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

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: Recruiting
• Conditions: Stage 0a Bladder Cancer AJCC v8; Stage 0is Bladder Cancer AJCC v8; Stage I Bladder Cancer AJCC v8; Non-Muscle Invasive Bladder Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Procedure: Cystoscopy; Biological: BCG Solution; Drug: Docetaxel; Drug: Gemcitabine; Other: Home Health Encounter; Drug: Mitomycin

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: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224-9980
      • Recruiting
      • Mayo Clinic in Florida
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Timothy D. Lyon, MD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
Incidence and severity of adverse events (AEs)	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	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

Outcome Measure	Measure Description	Time Frame
Patient-preferred treatment location	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	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

• Sponsor: Mayo Clinic
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Timothy D. Lyon, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 22, 2024
• First Submitted That Met QC Criteria: November 22, 2024
• First Posted (Actual): November 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Urologic Neoplasms; Carcinoma; Urinary Bladder Diseases; Non-Muscle Invasive Bladder Neoplasms; Urinary Bladder Neoplasms; Professional Practice; Organization and Administration; Health Services Administration; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Indoles; Taxoids; Cyclodecanes; Diterpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Health Services; Health Care Facilities Workforce and Services; Community Health Services; Diagnostic Techniques, Surgical; Endoscopy; Quinones; Azirines; Urologic Surgical Procedures; Urogenital Surgical Procedures; Diagnostic Techniques, Urological; Mitomycins; Indolequinones; Nursing Services; Docetaxel; Gemcitabine; Mitomycin; Cystoscopy; Mitozytrex; Home Care Services; House Calls
• Other Study ID 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