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History of Changes for Study: NCT04006522
89Zr-DFO-Atezolizumab ImmunoPET/CT in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma
Latest version (submitted August 2, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 1, 2019 None (earliest Version on record)
2 October 3, 2019 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 April 18, 2020 Recruitment Status, Study Status, Contacts/Locations and Study Design
4 September 30, 2020 Recruitment Status, Study Status, Contacts/Locations and Study Design
5 July 13, 2021 Contacts/Locations, Study Status and Eligibility
6 December 10, 2021 Sponsor/Collaborators, Contacts/Locations and Study Status
7 August 2, 2022 Study Status and Eligibility
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Study NCT04006522
Submitted Date:  July 1, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: STU-2019-0714
Brief Title: 89Zr-DFO-Atezolizumab ImmunoPET/CT in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma
Official Title: An Exploratory Study of 89Zr-DFO-Atezolizumab ImmunoPET/CT in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2019
Overall Status: Not yet recruiting
Study Start: July 15, 2019
Primary Completion: July 15, 2024 [Anticipated]
Study Completion: July 15, 2025 [Anticipated]
First Submitted: July 1, 2019
First Submitted that
Met QC Criteria:
July 1, 2019
First Posted: July 5, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
July 1, 2019
Last Update Posted: July 5, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Orhan Kemal Oz
Responsible Party: Sponsor-Investigator
Investigator: Orhan Kemal Oz
Official Title: Professor
Affiliation: University of Texas Southwestern Medical Center
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This is an exploratory clinical trial to assess the potential of 89Zr-DFO-Atezolizumab Positron Emission Tomography/Computed Tomography (PET/CT) scans in patients with locally advanced or metastatic renal cell carcinoma (RCC). This open label, nontherapeutic trial will test the correlation of 89Zr-DFO-Atezolizumab immunoPET/CT with programmed death-ligand 1 (PD-L1) expression and the response to immune checkpoint inhibitor therapy in patients with RCC. There will be two cohorts, one made up of patients with localized RCC who will undergo 89Zr-DFO-Atezolizumab PET/CT prior to nephrectomy and a second cohort of patients with metastatic RCC who will undergo 89Zr-DFO-Atezolizumab PET/CT prior to treatment with an immune checkpoint inhibitor.
Detailed Description:

PD-L1 expression in tissue of a variety of tumor types has both prognostic and predictive significance for patients treated with immune checkpoint inhibitors. A number of efforts are underway to better identify patients who will benefit from immune checkpoint inhibition. Among these efforts are the use of radiolabeled antibodies against PD-L1. While under investigation in a number of tumor types, to our knowledge this is the first such effort in renal carcinoma, despite the clear evidence of clinical efficacy of immune checkpoint inhibitors in kidney cancer. Our primary aim with this study is to explore 89Zr-DFO-Atezolizumab as a positron emission tomography (PET) tracer in patients with RCC.

The study involves 40 patients distributed across two different groups. The first group is made up of patients with high risk localized disease that will be having surgery. 89Zr-DFO-Atezolizumab PET/CT prior to surgery will be correlated with PD-L1. The second group is made up of patients with unresectable or metastatic RCC that will receive an anti-programmed death 1 (PD1)/programmed death-ligand 1 antibody (alone or in combination). 89Zr-DFO-Atezolizumab PET uptake at site of diseases will be evaluated within and across patients and correlated with treatment responsiveness in exploratory analyses. Each cohort will be comprised of 15-25 patients. Patients will be followed for signs of recurrence or progression of their cancer and repeat 89Zr-DFO-Atezolizumab PET scans will be offered at that time. Biopsy after subsequent PET/CT will be strongly encouraged.

Subjects will have data collected during the course of routine clinical care including response to immune checkpoint inhibitor therapy, and toxicities developed during immune checkpoint inhibitor therapy.

Co-primary endpoints will be an exploratory analysis correlating 89Zr-DFO-Atezolizumab uptake with PD-L1 immunohistochemical (IHC) analyses in locally advanced kidney cancer (cohort 1) and an investigation of whether 89Zr-DFO-Atezolizumab uptake across metastatic sites of kidney cancer correlates with known radiographically evident metastatic sites of disease, PD-L1 expression, and response to anti-PD1/PD-L1 immunotherapy treatment.

Open or close this module Conditions
Conditions: Renal Cell Carcinoma
Keywords: renal cell carcinoma
atezolizumab
PET/CT
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Diagnostic
Study Phase: Early Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 40 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Cohort 1
Patients with Localized RCC prior to nephrectomy.
Drug: 89Zr-DFO-Atezolizumab
89Zr-DFO-Atezolizumab infusion
Procedure: Positron Emission Tomography/Computed Tomography
PET/CT scan 7 days (± 1 day) after infusion of 89Zr-DFO-Atezolizumab.
Other Names:
  • PET/CT
Experimental: Cohort 2
Patients with Unresectable/Metastatic RCC prior to treatment with an immune checkpoint inhibitor.
Drug: 89Zr-DFO-Atezolizumab
89Zr-DFO-Atezolizumab infusion
Procedure: Positron Emission Tomography/Computed Tomography
PET/CT scan 7 days (± 1 day) after infusion of 89Zr-DFO-Atezolizumab.
Other Names:
  • PET/CT
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Correlation between 89Zr-DFO-Atezolizumab and PD-L1
[ Time Frame: Up to 5 years ]

Correlation between 89Zr-DFO-Atezolizumab PET/CT and PD-L1 expression at the time of nephrectomy in patients with localized kidney cancer.
2. Correlation between 89Zr-DFO-Atezolizumab and anti-PD1/PD-L1 therapy
[ Time Frame: Up to 5 years ]

Correlation between 89Zr-DFO-Atezolizumab PET/CT and response to anti-PD1/PD-L1 therapy.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Patients with suspected renal cell carcinoma with planned surgery or patients with metastatic RCC and a tissue diagnosis.
  • Ability to understand and the willingness to sign a written informed consent.
  • Patient must be able to lie still for a 30 to 60 minute PET/CT scan.
  • One of the following:
    1. Patients with locally advanced RCC planned for nephrectomy determined to be a high risk of recurrence, defined by presence of at least clinical T2 or thioredoxin 1 (TxN1), OR patients with metastatic RCC for whom treatment with metastasectomy is planned by the treating physician.
    2. Patients with metastatic RCC for whom checkpoint inhibitor therapy including an anti-PD1/PD-L1 agent is planned.
  • Women of child-bearing potential must agree to undergo and have documented a negative pregnancy test on the day of 89Zr-DFO-Atezolizumab administration.

Exclusion Criteria:

  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to atezolizumab or any other chimeric or humanized antibodies.
  • Concurrent use of an immune checkpoint inhibitor.
  • Uncontrolled severe and irreversible intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
  • Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
  • Significant autoimmune disease requiring treatment with either prednisone (or steroid equivalent) at a dose > 10 mg/day or other immunosuppressive agents. (Replacement steroid therapy is acceptable).
  • Any patient for whom immune checkpoint inhibitor therapy would be contraindicated for other reasons.
  • Subjects unable to provide informed consent.
  • Subjects who are claustrophobic or have other contraindications to PET/CT.
  • Subjects must not weigh more than the maximum weight limit for the table for the PET/CT scanner where the study is being performed. (>200 kg or 440 lbs).
Open or close this module Contacts/Locations
Central Contact Person: Kelli Key, PhD
Telephone: 214-648-8152
Email: Kelli.Key@UTSouthwestern.edu
Study Officials: Isaac Bowman, MD
Principal Investigator
UT Southwestern Medical Center
James Brugarolas, MD, PhD
Principal Investigator
UT Southwestern Medical Center
Orhan Oz, MD, PhD
Principal Investigator
UT Southwestern Medical Center
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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