NCT07284277

TTFields and Chemotherapy in Metastatic Pancreatic Adenocarcinoma (mPDAC)

Phase Ib-II, Non-randomized, Open-label Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With modFOLFIRINOX for Front-line Treatment of Metastatic Pancreatic Adenocarcinoma (NOVOFFOX)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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?

Detailed description

This is a phase Ib-II, non-randomized, open-label, one arm, multi-center study of the combination of NovoTTF-200T system with modFOLFIRINOX for the evaluation of the safety of the treatment in patients with metastatic pancreatic adenocarcinoma. Pancreatic ductal adenocarcinoma (PDAC) is the eight cause of cancer mortality in men and ninth in women worldwide. Nearly 50,000 patients are diagnosed annually and almost all of them are expected to die from the disease without any challenges in survival in the last decade. Unfortunately, in most of the cases the disease is already disseminated when tumor related symptoms appear, with 5-year survival rate of less than 8 percent in this population (Siegel et al, 2020). Tumor Treating Fields (TTFields) are a non-invasive regional antimitotic treatment with minimal toxicity. TTFields act by delivering alternate low-intensity electric fields (1-3 V/cm), intermediate frequency (100-300 kHz), and alternating electric fields to the tumor using non-invasive transducer arrays placed on the skin around the region of the body containing the tumor. TTFields act predominantly during two phases of mitosis: 1) during metaphase, by disrupting the formation of the mitotic spindle; and 2) during cytokinesis, by dielectrophoretic dislocation of intracellular constituents, leading apoptosis. There is an increasing interest in the addition of immunotherapy to treatment pancreatic adenocarcinoma. Thus, combining TTFields with immunotherapy represents an interest for future clinical trials. However, the combination of TTFields with FOLFIRINOX chemotherapy scheme has not been evaluated yet. In this trial, it is proposed to evaluate the combination of TTFields with modFOLFIRINOX chemotherapy in metastatic PDAC patients with liver metastases. The aim is to analyze both the safety of combining TTFields with modFOLFIRINOX chemotherapy scheme, and to study the potential effect of TTFields and chemotherapy on the TME of liver metastasis. Each patient shall participate in the trial for a maximum of 24 months. The trial will consist in two consecutive parts: * A first part (Phase Ib) consisting of a safety run-in cohort: This first part will include 6 patients that will be treated with standard dose of modFOLFIRINOX scheme combined with TTFields. * A second part (Phase II) consisting of an expansion cohort in which the rest of accorded patients will be included.

Conditions

• Pancreatic Adenocarcinoma Metastatic
• Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	TTFields concomitant with modFOLFIRINOX	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.

Timeline

• Start date: 2025-10-14
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2025-12-16
• Last updated: 2025-12-16

Locations

5 sites across 1 country: Spain