Phase Ib-II, non-randomized, open-label study of Tumor Treating Fields (TTFields, 150kHz) concomitant with modFOLFIRINOX for front-line treatment of metastatic pancreatic adenocarcinoma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Clinica Universidad De Navarra

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

14 Oct 2025 → ongoing

Decision date (initial)

2025-02-10

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Novocure · Clínica Universidad de Navarra

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To evaluate the safety of mFOLFIRINOX combined with TTFields using the NovoTTF-200T system as first-line treatment for patients with metastatic pancreatic adenocarcinoma.

Secondary objectives 2

1. To evaluate compliance with TTFields treatment.
2. To evaluated efficacy of TTFields treatment in combination with modFOLFIRINOX

Conditions and MedDRA coding

Histologically confirmed pancreatic adenocarcinoma with liver metastases, with no previous systemic treatment in the metastatic setting

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 13

1. Histological/cytological diagnosis of pancreatic adenocarcinoma.
2. The patient should be 18 years of age and older.
3. The patient has given consent to participate in the study.
4. The patient should be able to comply with all the requirements of the clinical trial.
5. Life expectancy of > 3 months.
6. Metastatic disease with, at least, one hepatic lesion that must be accessible for biopsy.
7. Measurable disease as defined by Response Evaluation Criteria in Solid Tumor v1.1 (RECIST 1.1) apart from the liver lesion to be biopsied.
8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
9. Amenable and assigned by the investigator to receive therapy with modFOLFIRINOX.
10. Prior chemotherapy or radiotherapy on the neoadjuvant or adjuvant setting is allowed as long as at least six months have elapsed since last chemotherapy treatment.
11. Able to operate the Novo TTF-200T System independently or with the help of a caregiver.
12. Adequate hematologic and organ function, defined by the following laboratory test results, obtained during the screening period and before C1D1. a. WBC > 2.5 x 109/L. b. ANC > 1.5 x 109/L without granulocyte colony-stimulating factor support. c. Platelet count > 100 x 109/L. without transfusion. d. Hemoglobin > 9 g/dL. e. Albumin > 2.5 g/dL. f. Serum bilirubin < 1.5 times de upper limit of normal (ULN); patients with known Gilbert´s disease may have a bilirubin value < 3 x ULN. g. INR and aPTT < 1.5 x ULN. h. AST, ALT, < 5 x ULN. i. Serum creatinine < 1,5 x ULN or Creatinine Clearance > 30ml/min (calculated using Cockcroft-Gault formula).
13. For women of childbearing potential: Negative serum pregnancy test within 14 days prior to C1D1. Agreement to remain abstinent (refrain from heterosexual intercourse) or use of contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 180 days after the last study treatment. A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (> 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).

Exclusion criteria 12

1. Malignancies other than pancreatic cancer within 3 years prior to Cycle 1 Day 1 (C1D1) with the exceptions of those with a negligible risk of metastasis or death (e.g., expected 5-year overall survival >90%), treated with expected curative outcome (such as but not limited to: adequately treated in situ carcinoma of the cervix, basal squamous or melanomatous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ of the breast treated surgically with curative intent).
2. Previous treatment with chemotherapy for metastatic pancreatic ductal adenocarcinoma.
3. Untreated CNS metastases. Treatment of brain metastases, either by surgical or radiation techniques, must have been completed at least 4 weeks prior to study entry.
4. Known dihydropyrimidine dehydrogenase deficiency or thymidylate synthase gene polymorphism predisposing the patient for 5-fluorouracil (5-FU) toxicity.
5. Previous radiation therapy within 14 days prior to C1D1 and/or persistence of radiation-related adverse effects.
6. Implantable electronic medical devices in the torso, such as pacemakers.
7. Known severe hypersensitivities to medical adhesives or hydrogel, or history of severe allergic, anaphylactic, or other hypersensitivity reactions to any of the study treatments used.
8. Spinal cord compression not definitively treated with surgery and/or radiation.
9. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
10. Pregnant and lactating women.
11. Patients who have received brivudine, sorivudine or analogues 4 weeks prior to Fluoracile administration.
12. Serious co-morbidities, including but not limited to: a. History of significant cardiovascular disease unless the disease is well controlled. Significant cardiac disease includes second/third degree hart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class II or worse. b. History of cerebrovascular accident (CVA) within 3 months prior to randomization or that is not stable. c. Active infection or serious underlying medical condition that would impair the ability of the patient to receive protocol therapy. d. History of any psychiatric condition that might impair patient´s ability to understand or comply with the requirements of the study or to provide consent.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Toxicity profile in patients with mPDAC treated at 1L with TTFields concomitantly with modFOLFIRINOX, measured by the rate of patients with treatment-emergent adverse events (TEAEs), using CTCAE v5.0.

Secondary endpoints 6

1. Total hours with TTField device functioning during every 14 days chemotherapy cycle
2. QoL assessed using EORTC QLQ-30 questioner
3. Progression-free survival (PFS): defined as the time from first modFOLFIRINOX administration until disease progression based on CT scan collected on the study according to RECIST 1.1 criteria or any cause related death, whichever occurs first
4. Overall survival (OS): defined as the time from first modFOLFIRINOX administration until patient death
5. Overall response rate (ORR): defined as the percentage of patients with complete response (CR) or partial response (PR) as best overall response (BOR) according to RECIST 1.1
6. Disease control rate (DCR): defined as the percentage of patients with CR or PR and the percentage of subjects with stable (SD) of at least 12 weeks duration as BOR according to RECIST 1.1

Investigational products

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

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Clinica Universidad De Navarra

Sponsor organisation

Clinica Universidad De Navarra

Address

Avenue Pio XII 36

City

Pamplona

Postcode

31008

Country

Spain

Scientific contact point

Organisation

Clinica Universidad De Navarra

Contact name

Mariano Ponz Sarvisé

Public contact point

Organisation

Clinica Universidad De Navarra

Contact name

Mariano Ponz Sarvisé

Third parties 1

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

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

Documents 8 files

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

Application history

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