The ENGOT-ov50/INNOVATE-3 trial (also known as the “EF-28 trial”) is a pivotal (like a drug Phase III), randomized controlled, open label trial designed to test the efficacy and safety of Tumor Treating Fields (TTFields), generated by a medical device, the NovoTTF-100L(O) System in combination with paclitaxel for patients with platinum-resistant ovarian cancer. The trial is expected to enroll a total of 540 patients.
The trial is enrolling patients in centers across Europe and will soon be enrolling patients in US and Canadian centers.
The INNOVATE-3 Trial Design
Patients who were recently diagnosed with platinum resistant ovarian cancer with up to maximum of 2 prior treatments for platinum resistant disease are candidates for this trial. Final eligibility can only be determined by the clinical trial doctor in one of the clinical trial centers. All patients enrolled in the trial will receive a standard of care treatment for their ovarian cancer with 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(O) System in addition to standard of care paclitaxel.
- The Standard of Care Group (control): standard of care 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 platinum resistant ovarian cancer.
The patient will receive continuous TTFields treatment using the NovoTTF-100L(O) System together to standard of care weekly paclitaxel. In order for the device to function, the patient needs to wear four Transducer Arrays taped on the abdomen, back and flanks, replaced twice a week. Transducer Array placement may require shaving of the abdomen/back before applying arrays.
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. Patients using the NovoTTF-100L(O) 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 patient will be educated by a Device Support Specialist (“DSS”) on how to use the device, and how to troubleshoot any potential issues with using it. The DSS can also help patients in finding technical solutions to allow each individual to receive TTFields while maintaining his/her normal daily routines.
Inclusion Criteria (summary, not complete list):
- Diagnosis of Ovarian carcinoma that has not responded to therapy containing platinum within the last 6 months
- At least 18 years of age
- Agreement to participate in the clinical trial (“informed consent”)
Exclusion Criteria (summary, not complete list):
- Patients with ovarian cancer for whom the treatment of weekly paclitaxel has not responded to
- Patients where cancer has been spread into the brain or brain membranes
Expected total enrollment is 540 patients. The trial is currently enrolling patients in centers in Europe and will soon be enrolling patients in multiple centers in the US and Canada.
The trial sponsor (Novocure) will pay for reasonable treatment related supplies, including the NovoTTF-100L(O) 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.