Continued Access Program for Tumor Treating Fields (TTFields) Used With Chemotherapy (Gemcitabine and Nab-Paclitaxel) in Adults With Locally Advanced Pancreatic Cancer (PANOVA-3CA) (PANOVA-3CA)

December 18, 2025 updated by: NovoCure GmbH

Tumor Treating Fields (TTFields, 150kHz) Concomitant With Gemcitabine and Nab-paclitaxel for Front-line Treatment of Locally Advanced Pancreatic Adenocarcinoma: EF-54/PANOVA-3CA

The EF-54 program (PANOVA-3CA) is a continued access program for adults with locally advanced pancreatic cancer to access TTFields therapy in combination with gemcitabine and nab-paclitaxel. The purpose of the program is to allow eligible patients to have access to TTFields while the NovoTTF-200T system is under FDA review. Safety and device performance will be monitored during routine clinical care.

Study Overview

Status

Temporarily not available

Conditions

Intervention / Treatment

Detailed Description

This is a non-comparative continued access program. All enrolled patients who meet eligibility criteria will receive TTFields with gemcitabine and nab-paclitaxel.

Eligible patients are ≥22 years old, have histologically or cytologically confirmed de novo pancreatic adenocarcinoma not amenable to surgical resection and without evidence of distant metastases, an ECOG performance status of 0-2, and are candidates for gemcitabine plus nab-paclitaxel chemotherapy.

Patients will continue TTFields therapy in combination with chemotherapy according to the treating physician's and site's local standard of care until local disease progression is identified. After discontinuation, subsequent care and follow-up are per treating physician's and site's local standard. There is no protocol defined post-treatment assessments mandated.

Study Type

Expanded Access

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  • Age ≥ 22 years
  • Histologically or cytologically confirmed de novo pancreatic adenocarcinoma
  • Locally advanced, non-metastatic disease
  • ECOG performance status of 0-2
  • Candidate for treatment with gemcitabine and nab-paclitaxel
  • Able to operate the NovoTTF-200T system independently or with caregiver support

Exclusion Criteria:

  • Prior palliative treatment to the pancreatic tumor
  • Other active malignancies within the past 5 years (except certain early-stage cancers)
  • Significant uncontrolled medical conditions or infections that would interfere with therapy
  • Implantable electronic devices in the torso
  • Known severe hypersensitivity to adhesives, hydrogel, or chemotherapy agents
  • Pregnancy or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NovoCure GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

December 18, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Actual)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EF-54

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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