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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing a vaccine made of DNA that targets proteins that help lung cancer cells grow. The vaccine is given with a substance that helps create a stronger immune response.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline percentage of CD8+ TIL in patients between the two arms
Incidence of adverse events
Secondary outcome measures
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 moreSide effects data
From 2021 Phase 4 trial • 87 Patients • NCT0432692022%
Infectious disorder (not COVID-19)
15%
Constipation
7%
Cardiac disorder
5%
Epistaxis
2%
Pneumonia
2%
Thormboembolic event
2%
Aspergillus infection
2%
Respiratory failure
2%
Hypoxia
2%
Multi-bacterial bacteremia causing hemorrhagic shock
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control Group
Active Sargramostim Treatment Group
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 2
~1700
Computed Tomography
2017
Completed Phase 2
~2720
Biopsy
2014
Completed Phase 4
~1090
Sargramostim
2008
Completed Phase 4
~850
Find a Location
Who is running the clinical trial?
United States Department of DefenseFED
864 Previous Clinical Trials
327,559 Total Patients Enrolled
University of WashingtonLead Sponsor
1,741 Previous Clinical Trials
1,847,726 Total Patients Enrolled
Shaveta VinayakPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recovered from major infections or surgeries and don't have other serious illnesses.I am 18 years old or older.I have brain metastases that are stable, untreated, or not worsening, and I haven't taken steroids for 2 weeks.My cancer can be measured by scans and has grown even after radiation.I am willing to have two biopsies during the study.My kidney function is normal or near normal.I have serious heart conditions, including unstable chest pain or heart failure.I am a woman who can have children and have a negative pregnancy test.I had another cancer but was treated successfully over 2 years ago with no signs of return.My liver function tests are within the required limits.I have a cancer site that can be biopsied, which hasn't been previously treated with radiation or has shown growth after radiation.Your lymphocyte count should be at least 800 cells per cubic millimeter within 30 days before your first vaccination.My cancer has specific genetic changes but I can't use or have tried all approved treatments.I have an autoimmune disease but only take medication for short-term issues or hormone replacement.I haven't taken systemic steroids in the last 28 days, except with pemetrexed.I cannot take medications similar to rhuGM-CSF due to health reasons.I am fully active or restricted in physically strenuous activity but can do light work.Your white blood cell count must be at least 3000 per cubic millimeter within 30 days before the first vaccination.Your total bilirubin level should be no higher than 1.5 mg/dl within 30 days before the first vaccination.I finished 4 cycles of specific cancer treatment without my cancer getting worse.I have been diagnosed with stage IV non-squamous NSCLC.You are expected to live for at least 6 more months.Your hemoglobin level is at least 9 grams per deciliter within 30 days before the first vaccination.I have had 2 or fewer cycles of pembrolizumab and pemetrexed and can continue this treatment.Your platelet count is at least 75,000 per cubic millimeter within the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (STEMVAC, sargramostim)
- Group 2: Arm II (sargramostim)
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Sargramostim received regulatory clearance from the Food and Drug Administration?
"Our internal evaluation of sargramostim's safety indicates that it falls under a score of 2, as Phase 2 trials are limited in both efficacy and safety data."
Answered by AI
Are individuals still able to join the current clinical experiment?
"Clinicaltrials.gov's information indicates that this trial, which began on November 21st 2022 and was recently updated October 21st 2022 is not actively recruiting participants at the moment. Nevertheless, there are currently 1,496 other medical trials searching for volunteers."
Answered by AI
What is the principal aim of this research endeavor?
"This clinical trial, which lasts for up to a year, aims to compare the change in CD8+ TIL between two different arms. Secondary objectives include determining overall survival rates through Kaplan-Meier estimations and 95% CIs at certain time points using Greenwood's formula; assessing changes from baseline of T-cell activation markers and Type I immune cells with Two-sample T-tests or Wilcoxon tests; as well as measuring the magnitude of Th1 STEMVAC specific immune response via IFN-gamma ELISPOTs before comparing it between both vaccine and adjuvant alone groups with a t test if no"
Answered by AI
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