This phase II trial tests whether [18F]F AraG positron emission tomography (PET) works in monitoring tumor response to checkpoint inhibitor chemotherapy (CkIT) in patients with solid tumors undergoing checkpoint inhibitor therapy. [18F]F AraG is a radioactive molecule, called a "radiotracer," that binds to certain cells in the immune system. When [18F]F AraG is injected into the blood, researchers are able to see where immune cells are working using a special scanner called a PET scanner. The PET scanner works by detecting the radioactive substance inside the body and making images that show where the radiation is concentrated. Diagnostic procedures, such as [18F]F AraG PET, may help measure a patient's response to checkpoint inhibitor therapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04260256.
PRIMARY OBJECTIVE:
I. To correlate change in fluorine F 18 Ara-G ([18F]F AraG) signal following CkIT therapy with change in level of T cell infiltration in tumor biopsies.
SECONDARY OBJECTIVES:
I. Correlate change in [18F]F AraG uptake signal in tumor lesions with clinical benefit rate (defined as complete response [CR] + partial response [PR] + stable disease > 4 months) using Immune-Modified Response Evaluation Criteria in Solid Tumors (iRECIST) criteria.
II. Correlate change in [18F]F AraG signal in lung and gastrointestinal (GI) tract with the occurrence of immune related toxicities.
OUTLINE:
Patients receive [18F]F AraG intravenously (IV) and undergo PET/computed tomography (CT) at baseline (up to 14 days before start of CkIT therapy) and up to 6 weeks after day 1 of CkIT therapy. Patients also undergo biopsies prior to and after treatment completion on study.
After completion of study intervention, patients are followed up every 3 months for up to 12 months or until the time of disease progression.
Lead OrganizationOHSU Knight Cancer Institute
Principal InvestigatorErik S. Mittra
