OncoMatch/Clinical Trials/NCT06202066
Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) for the Treatment of Patients With Progressing Metastatic Neuroendocrine Carcinomas
Is NCT06202066 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Incomplete Freund''s Adjuvant and Sargramostim for digestive system neuroendocrine neoplasm.
Treatment: Incomplete Freund''s Adjuvant · Sargramostim · SVN53-67/M57-KLH Peptide Vaccine · Temozolomide — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroendocrine Tumor
Tumor Agnostic
Biomarker criteria
Required: BIRC5 overexpression (positive by clinical immunohistochemistry)
Archival neuroendocrine tumor tissue must test positive for survivin presence by clinical immunohistochemistry prior to study enrollment
Disease stage
Metastatic disease required
Performance status
KARNOFSKY OR ECOG 80–1
Karnofsky performance status ≥ 80 or Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
Prior therapy
Must have received: systemic therapy
Patients must have failed at least one prior systemic therapy
Cannot have received: temozolomide (temozolomide)
Exception: excluded if progressed while on it in the advanced disease setting
Patients who have received temozolomide in the advanced disease setting either alone or as part of a combination therapy will be excluded if they progressed while on it
Cannot have received: SurVaxM (SurVaxM)
Has received prior treatment with SurVaxM
Cannot have received: checkpoint inhibitor
Exception: within 3 months prior to study enrollment or not recovered from adverse events due to agents administered more than 4 weeks earlier
Participants who have received checkpoint inhibitors within 3 months prior to study enrollment or, those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
Cannot have received: investigational agent
Exception: within 30 days prior to enrollment
Received an investigational agent within 30 days prior to enrollment
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L; Platelets ≥ 100 x 10^9/L; Hemoglobin (Hgb) > 9g/dL (obtained within 14 days prior to enrollment)
Kidney function
Creatinine clearance ≥ 60 mL/min (per Cockroft-Gault equation) (obtained within 14 days prior to enrollment)
Liver function
Plasma total bilirubin: ≤ 1.5 x ULN; ALT and AST ≤ 4 x ULN (obtained within 14 days prior to enrollment)
ANC ≥ 1.5 x 10^9/L; Platelets ≥ 100 x 10^9/L; Hemoglobin (Hgb) > 9g/dL; Plasma total bilirubin: ≤ 1.5 x ULN; ALT and AST ≤ 4 x ULN; Creatinine clearance ≥ 60 mL/min (all obtained within 14 days prior to enrollment)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Roswell Park Cancer Institute · Buffalo, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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