Perioperative Lenvatinib With Pembrolizumab in Patients With Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma (NCT04393350)

🧪 Interventions in This Study

• Lenvatinib (DRUG)
• Lenvatinib Mesylate (DRUG)
• Pembrolizumab (BIOLOGICAL)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Patients with a renal mass consistent with a clinical stage \>= T3Nx or TanyN+ or deemed unresectable by surgeon
2. Renal cell carcinoma with clear cell component on pre-treatment biopsy of the primary tumor
3. The participant (or legally acceptable representative if applicable) provides written informed consent and the willingness and ability to comply with all aspects of the protocol
4. Have an Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
5. Absolute neutrophil count (ANC) \>= 1500/uL (specimens must be collected within 72 hours prior to the start of study treatment)
6. Platelets \>= 100 000/uL (specimens must be collected within 72 hours prior to the start of study treatment)
7. Hemoglobin \>= 9.0 g/dL (specimens must be collected within 72 hours prior to the start of study treatment) or ≥5.6 mmol/La Renal: Creatinine =≤1.5 × ULN OR Measured or calculatedb creatinine clearance (GFR can also be used in place of creatinine or CrCl)=≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN. Hepatic: Total bilirubin=≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \>1.5 × ULN AST (SGOT) and ALT (SGPT)=≤2.5 × ULN (≤5 × ULN for participants with liver metastases) Coagulation: International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT)=≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants. ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal.
8. Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.
9. Creatinine clearance (CrCl) should be calculated per institutional standard.
10. International normalized ratio (INR) OR prothrombin time (PT) =\< 1.5 x upper limit of normal (ULN) unless participant is receiving anticoagulant therapy as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants (specimens must be collected within 72 hours prior to the start of study treatment)
11. Activated partial thromboplastin time (aPTT) =\< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants (specimens must be collected within 72 hours prior to the start of study treatment)
12. Serum creatinine =\< 1.5 x ULN OR measured or calculated creatinine clearance (glomerular filtration rate \[GFR\] can also be used in place of creatinine or creatinine clearance \[CrCl\]) \>= 40 mL/min (\>= 0.67 mL/sec) for participant with creatinine levels \> 1.5 x institutional ULN (specimens must be collected within 72 hours prior to the start of study treatment)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

• Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.