The PANOVA-3 trial (also known as the “EF-27 trial”) is a pivotal (analogous to a drug Phase III), randomized controlled trial, designed to test the efficacy and safety of Tumor Treating Fields (TTFields), generated by a medical device, the NovoTTF-100L(P) System [About TTFields] in combination with gemcitabine and nab-paclitaxel as front-line treatment for patients with locally advanced pancreatic adenocarcinoma which is not amenable to surgical resection. The trial is expected to enroll a total of 556 patients. The trial is now enrolling patients in multiple centers across Europe and will soon be open in the United States and Canada [PANOVA-3 Centers].
The PANOVA-3 Trial Design
Patients who were recently diagnosed with locally advanced pancreatic adenocarcinoma which is not amenable to surgical resection are candidates for this trial. Final eligibility can only be determined by the clinical trial physician in one of the clinical trial centers. All patients enrolled in the trial will receive a standard of care treatment for their pancreatic cancer with gemcitabine and nab-paclitaxel, similar to patients who are not participating in the trial. All patients will be randomly assigned to one of two groups:
- The TTFields Group: TTFields using the NovoTTF-100L(P) System in addition to standard of care gemcitabine and nab-paclitaxel.
• The Standard of Care Group (control): standard of care gemcitabine and nab-paclitaxel.
Each patient will have 50% chance of entering each of the two groups as determined by a “randomization process” (similar to a coin flip). Eligible patients can be enrolled in the trial no later than 28 days after their diagnosis of pancreatic adenocarcinoma.
If assigned to the TTFields Group, the patient will receive continuous TTFields treatment using the NovoTTF-100L(P) System. In order to apply the device, the patient needs to wear four Transducer Arrays taped on the abdomen, back and flanks. Transducer Array placement may require shaving of the abdomen/back before starting to use the device, and twice a week for as long as its use continues.
The use of the device will start in an outpatient setting and will include training on the operation of the equipment by a qualified Novocure Device Support Specialist (DSS). Patients will continue to use the device at home [Living with TTFields]. Patients using the NovoTTF-100L(P) System can maintain the use of the device alone (with the help of a family member or a care giver if needed) or may receive support from their DSS.
The system is user-friendly and all technical aspects related to using it are maintained by the DSS. The DSS can also help patients in finding technical solutions to allow each individual to receive TTFields while maintaining his/her normal daily routines.
In addition, patient will receive standard of care gemcitabine and nab-paclitaxel.
Standard of Care Group
Patients assigned to the Standard of Care Group will receive standard of care gemcitabine and nab-paclitaxel. Patients might benefit from receiving comprehensive follow up exams every 4 weeks that include some testing not typically included in standard of care at no cost to the patient.
In addition, all study participants contribute to future patients by providing additional information and data used to assess the efficacy of TTFields.
For the complete list of eligibility criteria please go to clinicaltrials.gov or consult with a PANOVA-3 trial physician:
Inclusion Criteria (summary, not complete list):
- New diagnosis of pancreatic adenocarcinoma in locally advanced stage and not amenable for surgery.
- At least 18 years of age.
Exclusion Criteria (summary, not complete list):
- Prior palliative treatment (e.g. surgery, radiation) to the tumor.
- Being unable to operate the NovoTTF-100L(P) device independently or with the help of a caregiver.
- Pregnant or breast feeding women.
- Significant illnesses not associated with the primary disease.
- Implanted electronic devices (e.g. pacemaker) in the torso.
Expected total enrollment is 556 patients. The trial is currently enrolling in multiple medical centers in Europe, and will soon be open in the United States and Canada. Please contact one of them as soon as possible if you would like to participate in the PANOVA-3 trial.
The trial sponsor (Novocure) will pay for reasonable treatment related supplies, including the NovoTTF-100L(P) System and accessories. Patients and their insurance will be responsible for medical treatments received in the normal course of patient care. The trial sponsor will also reimburse patients for some travel costs related to the trial’s procedures. Such reimbursement can be done only according to the policy of the trial center at which the patient is being treated. Please consult with the clinical trial team at the center prior to enrolling in the trial about the local reimbursement policy and your rights.