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A randomized phase II trial of niraparib plus either nivolumab or ipilimumab in patients with advanced pancreatic cancer whose cancer has not progressed on platinum-based therapy.

K. Reiss,R. Mick,M. O'Hara,U. Teitelbaum,T. Karasic,C. Schneider,P. O'dwyer,Danielle Karlson,Stacy Cowden,M. Fuhrer,E. Carpenter,A. Pantel,Mehran Makvandi,D. Mankoff,K. Nathanson,K. Maxwell,G. Beatty,S. Domchek

Published 2019 in Journal of Clinical Oncology

ABSTRACT

TPS4161 Background: The treatment paradigm for advanced pancreatic ductal adenocarcinoma (PDAC) typically involves ongoing chemotherapy until either disease progression or clinical deterioration. A subset of patients with advanced PDAC have exceptional responses to platinum-based chemotherapy. We hypothesized that durable platinum sensitivity in patients with advanced PDAC might be indicative of a DNA repair deficiency, and that these patients may respond to a combination of niraparib, a PARP inhibitor, plus immune checkpoint blockade. Methods: We have enrolled 25 of 84 planned patients on study NCT 03404960. Eligibility criteria include inoperable PDAC and stability on platinum-based chemotherapy for ≥16 weeks without evidence of progressive disease. Patients who have progressed on platinum-based treatment or who have received prior therapy with PARP inhibitors are excluded. Patients are randomized to receive oral niraparib 200mg PO daily plus nivolumab 240mg IV every two weeks in continuous 28 day cycles or oral niraparib 200mg PO daily plus ipilimumab 3mg/kg IV every three weeks for four doses in continuous 21 day cycles. The primary endpoint is progression-free survival at 6 months. Secondary endpoints include response rate, duration of response and overall survival. Paired biopsies are obtained, as well as serial blood collections for circulating tumor cells (CTCs), circulating tumor DNA (ctDNA) and peripheral blood mononuclear cells (PBMCs). Correlative assays will include germline whole exome sequencing and analyses of serially collected PBMCs, CTCs and ctDNA to identify genomic and immunologic innate and adaptive resistance mechanisms. Clinical trial information: NCT 03404960.

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