Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390059
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-02-29
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 GmbH
Organization:
NovoCure Ltd
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:
RECRUITING
Status Verified Date:
2024-05
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 testsand 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 v11 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 testsand 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 v11 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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EF-39 | OTHER | None | None |
| 2022-003157-55 | EUDRACT_NUMBER | Sponsor | None |