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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

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ClinicalTrials.gov Identifier: NCT03007719
Recruitment Status : Recruiting
First Posted : January 2, 2017
Last Update Posted : May 23, 2018
Sponsor:
Collaborator:
CellSight Technologies, Inc.
Information provided by (Responsible Party):
Lawrence Fong, 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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Drug: Fluorine F 18 Ara-G Procedure: Positron Emission Tomography Procedure: Magnetic Resonance Imaging Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : March 7, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1: Neoadjuvant
Patients with localized bladder cancer who are eligible for the UCSF phase 2 clinical trial of neoadjuvant atezolizumab before definitive surgery (NCT02451423) (Cohort 1). For the neoadjuvant cohort, study participants will undergo whole body PET/MR imaging with [18F]F-AraG within 7 days of initiating atezolizumab and within 7 days before surgery. Approximately 12 patients will be enrolled.
Drug: Fluorine F 18 Ara-G
Given IV
Other Names:
  • 2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine
  • VisAcT

Procedure: Positron Emission Tomography
Undergo PET/MR imaging
Other Names:
  • PET
  • PET Scan

Procedure: Magnetic Resonance Imaging
Undergo PET/MR imaging
Other Name: MRI

Experimental: Cohort 2: Standard of Care (SOC)
Patients with any cancer type who are planned to initiate standard of care (SOC) anti-PD-1 or anti-PD-L1 treatment (Cohort 2). For the SOC cohort, study participants will undergo whole body PET/MR imaging with [18F]F-AraG within 7 days of initiating Cycle 1 anti-PD-1 or anti-PD-L1, and between Cycle 1 Day 15 (C1D15) and Cycle 2 Day 7 (C2D7) anti-PD-1 or anti-PD-L1. Approximately 19 patients will be enrolled.
Drug: Fluorine F 18 Ara-G
Given IV
Other Names:
  • 2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine
  • VisAcT

Procedure: Positron Emission Tomography
Undergo PET/MR imaging
Other Names:
  • PET
  • PET Scan

Procedure: Magnetic Resonance Imaging
Undergo PET/MR imaging
Other Name: MRI




Primary Outcome Measures :
  1. 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 ]
    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 by study cohort.


Secondary Outcome Measures :
  1. Change in maximum standard uptake value (SUVmax) [ Time Frame: Baseline up to day 8 ]
    Will also be correlated to clinical and/or pathologic response, patients will be divided into two groups: those who achieved clinical response and/or pathologic downs-staging, and those who did not. The median and interquartile range of change in SUVmax from baseline to presurgery in the different groups will be descriptively reported. For Cohort 1, clinical response will be determined by abdominal imaging performed =< 30 days after the last dose of atezolizumab prior to cystectomy compared to baseline pretreatment imaging using Response Evaluation Criteria in Solid Tumors version 1.1 criteria. For Cohort 1, pathologic response will be determined by evidence of down-staging (e.g. from muscle invasive to non-muscle invasive, or complete pathologic response) at the time of cystectomy

  2. 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 ]
    The change between pre-treatment and post-treatment SUVmax in lymphoid organs (e.g. lymph nodes) on whole-body [18F]F-AraG PET/MR imaging (Cohort 1 and 2).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03007719


Contacts
Contact: Julie McCluggage, RN 877-827-3222 HDFCCC.CIP@ucsf.edu
Contact: Lissa Gray, NP 877-827-3222 HDFCCC.CIP@ucsf.edu

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94158
Contact: Julie McCluggage, RN    877-827-3222    HDFCCC.CIP@ucsf.edu   
Contact: Lissa Gray, NP    877-827-3222    HDFCCC.CIP@ucsf.edu   
Sponsors and Collaborators
Lawrence Fong
CellSight Technologies, Inc.
Investigators
Principal Investigator: Lawrence Fong, MD University of California, San Francisco

Responsible Party: Lawrence Fong, Professor in Residence, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03007719     History of Changes
Other Study ID Numbers: 16709
NCI-2017-01323 ( Registry Identifier: Clinical Trials Reporting Program (CTRP) )
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type