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

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


  • Org Study ID: 16709
  • Secondary ID: NCI-2017-01323
  • NCT ID: NCT03007719
  • NCT Alias:
  • Sponsor: Lawrence Fong - Other
  • Source: University of California, San Francisco

Brief 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.

Detailed Description


PRIMARY OBJECTIVES:

I. 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:

I. 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.

Overal Status Start Date Phase Study Type
Recruiting March 7, 2017 Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - 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.

Primary Outcome 1 - Time Frame: Baseline up to day 8

Condition:

  • Bladder Cancer

Eligibility

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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Lawrence Fong, MD

Role: Principal Investigator

Affiliation: University of California, San Francisco

Overall Contact

Name: Julie McCluggage, RN

Phone: 877-827-3222

Email: HDFCCC.CIP@ucsf.edu

Location

Facility Status Contact
University of California, San Francisco
San Francisco, California 94158
United States
Recruiting Julie McCluggage, RN
877-827-3222
HDFCCC.CIP@ucsf.edu