NCT02595918

Nivolumab in Treating Patients With High-Risk Kidney Cancer Before Surgery

A Pilot Study of Preoperative Nivolumab in High-Risk Non-Metastatic and Metastatic Renal Cell Carcinoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot phase I trial studies the side effects of nivolumab and how well it works in treating patients with high-risk kidney cancer before surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Detailed description

PRIMARY OBJECTIVE: I. To study the safety and feasibility of preoperative nivolumab administration in subjects with resectable, high-risk, non-metastatic and metastatic renal cell carcinoma undergoing planned cytoreductive nephrectomy or metastasectomy. SECONDARY OBJECTIVES: I. To assess overall response rate in patients receiving preoperative nivolumab. II. To assess recurrence free survival at 2 years in patients receiving preoperative nivolumab in patients with high-risk, non-metastatic disease. EXPLORATORY OBJECTIVES: I. To evaluate the association between baseline tumor mutational burden and both immune infiltration and radiographic tumor response to nivolumab. II. To explore predicted and expressed tumor neoantigens and their correlation with radiographic tumor response to nivolumab. III. To explore the association between the predicted immune signature (via ribonucleic acid sequencing \[RNAseq\]) in the tumor microenvironment with radiographic tumor response to nivolumab. IV. To determine whether changes in the tumor microenvironment before, during, and after therapy are associated with response. V. To assess the potential association between PD-L1 expression (by immunohistochemistry \[IHC\]) and radiographic tumor response to nivolumab. OUTLINE: Patients receive nivolumab intravenously (IV) over 30 minutes on days -56, -42, -28, and -14 in the absence of disease progression or unacceptable toxicity. Patients then undergo nephrectomy or metastasectomy on day 0. After completion of study treatment, patients are followed up at 14-28 days, at 90 days, and then at 24-28 months.

Conditions

• Clear Cell Renal Cell Carcinoma
• Metastatic Renal Cell Carcinoma
• Stage I Renal Cell Cancer AJCC v6 and v7
• Stage II Renal Cell Cancer AJCC v7
• Stage III Renal Cell Cancer AJCC v7
• Stage IV Renal Cell Cancer AJCC v7

Interventions

Type	Name	Description
PROCEDURE	Metastasectomy	Undergo metastasectomy
PROCEDURE	Nephrectomy	Undergo nephrectomy
BIOLOGICAL	Nivolumab	Given IV

Timeline

• Start date: 2016-05-19
• Primary completion: 2020-08-01
• Completion: 2020-08-01
• First posted: 2015-11-04
• Last updated: 2020-10-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study