This phase II trial studies how well fluorine F 18 Ara-G positron emission tomography (PET)/magnetic resonance (MR) imaging works in measuring clinical response to atezolizumab in patients with cancer. Diagnostic procedures, such as fluorine F 18 Ara-G PET/MR imaging, may help measure a patient's response to standard of care atezolizumab treatment.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03007719.
PRIMARY OBJECTIVES:
I. To assess the change in fluorine F 18 Ara-G ([18F]F-AraG) uptake in primary and/or metastatic tumor(s) on whole-body [18F]F-AraG PET/MR imaging associated with neoadjuvant and standard of care (SOC) anti-PD-1 or anti-PD-L1 treatment.
SECONDARY OBJECTIVES:
I. To correlate change in [18F]F-AraG uptake within the primary tumor with clinical and pathologic response in patients treated with neoadjuvant atezolizumab. (Cohort 1)
II. To assess [18F]F-AraG uptake in lymphoid organs before and after anti-PD-1 or anti-PD-L1. (Cohort 1 and 2)
TERTIARY OBJECTIVES:
I. To correlate change in [18F]F-AraG uptake within the primary tumor with quantification of tumor infiltrating T cells in cystectomy specimen. (Cohort 1)
II. To correlate change in [18F]F-AraG uptake within the primary tumor and/or metastatic tumor(s) with quantification of tumor infiltrating T cells in a pre-treatment biopsy or resection specimen. (Cohort 1 and 2)
OUTLINE: Patients are assigned to 1 or 2 cohorts.
COHORT I (NEOADJUVANT COHORT): Patients receive fluorine F 18 Ara-G intravenously (IV) and undergo PET/MR imaging over 1.5-3 hours within 7 days of starting standard of care atezolizumab and within 7 days before surgery.
COHORT II (SOC COHORT): Patients receive fluorine F 18 Ara-G IV and undergo PET/MR imaging over 1.5-3 hours within 7 days of initiating course 1 of atezolizumab and between day 15 of course 1 and day 7 of course 2 of atezolizumab.
After completion of study, patients are followed up at days 2 and 8.
Lead OrganizationUCSF Medical Center-Mount Zion
Principal InvestigatorLawrence Fong