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SurVaxM Vaccine for High-Risk Lung Cancer Prevention

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What is being tested

Biospecimen Collection

+ Montanide ISA 51 VG
+ Questionnaire Administration
Procedure
Drug
Other
Biological
Who is being recruted

Lung Carcinoma

Over 18 Years
+22 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Phase 2
Interventional
Study Start: February 2026

See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: September 12, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: February 25, 2026Actual date on which the first participant was enrolled.

This study aims to explore how a specific vaccine called SurVaxM can potentially help prevent lung cancer in people who are at a high risk of developing the disease. SurVaxM is designed to stimulate the body's immune system to target survivin, a protein often found in cancer cells. By encouraging an immune response against this protein, the study hopes to reduce the chances of cancer developing. Understanding how well this vaccine works could lead to new prevention strategies for people who face a high risk of lung cancer, offering a proactive approach to cancer care. Participants in the study receive the SurVaxM vaccine through a series of injections just under the skin, along with another substance called montanide, and a medication named sargramostim to boost the immune response. These injections are given on a schedule over several weeks, with an additional booster shot later on. The study monitors the participants' immune responses by regularly collecting blood samples and checking whether the vaccine is prompting the desired immune reactions. Safety and any side effects are closely watched to ensure the well-being of participants. Following the treatment phase, participants continue to be monitored to assess the long-term effects and benefits of the vaccine.

Official TitleEvaluating the Feasibility of a Survivin Peptide Vaccine (SurVaxM) as an Interception Agent in Patients at High Risk for Lung Cancer 
Principal SponsorNational Cancer Institute (NCI)
Last updated: September 12, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
80 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Lung Carcinoma
Criteria
11 inclusion criteria required to participate
Former and current smokers (male and female) with a >= 20 pack year smoking history
Prostate, Lung, Colorectal and Ovarian (PLCO)m2012 Lung Cancer Risk Prediction Score > 1.34%
Participants >= 18 years old will be enrolled. Because no dosing or adverse event (AE) data are currently available on the use of SurVaxM in participants < 18 years of age, children and adolescents are excluded from this study but will be eligible for future pediatric trials, if applicable
Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 60%)

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11 exclusion criteria prevent from participating
History of autoimmune disease necessitating systemic immunosuppression, immunodeficiency, and/or organ allograft
Participants may not be receiving any other chemotherapy (except hormonal agents), immunotherapy or investigational agent, or any immunosuppressive agent, including systemic steroids, including those given after organ transplant
Participants with current or prior malignancy except for the following
Malignancy treated with curative intent and with no evidence of active disease present for more than 3 years before screening and felt to be at low risk for recurrence by treating physician

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Patients receive SurVaxM with montanide SC followed by sargramostim SC on day 0, week 2, week 4, and week 6. Patients then receive a booster dose of SurVaxM with montanide SC followed by sargramostim SC on week 18. Patients also undergo collection of blood samples throughout the trial.
Study Objectives
Primary Objectives

Seroconversion rate will be summarized as the frequency and proportion of participants who achieved sufficient seroconversion, which will be reported with the corresponding 95% confidence intervals. A one-sample exact test for one proportion will be used to test whether seroconversion rate exceeds the unacceptably low rate of 50%.
Secondary Objectives

Proportions will be reported with the corresponding confidence intervals.

Proportions will be reported with the corresponding confidence intervals.

Proportions will be reported with the corresponding confidence intervals.

Proportions will be reported with the corresponding confidence intervals.

Will be measured on peripheral blood mononuclear cells. Will tabulate the proportion of participants mounting a cellular response using flow cytometry.

Participants will also be provided with a participant diary, thermometer, and injection site reaction measuring tools to assist in collection and documentation of adverse events post-injection. All adverse events attributable to the vaccine as well as their severity will be reported in a descriptive format. The incidence rate and severity of each attributable adverse event will be tabulated and reported. Adverse events will be assessed using Common Terminology Criteria for Adverse Events version 5.0.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 4 locations
Suspended
Rocky Mountain Regional VA Medical CenterAurora, United StatesSee the location
Suspended
Northwestern UniversityChicago, United States
Suspended
Roswell Park Cancer InstituteBuffalo, United States
Suspended
University of Tennessee - KnoxvilleKnoxville, United States
Recruiting soon4 Study Centers