NCT03126331

Intermittent Therapy in Metastatic Renal Cell Carcinoma Patients Treated With Ipilimumab and Nivolumab

A Single-arm Phase II Trial of Intermittent Nivolumab in Patients With Metastatic Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being done with patients with advanced kidney cancer (also called renal cell carcinoma or RCC). This is a research study involving the use of the drug Nivolumab (also known as Opdivo®). Nivolumab is an anti-PD-1 antibody. It works by attaching to and blocking a molecule called PD-1. PD-1 is a protein that is present on different types of cells in the immune system and controls parts of the immune system by shutting it down. Antibodies that block PD-1 can potentially prevent PD-1 from shutting down the immune system, thus allowing it to recognize and help destroy cancer cells. In many countries (including the United States, European Union and Japan) Nivolumab is approved to treat certain cancer types. The purpose of the study is to test the safety and effectiveness of nivolumab in patients with advanced RCC when given intermittently. Nivolumab is approved by the U.S. Food and Drug Administration (FDA) for the treatment of advanced kidney cancer, non small cell lung cancer, classical Hodgkin Lymphoma and Metastatic Melanoma. Nivolumab is FDA-approved for advanced RCC because has been shown to shrink RCC tumors that have spread outside the kidney.

Detailed description

Primary Objective: \- To determine the feasibility of intermittent nivolumab therapy in patients with metastatic renal cell carcinoma. Secondary Objectives: * To determine the clinical outcome (overall response rate (ORR), progressive free survival (PFS), overall survival (OS)) in metastatic renal cell carcinoma patients treated with intermittent nivolumab therapy. * To evaluate the toxicity of intermittent nivolumab therapy in patients with metastatic renal cell carcinoma. Correlative Objective \- Investigate correlations between baseline and post-treatment immunomodulatory cells \[specifically, myeloid-derived suppressor cells (MDSC) regulatory T cells (Treg), cluster of differentiation 4 (CD4) and cluster of differentiation 8 (CD8), T Cells, T-cell receptor (TCR) repertoire and time off therapy.

Conditions

• Metastatic Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab monotherapy will be administered dosed at 480mg IV over 30 minutes for all patients every 4 weeks, regardless of weight (when given in combination with ipilimumab, the dose of nivolumab is 3mg/kg every 3 weeks). Tumor assessed after 12 weeks If tumor decreases by 10% or more, then hold drug for 12 week and test tumor again. Continue treatment if tumor is not decreased by 10% or more.
DRUG	Ipilimumab	Ipilimumab is dosed at 1mg/kg over 30 minutes every 3 weeks

Timeline

• Start date: 2017-08-03
• Primary completion: 2023-10-24
• Completion: 2023-10-24
• First posted: 2017-04-24
• Last updated: 2024-03-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study