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Brachytherapy With Durvalumab or Tremelimumab for the Treatment of Patients With Platinum-Resistant, Refractory, Recurrent, or Metastatic Gynecological Malignancies

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study completion moved earlier from Dec 1, 2026 to Oct 11, 2026v13
  2. Primary completion date changed from estimate of Dec 1, 2025 to Oct 11, 2024v12
  3. Re-verified, no change to tracked fieldsv11
  4. Primary completion date: Dec 1, 2024 to Dec 1, 2025
    • Study completion date: Dec 1, 2025 to Dec 1, 2026
    v10
  5. Primary completion date: Jun 1, 2024 to Dec 1, 2024
    • Study completion date: Jun 1, 2025 to Dec 1, 2025
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Primary completion date: Jun 1, 2023 to Jun 1, 2024
    • Study completion date: Jun 1, 2024 to Jun 1, 2025
    v8
  2. Primary completion date: Jun 1, 2022 to Jun 1, 2023
    • Study completion date: Jun 1, 2023 to Jun 1, 2024
    v7
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 54 to confirmed 9
    • Site details revised
    v6
  4. Re-verified, no change to tracked fieldsv5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 1, 2020 to Aug 7, 2020
    • Site details revised
    • Collaborators expanded, about 1 word
    v4
  6. Collaborators shortened, about 4 wordsv3
  7. Start date: Jun 1, 2020 to Aug 1, 2020v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 phase II trial studies the side effects and how well brachytherapy with durvalumab or tremelimumab work for the treatment of gynecological malignancies that is resistant to platinum therapy (platinum-resistant), does not respond to treatment (refractory), has come back (recurrent), or has spread to other places in body (metastatic). Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial is being done to see whether brachytherapy with durvalumab or tremelimumab works better in treating patients with gynecological malignancies.
Trial Details
NCT Number NCT04395079
Lead Sponsor Jonsson Comprehensive Cancer Center
Collaborators: AstraZeneca
Conditions
(from sponsor)		 Metastatic Malignant Female Reproductive System Neoplasm, Platinum-Resistant Malignant Female Reproductive System Neoplasm, Recurrent Malignant Female Reproductive System Neoplasm, Refractory Malignant Female Reproductive System Neoplasm
Enrollment 9 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov