What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) like Pembrolizumab, a PD-1 pathway inhibitor, can cause side effects such as fatigue, rash, diarrhea, and severe immune-related adverse effects including pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. The CCL21-gene modified dendritic cell vaccine, which stimulates the immune response, may lead to injection site reactions, flu-like symptoms, and potential autoimmune reactions. Combining these treatments may heighten the risk of immune-related adverse events.

What prior FDA approvals exist?

Pembrolizumab, a PD-1 pathway inhibitor, has been FDA approved for the treatment of NSCLC, particularly in patients with high PD-L1 expression. Atezolizumab, another immune checkpoint inhibitor targeting PD-L1, is also approved for front-line treatment in patients with high PD-L1 expression. These approvals are based on clinical trials demonstrating improved overall survival and progression-free survival compared to traditional chemotherapy. Additionally, combination therapies involving pembrolizumab and chemotherapy have shown efficacy in improving survival outcomes in NSCLC patients.

What other types of research exist?

Promising alternatives for NSCLC treatment in 2024 include: 1) Nivolumab (another PD-1 inhibitor) combined with Ipilimumab (CTLA-4 inhibitor), which has shown efficacy in various cancers including NSCLC. 2) Atezolizumab (PD-L1 inhibitor) combined with chemotherapy, which has demonstrated improved overall survival in clinical trials. 3) Emerging therapies targeting novel pathways such as TIGIT inhibitors and LAG-3 inhibitors, which are currently under investigation and have shown potential in early-phase trials.

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Cancer Vaccine

Dendritic Cell Vaccine + Pembrolizumab for Lung Cancer

Phase 1

Waitlist Available

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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

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

0 / 5Eligibility 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) often involve immunotherapy approaches. The CCL21-gene modified dendritic cell vaccine stimulates the immune system to recognize and attack cancer cells, while Pembrolizumab, a PD-1 pathway inhibitor, blocks the interaction between PD-1 on immune cells and PD-L1 on tumor cells, preventing the tumor from evading the immune response. These treatments are significant for NSCLC patients as they enhance the body's natural defenses against cancer, potentially leading to more durable and effective responses compared to traditional therapies.

Addressing the unmet need in lung cancer: The potential of immuno-oncology.