A Phase II Study of Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) in Patients With Progressing Metastatic Neuroendocrine Carcinomas (NECs)

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Investigational drug late phase More information Active drug More information Moderate burden on patient More information

Trial Details

Sponsor: Roswell Park Cancer Institute (other)

Phase: 2

Start date: Jan. 11, 2024

Planned enrollment: 60

Trial ID: NCT06202066
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More trial details at ClinicalTrials.gov More info

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Investigational Drug AI Analysis

chevron Show for: SVN53-67/M57-KLH Peptide Vaccine (SurVaxM, DRU-2017-5947)

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Goal: Evaluate the efficacy and safety of adding the survivin-targeted vaccine SurVaxM to temozolomide in progressing metastatic neuroendocrine neoplasms.

Patients: Adults with measurable, survivin-positive, progressing metastatic well-differentiated grade 3 neuroendocrine tumors of gastrointestinal, pancreatic, or thoracic origin, or neuroendocrine carcinoma of any origin except small-cell lung cancer. Patients must have received at least one prior systemic therapy and have ECOG performance status 0–1 or Karnofsky performance status at least 80.

Design: Phase IIa, single-arm study. Although the trial description mentions comparison with temozolomide alone, the listed design has no randomized allocation or temozolomide-only arm.

Treatments: Temozolomide is an oral alkylating agent given daily on days 1–5 of each 28-day cycle for up to one year, with possible continuation at the investigator’s discretion. SurVaxM is an investigational peptide vaccine designed to elicit immune responses against survivin-expressing tumor cells. It is given subcutaneously with Montanide adjuvant and sargramostim every two weeks for four doses; patients benefiting without progression or unacceptable toxicity may receive additional doses at weeks 24, 36, and 48. Small, nonrandomized glioma studies have demonstrated immune responses and reported clinical activity, but have not established that SurVaxM improves outcomes; its efficacy in neuroendocrine neoplasms remains unknown.

Outcomes: Primary measures are progression-free survival at six months and adverse events through one year, graded by CTCAE v5.0. Secondary measures include RECIST v1.1 response and clinical benefit at 3, 6, 9, and 12 months; overall survival; time to progression; and anti-survivin IgG titer response. Exploratory analyses assess immune markers, MGMT status, and radiographic tumor growth rate.

Burden on patient: Moderate. Oral temozolomide can be taken at home, but the initial four vaccine visits occur every two weeks, with up to three later injection visits. Repeated blood collection and CT or MRI scans add monitoring and travel; no mandatory new biopsy or intensive pharmacokinetic sampling is specified.

Last updated: Sep 2026

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Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

[email protected] / 716-845-1300

Status: Recruiting

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