TTFields and Chemotherapy in Metastatic Pancreatic Adenocarcinoma (mPDAC)

NCT07284277 | Recruiting Phase 1 DMC

• 2 other identifiers: NOVOFFOX2024-511459-16-00
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this clinical trial is to assess the safety and tolerability of TTFields in combination with chemotherapy in adults with metastatic pancreatic adenocarcinoma based on treatment-emergent adverse events of chemotherapy (modFOLFIRINOX) or device (TTFields). The main questions it aims to answer are:

• Is TTFields treatment safe for the patients in combination with modFOLFIRINOX?
• Are participants compliant with the treatment?
• Is Is TTFields treatment effective in combination with modFOLFIRINOX against metastatic pancreatic adenocarcinoma?

Conditions

Pancreatic Adenocarcinoma Metastatic; Pancreatic Ductal Adenocarcinoma

Keywords

Pancreatic Cancer; Metastatic Pancreatic Adenocarcinoma; Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Toxicity profile in patients with mPDAC treated at 1L with TTFields concomitantly with modFOLFIRINOX

  Toxicity profile measured by the rate of patients with treatment-emergent adverse events (TEAEs), using CTCAE v5.0

  From the beginning of the first treatment cycle (cycle 1; each treatment cycle is 14 days) through study completion (for a maximum of 24 months per patient since inclusion)

Secondary Outcomes (9)

• Total hours with TTField device functioning during every 14 days chemotherapy cycle

  From the beginning of the first treatment cycle (cycle 1; each treatment cycle is 14 days) until discontinuation of last study treatment (for a maximum of 24 months per patient since inclusion).

• Quality of life (QoL) assessment

  Screening visit, from cycle 13 (since completion of treatment with mFOLFIRINOX) onwards at each visit with test according to protocol, and at post-treatment termination visit (for a maximum of 24 months per patient since inclusion).

• Progression-free survival (PFS)

  Every 8 weeks from the beginning of the first treatment cycle (cycle 1) through study completion (for a maximum of 24 months per patient since inclusion).

• Overall survival (OS)

  Since inclusion through study completion (for a maximum of 24 months per patient since inclusion).

• Overall response rate (ORR)

  Every 8 weeks from the beginning of the first treatment cycle (cycle 1) through study completion (for a maximum of 24 months per patient since inclusion).

Study Arms (1)

TTFields concomitant with modFOLFIRINOX

EXPERIMENTAL

Patients will receive a combination of modFOLFIRINOX with TTFields (150 kHz) in 14-day cycles.

Combination Product: TTFields concomitant with modFOLFIRINOX

Interventions

TTFields concomitant with modFOLFIRINOX COMBINATION_PRODUCT

Patients will receive the following medication in 14-day cycles: ModFOLFIRINOX * Folic acid (Leucovorin) 400mg/m2 (D,L, racemic form) or 200mg/m2 (L-isomer form) * 5-fluorouracil (5Fu) 2400 mg/m2 * Oxaliplatin 85mg/m2 * Irinotecan 150-180mg/m2 Combined with TTFields, which is a portable battery operated system intended for continuous home use (at least 18h/day) which delivers TTFields at a frequency of 150kHz to produces electric forces intended to disrupt cancer cell division.

TTFields concomitant with modFOLFIRINOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological/cytological diagnosis of pancreatic adenocarcinoma.
• The patient should be 18 years of age and older.
• The patient has given consent to participate in the study.
• The patient should be able to comply with all the requirements of the clinical trial.
• Life expectancy of at least 3 months.
• Metastatic disease with, at least, one hepatic lesion that must be accessible for biopsy.
• Measurable disease as defined by Response Evaluation Criteria in Solid Tumor v1.1 (RECIST 1.1) apart from the liver lesion to be biopsied.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Amenable and assigned by the investigator to receive therapy with modFOLFIRINOX.
• 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.
• Able to operate the Novo TTF-200T System independently or with the help of a caregiver.
• Adequate hematologic and organ function, defined by the following laboratory test results, obtained during the screening period and before C1D1.
• WBC higher than or equal to 2.5 x 10\^9/L.
• ANC higher than or equal to 1.5 x 10\^9/L without granulocyte colony-stimulating factor support.
• Platelet count higher than or equal to 100 x 10\^9/L without transfusion.

You may not qualify if:

• 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 higher than 90 percentage), 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).
• Previous treatment with chemotherapy for metastatic pancreatic ductal adenocarcinoma.
• 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.
• Known dihydropyrimidine dehydrogenase deficiency or thymidylate synthase gene polymorphism predisposing the patient for 5-fluorouracil (5-FU) toxicity.
• Previous radiation therapy within 14 days prior to C1D1 and/or persistence of radiation-related adverse effects.
• Implantable electronic medical devices in the torso, such as pacemakers.
• 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.
• Spinal cord compression not definitively treated with surgery and/or radiation.
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
• Pregnant and lactating women
• Patients who have received brivudine, sorivudine or analogues 4 weeks prior to Fluoracile administration.
• Serious co-morbidities, including but not limited to:
• 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.
• History of cerebrovascular accident (CVA) within 3 months prior to randomization or that is not stable.
• Active infection or serious underlying medical condition that would impair the ability of the patient to receive protocol therapy.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (5)

Clínica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Hospital Universitario de Cruces

Barakaldo, Vizcaya, 48903, Spain

NOT YET RECRUITING

Hospital de Galdakao

Galdakao, Vizcaya, 48960, Spain

NOT YET RECRUITING

Fundación Jiménez-Díaz

Madrid, 28040, Spain

NOT YET RECRUITING

Hospital Universitario de Araba

Vitoria-Gasteiz, Álava, 01009, Spain

NOT YET RECRUITING

Related Publications (1)

• Siegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin. 2018 Jan;68(1):7-30. doi: 10.3322/caac.21442. Epub 2018 Jan 4.

  PMID: 29313949 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Mariano Ponz Sarvisé, MD, PhD

  Clínica Universidad de Navarra

  PRINCIPAL INVESTIGATOR

• Patricia Seoane Couselo, MD

  Hospital Universitario de Araba

  PRINCIPAL INVESTIGATOR

• Fernando Garicano Goldáraz, MD

  Hospital de Galdakao

  PRINCIPAL INVESTIGATOR

• Alberto Muñoz Llarena, MD

  Hospital Universitario de Cruces

  PRINCIPAL INVESTIGATOR

• Ángela Lamarca Lete, MD, PhD

  Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariano Ponz Sarvisé, MD, PhD

CONTACT

+34 948255400; mponz@unav.es

Lucía Ceniceros

CONTACT

+34 948255400; lceniceros@unav.es

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a non-randomized, open-label, one arm, multi-center study of the combination of NovoTTF-200T system with modFOLFIRINOX. A safety run in cohort of six patients will be conducted to assess toxicity and safety of the combination. Then, a second part consisting of an expansion cohort in which the rest of accorded patients will be performed. The study shall end when the final randomized patient has completed the study, all the planned visits have been carried out and any inconsistencies have been resolved.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 16, 2025
• Study Start: October 14, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

ES (5)