Dr. Khushalani on Goals for the CA045-001 Trial in Melanoma

Nikhil Khushalani, MD
Published: Thursday, Jul 25, 2019



Nikhil Khushalani, MD, vice chair, Department of Cutaneous Oncology, Moffitt Cancer Center, discusses the plans for the CA045-001 trial, an international, multicenter study that is comparing bempegaldesleukin (NKTR-214) plus nivolumab (Opdivo) versus nivolumab monotherapy in patients with previously untreated, unresectable, or metastatic melanoma.

This trial intends to accrue 764 patients globally in a 1:1 unblinded randomized fashion, explains Khushalani. In the initial 45 patients, a key endpoint is pharmacokinetics to understand how the body responds to and works with bempegaldesleukin.

After 480 patients are randomized, researchers will examine the overall response rate. Investigators are hopeful to increase the response rate by at least 21% compared with nivolumab alone. The co-primary endpoints are progression-free survival (PFS) and overall survival. This trial would be considered a success if the hazard ratio is met at 0.7, which means a 30% improvement on historical PFS with nivolumab by itself, according to Khushalani.
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Nikhil Khushalani, MD, vice chair, Department of Cutaneous Oncology, Moffitt Cancer Center, discusses the plans for the CA045-001 trial, an international, multicenter study that is comparing bempegaldesleukin (NKTR-214) plus nivolumab (Opdivo) versus nivolumab monotherapy in patients with previously untreated, unresectable, or metastatic melanoma.

This trial intends to accrue 764 patients globally in a 1:1 unblinded randomized fashion, explains Khushalani. In the initial 45 patients, a key endpoint is pharmacokinetics to understand how the body responds to and works with bempegaldesleukin.

After 480 patients are randomized, researchers will examine the overall response rate. Investigators are hopeful to increase the response rate by at least 21% compared with nivolumab alone. The co-primary endpoints are progression-free survival (PFS) and overall survival. This trial would be considered a success if the hazard ratio is met at 0.7, which means a 30% improvement on historical PFS with nivolumab by itself, according to Khushalani.



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