1683TiP - Trial in progress: NEO-adjuvant chemo-IMmunotherapy in PAnCreaTic cancer-NEO-IMPACT

Background

Pancreatic cancer has one of the worst outcomes of any tumor type, with a five-year survival rate of 12%. In patients undergoing upfront resection, up to 30% do not receive adjuvant chemotherapy due to surgical complications. The success of neoadjuvant chemotherapy in converting inoperable patients into operative candidates has resulted in more widespread use of it in early disease. In other cancer types, the addition of neoadjuvant immunotherapy has resulted in increased pathological response rates. The aim of the NEO-IMPACT study is to assess the safety and tolerability of neoadjuvant chemo-immunotherapy in pancreatic adenocarcinoma patients prior to definitive surgery.

Trial design

NEO-IMPACT is a phase II multi-centre, single arm, investigator-initiated trial in patients with upfront or borderline resectable pancreatic adenocarcinoma. This trial is sponsored by the Australasian Gastro-Intestinal Trials Group. Patients receive neoadjuvant durvalumab 1500mg iv q4weekly in combination with mFOLFIRINOX (5- fluorouracil, leucovorin, irinotecan and oxaliplatin) q2weekly over 12 weeks, followed by restaging and multidisciplinary team (MDT) review. Patients who remain surgical candidates will proceed to resection within 6-8 weeks of neoadjuvant therapy. A further 6 cycles of mFOLFIRINOX will be given in the adjuvant setting. The primary endpoint is the proportion of patients receiving 80% of planned neoadjuvant treatment. Secondary objectives include R0 resection rate, pathological complete response rate, objective response rate and treatment tolerability. Exploratory objectives include analysis of pre-treatment and post-treatment tumour tissue for gene expression profiling. A translational sub study is planned to investigate the evolution of the pancreatic microbiome when exposed to neoadjuvant chemo-immunotherapy. Trial recruitment commenced May 2022. 11 of a planned 20 patients are enrolled. ANZCTR registration number: ACTRN12622000378729. This study was awarded the 2018 AGITG ‘New Concepts’ award. Trial conduct is funded through AGITG Philanthropic Major Donor funding, with Study Drug support from AstraZeneca Pty Ltd.

Clinical trial identification

ACTRN12622000378729.

Editorial acknowledgement

Legal entity responsible for the study

Australasian Gastrointestinal Trials Group.

Funding

Funded through AGITG Philantrophic Major.

Disclosure

N. Tebbutt: Other, Personal, Other, Consultant: AstraZeneca. J. Tie: Financial Interests, Personal, Advisory Board: AstraZeneca, BMS, Pierre Fabre, Inivata, BeiGene; Financial Interests, Personal, Invited Speaker: Servier, Merck; Financial Interests, Personal, Other, Consultancy: Haystack Oncology; Financial Interests, Institutional, Advisory Board: Daiichi Sankyo, Gilead. L. Christopherson: Financial Interests, Personal, Other, Family member: IMU, DXB, PIQ, IXC. L. Chantrill: Non-Financial Interests, Personal, Advisory Board: Amgen. All other authors have declared no conflicts of interest.