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

Launched by JAMES BRUGAROLAS · Jul 1, 2019

Keywords

ClinConnect Summary

This clinical trial is exploring a specialized imaging technique called 89Zr-DFO-Atezolizumab ImmunoPET/CT to see how well it can help doctors understand renal cell carcinoma (RCC), a type of kidney cancer. The goal is to find out how this imaging method relates to the presence of a protein called PD-L1, which can affect how well patients respond to certain cancer treatments known as immune checkpoint inhibitors. The study has two groups: one group consists of patients with localized RCC who are scheduled for surgery, and the other includes patients with metastatic RCC, which means their cancer has spread, who are about to start treatment.

To participate in this trial, patients need to have a confirmed diagnosis of RCC, either localized or metastatic, and they should be able to undergo a PET/CT scan lasting about 30 to 60 minutes. Women who can become pregnant must have a negative pregnancy test before joining the study. It's important to know that this trial does not involve providing treatment; instead, it focuses on the imaging process and the information it can provide about the cancer. Participants will need to sign a consent form and be willing to lie still during the scan.

Gender

ALL

Eligibility 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).