An open-label phase 2 trial is recruiting patients with previously treated advanced renal cell carcinoma (RCC) to evaluate MK-6482, a HIF-2α inhibitor, according to a poster presented at the 19th Annual Meeting of the International Kidney Cancer Symposium (IKCS 2020).
Loss of function of von Hippel-Lindau (VHL) occurs in up to 90% of clear cell RCC, resulting in the accumulation and overactivation of HIF-2α. This upregulates genes involved in cell invasion, metastasis, and survival, as well as angiogenesis and resistance to an immune response. The purpose of this trial is to evaluate the efficacy and safety of an HIF-2α inhibitor in this setting.
The open-label, phase 2 study will randomly assign approximately 150 patients to receive 120 mg or 200 mg of MK-6482 once daily. Patients with advanced or metastatic clear cell RCC are eligible if they have measurable disease and their disease progressed after first-line systemic therapy. Patients are ineligible if they received 3 or more prior lines of therapy.
The primary endpoint will be objective response rate. Secondary endpoints will include progression-free survival, overall survival, duration of response, pharmacokinetics, and safety.
The efficacy analysis will include the intention-to-treat population, which comprises all patients who undergo random assignment. The safety analysis will include all patients who received at least 1 dose of the study drug.
Recruiting is ongoing in the United States, parts of Europe, Russia, and Australia.
Disclosure: Funding for this research was provided by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. For a full list of disclosures, please refer to the abstract.
Atkins MB, Liu Y, Perini R, et al. Open-label phase 2 study of two doses of MK-6482 for the treatment of advanced renal cell carcinoma after progression on prior systemic therapy. Presented at: 19th Annual Meeting of the International Kidney Cancer Symposium (IKCS 2020); November 6-7, 2020. Abstract TIP136.
This article originally appeared on Cancer Therapy Advisor