The Evolution of Clinical Trials in Renal Cell Carcinoma: A Status Report for 2013–2016 from the ClinicalTrials.gov Website

Abstract

We previously published an analysis of clinical trials in renal cell carcinoma (RCC) using the publicly available ClinicalTrials.gov registry. Here we present a 3-year update to understand clinical research current trends in RCC compared to 2013.

The Website’s advanced search function was used to search for RCC trials. The characteristics of the trial were extracted, summarized and compared to 2013 data using Fisher’s exact tests.

We locked our search on May 26, 2016 with 165 trials eligible, compared with 169 trials on Sep 25, 2013. There were more phase I and I/II trials in 2016 compared to 2013 (40.8% vs 24.9%, p = 0.05). More clinical trials in 2016 compared to 2013 used immunotherapy (IT) alone or in combination with other drugs (24.2% vs 10.7%, p = 0.001), and the use of targeted therapy alone (TT) declined (32.9% vs 47.9%, p = 0.005). TT+IT combination trials more than doubled (6.7% vs 2.3%, p = 0.07). The number of trials with treatment in (neo)adjuvant settings in 2016 and 2013 were similar (9.7% vs 10.6%, p = 0.77), respectively. Compared to 2013, the number of trials with non-clear cell histology remained low (n = 10). Many more trials were sponsored by the pharmaceutical industry in 2016 vs 2013 (41.5% vs 16.0%, p = <0.001).

IT-based and industry sponsored clinical trials significantly increased from 2013 to 2016 with a concomitant drop in TT only trials. The increase in industry-sponsored studies may reflect the rapid uptake of expensive IT drugs. There continues to be a paucity of (neo)adjuvant studies and for non-clear cell histologies.

Authors: Ghatalia, Pooja | Koenigsberg, Rebecca| Pisarcik, David | Handorf, Elizabeth A. | Geynisman, Daniel M. | Zibelman, Matthew

Journal: Kidney Cancer, vol. 1, no. 2, pp. 151-159, 2017

Keywords: Retrospective, immunotherapy, neoadjuvant, adjuvant, kidney cancer