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Checkpoint Inhibitor

Immuno-Radiation for Pancreatic Cancer (EMPIRE Trial)

Miami, FL

Phase 2

Waitlist Available

Led By Benjamin Spieler, MD

Research Sponsored by Benjamin Spieler

Eligibility Criteria Checklist

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

Must have

Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Patients must have a histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma

Must not have

Liver tumor burden exceeding 25% of total liver volume

Active, untreated central nervous system (CNS) metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if combining radiation therapy (uses high-energy radiation to kill cancer cells) with immune checkpoint inhibitors (medications that help the body fight cancer) can help patients with advanced pancreatic

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Who is the study for?

This trial is for adults with metastatic pancreatic cancer who've had at least one prior treatment. They should be in good physical condition (ECOG 0 or 1), have a life expectancy of over 3 months, and not be infected with HIV or Hepatitis B. Women must test negative for pregnancy and all participants must agree to use contraception.Check my eligibility

What is being tested?

The EMPIRE trial is testing if combining radiation therapy with immune checkpoint inhibitors Botensilimab and Balstilimab can help treat metastatic pancreatic cancer. Patients will receive high-energy radiation aimed at destroying cancer cells along with medications designed to boost the body's immune response against the tumor.See study design

What are the potential side effects?

Potential side effects include typical reactions from immunotherapy such as fatigue, skin reactions, inflammation of organs, flu-like symptoms, and possible infusion-related reactions. Radiation may cause localized skin irritation, fatigue, and digestive issues.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or have some restrictions but can still care for myself.

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My cancer is confirmed as pancreatic ductal adenocarcinoma.

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My cancer is microsatellite stable.

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My condition worsened after at least one treatment.

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I am not currently on treatments like IL-2, interferon, or steroids.

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I do not have HIV or active Hepatitis B.

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I have a tumor that has not been treated with radiation and can be biopsied.

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I am 18 years old or older.

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Exclusion Criteria

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

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More than a quarter of my liver is affected by cancer.

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I have brain metastases that haven't been treated.

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I have had radiation or radioisotope therapy to the liver.

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I have had serious fluid buildup in my abdomen or liver failure recently.

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I have a serious heart condition.

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I have lasting side effects from previous treatments, but not nerve pain.

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I have difficulty making decisions due to my health condition.

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I have had a blockage in my intestines within the last 3 months.

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I am currently being treated for another cancer.

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I have had lung inflammation not caused by an infection.

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I am currently taking antibiotics for an infection.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Clinical Benefit Rate (CBR)

Secondary study objectives

Number of Participants Experiencing Grade 3 or Higher Toxicities

Objective Response Rate (ORR)

Overall Survival (OS)

+1 more

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: Radiation, Botensilimab Combined with Balstilimab Treatment GroupExperimental Treatment3 Interventions

Participants in this group will receive Stereotactic Body Radiation Therapy (SBRT), followed by Botensilimab immunotherapy (ImT) for up to 24 weeks, in combination with Balstilimab ImT for up to one year. Total participation duration is up to five years.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~790

Botensilimab

2019

Completed Phase 1

~100