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SBRT + Checkpoint Inhibitors for Cancer
Phase 2
Waitlist Available
Led By Yoshiya Yamada, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed metastatic cancer of any histology for which there is an FDA indication for an immune checkpoint inhibitor including melanoma, lung, bladder, renal and head/neck cancers
Patient must be eligible to continue to receive an immune checkpoint inhibitor after radiotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a combination of two different types of cancer treatment: checkpoint inhibitors and stereotactic body radiation therapy (SBRT). Checkpoint inhibitors help the immune system fight cancer, while SBRT is a type of radiation therapy that gives high doses of radiation to tumors with high precision. The use of checkpoint inhibitors in combination with SBRT has been suggested to improve the immune response against cancer, but this combination has not been tested in a formal clinical trial before. Up to three lesions can be treated with SBRT in this study.
Who is the study for?
Adults with certain metastatic cancers (like melanoma, lung, bladder, renal, head/neck) who've been on approved checkpoint inhibitors for at least 2 months can join. They must have up to 5 progressing lesions and be able to continue immunotherapy post-radiation. Exclusions include active brain metastases, recent other treatments or severe allergies to monoclonal antibodies.
What is being tested?
The trial tests if high-precision radiation therapy (SBRT) can boost the effectiveness of FDA-approved checkpoint inhibitors like Ipilimumab, Nivolumab, Pembrolizumab or Atezolizumab in treating cancer that's started growing again.
What are the potential side effects?
Possible side effects include typical reactions from radiation such as skin irritation and fatigue along with immune-related adverse effects from checkpoint inhibitors which may involve inflammation in various organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer type is approved for immune therapy by the FDA.
Select...
I can continue immune therapy after radiotherapy.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
evaluate overall response rate (ORR)
Side effects data
From 2008 Phase 2 trial • 20 Patients • NCT0035014215%
ulcer
10%
vomiting
5%
Perforation
5%
pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
SBRT With Gem
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: Stereotactic Body RadiotherapyExperimental Treatment2 Interventions
Image Guided, Stereotactic Body Radiotherapy (27 Gy over 3 fractions) to 1-3 lesions. Treatment with the checkpoint inhibitor will continue until progression at the discretion of the treating physician or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiotherapy
2017
Completed Phase 2
~220
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,976 Previous Clinical Trials
599,452 Total Patients Enrolled
Yoshiya Yamada, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
8 Previous Clinical Trials
308 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My brain cancer has been treated and stable for at least 8 weeks.I do not have an active autoimmune disease, except for allowed conditions like vitiligo or type I diabetes.I haven't taken steroids or immunosuppressants in the last 14 days, except for inhaled/topical ones or low-dose prednisone.I haven't had cancer treatment or been in a trial in the last 14 days.I can continue immune therapy after radiotherapy.I haven't had any cancer except for certain low-risk types in the past 3 years.I am 18 years old or older.Your most recent scans show only a small amount of tumor growth, or up to 5 new or growing lesions. If you have more than 5 lesions, you can still join if the study doctors agree.You have had an allergic reaction to checkpoint inhibitors in the past.You have had a serious allergic reaction to any type of monoclonal antibody in the past.I can take care of myself and am up and about more than half of my waking hours.My cancer type is approved for immune therapy by the FDA.I have been on immune therapy for at least 2 months.
Research Study Groups:
This trial has the following groups:- Group 1: Stereotactic Body Radiotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.