EF-39 PANOVA-4: Study of Tumor Treating Fields Concomitant With Atezolizumab, Gemcitabine and Nab-Paclitaxel as First-LineTreatment for Metastatic Pancreatic Ductal Adenocarcinoma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

August 28, 2023

Primary Completion Date

November 27, 2025

Study Completion Date

November 27, 2025

Conditions
Metastatic Pancreatic Ductal Adenocarcinoma
Interventions
DEVICE

Tumor Treating Fields

"The NovoTTF-200T is a portable, battery operated system intended for continuous home use, which delivers TTFields at a frequency of 150kHz to the patient by means of insulated transducer arrays. The NovoTTF-200T produces TTFields that exert electric forces intended to disrupt cancer cell division.~TTFields at 150 kHz application will be continuous for at least 18 hours a day on average. TTFields will be continued until disease progression according to RECISTv1.1 or loss of clinical benefit."

DRUG

Atezolizumab

"Atezolizumab is a humanized IgG1 monoclonal antibody which targets human PD-L1and inhibits its interaction with its receptors, PD-1 and B7.1 (CD80). Both of these interactions are reported to provide inhibitory signals to T cells. Atezolizumab is administered as an intravenous solution.~Atezolizumab may continue until disease progression according to RECIST v1.1 or loss of clinical benefit."

DRUG

Gemcitabine

"Gemcitabine is a standard of care chemotherapy drug administered as an intravenous infusion.~Gemcitabine may continue until disease progression according to RECIST v1.1 or loss of clinical benefit."

DRUG

nab-paclitaxel

"Nab-paclitaxel is a standard of care chemotherapy drug administered as an intravenous infusion.~Nab-paclitaxel may continue until disease progression according to RECIST v1.1 or loss of clinical benefit."

Trial Locations (15)

1708

Fribourg Cantonal Hospital, Internal Medicine and Oncology, Fribourg

3010

Inselspital, University Hospital Bern, Bern

22763

Asklepios Hospital Altona, Hamburg

28007

University General Hospital Gregorio Maranon, Madrid

28040

University Hospital Foundation Jimenez Diaz, Madrid

28050

Clara Campal Comprehensive Cancer Center (CIOCC), Madrid

29010

Regional University Hospital of Malaga, Málaga

31008

University Clinic of Navarra - Pamplona, Pamplona

72076

University Hospital Tuebingen, Tübingen

89081

University Hospital Ulm, Ulm

500 05

University Hospital Hradec Kralove, Hradec Králové

779 00

University Hospital Olomouc, Olomouc

150 06

University Hospital Motol, Prague

180 81

University Hospital Bulovka, Prague

08035

University Hospital Vall d'Hebron, Barcelona

All Listed Sponsors
lead

NovoCure Ltd.

INDUSTRY