EF-39 PANOVA-4: Study of Tumor Treating Fields Concomitant With Atezolizumab, Gemcitabine and Nab… (NCT06390059) | Clinical Trial Compass
CompletedPhase 2
EF-39 PANOVA-4: Study of Tumor Treating Fields Concomitant With Atezolizumab, Gemcitabine and Nab-Paclitaxel as First-LineTreatment for Metastatic Pancreatic Ductal Adenocarcinoma
Czechia, Germany84 participantsStarted 2023-08-28
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed Informed Consent Form for the study protocol.
✓. 18 years of age and older at the time of signing Informed Consent Form.
✓. ECOG (Eastern Cooperative Oncology Group) performance status of 0-1.
✓. Histologically or cytologically confirmed de-novo diagnosis of metastatic pancreatic ductal adenocarcinoma (PDAC).
✓. No prior treatment for PDAC.
✓. Life expectancy equal to or greater than 3 months.
✓. Measurable disease in the abdomen, as defined by RECIST (Response Evaluation Criteria in Solid Tumors) v1.1.
✓. Preferably, tumor accessible for tissue collection. Consent to provide blood and tumor tissue for exploratory study is highly encouraged. Patients who cannot or are unwilling to provide tissue or blood for the exploratory study are not excluded from the study.
Exclusion criteria
✕. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
✕. History of leptomeningeal disease.
✕. Uncontrolled tumor-related pain
✕. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage procedure (i.e., more than one time per month).
What they're measuring
1
Disease control rate (DCR)
Timeframe: at least 16 weeks for SD or confirmed PR/CR
✕. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
✕. Positive human immunodeficiency (HIV) test at screening or at any time prior to screening.