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

StatusRecruiting
PhasePhase 1/2
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 31, 2026 → Dec 31, 2027
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Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 31, 2026 to Dec 31, 2027
    • Study completion pushed from Dec 31, 2026 to Dec 31, 2028
    • Eligibility criteria expanded, about 33 words
    • Secondary endpoints: details revised at 2 of 2 entries
  2. Primary and study completion dates: Jun 6, 2026 to Dec 31, 2026v12
  3. 3 versions Re-verified since May 27, 2025, no change to tracked fieldsv9-v11
  4. Eligibility criteria expanded, about 21 wordsv8
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 15, 2025 to Apr 21, 2025
    • Site details revised
    v7
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  1. Start date: Mar 1, 2025 to Apr 15, 2025v6
  2. Eligibility criteria expanded, about 18 words
    • Study description shortened, about 17 words
    • Site contact updated
    v5
  3. Start date: Feb 6, 2025 to Mar 1, 2025v4
  4. Start date: Dec 6, 2024 to Feb 6, 2025v3
  5. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Mayo Clinic
1,024 trials monitored
See 128 trials at risk
Bladder Cancer
1,058 trials monitored
See 76 trials at risk
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.
Trial Details
NCT Number NCT06704191
Lead Sponsor Mayo Clinic
Collaborators: National Center for Advancing Translational Sciences (NCATS)
Conditions
(from sponsor)		 Non-Muscle Invasive Bladder Carcinoma, Stage 0a Bladder Cancer AJCC v8, Stage I Bladder Cancer AJCC v8, Stage 0is Bladder Cancer AJCC v8
Related terms Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov