RecruitingPhase 2NCT06202066

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

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


Sponsor

Roswell Park Cancer Institute

Enrollment

60 participants

Start Date

Apr 15, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a combination of the chemotherapy drug temozolomide plus a cancer vaccine called SurVaxM for people with certain fast-growing neuroendocrine tumors (rare cancers that can arise from the gut, pancreas, or lungs) that are no longer responding to prior treatment. **You may be eligible if...** - You have a confirmed, fast-growing neuroendocrine tumor (ki67 above 20%) from the gut, pancreas, or lungs, or any neuroendocrine carcinoma (excluding small cell lung cancer) - Your tumor tested positive for a protein called survivin - Your cancer has grown or spread over the past 12 months and you have already tried at least one other treatment - You are 18 or older - Your blood counts and organ function are adequate **You may NOT be eligible if...** - You previously received temozolomide and your cancer progressed while on it - You received another clinical trial drug in the last 30 days - You received immunotherapy (checkpoint inhibitors) in the last 3 months - You have an autoimmune disease or are HIV positive - You are on daily steroid doses higher than a small threshold - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREComputed Tomography

Undergo CT scan

BIOLOGICALIncomplete Freund''s Adjuvant

Given SC

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

BIOLOGICALSargramostim

Given SC

BIOLOGICALSVN53-67/M57-KLH Peptide Vaccine

Given SC

DRUGTemozolomide

Given PO


Locations(1)

Roswell Park Cancer Institute

Buffalo, New York, United States

View Full Details on ClinicalTrials.gov

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NCT06202066


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