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

June 1, 2023 updated by: James Brugarolas

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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. 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.

This is an exploratory analysis correlating 89Zr-DFO-Atezolizumab uptake with PD-L1 immunohistochemical (IHC) analyses in locally advanced kidney cancer (cohort 1) and will evaluate 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

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern Medical Center
        • Principal Investigator:
          • James Brugarolas, MD, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with suspected renal cell carcinoma with planned surgery or patients with metastatic RCC and a tissue diagnosis. (In standard clinical practice, biopsy is not routinely performed in patients who will be having surgery).
  • 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 surgery determined to be a high risk of recurrence, defined by presence of at least clinical T2 or TxN1, OR patients with metastatic RCC for whom treatment with cytoreductive nephrectomy and/or metastasectomy is planned by the treating physician.
    2. Patients with metastatic RCC for whom immuno-oncology (IO) therapy 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. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

    • Has not undergone a hysterectomy or bilateral oophorectomy; or
    • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

Exclusion Criteria:

  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to atezolizumab or any other chimeric or humanized antibodies.
  • 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 ICI therapy would be contraindicated for other reasons. Patients with adverse reactions to ICI therapy may undergo second 89Zr-DFO-Atezolizumab injection and PET/CT at the discretion of the treating physician considering that the dose of antibody represents 1% of a single therapeutic dose and therefore unlikely to cause adverse events.
  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 5 years
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.
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

James Brugarolas

Investigators

  • Principal Investigator: James Brugarolas, MD, PhD, UT Southwestern Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2019

Primary Completion (Estimated)

July 15, 2024

Study Completion (Estimated)

July 15, 2025

Study Registration Dates

First Submitted

July 1, 2019

First Submitted That Met QC Criteria

July 1, 2019

First Posted (Actual)

July 5, 2019

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

June 1, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU-2019-0714

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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