NCT06704191

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

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

Type	Name	Description
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

Timeline

• Start date: 2025-04-21
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-11-26
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States