Neoplasms

All Conditions

Heart and Blood Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Thrombosis

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Embolism

Embolism and Thrombosis

Vascular Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Lenvatinib

Immunomodulating Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Patients receive neoadjuvant lenvatinib (20 mg PO daily) for 12 weeks and pembrolizumab (200 mg IV every 3 weeks for four doses) prior to surgical resection of locally advanced RCC with IVC tumor thrombus. Following surgery, patients will receive adjuvant pembrolizumab (200 mg IV every 3 weeks for up to thirteen doses).

20 mg PO daily for 12 weeks prior to surgery

Neoadjuvant Lenvatinib

200 mg IV every 3 weeks for 4 doses prior to surgery

Neoadjuvant Pembrolizumab

Resection of locally advanced RCC with IVC tumor thrombus

Radical nephrectomy, IVC thrombectomy, retroperitoneal lymph node dissection

200 mg IV every 3 weeks for up to 13 doses after surgery

Adjuvant Pembrolizumab

Donna Mitchell

Doreen Simonsen

Vitaly Margulis

Vitaly Margulis, MD

This study will be evaluating safety and efficacy of the combination of lenvatinib and pembolizumab neoaadjuvant therapy prior to surgical resection of locally advanced renal cell carcinoma with IVC tumor thrombus.

Neoadjuvant Lenvatinib and Pembrolizumab for IVC Tumor Thrombus

Safety and Efficacy of Neoadjuvant Lenvatinib and Pembrolizumab in Patients With Renal Cell Carcinoma and IVC Tumor Thrombus

Identify metabolic signatures in plasma that are noninvasive predictors of therapy response and identify metabolic alterations following neoadjuvant therapy in patients who do and do not respond.

Evaluation of changes in size of primary tumor and size and level of IVC tumor thrombus on imaging due to neoadjuvant therapy prior to surgery.

Evaluation of local or metastatic progression on imaging prior to surgery following neoadjuvant therapy.

Assessment of 90 day post-operative safety and morbidity of neoadjuvant therapy by evaluating the incidence of 90 day post-operative grade 3-5 adverse events.

Estimated blood loss in mL during surgery

Operative time in minutes of surgery, length of stay, and intra-operative and post-operative complications

Length of stay of hospital stay for surgery in days, and intra-operative and post-operative complications

Complications that occur in the post-operative period

Evaluation of post-operative survival outcomes including recurrence-free survival and overall survival.

Spots Global Cancer Trial Database for neoadjuvant lenvatinib