New vaccine aims to train immune system to fight neuroendocrine tumors
NCT ID NCT03879694
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tested a vaccine called SurVaxM in 19 people with metastatic neuroendocrine tumors. The vaccine is designed to teach the immune system to recognize and attack tumor cells that produce a protein called survivin. The main goal was to see if the vaccine is safe and whether it triggers an immune response, not yet to prove it can shrink tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SurVaxM (survivin long peptide vaccine) combined with octreotide acetate and sargramostim
- What this could lead to
- If it works, this could point toward a new way to help the immune system attack neuroendocrine tumors that have spread.
- What could go wrong
- This is a very early, small phase 1 trial with only 19 people, so it is mainly checking safety, not whether the vaccine actually shrinks tumors. The vaccine may not produce a strong enough immune response to help patients.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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19 people
The number who actually took part.
- Started
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Jun 2019
- Finished
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Mar 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Have a Karnofsky performance status \>= 70 or Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (i.e. the patient must be able to care for himself/ herself with occasional help from others). * Pathologically confirmed diagnosis of neuroendocrine tumor of gastrointestinal, pancreatic or lung origin. * Patients who have been on somatostatin analogues (SSA) may continue to take SSA while on study treatment. * Patients must have documented progression within the last six months on CT or MRI scans performed at least four weeks apart per RECIST v1.1 criteria. In the case of retreatment, progression may be defined by the treating provider (e.g., clinical, radiographic, biochemical). * Archival neuroendocrine tumor tissue must test positive for survivin presence by clinical immunohistochemistry prior to study enrollment * Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (obtained within 14 days prior to enrollment). * Platelets \>= 100 x 10\^9/L (obtained within 14 days prior to enrollment). * Hemoglobin (Hgb) \> 9g/dL (obtained within 14 days prior to enrollment). * Plasma total bilirubin: =\< 1.5 x upper limit of normal (ULN) (obtained within 14 days prior to enrollment). * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 4 x ULN (obtained within 14 days prior to enrollment). * Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight \[LMW\] heparin) must meet the following criteria: * No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices, which carries a significant risk of bleeding in investigator's opinion). * Creatinine =\< 1.8 mg/dL (obtained within 14 days of enrollment). * Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and, have a negative pregnancy test prior to starting study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. * Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure. Exclusion Criteria: * The patient must not have received any immunotherapy for any malignancy,as long as it was \> 3 months prior to study start. * Patients with serious concurrent infection or medical illness, which in the treating physicians' opinion would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety. * Patients who are pregnant or breast-feeding. * Patients with a concurrent or prior malignancy are ineligible unless they are patients with curatively treated carcinoma-in-situ or basal cell carcinoma of the skin. Patients who have been free of disease (any prior malignancy) for at least 3 years are eligible for this study. * Known history of an autoimmune disorder. * Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS) related illness or other serious medical illness. * Previous local therapy (e.g. chemo-embolization, bland, or radio-embolization) is allowed if completed \> 6 weeks prior to randomization. For subjects who received local therapy prior to randomization, there must be documented growth of measurable disease within the embolization field prior to study. * Unwilling or unable to follow protocol requirements. * Systemic corticosteroid therapy \> 2 mg of dexamethasone or equivalent per day at study entry. * Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug. * Received an investigational agent within 30 days prior to enrollment. * Clinically significant cardiac arrhythmia, bradycardia, tachycardia that would compromise patient safety or the outcome of the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
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