Tremelimumab + Durvalumab(MEDI4736)+ Belinostat in Urothelial Carcinoma

Study acronym: RESOLVE
StatusCompleted
PhasePhase 1
Started

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Record History

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  1. Trial completed Show 7 more changesShow less
    • Final enrollment: 7 participants (planned 9)
    • Primary completion date changed from estimate of Aug 2026 to Jan 26, 2026
    • Study completion date changed from estimate of Feb 2028 to Apr 28, 2026
    • Eligibility criteria expanded, about 36 words
    • Secondary endpoints: details revised at 3 of 5 entries
    • Site details revised
    • Collaborators shortened, about 4 words
  2. Primary completion pushed from Apr 1, 2026 to Aug 2026
    • Study completion pushed from Nov 30, 2027 to Feb 2028
    v17
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v16
  4. Eligibility criteria expanded, about 31 wordsv15
  5. Primary completion date: Apr 1, 2025 to Apr 1, 2026
    • Study completion date: Nov 30, 2026 to Nov 30, 2027
    v14
Show 12 earlier versionsHide 12 earlier versions
  1. Trial status: Suspended to Recruitingv13 Show 4 more changesShow less
    • Eligibility criteria shortened, about 62 words
    • Study description shortened, about 19 words
    • Site details revised
    • Study title shortened, about 5 words
  2. Primary completion date: Nov 30, 2024 to Apr 1, 2025v12
  3. Trial status: Recruiting to Suspended Sponsor's reason: Pending approval of cohort expansion
    • Site details revised
    v11
  4. Eligibility criteria shortened, about 2 wordsv10
  5. Trial status: Suspended to Recruitingv9 Show 5 more changesShow less
    • Interventions: Belinostat (Drug), Durvalumab (Biological), Tremelimumab (Biological) to Belinostat (Drug), Durvalumab (Biological)
    • Eligibility criteria expanded, about 152 words
    • Study description expanded, about 17 words
    • Site details revised
    • Study title shortened, about 5 words
  6. Primary completion date: Nov 30, 2023 to Nov 30, 2024
    • Study completion date: Nov 30, 2025 to Nov 30, 2026
    v8
  7. Eligibility criteria expanded, about 14 words
    • Study description expanded, about 27 words
    v7
  8. Trial status: Recruiting to Suspended Sponsor's reason: Data Safety Monitoring Committee Requirement
    • Site details revised
    v6
  9. Eligibility criteria shortened, about 22 wordsv5
  10. Eligibility criteria shortened, about 11 wordsv4
  11. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 31, 2021 to Jan 14, 2022
    • Site details revised
    v3
  12. Start date: Nov 30, 2021 to Dec 31, 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.
University of Utah
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This phase I trial studies the side effects and best dose of belinostat when given together with durvalumab in treating patients with urothelial cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable) and has spread to nearby tissue or lymph nodes (locally advanced). Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Belinostat is a potential anti-cancer drug, known as a histone deacetylase (HDAC) inhibitor, which means that belinostat stops the activity of HDAC enzymes (an enzyme is a protein that in small amounts can speed up a biological reaction). HDAC enzymes play an important role in cell growth and cell death. Giving durvalumab and belinostat may improve the body's ability to fight cancer.
Trial Details
NCT Number NCT05154994
Lead Sponsor University of Utah
Conditions
(from sponsor)		 Infiltrating Urothelial Carcinoma, Sarcomatoid Variant, Locally Advanced Urothelial Carcinoma, Metastatic Urothelial Carcinoma, Unresectable Urothelial Carcinoma
Related terms Carcinoma, Transitional Cell
Enrollment 7 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov