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About
Immunotherapy with PD-1 blockade is a first-line treatment for patients with advanced melanoma, but unfortunately most patients progress on this therapy. Recent evidence suggests that radiation can enhance the immune response in the presence of checkpoint blockade. The investigators aim to determine if radiation can elicit increased immune responses in patients who have stable or progressive disease on nivolumab.
Full description
To determine safety of stereotactic body radiation therapy (SBRT) in presence of ICB in patients with advanced unresectable melanoma. Toxicity will be deemed acceptable if the rate of Grade 3+ adverse events (CTC v4) is ≤ 33%, with relevant AEs defined as either of the following occurring between the start of SBRT and 12 weeks following SBRT completion:
Secondary Endpoints:
• To determine whether SBRT results in a clinical abscopal effect on unirradiated lesions. The hypothesized rate of abscopal effect is >14%.
Exploratory Correlative studies:
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Inclusion criteria
Exclusion criteria
Target Disease Exceptions
Prior radiation within 6 months of enrollment (excluding brain metastases), or at any time to one of the 3 lesions for treatment/assessment
If patient has >1 lesion which requires immediate/urgent management with RT due to present or impending clinical consequences (uncontrolled pain, risk of loss of function), such a patient will not be enrolled on this trial
Medical History and Concurrent Diseases
Physical and Laboratory Test Findings: Any of the following laboratory test findings:
Allergies and Adverse Drug Reaction: History of severe hypersensitivity reaction to any monoclonal antibody or study drug components
Other Exclusion Criteria
Primary purpose
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Interventional model
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0 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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