Effect of Tumor Treating Fields (TTFields, 200 kHz) Concomitant With Weekly Paclitaxel for the Treatment of Recurrent Ovarian Cancer (ENGOT-ov50 / GOG-3029 / INNOVATE-3)

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of Tumor Treating Fields (TTFields) concomitant with weekly paclitaxel for the treatment of recurrent ovarian cancer . The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NovoCure Ltd.
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

1. 18 years of age and older

2. Epithelial histology of ovarian/primary peritoneal or fallopian tube carcinoma at the time of diagnosis

3. Life expectancy of ≥ 12 weeks

4. Maximum two prior lines of systemic therapy following diagnosis of platinum-resistance

5. Maximum total of 5 prior lines of systemic therapy

6. Amenable to receive weekly paclitaxel and able to operate the NovoTTF-100L(O) System

7. ECOG 0-1

8. Evaluable (measurable or non-measurable) disease in the abdominal/pelvic region per RECIST V1.

9. Signed informed consent form for the study protocol

Exclusion Criteria:

1. Primary platinum-refractory disease (progression per RECIST V1.1 during or within 1 month after first line therapy), while secondary platinum-refractory disease is allowed

2. Prior disease progression on a weekly paclitaxel for recurrent disease

3. Brain metastasis or leptomeningeal spread of the tumor

4. Albumin level <25 gram/liter (subjects should not receive total parenteral nutrition or albumin within 2 weeks of the test)

5. CTCAE V5.0 Grade 3 or higher peripheral neuropathy

6. Implantable electrical medical devices

7. Known allergies to medical adhesives or hydrogel

8. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to paclitaxel or drugs similar or related to paclitaxel, except for cases that were able to undergo desensitization per investigator

9. Prior malignancies treated primarily or for recurrence within 2 years prior to inclusion in this study, except for completely resected non-melanomatous skin carcinoma, or successfully treated in situ carcinoma of the skin, breast or cervix of the uterus

10. Serious co-morbidities

11. Concurrent anti-tumor therapy beyond weekly paclitaxel, excluding hormonal therapy for breast cancer

12. Concurrent active treatment in another clinical trial. However prior participation in clinical trials is allowed as well as participation during survival follow-up

13. Pregnancy or breast-feeding (female patients with reproductive potential and their partners must accept to use effective contraception throughout the entire study period and for 3 months after the end of treatment). All patients who are capable of becoming pregnant must take a pregnancy test which is negative within 72 hours before beginning treatment. The definition of effective contraception is left up to the decision of the investigator

14. Admitted to an institution by administrative or court order