Using a special imaging technique to assess treatment response in kidney cancer patients
An Exploratory Study of 89Zr-DFO-Atezolizumab ImmunoPET/CT in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma
This study is testing a special type of scan to see how well it can show treatment responses in kidney cancer patients, helping doctors choose the best immunotherapy for them.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Drugs / interventions | Atezolizumab, prednisone, immunotherapy |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT04006522 on ClinicalTrials.gov |
What this trial studies
This clinical trial explores the use of 89Zr-DFO-Atezolizumab Positron Emission Tomography/Computed Tomography (PET/CT) scans to evaluate programmed death-ligand 1 (PD-L1) expression and treatment response in patients with locally advanced or metastatic renal cell carcinoma (RCC). The study includes two cohorts: one with patients undergoing surgery for localized RCC and another with patients receiving immune checkpoint inhibitors for metastatic RCC. The trial aims to correlate PET scan results with PD-L1 expression and treatment outcomes, providing insights into patient selection for immunotherapy. A total of 40 patients will participate, with follow-up assessments for cancer recurrence or progression.
Who should consider this trial
Good fit: Ideal candidates include patients with high-risk localized renal cell carcinoma planned for surgery or those with metastatic RCC scheduled to receive immunotherapy.
Not a fit: Patients with renal cell carcinoma who are not candidates for surgery or immunotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the ability to identify which kidney cancer patients are most likely to benefit from immune checkpoint inhibitors.
How similar studies have performed: While similar approaches have been explored in other tumor types, this is the first investigation of this method specifically in renal cell carcinoma.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Dallas, Texas
- UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: James Brugarolas, MD, PhD — UT Southwestern Medical Center
- Study coordinator: Kelli Key, PhD
- Email: Kelli.Key@UTSouthwestern.edu
- Phone: 214-648-8152
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.