| Eligibility |
Inclusion Criteria:
1. Known or suspected diagnosis of renal clear cell carcinoma.
2. Age =18 years at time of diagnosis.
3. ECOG performance status 0-2.
4. Ability to understand and willingness to sign an informed consent document.
5. Patients must be eligible for or currently receiving treatment with immune checkpoint
inhibitor (ICI) therapy as determined by the patient's treating oncologist. The
treatment regimen may comprise more than one agent but must include at least one ICI
drug.
Examples of FDA-approved ICI drugs include pembrolizumab (Keytruda), nivolumab
(Opdivo), atezolizumab (Tecentriq), avelumab (Bavencio), durvalumab (Imfinzi),
cemiplimab (Libtayo), and ipilimumab (Yervoy). Immune-checkpoint inhibitors not on
this list may also be used, provided they are FDA-approved.
6. Patients undergoing an on-treatment biopsy must show a partial response of one or more
lesions, as assessed by the investigator, using RECIST 1.1 or irRECIST criteria.
7. Patients undergoing surgical resection of residual tumors must show a partial response
by RECIST 1.1 or irRECIST criteria of at least one of the resected lesions.
8. Patients undergoing an on-treatment biopsy must have a cancer lesion that is amenable
for biopsy under local anesthesia or moderate sedation per standard procedures. The
tumor biopsy must have an acceptable clinical risk, as judged by the investigator.
9. Platelet count =50×109 /L prior to biopsy or per the service performing the biopsy.
10. Absolute neutrophil count =1500×103 /L.
11. Must be able to safely hold aspirin, clopidogrel (Plavix), prasugrel (Effient),
cangrelor (Kengreal), or ticagrelor (Brilinta) for =5 days prior to biopsy.
12. Not receiving therapeutic anticoagulation at the time of the biopsy. Patients on
therapeutic anticoagulation must be able to safely hold anticoagulation for the
procedure with an acceptable risk, as judged by the investigator. Patients who are on
anticoagulation for clinical reasons and deemed appropriate for biopsy must be OFF
anticoagulation prior to biopsy as follows:
1. No warfarin (Coumadin) for 5 days.
2. No low-molecular weight heparin (LMWH; e.g. dalteparin/ Fragmin, enoxaparin/
Lovenox) for 24 hours.
3. No fondaparinux/ Arixtra for 48 hours.
4. Patients receiving alternative forms of anticoagulation not listed above (e.g.,
dabigatran, rivaroxaban, apixaban, edoxaban) should consult with the prescribing
physician and the service performing the biopsy regarding safety and
administration guidelines prior to biopsy. Bleeding risks with these agents
should be considered when deciding on whether to perform the biopsy if for
research purposes only.
Exclusion Criteria:
1. Concurrent disease or condition that would make the patient inappropriate for study
participation, or any serious medical or psychiatric disorder that would interfere
with the subject's safety.
2. Dementia, altered mental status, or any psychiatric condition that would prohibit the
understanding or rendering of informed consent.
3. History of serious or life-threatening allergic reaction to local anesthetics (i.e.,
lidocaine, xylocaine).
4. Pregnant women are excluded because there may be an increased risk to both mother and
fetus in the setting of moderate sedation, which is required for biopsies of certain
anatomic sites (e.g., liver, lung, bone). Also, ionizing radiation from CT-guided
biopsies may pose a risk to the unborn fetus.
5. Active cardiac disease, defined as:
- Uncontrolled or symptomatic angina within the past 3 months.
- History of clinically significant arrhythmias (such as ventricular tachycardia,
ventricular fibrillation, torsades de pointes). Atrial fibrillation with
controlled ventricular response on treatment is not an exclusion.
- Myocardial infarction < 6 months from study entry.
- Uncontrolled or symptomatic congestive heart failure.
6. Any other condition, which in the opinion of the patient's treating oncologist or the
physician performing the biopsy procedure, would make participation in this protocol
unreasonably hazardous for the patient.
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