NCT06094140

NEO-adjuvant Chemo-immunotherapy in Pancreatic Cancer

NEO-adjuvant Chemo-Immunotherapy in Pancreatic Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Australasian Gastro-Intestinal Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine the safety and tolerability of adding durvalumab to mFOLFIRINOX prior to surgery in patients with resectable or borderline resectable pancreatic adenocarcinoma.

Detailed description

Despite curative surgery, pancreatic cancer patients have five-year survival rates of 20%. Adjuvant chemotherapy has improved survival in resected pancreatic cancer patients but only 10-15% are suitable for surgery and 30% of the resected pancreatic cancer patients miss out on adjuvant chemotherapy due to postoperative complications. Neoadjuvant chemotherapy has improved the resection rates in the patients with non-metastatic pancreatic cancer. There is a growing interest to combine chemotherapy with checkpoint inhibitors to improve disease control in the early stage of pancreas cancer. The investigators propose a pilot study to evaluate the feasibility and safety of combining modified FOLFIRINOX (mFOLFIRINOX) with durvalumab (MEDI4736) in patients with resectable or borderline resectable pancreatic adenocarcinoma.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Durvalumab	Durvalumab will be supplied by AstraZeneca as a 500 mg vial concentrate for solution for infusion. The solution contains 50 mg/mL durvalumab, 26 mM histidine/histidine-hydrochloride, 275 mM trehalose dihydrate, and 0.02% weight/volume (w/v) polysorbate 80; it has a pH of 6.0 and density of 1.054 g/mL. The label-claim volume is 10 mL. Durvalumab is a sterile, clear to opalescent, colorless to slightly yellow solution, free from visible particles. Investigational product vials are stored at 2°C to 8°C (36°F to 46°F) and must not be frozen. Investigational product must be kept in original packaging until use to prevent prolonged light exposure.
DRUG	Oxaliplatin	85mg/m2 intravenously on day 1
DRUG	Irinotecan	150mg/m2 intravenously on day 1
DRUG	Calcium folinate (leucovorin)	50mg as an intravenous bolus
DRUG	Fluorouracil	2400mg/m2 by continuous infusion via pump over 46 hours starting on day 1
DRUG	Pegylated G-CSF	6mg by subcutaneous injection to be given on day 3 of each cycle.

Timeline

• Start date: 2022-05-20
• Primary completion: 2024-06-30
• Completion: 2026-06-01
• First posted: 2023-10-23
• Last updated: 2024-12-03

Locations

3 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study