protocolSection identificationModule nctId: NCT06390059, orgStudyIdInfo id: EF-39, secondaryIdInfos id: EF-39, type: OTHER, domain: Sponsor, secondaryIdInfos id: 2022-003157-55, type: EUDRACT_NUMBER, briefTitle: EF-39 PANOVA-4: Study of Tumor Treating Fields Concomitant With Atezolizumab, Gemcitabine and Nab-Paclitaxel as First-LineTreatment for Metastatic Pancreatic Ductal Adenocarcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-28, primaryCompletionDateStruct date: 2026-08, completionDateStruct date: 2026-08, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: NovoCure GmbH, class: INDUSTRY, descriptionModule briefSummary: The PANOVA-4 study is designed to evaluate the safety and efficacy of Tumor Treating Fields (TTFields) therapy together with atezolizumab, gemcitabine and nab-paclitaxel, for the treatment of metastatic pancreatic cancer. The study is intended for patients who have been diagnosed with metastatic pancreatic cancer and have not received prior systemic therapy., conditionsModule conditions: Metastatic Pancreatic Ductal Adenocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective, open-label, single arm, multi-center, historical control pilot study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: Tumor Treating Fields, interventions name: Atezolizumab, interventions name: Gemcitabine, interventions name: nab-paclitaxel, outcomesModule primaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: 1-Year survival rate, secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Progression free survival at 6 months (PFS6), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Rate of of patients with treatment emergent adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Vall d'Hebron, status: RECRUITING, city: Barcelona, zip: 08035, country: Spain, contacts name: Teresa Macarulla Mercade, role: CONTACT, phone: 34 (93) 274 6085, email: tmacarulla@vhebron.net, geoPoint lat: 41.38879, lon: 2.15899, locations facility: University Hospital Foundation Jimenez Diaz, status: RECRUITING, city: Madrid, zip: 28040, country: Spain, contacts name: Angela Lamarca Lete, role: CONTACT, phone: 34 951 504800, email: angela.lamarca@quironsalud.es, contacts name: 1, role: CONTACT, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Clara Campal Comprehensive Cancer Center (CIOCC), status: RECRUITING, city: Madrid, zip: 28050, country: Spain, contacts name: Antonio Cubillo Gracian, role: CONTACT, phone: 34 91 756 7800, email: acubillo@hmhospitales.com, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Regional University Hospital of Malaga, status: RECRUITING, city: Málaga, zip: 29010, country: Spain, contacts name: Inmaculada Ales, role: CONTACT, phone: 34 951308129, email: inales@hotmail.com, geoPoint lat: 36.72016, lon: -4.42034, locations facility: University Clinic of Navarra - Pamplona, status: RECRUITING, city: Pamplona, zip: 31008, country: Spain, contacts name: Mariano Ponz-Sarvise, role: CONTACT, phone: 34 948 255 400, email: mponz@unav.es, geoPoint lat: 42.81687, lon: -1.64323, hasResults: False