15 Participants Needed

Radiation + Pembrolizumab for Advanced Breast Cancer

KC
ER
Overseen ByElizabeth Riley, MD
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: University of Louisville
Must be taking: Taxane, CDK 4/6 inhibitors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a phase 2, open-label, single-arm trial designed to evaluate the efficacy and safety of stereotactic body radiation therapy (SBRT) in combination with pembrolizumab following disease progression after two prior lines of standard therapy in unresectable metastatic stage IV breast cancer

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, it mentions that concurrent endocrine therapy or trastuzumab therapy is allowed if clinically indicated, and concurrent bone-modifying agents are allowed for patients with bone metastases.

Is the combination of radiation therapy and pembrolizumab safe for humans?

The combination of stereotactic body radiotherapy (SBRT) and pembrolizumab has been studied for safety in patients with advanced solid tumors, showing some dose-limiting toxicities in a small percentage of patients. Pembrolizumab alone has been associated with common side effects like fatigue, cough, and nausea, as well as immune-related reactions such as lung inflammation and thyroid issues.12345

How is the treatment of radiation plus pembrolizumab unique for advanced breast cancer?

This treatment combines pembrolizumab, an immune system-boosting drug, with radiation therapy to potentially enhance the body's ability to fight cancer. Pembrolizumab works by blocking a protein that stops the immune system from attacking cancer cells, and when combined with radiation, it may improve the overall response to treatment.36789

What data supports the effectiveness of the treatment combining radiation and pembrolizumab for advanced breast cancer?

Research shows that combining radiation with pembrolizumab can enhance the body's immune response against tumors, as radiation can change the tumor environment to make it more responsive to immunotherapy. Studies in various cancers, including breast cancer, have reported that this combination can improve tumor response and potentially increase survival rates.3481011

Who Is on the Research Team?

ER

Elizabeth Riley, MD

Principal Investigator

UL Health Brown Cancer Center Deputy Director, Health Affairs

Are You a Good Fit for This Trial?

This trial is for women over 18 with stage IV breast cancer that's spread and can't be removed by surgery. They must have tried two previous treatments, including a taxane and specific therapies based on their cancer type. Good organ function and no active brain metastases or immune diseases are required. Women must not be pregnant, breastfeeding, or planning pregnancy soon.

Inclusion Criteria

I am a woman who can have children and have a recent negative pregnancy test.
I have fully recovered from any major surgery before joining the trial.
Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures.
See 11 more

Exclusion Criteria

I do not have an autoimmune disease that could get worse with pembrolizumab treatment.
I am not willing to use birth control during the study and for 4 months after.
I am not pregnant, breastfeeding, nor planning to become pregnant soon.
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive stereotactic body radiation therapy (SBRT) in combination with pembrolizumab

1-5 weeks
Pembrolizumab administered every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

What Are the Treatments Tested in This Trial?

Interventions

  • Palliative Radiation
  • Pembrolizumab
Trial Overview The study tests combining stereotactic body radiation therapy (SBRT) with pembrolizumab in patients whose disease progressed after standard treatments. It's an open-label phase 2 trial where all participants receive the same experimental treatment to assess its effectiveness and safety.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Palliative Radiation in Combination with PembrolizumabExperimental Treatment1 Intervention

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸
Approved in United States as KEYTRUDA for:
🇪🇺
Approved in European Union as KEYTRUDA for:
🇬🇧
Approved in United Kingdom as KEYTRUDA for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials
353
Recruited
76,400+

James Graham Brown Cancer Center

Collaborator

Trials
44
Recruited
9,200+

Published Research Related to This Trial

Pembrolizumab, an immunotherapy targeting PD-1, showed limited effectiveness in a patient with metastatic renal cell carcinoma, highlighting that only 20-40% of patients benefit from such treatments due to individual tumor biology and immune checkpoint diversity.
The patient's rapid disease progression during treatment may be linked to a lack of tumor-infiltrating lymphocytes (TILs) and the specific radiation dose and schedule used, which could affect the tumor microenvironment and the potential synergy with pembrolizumab.
Immune biomarkers of treatment failure for a patient on a phase I clinical trial of pembrolizumab plus radiotherapy.Alexander, GS., Palmer, JD., Tuluc, M., et al.[2022]
Radiation therapy not only helps eliminate cancer cells but also modifies the tumor microenvironment, potentially enhancing the body's immune response against tumors.
Combining radiation with immune checkpoint inhibitors has shown promise in early clinical trials for breast cancer, suggesting a synergistic effect that could improve treatment outcomes.
Advances in Combining Radiation and Immunotherapy in Breast Cancer.Nguyen, AT., Shiao, SL., McArthur, HL.[2021]
The combination of stereotactic body radiotherapy (SBRT) and pembrolizumab (SBRT+P) is safe for patients with large, advanced solid tumors, with only 7.2% experiencing dose-limiting toxicities in a study involving 97 patients.
Patients who showed a positive response to SBRT+P had significantly better overall survival rates, with a 1-year overall survival of 71% for responders, compared to 0% for nonresponders, highlighting the potential efficacy of this treatment approach.
Partial tumor irradiation plus pembrolizumab in treating large advanced solid tumor metastases.Korpics, MC., Onderdonk, BE., Dadey, RE., et al.[2023]

Citations

Immune biomarkers of treatment failure for a patient on a phase I clinical trial of pembrolizumab plus radiotherapy. [2022]
Advances in Combining Radiation and Immunotherapy in Breast Cancer. [2021]
Partial tumor irradiation plus pembrolizumab in treating large advanced solid tumor metastases. [2023]
Impact of radiotherapy to the primary tumor on the efficacy of pembrolizumab for patients with advanced urothelial cancer: A preliminary study. [2023]
A Phase II Study of Pembrolizumab in Combination With Palliative Radiotherapy for Hormone Receptor-positive Metastatic Breast Cancer. [2021]
Previous radiotherapy and the clinical activity and toxicity of pembrolizumab in the treatment of non-small-cell lung cancer: a secondary analysis of the KEYNOTE-001 phase 1 trial. [2022]
A Randomized Trial of Combined PD-L1 and CTLA-4 Inhibition with Targeted Low-Dose or Hypofractionated Radiation for Patients with Metastatic Colorectal Cancer. [2022]
FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. [2021]
New Approved Use for Keytruda. [2022]
Pembrolizumab joins the anti-PD-1 armamentarium in the treatment of melanoma. [2017]
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]
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