First-in-human Intravesical Delivery of Pembrolizumab Identifies Immune Activation in Bladder Cancer Unresponsive to Bacillus Calmette-Guerin.

ABSTRACT:

Background

Intravenous immune checkpoint inhibition is an effective anticancer strategy for bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) but may be associated with greater systemic toxicity compared with localized therapies.

Objective

We assessed the safety and antitumor activity of intravesical pembrolizumab combined with BCG.

Design, setting, and participants

A 3 + 3 phase 1 trial of pembrolizumab + BCG was conducted in patients with BCG-unresponsive NMIBC (NCT02808143).

Intervention

Pembrolizumab was given intravesically (1-5 mg/kg for 2 h) beginning 2 weeks prior to BCG induction until recurrence. Urine profiling during treatment and spatial transcriptomic profiling of pre- and post-treatment tumors were conducted t

SUBMITTER: Meghani K 

PROVIDER: S-EPMC9669228 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature