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

Must not have

Any use of systemic corticosteroids within 10 days of treatment initiation

Acute viral, bacterial, or fungal infection, which requires specific therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a special vaccine made from the patient's own cells and a virus, combined with a drug that boosts the immune system, in patients with advanced lung cancer who have already tried other treatments. The vaccine helps the immune system recognize cancer, and the drug helps the immune system attack it.

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.

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.

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.

Exclusion Criteria

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

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I haven't taken any corticosteroids in the last 10 days.

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I am currently being treated for an acute infection.

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I have active hepatitis B or C.

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I am currently breastfeeding.

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I have received an organ transplant.

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I have an autoimmune disease treated with steroids or immunosuppressants.

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I have severe breathing problems.

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I have active cancer spread to my brain.

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

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

Primary study objectives

Overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 (dose expansion)

Secondary study objectives

Biomarker assessment

Awards & Highlights

No Placebo-Only Group

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

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 3

~2810

0 / 13Eligibility 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.