NCT04006522

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: James Brugarolas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 55 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.

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-10-02
• Primary completion: 2025-10-07
• Completion: 2026-12-31
• First posted: 2019-07-05
• Last updated: 2026-02-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study