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89Zr-DFO-Atezolizumab ImmunoPET/CT in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT04006522
Recruitment Status : Recruiting
First Posted : July 5, 2019
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Orhan Kemal Oz, University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE July 1, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date October 5, 2020
Actual Study Start Date  ICMJE October 2, 2019
Estimated Primary Completion Date July 15, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 89Zr-DFO-Atezolizumab ImmunoPET/CT in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma
Official Title  ICMJE An Exploratory Study of 89Zr-DFO-Atezolizumab ImmunoPET/CT in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Renal Cell Carcinoma
Intervention  ICMJE
  • 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 Name: PET/CT
Study Arms  ICMJE
  • Experimental: Cohort 1
    Patients with Localized RCC prior to nephrectomy.
    Interventions:
    • Drug: 89Zr-DFO-Atezolizumab
    • Procedure: Positron Emission Tomography/Computed Tomography
  • Experimental: Cohort 2
    Patients with Unresectable/Metastatic RCC prior to treatment with an immune checkpoint inhibitor.
    Interventions:
    • Drug: 89Zr-DFO-Atezolizumab
    • Procedure: Positron Emission Tomography/Computed Tomography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 1, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 15, 2025
Estimated Primary Completion Date July 15, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kelli Key, PhD 214-648-8152 Kelli.Key@UTSouthwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04006522
Other Study ID Numbers  ICMJE STU-2019-0714
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Orhan Kemal Oz, University of Texas Southwestern Medical Center
Study Sponsor  ICMJE Orhan Kemal Oz
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Isaac Bowman, MD UT Southwestern Medical Center
Principal Investigator: James Brugarolas, MD, PhD UT Southwestern Medical Center
Principal Investigator: Orhan Oz, MD, PhD UT Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP