Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) MedDRA version: 21.0 Level: LLT Classification code 10033599 Term: Pancreatic adenocarcinoma metastatic System Organ Class: 100000004864
Conditions
Sponsors
Novocure GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Signed Informed Consent Form - 18 years of age and older - ECOG performance status of 0-1 - Histologically or cytologically confirmed de-novo diagnosis of metastatic pancreatic ductal adenocarcinoma - No prior treatment for PDAC - Life expectancy equal to or greater than 3 months - Measurable disease in the abdomen, as defined by RECIST v1.1 - Preferably, tumor accessible for tissue collection. Consent to provide blood and tumor tissue for exploratory study is highly encouraged - Amenable and assigned by the investigator to receive therapy with gemcitabine and nab- paclitaxel - Adequate hematologic and end-organ function - Able to operate the NovoTTF-200T device Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 36
Exclusion criteria
Exclusion criteria: - Symptomatic, untreated, or actively progressing CNS metastases - History of leptomeningeal disease - Uncontrolled tumor-related pain - Active or history of autoimmune disease - Severe infection within 4 weeks prior to initiation of study treatment - History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins - Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug or device, may affect the interpretation of the results, or may render the patient at high risk from treatment complications - Concurrent anti-tumor therapy beyond gemcitabine and nab-paclitaxel - Implantable electronic medical devices in the torso, such as pacemakers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the disease control rate (DCR) by RECIST v1.1 in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel.;Secondary Objective: To evaluate the overall survival (OS) and 1-year survival rate in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel. To evaluate the safety and tolerability profile of TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel in patients with 1L mPDAC. To evaluate the progression free survival (PFS) by RECIST v1.1 in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel. To evaluate the objective response rate (ORR) by RECIST v1.1 in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel. To evaluate the PFS rate at 6 months (PFS6) in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel. To evaluate the duration of response (DOR) by RECIST v1.1 in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel. ;Primary end point(s): Disease control rate (DCR) by RECIST v1.1 in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel, measured as the proportion of patients with stable disease for at least 16 weeks or confirmed PR or CR.;Timepoint(s) of evaluation of this end point: Stable disease for at least 16 weeks, or confirmed PR or CR. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Overall survival (OS) in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel, measured as the period between the time of treatment initiation and the time of death. • Progression free survival (PFS) by RECIST v1.1 in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel, measured from the time of treatment initiation. • 1-year survival rate in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel, measured as the proportion of patients alive one year after treatment initiation. • Objective response rate (ORR) by RECIST v1.1 in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel, measured as the proportion of patients with partial or complete response between the time of treatment initiation and the time of death. • Progression free survival rate at 6 months (PFS6) by RECIST v1.1 in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel, defined as the proportion of patients who are alive and are progression free six months after treatment initiation. • Duration of response (DOR) by RECIST v1.1 in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel, measured as the time from the first occurance of a documented objective response to disease progression or death from any cause (whichever occurs first). • Toxicity profile in 1L mPDAC patients treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel, measured by the rate of patients with treatment-emergent adverse events (based on CTCAE V5.0).;Timepoint(s) of evaluation of this end point: As stated in E.5.2. | — |
Countries
Czechia, Czech Republic, Germany, Hungary, Spain, Switzerland
Contacts
Public ContactDirector, Global Clinical Operation
Novocure GmbH
Outcome results
None listed