Phase II Study of Pegvorhyaluronidase Alfa (PEGPH20) and Pembrolizumab for Patients with Hyaluronan-High, Pretreated Metastatic Pancreatic Ductal Adenocarcinoma: PCRT16-001.

ABSTRACT: Background: Stromal hyaluronic acid (HA) poses a physical barrier and protects tumor cells from immune surveillance. Stroma targeting with pegylated human recombinant PH20 hyaluronidase (PEGPH20) demonstrated improved infiltration of cytotoxic T-lymphocytes and delivery of chemotherapy and PD1/PD-L1 antibodies in tumor models. This multicenter phase II study of PEGPH20 plus pembrolizumab evaluated the efficacy, safety and immune and stromal biomarkers in patients with HA-high refractory metastatic pancreatic ductal adenocarcinoma (mPDA). Patients and Methods: Patients were treated with PEGPH20 3 µg/kg IV weekly and pembrolizumab 200 mg IV in 3-week cycles. Tumor and blood samples were collected at baseline and on-study for biomarker analyses. Results: Between May and N

SUBMITTER: Chiorean EG 

PROVIDER: S-EPMC12896646 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature