This is a Phase II clinical study for people with stage IV cancer. The study will evaluate the use of stereotactic body radiation therapy (SBRT), a type of focused radiation treatment, together with immunotherapy-based treatment. SRBT will be used to treat multiple areas of cancer that have spread to other parts of the body. The study will evaluate whether this treatment approach can be safely given while patients continue their planned cancer treatment and may help control their cancer.
Histologically proven advanced or stage IV head & neck, non-small cell lung cancer, cervical, esophageal, gastric, and gastroesophageal cancer at least 6 metastases that are eligible for SBRT comprising: lung, liver, adrenal glands, bone, and lymph node sites with at least 1 other lesion meeting RECIST criteria of which this additional lesion not be treated with SBRT (biopsies performed for diagnosis are standard of care).
At least 6 metastases eligible for SBRT comprising: lung, liver, adrenal glands, bone, and lymph node sites
The 1 irradiated lesion must have a max point dose of 5Gy or less.
Eligible for Immunotherapy for an FDA-approved indication as defined in section 6.1. NOTE: No limit is placed on prior systemic treatment unless it affects the eligibility for administration of immune checkpoint inhibitor therapy.
Presence of < or equal to 5 sites amenable to SBRT
Ineligible for immune checkpoint inhibitors based on package insert of the chosen immune checkpoint inhibitor
No more than 7 metastatic sites to an organ, defined as liver, left lung, right lung, single anatomically bone site (e.g. femur, humerus, single vertebral body).
Peritoneal involvement, at the discretion of the study PI. NOTE: Peritoneal metastasis does not exclude GI nor cervical cancer, except in cases where there is a separate focus of spread to the peritoneum.
Single group
Stereotactic Body Radiation Therapy (SBRT)
RadiationSBRT administered to 6-10 metastatic lesions during the first cycle of immunotherapy.
Pembrolizumab
DrugFDA-approved immune checkpoint inhibitor administered according to standard clinical practice and disease-specific indications.
Nivolumab
DrugFDA-approved immune checkpoint inhibitor administered according to standard clinical practice and disease-specific indications.
Atezolizumab
DrugFDA-approved immune checkpoint inhibitor administered according to clinical practice and disease-specific indications.
Ipilimumab
DrugFDA-approved immune checkpoint inhibitor administered according to standard clinical practice and disease-specific indications.
6-Month Progression-Free Survival (PFS)
Progression-Free Survival (PFS) measured from study enrollment until disease progression or death from any cause.
Acute Grade 2 or Higher Toxicity
Number of participants experiencing Grade 2 or higher adverse events according to CTCAE version 6.0.
Overall Survival
Overall survival from study enrollment.
Local Recurrence-Free Survival
Time from study enrollment to local recurrence.
Distant Metastasis Progression-Free Survival
Time from study enrollment to distant metastatic progression.
Click on the lead sponsor to view all of their trials.
Mark Bernard
Lead sponsor
University of Kentucky
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
