Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-03 @ 6:36 AM
Study NCT ID:
NCT02595918
Status:
TERMINATED
Last Update Posted:
2020-10-23
First Post:
2015-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nivolumab in Treating Patients With High-Risk Kidney Cancer Before Surgery
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Pilot Study of Preoperative Nivolumab in High-Risk Non-Metastatic and Metastatic Renal Cell Carcinoma
Status:
TERMINATED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inadequate accrual rate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: