What side effects are associated with this type of intervention?

Common side effects of treatments for brain metastasis, such as dendritic cell vaccines and pembrolizumab, include immune-related adverse events. These can range from mild to severe and often involve inflammation of various organs. Common side effects include fatigue, skin rashes, diarrhea, and endocrine disorders like hypothyroidism. More severe but less frequent side effects can include pneumonitis, colitis, hepatitis, and neurotoxicity. It is crucial for patients to be closely monitored for these adverse events to manage them promptly and effectively.

What prior FDA approvals exist?

FDA approvals for the treatment of brain metastasis have included immune checkpoint inhibitors like pembrolizumab, which enhances the immune response against cancer cells. Pembrolizumab has shown efficacy in various cancers, including non-small cell lung cancer and melanoma, which can metastasize to the brain. While dendritic cell vaccines are still under investigation, they aim to boost the immune system to recognize and destroy cancer cells. These treatments represent a growing focus on immunotherapy for managing brain metastases.

What other types of research exist?

Promising novel alternatives for brain metastasis patients in 2024 include: 1) Nivolumab, another immune checkpoint inhibitor, which has shown efficacy in various cancers including those with brain metastases. 2) Combination therapies involving immune checkpoint inhibitors like Nivolumab and Ipilimumab, which have demonstrated enhanced effectiveness. 3) Targeted therapies such as those focusing on specific genetic mutations (e.g., BRAF inhibitors for BRAF-mutant tumors). 4) Advanced CAR-T cell therapies, which are being explored for their potential to target and eliminate cancer cells more precisely.

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Cancer Vaccine

Dendritic Cell Vaccine + Pembrolizumab for Brain Metastasis from Breast Cancer

Phase 2

Recruiting

Led By Shipra Gandhi

Research Sponsored by Roswell Park Cancer Institute

Eligibility Criteria Checklist

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

Must have

Measurable brain disease as per RANO-BM criteria modified to include the cut off point of 0.5 cm or higher

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Must not have

Has known active hepatitis B or hepatitis C infection

History of stroke or transient ischemic attack within 6 months prior to study enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies a treatment combining a vaccine and a drug to boost the immune system in patients with aggressive breast cancer that has spread to the brain. The vaccine helps the immune system recognize cancer cells, while the drug enhances its ability to fight them.

Who is the study for?

This trial is for women with triple negative or HER2+ breast cancer that has spread to the brain. Participants must not be pregnant, agree to use birth control, and can have had certain prior treatments. They should have a life expectancy over 3 months and good organ function.

What is being tested?

The trial tests dendritic cell vaccines targeting Her2/Her3 combined with pembrolizumab, an immune checkpoint inhibitor. The goal is to see if this combination can shrink brain metastases from breast cancer by enhancing the body's immune response.

What are the potential side effects?

Possible side effects include reactions related to boosting the immune system which may lead to flu-like symptoms, fatigue, possible inflammation in various organs including lungs (pneumonitis), and potential infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

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

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I have brain disease that can be measured and is larger than 0.5 cm.

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I am fully active or can carry out light work.

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My breast cancer is triple negative.

Exclusion Criteria

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

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I have an active hepatitis B or C infection.

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I have not had a stroke or mini-stroke in the last 6 months.

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I have been treated for an autoimmune disease in the last 2 years.

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I have a brain tumor causing significant pressure or fluid buildup.

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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

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I have or had lung inflammation that needed steroids.

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My cancer has spread to the lining of my brain and spinal cord.

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I haven't been part of any clinical trials or used experimental treatments in the last 4 weeks.

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I have brain metastases that are causing symptoms.

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I have a condition that weakens my immune system, like HIV or AIDS.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Central nervous system (CNS) objective response rate (ORR)

Secondary study objectives

Incidence of adverse events

Median CNS progression free survival (PFS)

Non-CNS (i.e. of systemic disease) response rate

+3 more

Other study objectives

Changes in cytokine expression

Changes in tumor PDL-1 expression

Changes in tumor circulating tumor lymphocyte (CTL)s

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 (anti-HER2/3 dendritic cell vaccine)Experimental Treatment2 Interventions

TREATMENT PHASE: Patients receive anti-HER2/HER3 dendritic cell vaccine ID on days 1, 22, and 43. Patients will also receive pembrolizumab IV on the same days. MAINTENANCE PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients may also receive a booster dose of anti-HER2/3 dendritic cell vaccine ID, every 3-6 months in the opinion of principal investigator.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3130

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

Dendritic cell vaccines enhance the immune system's ability to recognize and attack cancer cells by presenting cancer antigens to T cells, stimulating a targeted immune response. Pembrolizumab, an immune checkpoint inhibitor, blocks the PD-1 pathway, which cancer cells use to evade immune detection, thereby allowing the immune system to more effectively target and destroy cancer cells. These treatments are crucial for brain metastasis patients as they can potentially enhance immune activity in the brain, leading to better control and reduction of metastatic tumors.