← Back to Search

Checkpoint Inhibitor

Radiation Therapy for Cancer

N/A

Waitlist Available

Led By Michael D Chuong, MD

Research Sponsored by Baptist Health South Florida

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group performance status of 0, 1, or 2

Metastatic carcinoma confirmed by biopsy or imaging study if biopsy is not deemed feasible

Must not have

Symptomatic or uncontrolled brain metastasis requiring treatment

Prior radiation therapy to a lesion located within 4 cm of previously irradiated structures: spinal cord that previously received >45 Gy; brachial plexus that previously received >45 Gy; small/large intestine or stomach that previously received >45 Gy; prior total lung V20 >30%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment in patients who have not responded well to other treatments.

Who is the study for?

Adults with metastatic solid tumors who've seen limited cancer growth in 1-5 spots while on immune checkpoint inhibitors can join. They must be able to continue the therapy, have good organ function, a performance status of 0-2, and not be pregnant or breastfeeding. Exclusions include MRI contraindications, unresolved severe side effects from past treatments, certain prior cancers or therapies, autoimmune diseases (with some exceptions), recent other cancer treatments, and brain metastasis needing treatment.

What is being tested?

This phase 2 trial tests MR-guided SBRT radiation therapy for patients whose cancer has progressed in a few areas despite being on immune checkpoint inhibitor drugs like ipilimumab or pembrolizumab. It's an open-label study where all participants receive the same experimental treatment.

What are the potential side effects?

Potential side effects may include typical reactions to radiation such as skin changes at the treated site, fatigue, nausea and potential damage to nearby organs depending on where the radiation is targeted. The ongoing use of immune checkpoint inhibitors could also contribute additional side effects.

Eligibility Criteria

Inclusion Criteria

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

Select...

I can take care of myself and am up and about more than 50% of my waking hours.

Select...

My cancer has spread, confirmed by a biopsy or imaging.

Select...

I am 18 years old or older.

Select...

My cancer has grown despite treatment with an immune checkpoint inhibitor.

Select...

I can continue immune therapy during and after radiation.

Select...

My last cancer treatment was with a specific immune therapy drug.

Select...

I have 3 separate cancer spots that can be seen on scans, each at least 0.5 cm apart.

Select...

I stopped taking immunosuppressive drugs, including steroids, at least 14 days before starting radiation therapy.

Exclusion Criteria

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

Select...

I need treatment for my brain metastasis symptoms.

Select...

I've had radiation near sensitive areas but not above safe levels.

Select...

I have not had chemotherapy, radiation, or any experimental treatments in the last 14 days.

Select...

I have had an organ transplant from another person.

Select...

I cannot have IV contrast for scans, even with allergy medication.

Select...

I have had radiation therapy that may risk significant injury, as assessed by my doctor.

Select...

I have not had radiation on the area that would be treated in this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 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

Change in overall response rate according to RECIST 1.1 criteria

Secondary study objectives

Change in immune-related response criteria

Duration of response

Measure the number of progression free survival

+2 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 therapy (RT)Experimental Treatment1 Intervention

RT for all subjects will consist of treating one tumor of the treating physician's preference (40 Gy in 5 fractions), and after a 1-week interval during which Immune checkpoint inhibitor (ICI) is continued alone, RT will be given to a second and separate tumor (30 Gy in 5 fractions).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 15Eligibility criteria met