NEO-IMPACT

Protocol Title

NEO-adjuvant chemo-IMmunotherapy in PAnCreaTic cancer

Purpose of the Study

Pancreatic cancer continues to be a challenging cancer to diagnose and treat, with a 5-year survival rate of 8.9%. NEO-IMPACT is a pilot study, which aims to investigate the efficacy, safety and tolerability of using chemotherapy (mFOLFIRINOX) in combination with immunotherapy (durvalumab) prior to surgery in people diagnosed with early-stage pancreatic cancer. In addition, this study will also seek to investigate the changes that occur to the gut microbiome (the make-up of the individual’s gut bacteria) during initial anti-cancer treatment.

ELIGIBILITY CRITERIA

Inclusion Criteria

• Adults aged 18 years and older, with cytologically or histologically proven resectable or borderline resectable pancreatic adenocarcinoma.
• Adequate normal organ and marrow function as defined below:
  • Haemoglobin ≥9.0 g/dL
  • Absolute neutrophil count (ANC) ≥1.5 × 10⁹ /L
  • Platelet count ≥100× 10⁹/L
• Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN).
• AST (SGOT)/ALT (SGPT) ≤3 x institutional upper limit of normal unless
  • There has been recent biliary drainage in the past 30 days, in which case it must be ≤5 x ULN
• Measured creatinine clearance (CL) >50 mL/min or Calculated creatinine CL >50 mL/min by the Cockcroft-Gault formula
• Study treatment both planned and able to start within 14 days of registration.
• Body weight >30 kg.
• Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
• Must have a life expectancy of at least 12 weeks.
• At least 1 lesion that qualifies as a RECIST 1.1 target lesion (TL) at baseline. Tumor assessment by computed tomography (CT) scan or magnetic resonance imaging (MRI) must be performed within 28 days prior to randomization.
• Signed, written informed consent (main study and tissue banking).

Exclusion Criteria

• Locally advanced or metastatic pancreatic adenocarcinoma.
• Neuroendocrine pancreatic carcinoma.
• Prior treatment for pancreatic cancer including chemotherapy, checkpoint inhibitor or investigational treatments.
• Participation in another clinical study with an investigational product during the last 30 days.
• Concurrent enrolment in another clinical study.
• Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.
• Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
• History of allogenic organ transplantation.
• Active or prior documented autoimmune or inflammatory disorders
• Patients with vitiligo or alopecia.
• Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement.
• Any chronic skin condition that does not require systemic therapy.
• Patients without active disease in the last 5 years may be included but only after consultation with the study physician.
• Patients with celiac disease controlled by diet alone.
• Uncontrolled intercurrent illness.
• History of another primary malignancy
• Active infection including tuberculosis , hepatitis B , hepatitis C.
• Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
• Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab.
• Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
• Prior randomisation or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.
• Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.

Contact Email

NEO-IMPACT@mh.org.au

Detailed Information AVAILABLE

Available online at the Australian New Zealand Clinical Trial Registry (ANZCTR) please click here.

STUDY CHAIRS

Professor Lorraine Chantrill
Dr Sarah Maloney

Funding

Philanthropic Funding