Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2025-12-25 @ 11:53 PM
Study NCT ID:
NCT06390059
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-30
First Post:
2024-02-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EF-39 PANOVA-4: Study of Tumor Treating Fields Concomitant With Atezolizumab, Gemcitabine and Nab-Paclitaxel as First-LineTreatment for Metastatic Pancreatic Ductal Adenocarcinoma
Sponsor:
NovoCure Ltd.
Organization:
Study Overview
Official Title:
PANOVA-4: Pilot, Single Arm Study of Tumor Treating Fields (TTFields, 150kHz) Concomitant With Atezolizumab, Gemcitabine and Nab-Paclitaxel as First-Line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
The PANOVA-4 study is an international, multi-center, research study for female and male adult patients diagnosed with metastatic pancreatic ductal adenocarcinoma (mPDAC).
The purpose of the study is to test the efficacy and safety of TTFields, delivered using the NovoTTF-200T Treatment Kit, concomitantly with atezolizumab, gemcitabine and nab-paclitaxel as first line treatment for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC).
The chemotherapy used in this study, gemcitabine and nab-paclitaxel, are standard-of-care treatment for metastatic pancreatic cancer. The atezolizumab drug and the NovoTTF-200T device are investigational for this tumor type. Atezolizumab is an immunotherapy drug that works with the immune system to help fight cancer. NovoTTF-200T is a non-invasive medical device that delivers Tumor Treating Fields (TTFields) at 150kHz to the cancer in the abdominal region, where the tumor is located.
The study is expected to enroll 76 patients in centers around the world. The expected duration on study per patient is approximately 12 months.
Patients with previously untreated mPDAC who meet all inclusion criteria and none of the exclusion criteria as determined by the investigator will initiate study treatment within 28 days from signing the Informed Consent Form (ICF) to receive TTFields (150 kHz), atezolizumab, gemcitabine and nab-paclitaxel.
All patients enrolled in the study will receive continuous TTFields therapy concomitant with monthly atezolizumab treatments for their metastatic pancreatic cancer and weekly gemcitabine and nab-paclitaxel.
While on the study, patients will be asked to visit the clinic every 4 weeks, in order to perform a physical examination, blood tests,and some other assessments. Patients will be asked to have a radiological examination (CT scan of the chest abdomen and pelvis) every 8 weeks to assess the status of the disease.
Study treatments will continue until disease progression according to RECIST v1.1, or loss of clinical benefit.
Patients who experience disease progression will be permitted to continue study treatments if there is evidence of clinical benefit.
Subjects will return to the clinic for one final visit approximately 30 days after discontinuation of the last study treatment.
Following the final visit, the subjects will be contacted every three months by telephone to answer basic questions about their health status.
The purpose of the study is to test the efficacy and safety of TTFields, delivered using the NovoTTF-200T Treatment Kit, concomitantly with atezolizumab, gemcitabine and nab-paclitaxel as first line treatment for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC).
The chemotherapy used in this study, gemcitabine and nab-paclitaxel, are standard-of-care treatment for metastatic pancreatic cancer. The atezolizumab drug and the NovoTTF-200T device are investigational for this tumor type. Atezolizumab is an immunotherapy drug that works with the immune system to help fight cancer. NovoTTF-200T is a non-invasive medical device that delivers Tumor Treating Fields (TTFields) at 150kHz to the cancer in the abdominal region, where the tumor is located.
The study is expected to enroll 76 patients in centers around the world. The expected duration on study per patient is approximately 12 months.
Patients with previously untreated mPDAC who meet all inclusion criteria and none of the exclusion criteria as determined by the investigator will initiate study treatment within 28 days from signing the Informed Consent Form (ICF) to receive TTFields (150 kHz), atezolizumab, gemcitabine and nab-paclitaxel.
All patients enrolled in the study will receive continuous TTFields therapy concomitant with monthly atezolizumab treatments for their metastatic pancreatic cancer and weekly gemcitabine and nab-paclitaxel.
While on the study, patients will be asked to visit the clinic every 4 weeks, in order to perform a physical examination, blood tests,and some other assessments. Patients will be asked to have a radiological examination (CT scan of the chest abdomen and pelvis) every 8 weeks to assess the status of the disease.
Study treatments will continue until disease progression according to RECIST v1.1, or loss of clinical benefit.
Patients who experience disease progression will be permitted to continue study treatments if there is evidence of clinical benefit.
Subjects will return to the clinic for one final visit approximately 30 days after discontinuation of the last study treatment.
Following the final visit, the subjects will be contacted every three months by telephone to answer basic questions about their health status.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: