Summary

for people ages 18 years and up (full criteria)
at San Francisco, California
study started
estimated completion
Lawrence Fong

Description

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.

Details

PRIMARY OBJECTIVES:

  1. 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 atezolizumab and standard of care (SOC) anti-PD-1 or anti-PD-L1 treatment.

SECONDARY OBJECTIVES:

  1. 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 treatment. (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 anti-PD-1 or anti-PD-L1 therapy and between day 15 of course 1 and day 7 of course 2 of anti-PD-1 or anti-PD-L1 treatment.

After completion of study, patients are followed up at days 2 and 8.

Keywords

Bladder CancerUrinary Bladder NeoplasmsCarcinoma, Transitional CellFluorine F 18 Ara-GPositron Emission TomographyMagnetic Resonance Imaging

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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

Location

  • University of California, San Francisco accepting new patients
    San FranciscoCalifornia94158United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Lawrence Fong
ID
NCT03007719
Phase
Phase 2
Study Type
Interventional
Last Updated