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

NCT ID: NCT03007719

Last Updated: 2020-01-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-07
• Study Completion Date: 2019-01-11

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.

Conditions

Bladder Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Fluorine F 18 Ara-G

Intervention Type: DRUG

Given IV

Positron Emission Tomography

Intervention Type: PROCEDURE

Undergo PET/MR imaging

Magnetic Resonance Imaging

Intervention Type: PROCEDURE

Undergo PET/MR imaging

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.

Group Type: EXPERIMENTAL

Fluorine F 18 Ara-G

Intervention Type: DRUG

Given IV

Positron Emission Tomography

Intervention Type: PROCEDURE

Undergo PET/MR imaging

Magnetic Resonance Imaging

Intervention Type: PROCEDURE

Undergo PET/MR imaging

Interventions

Fluorine F 18 Ara-G

Given IV

Intervention Type: DRUG

Positron Emission Tomography

Undergo PET/MR imaging

Intervention Type: PROCEDURE

Magnetic Resonance Imaging

Undergo PET/MR imaging

Intervention Type: PROCEDURE

Other Intervention Names

2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine; VisAcT; PET; PET Scan; MRI

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CellSight Technologies, Inc.

INDUSTRY

Sponsor Role: collaborator

Lawrence Fong

OTHER

Sponsor Role: lead

Responsible Party

Lawrence Fong

Professor in Residence

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lawrence Fong, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NCI-2017-01323

Identifier Type: REGISTRY

Identifier Source: secondary_id

16709

Identifier Type: -

Identifier Source: org_study_id