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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
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I can take care of myself and am up and about more than 50% of my waking hours.
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My cancer has spread, confirmed by a biopsy or imaging.
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My organs and bone marrow are functioning well.
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I am 18 years old or older.
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I am a woman not able to have children, not pregnant, and not breastfeeding.
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My cancer has grown despite treatment with an immune checkpoint inhibitor.
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I can continue immune therapy during and after radiation.
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My last cancer treatment was with a specific immune therapy drug.
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I have 3 separate cancer spots that can be seen on scans, each at least 0.5 cm apart.
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I stopped taking immunosuppressive drugs, including steroids, at least 14 days before starting radiation therapy.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in overall response rate according to RECIST 1.1 criteria
Secondary outcome measures
Change in immune-related response criteria
Duration of response
Measure the number of progression free survival
+2 more

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

Find a Location

Who is running the clinical trial?

Baptist Health South FloridaLead Sponsor
48 Previous Clinical Trials
7,858 Total Patients Enrolled
Viewray Inc.Industry Sponsor
12 Previous Clinical Trials
1,076 Total Patients Enrolled
Michael D Chuong, MDPrincipal InvestigatorMiami Cancer Institute (MCI) at Baptist Health, Inc.

Media Library

Immune Checkpoint Inhibitor (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04376502 — N/A
Cancer Research Study Groups: radiation therapy (RT)
Cancer Clinical Trial 2023: Immune Checkpoint Inhibitor Highlights & Side Effects. Trial Name: NCT04376502 — N/A
Immune Checkpoint Inhibitor (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04376502 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential enrollees still accepted for this experiment?

"According to clinicaltrials.gov this research is currently recruiting participants, having been first announced on April 8th 2020 and last modified on November 8th 2022."

Answered by AI

How many participants will be included in this research endeavor?

"Affirmative. Clinicaltrials.gov has the information that this research is presently looking for participants, with a first post date of April 8th 2020 and an edit on November 8th 2022; 52 individuals need to be recruited at one medical facility."

Answered by AI
~3 spots leftby Mar 2025