The ENGOT-ov50/INNOVATE-3 study is a pivotal (like a Phase III), randomized, controlled, open label study designed to test the efficacy and safety of Tumor Treating Fields (TTFields), generated by a medical device, the NovoTTF-100L(O), in combination with paclitaxel for patients with recurrent ovarian cancer. The study is expected to enroll a total of 540 patients.
The study is enrolling patients in centers across Europe, Israel, Canada, and the United States.
The INNOVATE-3 Study Design
Patients who were recently diagnosed with recurrent ovarian cancer with up to maximum of 2 prior treatments for platinum resistant disease are candidates for this study. Final eligibility can only be determined by the clinical study doctor at one of the clinical study centers. All patients enrolled in the study will receive a standard of care treatment for their ovarian cancer, paclitaxel, similar to patients who are not participating in the study. All patients will be randomly assigned to one of two groups:
- The TTFields Group: Patients will receive TTFields using the NovoTTF-100L(O) device in addition to standard of care paclitaxel.
- The Standard of Care Group (control): Patients will receive standard of care paclitaxel.
Each patient will have a 50% chance of entering each of the two groups as determined by a “randomization process” (similar to a coin flip). Eligible patients will be randomized within 28 days of signing an Informed Consent Form for the clinical study.
The patient will receive continuous TTFields treatment using the NovoTTF-100L(O) together with standard of care weekly paclitaxel. In order for the device to function, the patient needs to wear four transducer arrays on the abdomen, back and sides, and will replace them 2-3 times per week. Transducer array placement may require shaving of the abdomen/back before application.
The use of the device will start with an initial on-site 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) device 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.
Key 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 study (“informed consent”)
Key Exclusion Criteria (summary, not complete list):
- Patients with ovarian cancer for whom the treatment of weekly paclitaxel has not resulted in a response
- Patients where cancer has been spread into the brain or brain membranes
Expected total enrollment is 540 patients. The study is currently enrolling patients in centers in Europe, Israel, Canada, and the United States.
The study sponsor (Novocure) will pay for reasonable treatment related supplies, including the NovoTTF-100L(O) device and accessories. Patients and their insurance will be responsible for medical treatments received in the normal course of patient care. The study sponsor will also reimburse patients for some travel costs related to the study’s procedures. Such reimbursement can be done only according to the policy of the study center at which the patient is being treated. Please consult with the clinical study team at the center prior to enrolling in the study about the local reimbursement policy and your rights.