PREOPANC-6 study: dendritic cell immunotherapy after FOLFIRINOX chemotherapy in patients with resectable pancreatic cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]

Decision date (initial)

2026-05-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Amphera · Dutch Cancer Society (KWF)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

Phase II: An improvement in the progression-free survival (PFS) per RECIST 1.1 of adjuvant dendritic cell therapy (MesoPher) in patients with ABC borderline resectable pancreatic cancer (exploratory)
Phase III: To investigate the overall survival (OS) of MesoPher treatment.

Secondary objectives 10

1. Phase II To assess immune responses
2. Phase II To investigate disease-free survival (DFS) per RECIST 1.1
3. Phase II To evaluate the Quality of Life of MesoPher
4. Phase II To evaluate the safety, tolerability and feasibility of MesoPher treatment
5. Phase III To assess immune responses
6. Phase III To investigate disease-free survival (DFS) per RECIST 1.1
7. Phase III To investigate event-free survival (EFS) per RECIST 1.1
8. Phase III To evaluate the Quality of Life of MesoPher
9. Phase III To evaluate the safety, tolerability and feasibility of MesoPher treatment
10. Phase III: An improvement in the progression-free survival (PFS) per RECIST 1.1 of adjuvant dendritic cell therapy (MesoPher) in patients with ABC borderline resectable pancreatic cancer

Conditions and MedDRA coding

ABC borderline resectable pancreatic cancer

Study design 1 period

Regulatory references

Scientific advice from competent authorities

Medicines Evaluation Board

Plan to share IPD

Yes

IPD plan description

Individual participant data that underlie the results reported in publications will be made available after de-identification, upon reasonable request. Data will be shared with researchers who provide a methodologically sound proposal which has received EC approval and whose use of the data has been approved by the sponsor and the trial steering committee. Proposals should be directed to the sponsor (Erasmus MC). A data sharing agreement will be required.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. At registration: ABC borderline resectable pancreatic cancer, histologically or cytologically confirmed. ABC borderline is defined as resectable pancreatic cancer with a CA-19.9 level > 500 kU/L at diagnosis or borderline resectable pancreatic cancer. Resectability criteria are defined by the DPCG criteria.
2. Men must be willing to use an effective contraceptive method (e.g. condom, vasectomy) during the study and for at least 12 months after the last study drug administration.
3. Ability to return to the hospital for adequate follow-up as required by this protocol.
4. Written informed consent according to ICH-GCP.
5. Inclusion and randomisation: Borderline resectable or resectable tumours according to the DPCG criteria. CA-19.9 levels of no more than 500 kU/L at the time of screening, and a valid reduction during neoadjuvant FOLFIRINOX according to the treating physician. Predefined exceptions apply for CA19-9 non-producers with PET-CT showing no metabolic progression, and for patients with CA19-9 levels above 500 kU/L who have demonstrated a valid reduction during FOLFIRINOX and are deemed clinically eligible by the treating physician, subject to approval after consultation with the central study team.
6. Patients must be at least 18 years old and be able to give written informed consent.
7. WHO performance status 0-1.
8. Patients must be able to undergo surgery.
9. Patients must have normal organ function and adequate bone marrow reserve: absolute neutrophil count > 1.0 x 109/l, total leucocyte count ≥ 3.0 x 109/l, platelet count > 100 x 109/l, renal function E-GFR ≥ 50 ml/min, and Hb > 6.0 mmol/l.
10. Laboratory tests: ASAT/ALAT <5xULN (upper limit of normal), bilirubin <1.5xULN, Lactate dehydrogenase value < ULN and albumin value > 30.
11. Women of childbearing potential (WOCB) must have a negative serum pregnancy test at screening. They must be willing to use an effective contraceptive method (intrauterine devices, hormonal contraceptives, contraceptive pill, implants, transdermal patches, hormonal vaginal devices, infusions with prolonged release) or true abstinence (when this is in line with the preferred and usual lifestyle*) during the study and for at least 12 months after the last study drug administration. *True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (such as calendar, ovulation, symptothermal, and post-ovulation methods) and withdrawal are not acceptable methods of contraception.

Exclusion criteria 20

1. At registration: a. Metastatic or locally advanced (unresectable) pancreatic cancer according to the DPCG criteria. b. Resectable pancreatic cancer with a CA19-9 < 500 kU/L at registration, unless predefined exception criteria (e.g. CA19-9 non-producer with PET-CT showing no distant metastases and no metabolic progression) are met and eligibility is confirmed by the central study team.
2. At inclusion: Registered patients are excluded from randomisation if, during neoadjuvant FOLFIRINOX: a. they develop RECIST-defined progressive disease (see 11.3.2.3); or b. they fail to demonstrate a CA19-9 response compared with baseline values or have CA19-9 levels > 500 kU/L at screening, unless predefined exception criteria apply
3. Ampullary or distal bile duct cancer.
4. Severe concomitant systemic disorders that would compromise the safety of the patient or their ability to complete the study at the discretion of the investigator.
5. A WOCPB who has a positive urine pregnancy test at screening. A serum pregnancy test will be performed if the urine test cannot be confirmed as negative.
6. Current or previous use of autologous DC therapy or anti-tumour vaccinations.
7. A known allergy or hypersensitivity to the study drug or any study drug excipients.
8. History of life-threatening toxicity related to prior immune therapy that wasn’t manageable by the standard of care treatment.
9. Current use of steroids (or other immunosuppressive agents). Patients must have discontinued treatment for at least six weeks and not use such therapy during the study.
10. Has a known additional malignancy that is progressing or has required active treatment within the past two years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (e.g., breast cancer, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
11. Has active autoimmune disease that has required systemic treatment in the past two years (i.e. with the use of disease-modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment and is allowed.
12. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
13. Has an active infection requiring systemic therapy.
14. Has a known history of Human Immunodeficiency Virus (HIV) infection.
15. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen or known active Hepatitis C virus infection.
16. Active or inadequately treated syphilis (Lues).
17. Has a history of current evidence of any condition, therapy or laboratory abnormality that might confound the results of the study, interfere with the participant’s participation for the entire duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
18. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
19. 19. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study or within 12 months after the last administration of study treatment
20. Has had an allogeneic tissue/solid organ transplant.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Phase II Progression-free survival (PFS): defined as the time from initiation of study treatment to the first documented recurrent disease or progressive disease (PD) per RECIST 1.1, or death to any cause, whichever occurs first (exploratory endpoint)
2. Phase III Overall survival (OS): the time from inclusion to death due to any cause.

Secondary endpoints 10

1. Phase II Assessments of immune responses • Vaccine-induced responses by analysing peripheral blood mononuclear cells (PBMCs) and performing NanoString analyses • Modulation of peripheral immune cell subsets by analysing PBMCs • Predictive gene expression signatures related to therapy outcome by using nCounter NanoString analyses
2. Phase II Disease-free survival: defined as the first documented evidence of recurrence of disease as defined by RECIST 1.1 criteria.
3. Phase II Patient reported quality of life using the EORTC QLQC30 and the EORTC-QLQPAN26 questionnaires.
4. Phase II To assess safety by AEs and study intervention discontinuations due to AEs.
5. Phase III Assessments of immune responses • Vaccine-induced responses by analysing peripheral blood mononuclear cells (PBMCs) and performing NanoString analyses •Modulation of peripheral immune cell subsets by analysing PBMCs • Predictive gene expression signatures related to therapy outcome by using nCounter NanoString analyses
6. Phase III Disease-free survival: defined as the first documented evidence of recurrence of disease as defined by RECIST 1.1 criteria.
7. Pase III Event-free survival: defined as the time from randomisation to any of the following events: failure to undergo surgery, disease recurrence, or death from any cause.
8. Phase III Patient reported quality of life using the EORTC QLQC30 and the EORTC-QLQPAN26 questionnaires.
9. Phase III To assess safety by AEs and study intervention discontinuations due to AEs.
10. Phase III: Progression-free survival (PFS): defined as the time from initiation of study treatment to the first documented recurrent disease or progressive disease (PD) per RECIST 1.1, or death to any cause, whichever occurs first.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Sponsor organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Address

Dr. Molewaterplein 40

City

Rotterdam

Postcode

3015 GD

Country

Netherlands

Scientific contact point

Organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Contact name

Study coordinator

Public contact point

Organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Contact name

Study coordinator

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications