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PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Enrollment target: 46 to 24v14 Show 11 more changesShow less
    • Primary completion date: Jan 30, 2028 to Nov 11, 2026
    • Start date: Mar 21, 2025 to Nov 11, 2025
    • Primary endpoint revised
    • Study completion date: Jan 30, 2028 to Nov 30, 2030
    • Interventions: PRGN-2009 plus Pembrolizumab (Biological), Pembrolizumab alone (Drug) to PRGN-2009 plus Pembrolizumab (Biological)
    • Eligibility criteria expanded, about 57 words
    • Secondary endpoints revised (5)
    • Study description expanded, about 10 words
    • Site contacts updated at 1 of 3 sites
    • Study arms: 2 to 1
    • Study title shortened, about 2 words
  2. Site details revised at 2 of 3 sitesv13
  3. Site contacts updated at 1 of 3 sitesv12
  4. Site details revised at 1 of 3 sitesv11
  5. Start date changed from estimate of Nov 2024 to Mar 21, 2025v10
Show 8 earlier versionsHide 8 earlier versions
  1. Start date: Aug 2024 to Nov 2024v9
  2. Start date: Jul 2024 to Aug 2024
    • Site details revised at 2 of 3 sites
    v8
  3. Site contacts updated at 1 of 3 sitesv7
  4. Start date: Jun 2024 to Jul 2024v6
  5. Start date: May 2024 to Jun 2024v5
  6. Study sites: 2 to 3
    • Start date: Apr 2024 to May 2024
    v4
  7. Start date: Feb 20, 2024 to Apr 2024
    • Study sites: 1 to 2
    v3
  8. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Dec 3, 2023 to Feb 20, 2024
    • Site details revised
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 2 study will evaluate the efficacy and safety of PRGN-2009 in combination with pembrolizumab in patients with pembrolizumab-resistant recurrent or metastatic cervical cancer.
Trial Details
NCT Number NCT06157151
Lead Sponsor Precigen, Inc
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Cervical Cancer, HPV-Related Carcinoma, HPV-Related Malignancy, Recurrent Cervical Carcinoma, Metastatic Cervical Cancer
Related terms Uterine Cervical Neoplasms
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov