Toni K. Choueiri, MD, discusses the design of the phase 3 LITESPARK-022 study, which investigates adjuvant pembrolizumab in patients with clear cell renal cell carcinoma.
Toni Choueiri, MD, medical director, International Strategic Initiatives, director, Lank Center for Genitourinary Oncology, director, Kidney Cancer Center and senior physician at Dana-Farber Cancer Institute as well as the Jerome and Nancy Kohlberg Chair and Professor of Medicine at Harvard Medical School, discusses the phase 3 LITESPARK-022 (NCT05239728) study design.
Trial Name: A Multicenter, Double-blind, Randomized Phase 3 Study to Compare the Efficacy and Safety of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab, in the Adjuvant Treatment of Clear Cell Renal Cell Carcinoma (ccRCC) Post Nephrectomy (MK-6482-022)
Indentifier: NCT05239728
Completion Date: January 25, 2030
Sponsor: Merck Sharp & Dohme LLC
Recruitment Contact: 1-888-577-8839, Trialsites@merck.com
LITESPARK-022 follows the phase 3 KEYNOTE-564 clinical trial (NCT03142334), in which adjuvant pembrolizumab (Keytruda) or placebo was administered to patients with clear cell renal cell carcinoma (ccRCC). Results from the study showed that pembrolizumab significantly improved disease-free survival compared with placebo. The findings led the FDA to grant approval to pembrolizumab for the treatment of patients with RCC at intermediate-high or high risk for recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions.
Even with the success of pembrolizumab monotherapy, patients with risk of recurrence after definitive surgery require more effective treatment options. According to Choueiri, the addition of belzutifan (Welireg) to pembrolizumab will being tested in LITESPARK-022 based on its prior activity and tolerability in patients with ccRCC at risk for recurrence after definitive surgery.
Choueiri will be presenting the study design in full during the 2022 ASCO Annual Meeting.
0:08 | This is a large trial of around 1,600 patients with resected renal cell cancer. So, it follows the same structure N1 and M1 NED. It’s within 2 years, that's the difference [from] KEYNOTE-564, [it was] twice a year [and] we include also microscopic positive margin.
0:37 | Patients will be randomized to pembrolizumab for a year or pembrolizumab plus belzutifan, and also for the year the primary endpoint is disease-free survival with overall survival and safety as secondary endpoints. The study is going to be international open in multiple sites. The study already opened in a few sites. So, we're looking forward to improving the outcome of patients with kidney cancer with this study.
REFERENCES:
Choueiri TK, Bedke J, Karam JA, et al. LITESPARK-022: A phase 3 study of pembrolizumab + belzutifan as adjuvant treatment of clear cell renal cell carcinoma (ccRCC). J Clin Oncol. 2022;40 (suppl 16; abstr TPS4602). doi: 10.1200/JCO.2022.40.16_suppl.TPS4602
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