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

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.

Timeline

Start

2017-08-03

Primary completion

2023-10-24

Completion

2023-10-24

Outcome

Met primary endpoint

paper Five patients (36%) met the criteria for the intermittent phase of the trial (median TB decrease 46%) and all agreed to intermittent therapy. PMID 31097024 ↗

Publications

• Ornstein MC, George L, Wei W, Diaz-Montero CM, Rayman P, Martin A, Basu A, Beckermann KE, Nizam A, Wee CE, Gilligan TD, Gupta S, Rini BI. Phase II Trial of Intermittent Therapy in Patients with Metastatic Renal Cell Carcinoma Treated with Front-line Ipilimumab and Nivolumab. Clin Genitourin Cancer. 2024 Dec;22(6):102181. doi: 10.1016/j.clgc.2024.102181. Epub 2024 Jul 31.
• Ornstein MC, Wood LS, Hobbs BP, Allman KD, Martin A, Bevan M, Gilligan TD, Garcia JA, Rini BI. A phase II trial of intermittent nivolumab in patients with metastatic renal cell carcinoma (mRCC) who have received prior anti-angiogenic therapy. J Immunother Cancer. 2019 May 16;7(1):127. doi: 10.1186/s40425-019-0615-z.

Drugs

Indications