PIVOT-10 Trial

Arlene O. Siefker-Radtke, MD:Most recently, we have opened the PIVOT-10 trial, which is a clinical trial of bempegaldesleukin plus nivolumab in patients with stage IV metastatic surgically unresectable urothelial cancer who are not candidates for cisplatin-based chemotherapy and have low PD-L1 [programmed death-ligand 1] expression. This clinical trial has an arm combining bempegaldesleukin with nivolumab given on a 3-week schedule. There’s a reference arm studying gemcitabine-carboplatin in this group of patients as well. So patients will be randomized to either bempegaldesleukin plus nivolumab or gemcitabine-carboplatin.

The gemcitabine-carboplatin arm is not going to be compared directly against the response rate, but rather it’s to provide a reference as to what the objective response rate would be with carboplatin-based chemotherapy and PD-L1—low tumors. One reason for this strategy is that there have been thoughts raised that perhaps chemotherapy doesn’t work as well in PD-L1–low tumors. If we look in the neoadjuvant setting, there are data suggesting cisplatin-based chemotherapy has the highest impact in a basal subtype of bladder cancer, and that basal subtype typically has the highest levels of PD-L1 expression.

So this trial design will provide a referent arm on the response rate associated with gemcitabine-carboplatin.

Patients randomized to gemcitabine-carboplatin will be allowed to receive treatment with bempegaldesleukin plus nivolumab upon progression from gemcitabine-carboplatin, which will also provide some intriguing information on the use of this combination in a postchemotherapy setting.

Transcript edited for clarity.