Functional Imaging of T-Cell Activation With [18F]F-AraG in Urothelial Carcinoma Patients Receiving Neoadjuvant Therapy or Patients With Cancer Receiving Standard of Care Anti-PD-1/L1

• Status: Terminated
• Trial end date: 2019-01-11
• Target enrollment: 0
• Participant gender: All

Summary

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 or patients with cancer receiving standard of care Anti-PD-1/L1. Diagnostic procedures, such as fluorine F 18 Ara-G PET/MR imaging, may help measure a patient's response to standard of care atezolizumab or Anti-PD-1/L1 treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawrence Fong
• Collaborator: CellSight Technologies, Inc.
• Treatments: Fluorides

Criteria

Inclusion Criteria:

• Histologically or cytologically documented cancer to which anti-PD1 or anti-PDL1 are approved therapies

• Eligible for with plan to undergo neoadjuvant treatment with atezolizumab followed by surgery as part of a companion study (NCT02451423), or planned to undergo treatment with anti-PD-1 or anti-PD-L1 per standard of care

• Must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 regardless of disease stage (e.g. localized, locally advanced, or metastatic)

• In female patients, negative pregnancy test with no plans to become pregnant during the duration of the study

• Able to provide informed consent and follow the study guidelines

• Archival tumor tissue from biopsy or resection will be required for all patients; archival tissue should be of good quality based on total and viable tumor contents; fine needle aspiration, brushing, and cytologic cell pellets are not acceptable

Exclusion Criteria:

• History of prior treatment with immune checkpoint antibodies (e.g. anti-PD1, anti-PDL1, anti-CTLA4 antibody) or co-stimulatory agonist antibodies (e.g. anti-41BB, anti-OX40)

• Prior intravesical treatment with Bacillus Calmette-Guerin (BCG) is allowed; however, the last dose must be at least 6 weeks from time of enrollment and patients must have documented progressive disease at least 6 weeks from completion of last BCG

• Diagnosis of immunodeficiency including history of human immunodeficiency virus (HIV)

• Receiving systemic steroid therapy or any form of immunosuppressive therapy within 7 days prior to first injection of [18F]F-AraG

• Topical and inhaled corticosteroids are allowed

• Prior allogeneic stem cell or solid organ transplant

• Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study

• Biopsy or resection of the primary tumor within 14 days the first injection of [18F]F-AraG

• Contraindication to magnetic resonance (MRI) imaging, as determined through review of the University of California, San Francisco (UCSF) MRI screening form by study investigator

• Evidence of active infection within 14 days of study enrollment

• Female patients who are pregnant or breastfeeding

• Inability to receive furosemide (Lasix) in the opinion of the treating investigator

• Patients that plan to receive off-label use of anti-PD1 or anti-PDL1