P99. Perioperative safety from clinical trial of novel immuno-oncology combination with radiotherapy for locally advanced pancreatic cancer

Saturday, March 7, 2026

9:42 AM - 9:49 AM MST

Location: 105A-C

Primary Presenter(s)

Sagar D. Patel, DO (he/him/his)

Post Doctoral Surgery Resident
Johns Hopkins Hospital
Baltimore, Maryland, United States

Co-Author(s)

TM

Thomas J. McPhaul, MS

Research Fellow, Department of Surgery
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
RB

Richard A. Burkhart, MD

Associate Professor
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
JC

John L. Cameron, MD

Professor of Surgery
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Eric Christenson, MD (he/him/his)

Assistant Professor of Oncology
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Jin He, MD PhD

Associate Professor
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
EJ

Elizabeth Jaffee, MD

Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
KL

Kelly Lafaro, MD MPH

Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
AN

Amol Narang, MD

Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
CS

Christopher R. Shubert, MD MBA

Associate Professor
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
LZ

Lei Zheng, MD PhD

Professor of Oncology
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States

Primary Author(s)

William R. Burns, MD

Assistant Professor
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States

Introduction: A previous locally advanced pancreatic cancer (LAPC) study, which combined GVAX/anti-PD-1 immuno-oncology (IO) with radiotherapy (RT), showed promising anti-tumor immune responses that were associated with long-term survival despite increased immunosuppressive tumor-associated macrophages (TAMs). Our current LAPC study added an IO targeting TAMs in combination with GVAX/anti-PD-1 and RT. We report the perioperative safety data from this clinical trial.

Methods: Patients in this Phase I/II clinical trial (NCT03767582) received six months of standard-of-care FOLFIRINOX chemotherapy, followed by stereotactic RT and combinatorial IO with anti-PD-1 antibody (Nivolumab) and CCR2/CCR5 inhibitor (BMS-813160) targeting TAMs, with or without a pancreatic cancer vaccine (GVAX). Patients were then considered for conversion surgery. We report perioperative outcomes following pancreatectomy, comparing results to a 4:1 propensity score-matched resected LAPC cohort at our institution.

Results: Of the 22 patients who completed treatment, 14 patients (64%) underwent conversion surgery, whereas 4 patients (18%) were found to have metastatic disease and 4 patients (18%) were deemed unresectable. Whipple procedures were performed in 57% of patients and there were high rates of vascular resection including venous reconstruction (7/14; 50%) and arterial resection (3/14; 21%). The vast majority (12/14; 86%) had negative margins. These 14 patients were compared to 55 LAPC patients, matched based on radiographic tumor size, extent of vessel involvement, and preoperative CA19-9. Both cohorts had similar rates of larger tumors (P=0.76), elevated CA19-9 (P=1), and extensive vessel involvement (P=0.97). Perioperative safety and surgical outcomes were also similar, including length of stay (7 vs. 8 days, P=0.92), all post-operative complications (50% vs 75%, P=0.15), severe complications (21% vs 24%, P=1); no complications were attributable to the novel IO combination. Rates of re-operation (7% vs 2%, P=0.37), 30-day mortality (0% vs 4%, P=1), and 90-day readmission (36% vs 36%, P=1) were comparable as well.

Conclusions: This preliminary report of NCT03767582 demonstrates perioperative safety of a novel IO combination including a CCR2/CCR5 inhibitor targeting TAMs. No surgical complications resulted from the study drugs and perioperative outcomes were comparable to a matched cohort. Cancer-specific outcomes, immunologic endpoints, and survival data will be reported in forthcoming analyses.

Learning Objectives:

To evaluate the perioperative safety from a clinical trial using a novel immuno-oncology combination with TAM-targeting immunotherapy with GVAX/anti-PD1 and radiotherapy in patients with LAPC.
To compare perioperative outcomes between treated LAPC patients within the trial schemata and a propensity score-matched resected LAPC cohort.