SBRT + Checkpoint Inhibitors for Cancer

Recruiting in Palo Alto (17 mi)

+11 other locations

Overseen byYoshiya Yamada, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

Drugs called checkpoint inhibitors help the immune system fight cancer. When the effectiveness of these drugs wears off, it may be possible to renew their effectiveness by combining it with a special type of radiation therapy called stereotactic body radiation therapy (SBRT). SBRT is a commonly used type of radiation therapy that gives high dose radiation with high precision to tumors in 1-5 treatments. Radiation therapy, such as SBRT can also treat sites of metastases. The use of checkpoint inhibitors in combination with SBRT has been suggested to improve the immune response against cancer but has not been tested in a formal clinical trial. Up to three lesions can be treated with SBRT. This study only allows checkpoint inhibitors that are already approved by the Federal Drug Agency (FDA) for the treatment of your disease. All radiation therapy will be done on machines which are FDA approved.

Eligibility Criteria

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.

Inclusion Criteria

Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other study obligations

I can continue immune therapy after radiotherapy.

I am 18 years old or older.

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Exclusion 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.

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Treatment Details

Interventions

Atezolizumab (Checkpoint Inhibitor)
Ipilimumab (Checkpoint Inhibitor)
Nivolumab (Checkpoint Inhibitor)
Pembrolizumab (Checkpoint Inhibitor)
Stereotactic Body Radiotherapy (Radiation)

Trial OverviewThe 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.

Participant Groups

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.

Stereotactic Body Radiotherapy is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Stereotactic Body Radiation Therapy for: