Brian Rini, MD, on Expectations For a Trial Examining MK-1308A Plus Lenvatinib and Pembrolizumab With Other Combinations in ccRCC

Brian I. Rini, MD, detailed the focus, goals, and key end points of a 3-arm, phase 3 trial comparing MK-1308A or belzutifan plus lenvatinib and pembrolizumab to the control of lenvatinib and pembrolizumab alone to treat patients with advanced clear cell renal cell carcinoma.

Brian I. Rini, MD, chief of clinical trials and professor of medicine at the Vanderbilt-Ingram Cancer Center, spoke with CancerNetwork® at the 2021 European Society for Medical Oncology (ESMO) Congress about his expectations for the results of the upcoming randomized, open-label, phase 3 trial (NCT04736706). The 3-arm study will compare MK-1308A or belzutifan (Welireg) added to lenvatinib (Lenvima) and pembrolizumab (Keytruda) versus the control arm of pembrolizumab plus lenvatinib to treat advanced clear cell renal cell carcinoma in the first-line setting.


The trial’s powered for overall survival and we’ll also look at progression-free survival, response rate, and other typical end points. If positive, it would presumably set a new standard of care and ideally care [for] more patients. We’re now at the point in kidney cancer where we’re curing around 15% to 20% of patients, but that’s obviously still the minority of patients. The hope is, as has been done in other malignancies, by building combination regimens, we can care more patients. That's absolutely the goal.


Rini BI, Plimack ER, Powles TB, et al. Randomized, open-label, 3-arm phase III study comparing MK-1308A + lenvatinib and pembrolizumab (pembro) + belzutifan + lenvatinib versus pembro + lenvatinib as first-line (1L) treatment for advanced clear cell renal cell carcinoma (ccRCC). Ann Oncol. 2021;32(suppl 5):717TiP. doi:10.1016/annonc/annonc675