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Pancreatic CancerPhase 2NEO-IMPACTNCT06094140

NEO-adjuvant Chemo-immunotherapy in Pancreatic Cancer

A Phase 2 study testing Durvalumab, Oxaliplatin and Irinotecan in people with Pancreatic Cancer, run by Australasian Gastro-Intestinal Trials Group at 3 sites in Australia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
Durvalumab, Oxaliplatin and Irinotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
3 sitesAustralia
Study dates
20 May 2022to Jun 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults, aged 18 years and older, with cytologically or histologically proven resectable or borderline resectable pancreatic adenocarcinoma as per Australasian Gastro-Intestinal Trials Group (AGITG) consensus guidelines. Those in whom cytology is suspicious for pancreatic adenocarcinoma but not diagnostic may be allowed on study following discussion with the study chair (or their representative).
  • ECOG 0-1
  • 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
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  • Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). [This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.]
  • AST (SGOT)/ALT (SGPT) ≤2.5 x institutional ULN unless;
  • o 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 (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance: Males: Creatinine CL (mL/min) = Weight (kg) x (140 - Age) / 72 x serum creatinine (mg/dL) Females: Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85 / 72 x serum creatinine (mg/dL)
  • 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.
  • Tumor assessment by computed tomography (CT) scan or magnetic resonance imaging (MRI) must be performed within 28 days prior to first study treatment.
  • Signed, written informed consent.

Who cannot join

  • Locally advanced or metastatic pancreatic adenocarcinoma.
  • Neuroendocrine pancreatic carcinoma.
  • Prior treatment for pancreatic cancer including chemotherapy, checkpoint inhibitor or investigational treatments, the exception of a maximum of 1 cycle of neoadjuvant intent mFOLFIRINOX.
  • Participation in another clinical study with an investigational product during the last 30 days.
  • Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or enrolment occurs during the follow-up period.
  • Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
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  • 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 (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
  • 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 coeliac disease controlled by diet alone.
  • Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, active infection requiring systemic therapy within 14 days before the first dose of study drug, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
  • History of another primary malignancy except for:
  • Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence.
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
  • Adequately treated carcinoma in situ without evidence of disease.
  • History of leptomeningeal carcinomatosis.
  • History of active primary immunodeficiency.
  • Active infection including:
  • Positive test for human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies)
  • Active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice)
  • Active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (HBcAb or anti-HBc), at screening. Participants with a past or resolved HBV infection (defined as the presence of HBcAb or anti HBc and absence of HBsAg) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
  • Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection).
  • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent.
  • Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
  • For patients enrolling after receipt of 1 cycle of mFOLFIRINOX, steroids given pre and post chemotherapy as part of routine care.
  • Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.
  • 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.

Trial locations and contacts

3 sites in 1 country.

Australia3 sites

  • Warringal Private Hospital

    Melbourne, Victoria, 3084

  • GenesisCare North Shore

    Sydney, New South Wales, 2065

  • Wollongong Hospital

    Wollongong, New South Wales, 2500

Other trials in Australia

About this study

Official title: NEO-adjuvant Chemo-Immunotherapy in Pancreatic Cancer

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

Read the 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.

Being tested
Durvalumab, Oxaliplatin, Irinotecan, Calcium folinate (leucovorin), Fluorouracil
Keywords
Resectable, Border-line, Pancreas
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DurvalumabDrug

    Also called Imfinzi

    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.

  • OxaliplatinDrug

    Also called Eloxatin

    85mg/m2 intravenously on day 1

  • IrinotecanDrug

    Also called Camptosar, Campto

    150mg/m2 intravenously on day 1

  • Calcium folinate (leucovorin)Drug

    Also called Folinic acid

    50mg as an intravenous bolus

  • FluorouracilDrug

    Also called Adrucil

    2400mg/m2 by continuous infusion via pump over 46 hours starting on day 1

  • Pegylated G-CSFDrug

    Also called Neulasta

    6mg by subcutaneous injection to be given on day 3 of each cycle.

Study groups in NCT06094140
Study groupRoleWhat they receive
Single arm study, mFOLFIRINOX and durvalumab, neoadjuvant resectable pancreatic cancer.ExperimentalAll patients enrolled to this study will receive mFOLFIRINOX, delivered Q2W for 6 cycles and durvalumab delivered Q4W for 3 cycles in the neoadjuvant setting for resectable or borderline resectable pancreatic cancer patients. Patients will then undergo restaging, discussion at MDM and surgical resection where appropriate. Following resection, patients will commence 6 cycles of adjuvant mFOLFIRINOX alone (or gemcitabine-based chemotherapy if deemed by investigator as more appropriate). Patients will be followed up on study for 12 months from surgery, or from completion of neoadjuvant
Receives: Drug: Durvalumab; Drug: Oxaliplatin; Drug: Irinotecan; Drug: Calcium folinate (leucovorin); Drug: Fluorouracil; Drug: Pegylated G-CSF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The proportion of patients receiving at least 80% of planned neoadjuvant treatment.

    80% of planned neoadjuvant treatment is defined as at least 5 cycles of mFOLFIRINOX and at least 2 of 3 cycles durvalumab. Dose modified cycles count towards received treatment.

    Justification: As a pilot study, this primary objective addresses feasibility. A phase II study assessing use of neoadjuvant FOLFIRINOX in borderline resectable pancreatic cancer patients has previously demonstrated an 80% rate of receipt of all planned neoadjuvant therapy (Murphy et al 2018).

    Measured: At completion of neo-adjuvant treatment (at 3 months post enrollment)

Secondary outcomes (5)

  1. The proportion of patients missing surgery due to significant treatment related adverse events.

    Address efficacy and safety of patients missing surgery due to significant treatment related adverse events.

    Measured: Every 2 weeks during neo-adjuvant treatment, at the completion of treatment (at 3 months post enrolment) and 30 to 42 days after the last dose of immunotherapy.

  2. Treatment tolerability (Rates of adverse events as per CTCAE v5.0).

    Address efficacy and safety of treatment tolerability

    Measured: Through study completion, an average of 1 year

  3. R0 resection rate.

    Address efficacy and safety of the R0 resection rate.

    Measured: Through study completion, an average of 1 year

  4. Pathological complete response rate.

    Address efficacy and safety of the pathological complete response rate.

    Measured: Through study completion, an average of 1 year

  5. Objective response rate.

    Address efficacy and safety of the objective response rate.

    Measured: Through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2023
  2. Study start20 May 2022
  3. Primary completion30 Jun 2024
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06094140
Sponsor's protocol ID
NEO-IMPACT
Acronym
NEO-IMPACT
Status last verified
May 2026
First submitted
7 Aug 2023
Last updated
6 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Durvalumab, Oxaliplatin and Irinotecan in people with Pancreatic Cancer, run by Australasian Gastro-Intestinal Trials Group at 3 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of patients receiving at least 80% of planned neoadjuvant treatment. (time frame: At completion of neo-adjuvant treatment (at 3 months post enrollment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06094140.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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