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Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Jun 15, 2027 → May 15, 2028
See other at-risk trials from Roswell Park Cancer Institute

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jun 15, 2027 to May 15, 2028
    • Study completion pushed from Dec 15, 2027 to May 15, 2028
    v35
  2. Eligibility criteria shortened, about 1 wordv34
  3. Site details revised at 1 of 3 sitesv33
  4. Primary completion date: Dec 15, 2025 to Jun 15, 2027
    • Study completion date: Dec 15, 2026 to Dec 15, 2027
    v32
  5. Primary completion date: Jun 15, 2025 to Dec 15, 2025v31
Show 29 earlier versionsHide 29 earlier versions
  1. Site contacts updated at 1 of 3 sitesv30
  2. Eligibility criteria expanded, about 6 wordsv29
  3. Re-verified, no change to tracked fieldsv28
  4. Site details revised at 1 of 3 sitesv27
  5. Study sites: 2 to 3v26
  6. Primary completion date: Apr 15, 2024 to Jun 15, 2025
    • Study completion date: Apr 15, 2025 to Dec 15, 2026
    v25
  7. Study sites: 1 to 2v24
  8. Study description revisedv23
  9. Start date: Apr 7, 2022 to Dec 19, 2022v22
  10. Eligibility criteria shortened, about 65 wordsv21
  11. Eligibility criteria expanded, about 12 wordsv20
  12. Collaborator revisedv19
  13. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 15, 2022 to Apr 7, 2022
    • Site details revised
    v18
  14. Start date: Feb 1, 2022 to Apr 15, 2022v17 Show 6 more changesShow less
    • Primary completion date: Feb 1, 2024 to Apr 15, 2024
    • Study completion date: Feb 1, 2025 to Apr 15, 2025
    • Interventions: Anti-HER2/HER3 Dendritic Cell Vaccine (Biological), Celecoxib (Drug), Pembrolizumab (Biological), Recombinant Interferon Alfa-2b… to Anti-HER2/HER3 Dendritic Cell Vaccine (Biological), Pembrolizumab (Biological)
    • Eligibility criteria shortened, about 160 words
    • Study description shortened, about 53 words
    • Study title shortened, about 3 words
  15. Start date: Dec 1, 2021 to Feb 1, 2022
    • Primary completion date: Dec 1, 2023 to Feb 1, 2024
    • Study completion date: Dec 1, 2024 to Feb 1, 2025
    v16
  16. Start date: Oct 1, 2021 to Dec 1, 2021
    • Primary completion date: Oct 1, 2023 to Dec 1, 2023
    • Study completion date: Oct 1, 2024 to Dec 1, 2024
    v15
  17. Start date: Aug 30, 2021 to Oct 1, 2021
    • Primary completion date: Aug 30, 2023 to Oct 1, 2023
    • Study completion date: Aug 30, 2024 to Oct 1, 2024
    v14
  18. Start date: Jul 30, 2021 to Aug 30, 2021
    • Primary completion date: Jul 30, 2023 to Aug 30, 2023
    • Study completion date: Jul 30, 2024 to Aug 30, 2024
    v13
  19. Start date: Jun 30, 2021 to Jul 30, 2021
    • Primary completion date: Jun 30, 2023 to Jul 30, 2023
    • Study completion date: Jun 30, 2024 to Jul 30, 2024
    v12
  20. Start date: May 15, 2021 to Jun 30, 2021
    • Primary completion date: May 15, 2023 to Jun 30, 2023
    • Study completion date: May 15, 2024 to Jun 30, 2024
    v11
  21. Start date: Mar 15, 2021 to May 15, 2021
    • Primary completion date: Mar 15, 2023 to May 15, 2023
    • Study completion date: Mar 15, 2024 to May 15, 2024
    v10
  22. Start date: Feb 1, 2021 to Mar 15, 2021
    • Primary completion date: Feb 1, 2023 to Mar 15, 2023
    • Study completion date: Feb 1, 2024 to Mar 15, 2024
    v9
  23. Primary completion date: Apr 1, 2022 to Feb 1, 2023
    • Start date: Dec 15, 2020 to Feb 1, 2021
    • Study completion date: Apr 1, 2023 to Feb 1, 2024
    v8
  24. Start date: Nov 1, 2020 to Dec 15, 2020v7
  25. Start date: Oct 1, 2020 to Nov 1, 2020v6
  26. Eligibility criteria expanded, about 3 wordsv5
  27. Start date: Aug 1, 2020 to Oct 1, 2020v4
  28. Study description expanded, about 3 wordsv3
  29. Start date: Jun 1, 2020 to Aug 1, 2020
    • Eligibility criteria expanded, about 309 words
    v2
  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 IIa trial studies how well dendritic cell vaccines against Her2/Her3 and pembrolizumab work for the treatment of triple negative breast cancer or HER2+ breast cancer or HER+ Breast cancer that has spread to the brain (brain metastasis). Dendritic cell vaccines work by boosting the immune system (a system in the body that protect against infection) to recognize and destroy the cancer cells. . Pembrolizumab is an "immune checkpoint inhibitor" which is designed to either "unleash" or "enhance" the cancer immune responses that already exist by either blocking inhibitory molecules" or by activating stimulatory molecules. Giving dendritic cell vaccines and pembrolizumab may shrink the cancer.
Trial Details
NCT Number NCT04348747
Lead Sponsor Roswell Park Cancer Institute
Collaborators: United States Department of Defense
Conditions
(from sponsor)		 Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Malignant Neoplasm in the Brain, Metastatic Triple-Negative Breast Carcinoma, Prognostic Stage IV Breast Cancer AJCC v8
Related terms Brain Neoplasms, Triple Negative Breast Neoplasms
Enrollment 23 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov