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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 below

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My cancer type is approved for immune therapy by the FDA.

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I can continue immune therapy after radiotherapy.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

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 • NCT00350142

15%

ulcer

10%

vomiting

Perforation

pain

100%

80%

60%

40%

20%

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

0 / 3Eligibility criteria met