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Low-Dose-Rate Brachytherapy Combined With Immune Checkpoint Inhibition in Cancer

StatusActive, Not Recruiting
PhasePhase 1
Started
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Record History

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  1. Study completion date: Feb 1, 2026 to Sep 1, 2026v16
  2. Study completion date: Sep 1, 2025 to Feb 1, 2026v15
  3. Primary completion date changed from estimate of Jun 1, 2025 to Mar 20, 2024v14
  4. Phase: Phase 1/2 to Phase 1v13
  5. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 15 to confirmed 5
    • Site details revised
    v12
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  1. Primary completion date: Dec 1, 2024 to Jun 1, 2025
    • Study completion date: Mar 1, 2025 to Sep 1, 2025
    • Eligibility criteria expanded, about 37 words
    v11
  2. Primary completion date: Jun 1, 2024 to Dec 1, 2024
    • Study completion date: Sep 1, 2024 to Mar 1, 2025
    v10
  3. Primary completion date: Dec 2023 to Jun 1, 2024
    • Study completion date: Mar 2024 to Sep 1, 2024
    v9
  4. Eligibility criteria expanded, about 22 words
    • Study description expanded, about 12 words
    v8
  5. Interventions: Low Dose Rate Brachytherapy (LDR) (Radiation), Nivolumab (Drug) to Low Dose Rate Brachytherapy (LDR) (Radiation), Standard-of-Care Immunotherapy (Drug)
    • Study description shortened, about 6 words
    v7
  6. Re-verified, no change to tracked fieldsv6
  7. Start date changed from estimate of Jul 2021 to May 27, 2021v5
  8. Start date: Apr 1, 2021 to Jul 2021v4
  9. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2021 to Apr 1, 2021
    • Site details revised
    v3
  10. Start date: Dec 2020 to Mar 2021v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
This is a pilot study of combination low dose rate brachytherapy (LDR) added to standard of care (SOC) immunotherapy in stage III and IV melanoma, stage IV renal call cancer, and stage IV urothelial cancer.
Trial Details
NCT Number NCT04620603
Lead Sponsor Case Comprehensive Cancer Center
Conditions
(from sponsor)		 Cutaneous Malignant Melanoma, Renal Cell Cancer, Urothelial Cancer of Renal Pelvis
Related terms Carcinoma, Renal Cell, Cutaneous Malignant Melanoma
Enrollment 5 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov