Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) for the Treatment of Patients With Progressing Metastatic Neuroendocrine Carcinomas

StatusNot Yet Recruiting
PhasePhase 2
Started

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Record History

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  1. Trial status changed: Suspended → Not Yet Recruiting Show 8 more changesShow less
    • Start date: Oct 15, 2026 to Dec 15, 2026
    • Primary completion date: Oct 15, 2027 to Dec 15, 2027
    • Study completion date: Oct 15, 2028 to Dec 15, 2028
    • Interventions: Biospecimen Collection (Procedure), Computed Tomography (Procedure), Incomplete Freund''s Adjuvant (Biological), Magnetic Resonance Imaging… to Biospecimen Collection (Procedure), Computed Tomography (Procedure), Incomplete Freund''s Adjuvant (Biological), Magnetic Resonance Imaging…
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints: details revised at 3 of 4 entries
    • Site contact updated
    • Study description expanded, about 2 words
  2. Recruitment suspended Sponsor's reason: pending protocol changes
    • Start date: Jul 15, 2026 to Oct 15, 2026
    • Site details revised
    v16
  3. Start date: Apr 15, 2026 to Jul 15, 2026v15
  4. Trial status: Suspended to Recruiting
    • Start date: Mar 15, 2026 to Apr 15, 2026
    • Eligibility criteria revised
    • Site details revised
    v14
  5. Start date: Feb 15, 2026 to Mar 15, 2026
    • Eligibility criteria shortened, about 3 words
    v13
Show 11 earlier versionsHide 11 earlier versions
  1. Trial status: Not Yet Recruiting to Suspended Sponsor's reason: pending protocol changes
    • Start date: Nov 15, 2025 to Feb 15, 2026
    • Site contact updated
    v12
  2. Start date: Sep 15, 2025 to Nov 15, 2025v11
  3. Enrollment target: 132 to 60v10 Show 7 more changesShow less
    • Start date: Aug 15, 2025 to Sep 15, 2025
    • Primary endpoints: 3 to 2
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: 9 to 4
    • Study description shortened, about 240 words
    • Study title revised
    • Study arms: 3 to 1
  4. Start date: Jun 15, 2025 to Aug 15, 2025v9
  5. Start date: Dec 15, 2024 to Jun 15, 2025v8
  6. Start date: Oct 15, 2024 to Dec 15, 2024v7
  7. Primary completion date: Jan 15, 2027 to Oct 15, 2027
    • Start date: Jul 15, 2024 to Oct 15, 2024
    • Study completion date: Jan 15, 2028 to Oct 15, 2028
    v6
  8. Eligibility criteria expanded, about 86 wordsv5
  9. Start date: Apr 15, 2024 to Jul 15, 2024v4
  10. Start date: Mar 15, 2024 to Apr 15, 2024v3
  11. Start date: Jan 15, 2024 to Mar 15, 2024v2
  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 compares the safety and effect of temozolomide combined with survivin long peptide vaccine (SurVaxM) to temozolomide alone in patients with neuroendocrine tumors (NET) that has spread from where it first started (primary site) to other places in the body (metastatic) and is growing, spreading or getting worse (progressing). Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill tumor cells and slow down or stop tumor growth. Survivin, a protein, is expressed in 50% of patients that have neuroendocrine tumors and, is associated with poor outcomes. SVN53-67/M57-KLH peptide vaccine (SurVaxM) is a vaccine that has been shown to produce an immune system response against cancer cells that express a survivin and may block the growth of new tumor cells. Giving temozolomide with SurVaxM may kill more tumor cells in patients with progressing metastatic neuroendocrine tumors.
Trial Details
NCT Number NCT06202066
Lead Sponsor Roswell Park Cancer Institute
Conditions
(from sponsor)		 Digestive System Neuroendocrine Neoplasm, Lung Neuroendocrine Neoplasm, Malignant Solid Neoplasm, Pancreatic Neuroendocrine Neoplasm
Related terms Adenoma, Islet Cell
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov