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 Cancer Urinary Bladder Neoplasms Carcinoma, Transitional Cell Fluorine F 18 Ara-G Positron Emission Tomography Magnetic 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 Francisco California 94158 United 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