New vaccine aims to train immune system to fight neuroendocrine tumors

NCT ID NCT03879694

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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

19 people

The number who actually took part.

Started

Jun 2019

Finished

Mar 2025

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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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