What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC), particularly immunotherapies and antigen-specific treatments like the STEMVAC trial, often result in immune-related adverse events. These include pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Patients may also experience fatigue, nausea, and infusion-related reactions. Severe side effects can include decreased neutrophil count, anemia, and interstitial lung disease.

What prior FDA approvals exist?

FDA-approved treatments for Non-Small Cell Lung Cancer (NSCLC) include several immunotherapy options. Atezolizumab, a PD-L1 inhibitor, has been approved for use in combination with chemotherapy for first-line treatment of nonsquamous NSCLC and as adjuvant therapy following resection and platinum-based chemotherapy for stage II to IIIA NSCLC with PD-L1 expression. Cemiplimab, a PD-1 inhibitor, is approved for advanced NSCLC with high PD-L1 expression. Pembrolizumab, another PD-1 inhibitor, is also approved in combination with chemotherapy for advanced NSCLC. These treatments focus on enhancing the immune system's ability to target and destroy cancer cells, similar to the approach of the STEMVAC trial, which aims to activate immune cells to recognize and kill lung cancer cells by targeting specific proteins.

What other types of research exist?

Promising novel alternatives to STEMVAC for NSCLC patients include: 1) Durvalumab plus chemotherapy, which has shown improved progression-free survival in metastatic NSCLC lacking EGFR or ALK mutations. 2) Pembrolizumab monotherapy, particularly for patients with PD-L1 expression of 1% or higher, as it has demonstrated prolonged overall survival in the KEYNOTE-042 trial. 3) BIIB015, an antibody-cytotoxic conjugate targeting Cripto, which has shown robust activity in lung cancer xenograft models.

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Cancer Vaccine

STEMVAC Vaccine for Lung Cancer

Phase 2

Recruiting

Led By Shaveta Vinayak

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be at least 18 years of age

Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 within one month of first vaccine. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions

Must not have

Patients with any of the following cardiac conditions: Symptomatic restrictive cardiomyopathy, Unstable angina within 4 months prior to enrollment, New York Heart Association functional class III-IV heart failure on active treatment, Symptomatic pericardial effusion

Patients with any contraindication to receiving recombinant human granulocyte-macrophage colony stimulating factor (rhuGM-CSF) based products

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new DNA-based vaccine called STEMVAC, combined with GM-CSF, in patients with advanced lung cancer. The vaccine helps the immune system recognize and attack cancer cells, while GM-CSF boosts this response. The goal is to see if this combination can shrink tumors in these patients. GM-CSF has been used in various tumor vaccines to stimulate the immune system and enhance antitumor responses.

Who is the study for?

Adults with stage IV non-squamous NSCLC who've completed certain chemotherapy and immunotherapy without disease progression. They must have good organ function, no severe autoimmune diseases or untreated brain metastases, not be pregnant/breastfeeding, and agree to use contraception.

What is being tested?

The trial is testing STEMVAC, a DNA vaccine targeting proteins that help lung cancer grow. It's given with GM-CSF as an adjuvant to boost immune response. The goal is to see if this combination can shrink tumors in patients on maintenance therapy for NSCLC.

What are the potential side effects?

Possible side effects include reactions at the injection site, flu-like symptoms such as fever and chills, fatigue, muscle aches, and potential immune system-related issues due to the stimulation of the body's defense mechanisms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My cancer can be measured by scans and has grown even after radiation.

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I am willing to have two biopsies during the study.

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My liver function tests are within the required limits.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I finished 4 cycles of specific cancer treatment without my cancer getting worse.

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I have been diagnosed with stage IV non-squamous NSCLC.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have serious heart conditions, including unstable chest pain or heart failure.

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I cannot take medications similar to rhuGM-CSF due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline percentage of CD8+ TIL in patients between the two arms

Incidence of adverse events

Secondary study objectives

Magnitude of the immune response to CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine (STEMVAC)

Overall response rate (ORR)

Overall survival (OS)

+3 more

Side effects data

From 2021 Phase 4 trial • 87 Patients • NCT04326920

22%

Infectious disorder (not COVID-19)

15%

Constipation

Cardiac disorder

Epistaxis

Multi-bacterial bacteremia causing hemorrhagic shock

Respiratory failure

Hypoxia

Pneumonia

Thormboembolic event

Aspergillus infection

100%

80%

60%

40%

20%

Study treatment Arm

Control Group

Active Sargramostim Treatment Group

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (STEMVAC, sargramostim)Experimental Treatment5 Interventions

Patients receive STEMVAC ID and sargramostim ID on day 14 (+3 days) of the 21-day maintenance therapy cycle for a series of 3 vaccine doses and a booster vaccine 9 weeks after the third vaccine dose. Patients also undergo CT and biopsy during screening and on the trial, as well as blood sample collection on trial and during follow-up.

Group II: Arm II (sargramostim)Active Control4 Interventions

Patients receive sargramostim ID on day 14 (+3 days) of the 21-day maintenance therapy cycle for a series of 3 vaccine doses and a booster vaccine 9 weeks after the third vaccine dose. Patients also undergo CT and biopsy during screening and on the trial, as well as blood sample collection on trial and during follow-up.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2030

Sargramostim

2006

Completed Phase 4

~850

Computed Tomography

2017

Completed Phase 2

~2790

Biopsy

2014

Completed Phase 4

~1150

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include immunotherapy and targeted therapies. Immunotherapy, such as immune checkpoint inhibitors, enhances the immune system's ability to attack cancer cells by blocking proteins that inhibit immune responses. Targeted therapies focus on specific genetic mutations or proteins that drive cancer growth, such as EGFR or ALK inhibitors. The STEMVAC trial explores a DNA vaccine targeting multiple proteins (CDH3, CD105, YB-1, MDM2, and SOX2) to elicit an immune response, aiming to train the immune system to recognize and kill cancer cells. This approach is significant as it may offer a broader and more robust immune response compared to single-target treatments.

Polycaprolactone Electrospun Scaffolds Produce an Enrichment of Lung Cancer Stem Cells in Sensitive and Resistant EGFRm Lung Adenocarcinoma.Ionizing Radiation Promotes Epithelial-Mesenchymal Transition Phenotype and Stem Cell Marker in The Lung adenocarcinoma: In Vitro and Bioinformatic Studiesc.Research into the biological differences and targets in lung cancer patients with diverse immunotherapy responses.