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Checkpoint Inhibitor

High-Dose Radiation + Immunotherapy for Cancer

Phase 1

Waitlist Available

Led By Gregory Gan, MD

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate organ function as defined by specific laboratory test results

At least 1st line (1L) systemic therapy or immunotherapy must have failed for participants and standard of care therapy options must also be exhausted

Must not have

Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study

History of prior immunotherapy induced pneumonitis and/or peritonitis that is Grade ≥3

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if using a high dose of targeted radiation therapy along with immunotherapy is safe and possible for patients with advanced cancer who have already tried standard treatment options."

Who is the study for?

This trial is for adults with metastatic cancer who have tried at least one line of systemic therapy or immunotherapy without success. They must have a large enough lesion, good organ function, and no active severe infections or immune disorders. Pregnant women and those planning to become pregnant soon cannot participate.

What is being tested?

The study tests the combination of ultra-high dose Stereotactic Ablative Radiotherapy (SBRT) with the immunotherapy drug Atezolizumab in patients with bulky metastatic disease who've exhausted standard treatments. It aims to see if this approach is safe and doable.

What are the potential side effects?

Potential side effects include reactions related to the immune system such as inflammation in various organs, infusion-related reactions, fatigue, possible infection risks, and allergic responses specific to components in Atezolizumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My organ function tests are within normal ranges.

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My first treatment for cancer did not work, and I have no standard treatment options left.

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I have a tumor that is at least 65 cc in size.

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My cancer is confirmed to have spread and includes lung, head and neck, ovarian, colorectal, or sarcoma.

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I have at least two tumors that can be measured, and one is larger than 65 cc.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not planning to use other cancer treatments during this study.

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I have had severe lung or abdominal inflammation from immunotherapy.

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I have active tuberculosis.

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My cancer has only spread to my bones.

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I have a condition that weakens my immune system.

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I am currently on medication for hepatitis B.

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I am currently experiencing severe symptoms of COVID-19 or am hospitalized due to COVID-19.

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I have a history of specific lung conditions or signs of lung inflammation on a CT scan.

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I have not had major surgery in the last 4 weeks.

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I haven't taken any immune-boosting drugs in the last 4 weeks or 5 half-lives before starting the study treatment.

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I have previously received immunotherapy.

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I have not had a severe infection in the last 2 weeks.

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I do not have any uncontrolled illnesses or infections.

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My brain metastases are not currently being treated.

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I have brain metastases that are untreated or getting worse.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose of ultra-high dose Stereotactic Ablative Radiotherapy (SBRT) for 3 different body sites

Secondary study objectives

Evaluate the number of participants receiving ultra-high dose ablative radiosurgery with immunotherapy who develop treatment-related adverse events as assessed by CTCAE v4.0

Overall Survival of participants receiving ultra-high dose Stereotactic Ablative Radiotherapy (SBRT) with concurrent and adjuvant atezolizumab

Overall tumor response rate to ultra-high dose SBRT for 3 different body sites

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