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Cancer Vaccine
Dendritic Cell Vaccine + Pembrolizumab for Lung Cancer
Phase 1
Recruiting
Led By Edward B Garon
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Creatinine =< 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) >= 30mL/min for participant with creatinine levels >1.5 x institutional ULN
Stage IV pathologically proven NSCLC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial tests a vaccine made from a patient's own cells and a gene-modified virus, combined with pembrolizumab, to treat stage IV non-small cell lung cancer.
Who is the study for?
This trial is for adults with stage IV non-small cell lung cancer (NSCLC) who have already tried systemic anti-cancer therapy. They must be physically able to perform daily activities (ECOG status 0 or 1), have proper kidney, liver, and blood function, and not be pregnant or breastfeeding. Participants need measurable disease by RECIST v1.1 standards and agree to use contraception.Check my eligibility
What is being tested?
The trial tests a combination of a CCL21-gene modified dendritic cell vaccine with pembrolizumab, an antibody treatment. The vaccine aims to help the immune system attack cancer cells while pembrolizumab may stop tumor growth by blocking certain proteins.See study design
What are the potential side effects?
Potential side effects include reactions at the injection site from the vaccine, flu-like symptoms such as fever and chills, fatigue, changes in blood counts leading to increased infection risk or bleeding problems, liver inflammation causing jaundice or itchy skin, and possible autoimmune responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is within the required range.
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My lung cancer is at stage IV.
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I am fully active or have some restrictions but can still care for myself.
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My lung cancer diagnosis was confirmed through tissue examination.
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I am not pregnant, not breastfeeding, and follow birth control guidelines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD)/maximum administered dose (MAD) (dose escalation)
Overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 (dose expansion)
Secondary outcome measures
Biomarker assessment
Incidence of adverse events per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (Ad-CCL21-DC vaccine, pembrolizumab)Experimental Treatment2 Interventions
Patients receive pembrolizumab IV over 30 minutes followed by autologous dendritic cell-adenovirus CCL21 vaccine by CT-guided or bronchoscopic IT injection on days 0, 21, and 42. Patients then receive pembrolizumab every 3 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
360 Previous Clinical Trials
27,688 Total Patients Enrolled
California Institute for Regenerative Medicine (CIRM)OTHER
64 Previous Clinical Trials
3,133 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,060,071 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any corticosteroids in the last 10 days.I am currently being treated for an acute infection.I have active hepatitis B or C.I am currently breastfeeding.My kidney function is within the required range.My blood clotting time is normal or I'm on blood thinners.I have received an organ transplant.I have an autoimmune disease treated with steroids or immunosuppressants.My lung cancer is at stage IV.I have severe breathing problems.You have HIV.Your AST and ALT levels in your blood are not more than 2.5 times the upper limit of normal, unless you have liver metastases, in which case they should not be more than 5 times the upper limit of normal.I do not have any health or mental conditions that would stop me from following the study's requirements.Your disease can be measured using specific guidelines called RECIST version 1.1.Your white blood cell count is at least 1500 per microliter.Your hemoglobin level is at least 9.0 g/dL or 5.6 mmol/L.I agree to use birth control and not donate sperm for 4 months after my last treatment dose.Your bilirubin levels must be within a certain range, or you must have a specific type of bilirubin within a different range if your total bilirubin levels are too high.I have had treatment for cancer that has spread.I am fully active or have some restrictions but can still care for myself.Your platelet count needs to be 100,000 or higher per microliter of blood.You have a spot that the doctor wants to look at using a special camera or using a CT scan and needle.My lung cancer diagnosis was confirmed through tissue examination.My blood clotting time is normal or slightly above, unless I'm on blood thinners.I have active cancer spread to my brain.I am not pregnant, not breastfeeding, and follow birth control guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (Ad-CCL21-DC vaccine, pembrolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What prior research has there been into the efficacy of Autologous Dendritic Cell-Adenovirus CCL21 Vaccine?
"Currently, there are 963 clinical trials related to Autologous Dendritic Cell-Adenovirus CCL21 Vaccine technology with 122 of those in the advanced phase 3 stage. These experiments are mostly conducted within Houston, Texas but span 35772 locations worldwide."
Answered by AI
To what extent is the sample size of this research endeavor?
"Affirmative, the details on clinicaltrials.gov demonstrate that this trial is actively seeking participants. This research effort was first announced December 5th 2018 and most recently updated July 21st 2022; 24 individuals are required from one centre."
Answered by AI
Has Autologous Dendritic Cell-Adenovirus CCL21 Vaccine achieved regulatory approval?
"Our experts at Power have rated the safety of Autologous Dendritic Cell-Adenovirus CCL21 Vaccine as a 1, due to its Phase 1 status. This means there is limited scientific data supporting both efficacy and safety."
Answered by AI
What are Autologous Dendritic Cell-Adenovirus CCL21 Vaccine's typical therapeutic applications?
"Autologous Dendritic Cell-Adenovirus CCL21 Vaccine is primarily employed to treat malignant neoplasms. However, it may also be utilized in cases of unresectable melanoma and microsatellite instability high disease progression after chemotherapy has been administered."
Answered by AI
Are opportunities still available to volunteers for this research project?
"According to clinicaltrials.gov, enrolment for this study is currently open and has been since December 5th 2018. The page was recently updated on July 21st 2022."
Answered by AI
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