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

Stopped early · Phase 2

Conditions studied: Bladder Cancer

In brief

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.

Key facts

Study ID

NCT03007719

Run by

Lawrence Fong

People needed

4

Starts

2017-03-07

Expected to finish

2019-01-11

Last updated by the study team

2020-01-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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