Functional Imaging of T-cell Activation With [18F]F-AraG in Bladder Cancer Patients Receiving Neoadjuvant or Standard of Care Atezolizumab

Uncategorized

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

Condition: Bladder Cancer

Intervention:

  • Drug: Fluorine F 18 Ara-G
  • Procedure: Positron Emission Tomography
  • Procedure: Magnetic Resonance Imaging

Purpose: 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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03007719

Sponsor: Lawrence Fong

Primary Outcome Measures:

  • Measure: The change between pre-treatment and post-treatment SUVmax (Standardized Uptake Values) in the primary and/or metastatic tumor(s) on whole-body [18F]F-AraG PET/MR (Positron Emission Tomography/Magnetic Resonance) imaging.
  • Time Frame: Baseline up to day 8
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Change in maximum standard uptake value (SUVmax)
  • Time Frame: Baseline up to day 8
  • Safety Issue:
  • Measure: The change between pre-treatment and post-treatment SUVmax in lymphoid organs on whole-body [18F]F-AraG PET/MR imaging (Cohort 1 and 2).
  • Time Frame: Baseline up to 8 days
  • Safety Issue:

Estimated Enrollment: 31

Study Start Date: March 7, 2017

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

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

Contact:

  • Julie McCluggage, RN
  • 877-827-3222

Location:

  • University of California, San Francisco
  • San Francisco California 94158 United States

View trial on ClinicalTrials.gov

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