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

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.

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.

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