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

Who is this study for? Patients with locally advanced or metastatic renal cell carcinoma
What treatments are being studied? 89Zr-DFO-Atezolizumab+Positron emission tomography/Computed tomography
Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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:

∙ 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.

‣ 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).

Locations
United States
Texas
UT Southwestern Medical Center
RECRUITING
Dallas
Contact Information
Primary
Kelli Key, PhD
Kelli.Key@UTSouthwestern.edu
214-648-8152
Time Frame
Start Date: 2019-10-02
Estimated Completion Date: 2027-01-15
Participants
Target number of participants: 55
Treatments
Experimental: Cohort 1
Patients with Localized RCC prior to nephrectomy.
Experimental: Cohort 2
Patients with Unresectable/Metastatic RCC prior to treatment with an immune checkpoint inhibitor.
Authors
Isaac A Bowman, Orhan Oz
Related Therapeutic Areas
Sponsors
Leads: James Brugarolas

This content was sourced from clinicaltrials.gov