The INNOVATE trial (also known as the “EF-22 trial”) is a Pilot (analogous to drug Phase II), single arm trial. It is designed to test the safety and preliminary efficacy of a medical device, the NovoTTF-100L(O) system in patients with ovarian cancer who progressed after initial treatment, when the device is combined with one of the standard chemotherapy for ovarian cancer – paclitaxel. The trial is expected to enroll a total of 30 patients. The trial is now enrolling patients in multiple centers in Europe.
The INNOVATE Trial Design
Patients with recurrent (previously treated) ovarian carcinoma are candidates for the clinical trial. Final eligibility can only be determined by the clinical trial physician at one of the clinical trial sites. All patients enrolled in the trial will receive the best standard treatments (including chemotherapy) indicated for the treatment of their ovarian cancer and for any other medical condition, similar to patients who are not participating in the trial, combined with TTFields. TTFields will be administered continuously to all patients enrolled in the trial, until disease progression. Eligible patients will start both chemotherapy and TTFields at the same time, and should therefore consult with their treating doctor about their potential participation in the trial soon after being diagnosed with recurring ovarian cancer.
In order to apply the NovoTTF-100L(O) device, the patient needs to wear four transducer arrays taped around the lower abdominal region. The transducer array will be routinely replaced, every 3-4 days. Since the transducer arrays are placed on skin covered by clothing, they may not be visible to others.
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. Following the first eight weeks of combined paclitaxel and TTFields administration, patients will receive TTFields for the first 3 weeks of each 4 week course (i.e. 3 weeks on 1 week off). 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 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.
Inclusion Criteria (Summary, not complete list)
- At least 18 years of age
- Recurrent ovarian, fallopian tube or primary peritoneal carcinoma (any number of prior therapies)
- No concurrent anti-tumor therapy (beyond the investigational protocol)
Exclusion Criteria (Summary, not complete list)
- Symptomatic or non-treated brain metastasis
- Pacemaker or other implanted electronic devices
Expected total enrollment is 30 patients. The trial is currently enrolling in several European medical centers. Please contact one of them as soon as possible if you would like to participate in the INNOVATE trial.
The trial sponsor (Novocure) will pay for reasonable treatment related supplies associated with trial procedures that are outside of the standard of care, including the NovoTTF-100L(O) system and accessories. The trial sponsor will also reimburse patients for some travel costs related to trials procedure. Such reimbursement can only be done according to the policy of the trial center the patient is treated at and upon approval by the trial sponsor. Please consult with the clinical trial team at the center prior to enrolling in the trial about the local reimbursement policy and your rights. Patients and their insurance will be responsible for medical treatments received in the normal course of patient care.