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

NCT06202066 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-11

No results posted yet for this study

Summary

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.

Conditions

  • Digestive System Neuroendocrine Neoplasm
  • Lung Neuroendocrine Neoplasm
  • Malignant Solid Neoplasm
  • Pancreatic Neuroendocrine Neoplasm

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT scan

BIOLOGICAL

Incomplete Freund''s Adjuvant

Given SC

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Sargramostim

Given SC

BIOLOGICAL

SVN53-67/M57-KLH Peptide Vaccine

Given SC

DRUG

Temozolomide

Given PO

Sponsors & Collaborators

  • Roswell Park Cancer Institute

    lead OTHER

Principal Investigators

  • Jasmeet Kaur, MD · Roswell Park Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-15
Primary Completion
2027-10-15
Completion
2028-10-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06202066 on ClinicalTrials.gov