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PD-1 Inhibitor

Pembrolizumab for Triple Negative Breast Cancer (Pembro/IORT Trial)

Phase 1

Recruiting

Led By Eileen Connolly, MD

Research Sponsored by Eileen Connolly

Eligibility Criteria Checklist

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

Must have

Be > or = 21 years of age on day of signing informed consent

Clinically node negative, no evidence of metastatic disease

Must not have

Has metastatic disease

Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing a new cancer drug, pembrolizumab, to see if it is effective against triple negative breast cancer. The trial will assess the response to the drug in the primary tumor, normal breast tissue, and in circulating lymphocytes and serum exosomes.

Who is the study for?

This trial is for women over 21 with early-stage triple negative breast cancer (TNBC) that's ≤3cm and hasn't spread. They must have good organ function, no prior cancer treatments in the last 6 months, not be pregnant or breastfeeding, and agree to use contraception. Excluded are those with larger tumors, active infections or autoimmune diseases requiring recent treatment, certain other cancers within 5 years, psychiatric/substance issues affecting participation, previous immunotherapy or live vaccines recently.

What is being tested?

The study tests Pembrolizumab's effects on TNBC before surgery by measuring changes in tumor-infiltrating lymphocytes. Participants receive two doses of Pembrolizumab followed by a lumpectomy where Intraoperative radiation therapy (IORT) is also applied. The goal is to see how the drug alters the tumor environment and immune response.

What are the potential side effects?

Pembrolizumab may cause immune-related side effects like inflammation in various organs including lungs (pneumonitis), liver problems, skin reactions, hormone gland issues (like thyroid disorders), infusion reactions; fatigue; digestive troubles; potential for infection increase.

Eligibility Criteria

Inclusion Criteria

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

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I am 21 years old or older.

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My cancer has not spread to my lymph nodes or other parts of my body.

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I haven't had any cancer treatment or surgery in the last 6 months.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer spot is smaller than 3 cm.

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My breast size is B cup or larger, suitable for IORT.

Exclusion Criteria

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

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My cancer has spread to other parts of my body.

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I haven't needed systemic treatment for an autoimmune disease in the last 2 years.

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My main cancer lesion is larger than 3 cm, and I don't have cancer in my lymph nodes.

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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 multiple cancer areas within the same breast.

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I cannot have breast cancer radiation due to a medical condition or previous radiation.

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I have had a stem cell transplant from a donor.

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I have been treated with drugs targeting immune checkpoints.

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I am currently being treated for an infection.

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I have a history of active tuberculosis.

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I have had pneumonitis treated with steroids or have it now.

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I have not received a live vaccine in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of subjects with significant mean percent change in TILs

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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: Single Arm open labelExperimental Treatment2 Interventions

Participants receive 'Merck 3475 Pembrolizumab' by vein one to two times before Intraoperative radiation therapy (IORT). The Intrabeam® Photon Radiosurgery System is a miniature electron beam-driven X-ray source which provides a point source of low energy X-rays (50 kV maximum) at the tip of a 3.2 mm diameter tube. The radiation source can be inserted into the area of interest immediately after excision of the tumor and switched on for 20-35 minutes to provide intraoperative radiotherapy accurately targeted to the tissues that are at the highest risk of local recurrence. The dosimetric characteristics and early clinical applications of this device have been well studied and this is the device which was utilized in the international TARGIT trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intraoperative radiation therapy (IORT)

2017

Completed Phase 1

~80

0 / 18Eligibility criteria met