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Pembrolizumab and Lenvatinib in Advanced/Metastatic Neuroendocrine Prostate Cancer

Study acronym: PLANE-PC
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Study completion pushed from Apr 2026 to Apr 2027v18
  2. Results first posted: Feb 12, 2026v17
  3. Primary endpoints: 2 to 1
    • Enrollment target: estimated 50 to confirmed 45
    • Study completion date: Dec 2025 to Apr 2026
    • Secondary endpoints revised (4)
    v16
  4. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Dec 2024 to Jan 8, 2025
    • Study completion date: Dec 2024 to Dec 2025
    • Site details revised at 5 of 5 sites
    v15
  5. Primary and study completion dates: Jul 2024 to Dec 2024v14
Show 12 earlier versionsHide 12 earlier versions
  1. Primary and study completion dates: Dec 2023 to Jul 2024v13
  2. Site contacts updated at 1 of 5 sitesv12
  3. Study sites: 4 to 5
    • Primary and study completion dates: Oct 2023 to Dec 2023
    v11
  4. Lead sponsor: Ulka Vaishampayan to University of Michigan Rogel Cancer Center
    • Collaborators revised (2)
    v10
  5. Study sites: 3 to 4v9
  6. Re-verified, no change to tracked fieldsv8
  7. Study sites: 2 to 3v7
  8. Primary completion date: Oct 2022 to Oct 2023
    • Study completion date: Jul 2023 to Oct 2023
    • Eligibility criteria expanded, about 3 words
    v6
  9. Eligibility criteria expanded, about 2 wordsv5
  10. Study sites: 1 to 2v4
  11. Re-verified, no change to tracked fieldsv3
  12. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Primary completion date: Jan 2024 to Oct 2022
    • Study sites: 0 to 1
    • Study completion date: Jan 2025 to Jul 2023
    • Start date changed from estimate of May 2021 to May 25, 2021
    • Study title shortened, about 1 word
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Eligible patients will be treated with the combination of lenvatinib and pembrolizumab. A cycle equals 21 days and therapy will continue until radiographic progression, intolerable toxicity, or patient/physician wishes to discontinue protocol therapy. A maximum of 35 cycles may be administered. On Day 1, when both pembrolizumab and lenvatinib are administered, patients should take the lenvatinib per their normal routine.
Trial Details
NCT Number NCT04848337
Lead Sponsor University of Michigan Rogel Cancer Center
Collaborators: Merck Sharp & Dohme LLC, Hoosier Cancer Research Network
Conditions
(from sponsor)		 Prostate Cancer Metastatic, Neuroendocrine Tumors
Related terms Neuroendocrine Tumors
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov