
    • Psychiatric illness/social situations that would limit compliance with study requirements
  • Anticipation of the need for major surgery during the course of study treatment
  • Known allergy or previous intolerance to drug regimens
  • Pregnancy or breastfeeding
  • Hypersensitivity or allergy to polysorbate 80 or paclitaxel

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment (BCG, gemcitabine, docetaxel, mitomycin)

INDUCTION (PHASE IB COHORT AND PHASE II COHORT): Patients receive BCG intravesically over 1-2 hours, gemcitabine intravesically over 1-2 hours, gemcitabine intravesically over 1 hour followed by docetaxel intravesically over 1 hour or mitomycin C intravesically over 1-2 hours in the urology clinic. Treatment repeats once weekly in the home for up to 5 weeks in the absence of disease progression or unacceptable toxicity.

MAINTENANCE (PHASE II COHORT ONLY): Patients receive in-home BCG intravesically over 1-2 hours once weekly for 3 weeks, gemcitabine intravesically over 1-2 hours once monthly for 3 months, gemcitabine intravesically over 1 hour followed by docetaxel intravesically over 1 hour once monthly for 3 months or mitomycin C intravesically over 1-2 hours once monthly for 3 months in the absence of disease progression or unacceptable toxicity.

Additionally, patients undergo cystoscopy at end of study and receive access to CCBW home health visits throughout the study.
Other: Questionnaire Administration
Ancillary studies
Procedure: Cystoscopy
Undergo cystoscopy
Other Names:
  • CS
Biological: BCG Solution
Given intravesically
Other Names:
  • Bacillus Calmette Guerin Solution
  • Bacillus Calmette-Guerin Solution
  • TICE BCG Solution
Drug: Docetaxel
Given intravesically
Other Names:
  • Taxotere
  • Docecad
  • RP56976
  • Taxotere Injection Concentrate
  • RP 56976
  • RP-56976
Drug: Gemcitabine
Given intravesically
Other Names:
  • dFdCyd
  • dFdC
  • Difluorodeoxycytidine
Other: Home Health Encounter
Receive access to CCBW home health visits
Other Names:
  • HH
  • Home
  • Home Care Visit
  • Home Health
Drug: Mitomycin
Given intravesically
Other Names:
  • Mutamycin
  • Ametycine
  • Jelmyto
  • MITO
  • Mito-C
  • Mito-Medac
  • Mitocin
  • Mitocin-C
  • Mitolem
  • Mitomycin C
  • Mitomycin-C
  • Mitomycin-X
  • Mitomycine C
  • Mitosol
  • Mitozytrex
  • Mutamycine
  • NCI-C04706
  • Mitomycin pyelocalyceal

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence and severity of adverse events (AEs)
Time Frame: 12 weeks
The incidence, type, and severity of AEs experienced will be reported. The maximum grade for each type of AE will be summarized using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
12 weeks
Feasibility of in-home intravesical therapy
Time Frame: 12 weeks
Feasibility will be indicated by the proportion of patients who receive at least 4 of 5 planned doses of induction therapy in the home within 12 weeks of the first dose of intravesical therapy (received in the outpatient clinic).
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient-preferred treatment location
Time Frame: Up to 1 year
The frequency and proportion of patients who indicate a preference for in-home intravesical therapy versus a traditional setting will be assessed using the Patient Satisfaction and Feedback Questionnaire. The questionnaire consists of 4 questions related to receipt of care [answered on a 5-point scale (e.g., Excellent/Very Good/Good/Fair/Poor or Very Effective/Capable and Effective/Neutral/Somewhat Effective/Needs Development)]; 1 question related to preference for treatment location; 3 questions answered with yes, no, or uncertain; 1 question related to experience (better than expected, same as expected, worse than expected); and 1 opened ended for feedback as to what could have improved the experience.
Up to 1 year
Patient-reported likelihood to recommend at home therapy
Time Frame: Up to 1 year
Will be assessed using the Patient Satisfaction and Feedback Questionnaire. The frequency and proportion of patients who would recommend in-home intravesical therapy to other patients will be reported. The questionnaire consists of 4 questions related to receipt of care [answered on a 5-point scale (e.g., Excellent/Very Good/Good/Fair/Poor or Very Effective/Capable and Effective/Neutral/Somewhat Effective/Needs Development)]; 1 question related to preference for treatment location; 3 questions related to acceptability and likely recommendation answered with yes, no, or uncertain; 1 question related to experience (better than expected, same as expected, worse than expected); and 1 opened ended for feedback as to what could have improved the experience.
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Center for Advancing Translational Sciences (NCATS)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Timothy D. Lyon, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 21, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MC240502 (Other Identifier: Mayo Clinic)
  • UL1TR002377 (U.S. NIH Grant/Contract)
  • NCI-2024-09555 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • 24-002176 (Other Identifier: Mayo Clinic Institutional Review Board)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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