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SBRT + Checkpoint Inhibitors for Cancer

Phase 2

Recruiting

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,838 Total Patients Enrolled

Yoshiya Yamada, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

8 Previous Clinical Trials

308 Total Patients Enrolled

Media Library

Stereotactic Body Radiotherapy Clinical Trial Eligibility Overview. Trial Name: NCT03693014 — Phase 2

Lung Cancer Research Study Groups: Stereotactic Body Radiotherapy

Lung Cancer Clinical Trial 2023: Stereotactic Body Radiotherapy Highlights & Side Effects. Trial Name: NCT03693014 — Phase 2

Stereotactic Body Radiotherapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03693014 — Phase 2

Frequently Asked Questions

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

How many facilities are managing this clinical trial?

"10 facilities are currently enrolling participants for this clinical trial, including Memoral Sloan Kettering Westchester in Harrison, Memorial Sloan Kettering Nassau in Uniondale and Memorial Sloan Kettering Cancer Center. Additionally, there are another 7 centres across the nation."

Answered by AI

Has Stereotactic Body Radiotherapy been studied previously in other research projects?

"Stereotactic Body Radiotherapy was initially studied in 2008 at SCRI Tennessee Oncology Chattanooga with 671 studies having been conducted since. Currently, 2001 clinical trials are actively being performed around the country, many of which located near Harrison, NY."

Answered by AI

To what types of medical issues is Stereotactic Body Radiotherapy typically applied?

"Stereotactic Body Radiotherapy is generally employed to treat malignant tumors, but can also be used as a treatment option for unresectable melanoma and microsatellite instability high squamous cell carcinoma."

Answered by AI

Is enrollment still open for this research trial?

"Affirmative, the information hosted on clinicaltrials.gov suggests that this medical trial is actively recruiting volunteers. The protocol was first released to the public on October 1st 2018 and has recently been updated November 17th 2022. Sixty patients are needed across 10 different sites for enrollment into this study."

Answered by AI

What is the current cohort size participating in this clinical research?

"The study requires 60 eligible participants, all of whom must meet the stated criteria. Individuals can join at either Memorial Sloan Kettering Westchester in Harrison, New york or Memorial Sloan Kettering Nassau in Uniondale, Connecticut."

Answered by AI

Is this endeavor unprecedented in the medical field?

"Since 2008, the efficacy of Stereotactic Body Radiotherapy has been investigated. Initially funded by Hoffmann-La Roche, this drug was granted Phase 2 approval after a 720 patient trial in 2008. Currently there are 2001 live studies taking place across 4008 cities and 78 nations."

Answered by AI

Has the FDA sanctioned Stereotactic Body Radiotherapy as an acceptable medical therapy?

"Our experts at Power rank Stereotactic Body Radiotherapy's safety as a 2, since the trial is currently in Phase 2. This means that while there is some evidence suggesting its level of security, no data confirms its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Several Radiation Doses for Patients With Progression on Immunotherapy/Checkpoint Inhibitors

2018. "A Study of Several Radiation Doses for Patients With Progression on Immunotherapy/Checkpoint Inhibitors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03693014.

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