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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06094140




Registration number
NCT06094140
Ethics application status
Date submitted
7/08/2023
Date registered
23/10/2023

Titles & IDs
Public title
NEO-adjuvant Chemo-immunotherapy in Pancreatic Cancer
Scientific title
NEO-adjuvant Chemo-Immunotherapy in Pancreatic Cancer
Secondary ID [1] 0 0
NEO-IMPACT
Universal Trial Number (UTN)
Trial acronym
NEO-IMPACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Durvalumab
Treatment: Drugs - Oxaliplatin
Treatment: Drugs - Irinotecan
Treatment: Drugs - Calcium folinate (leucovorin)
Treatment: Drugs - Fluorouracil
Treatment: Drugs - Pegylated G-CSF

Experimental: Single arm study, mFOLFIRINOX and durvalumab, neoadjuvant resectable pancreatic cancer. - All 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


Treatment: Drugs: 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.

Treatment: Drugs: Oxaliplatin
85mg/m2 intravenously on day 1

Treatment: Drugs: Irinotecan
150mg/m2 intravenously on day 1

Treatment: Drugs: Calcium folinate (leucovorin)
50mg as an intravenous bolus

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

Treatment: Drugs: Pegylated G-CSF
6mg by subcutaneous injection to be given on day 3 of each cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The proportion of patients receiving at least 80% of planned neoadjuvant treatment.
Timepoint [1] 0 0
At completion of neo-adjuvant treatment (at 3 months post enrollment)
Secondary outcome [1] 0 0
The proportion of patients missing surgery due to significant treatment related adverse events.
Timepoint [1] 0 0
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.
Secondary outcome [2] 0 0
Treatment tolerability (Rates of adverse events as per CTCAE v5.0).
Timepoint [2] 0 0
Through study completion, an average of 1 year
Secondary outcome [3] 0 0
R0 resection rate.
Timepoint [3] 0 0
Through study completion, an average of 1 year
Secondary outcome [4] 0 0
Pathological complete response rate.
Timepoint [4] 0 0
Through study completion, an average of 1 year
Secondary outcome [5] 0 0
Objective response rate.
Timepoint [5] 0 0
Through study completion, an average of 1 year

Eligibility
Key inclusion criteria
1. 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).
2. ECOG 0-1
3. 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). [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)
4. Study treatment both planned and able to start within 14 days of registration.
5. Body weight >30 kg.
6. 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.
7. Must have a life expectancy of at least 12 weeks.
8. Tumor assessment by computed tomography (CT) scan or magnetic resonance imaging (MRI) must be performed within 28 days prior to first study treatment.
9. Signed, written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Locally advanced or metastatic pancreatic adenocarcinoma.
2. Neuroendocrine pancreatic carcinoma.
3. Prior treatment for pancreatic cancer including chemotherapy, checkpoint inhibitor or investigational treatments, the exception of a maximum of 1 cycle of neoadjuvant intent mFOLFIRINOX.
4. Participation in another clinical study with an investigational product during the last 30 days.
5. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or enrolment occurs during the follow-up period.
6. 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.
7. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
8. History of allogenic organ transplantation.
9. 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:

1. Patients with vitiligo or alopecia.
2. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement.
3. Any chronic skin condition that does not require systemic therapy.
4. Patients without active disease in the last 5 years may be included but only after consultation with the study physician.
5. Patients with coeliac disease controlled by diet alone.
10. 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.
11. History of another primary malignancy except for:

1. 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.
2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
3. Adequately treated carcinoma in situ without evidence of disease.
12. History of leptomeningeal carcinomatosis.
13. History of active primary immunodeficiency.
14. Active infection including:

1. Positive test for human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies)
2. Active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice)
3. 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
15. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:

1. Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection).
2. Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent.
3. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
4. For patients enrolling after receipt of 1 cycle of mFOLFIRINOX, steroids given pre and post chemotherapy as part of routine care.
16. 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.
17. 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.
18. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
19. Prior randomisation or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.
20. 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
GenesisCare North Shore - Sydney
Recruitment hospital [2] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [3] 0 0
Warringal Private Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2065 - Sydney
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
3084 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Australasian Gastro-Intestinal Trials Group
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of New South Wales
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Walter and Eliza Hall Institute of Medical Research
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lorraine Chantrill, Professor
Address 0 0
AGITG
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Laura Carolan
Address 0 0
Country 0 0
Phone 0 0
+61 2 7208 2710
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06094140