Tissue Collection to ID TCRs From Renal Clear Cell Carcinoma Patients Responding to Immune Checkpoint Inhibitors

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.