Ovarian Cancer Clinical Trial

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)

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.

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Full Description

PAST PRE-CLINICAL AND CLINICAL EXPERIENCE:

The effect of the electric fields (TTFields, TTF) has demonstrated significant activity in in vitro and in vivo ovarian carcinoma pre-clinical models both as a single modality treatment and in combination with chemotherapies. TTFields have been demonstrated to act synergistically with taxanes and have been shown to be additive when combined with other chemotherapies. In addition, TTFields have shown to inhibit metastatic spread of malignant melanoma in in vivo experiment.

In a pilot study, 31 patients with recurrent platinum-resistant ovarian carcinoma received paclitaxel together with TTFields (200 kHz) applied to the abdomen/pelvis until disease progression. The combination was well tolerated and the only device-related adverse event was contact dermatitis.

In addition, a phase III trial of Optune® (200 kHz) as monotherapy compared to active chemotherapy in recurrent glioblastoma patients showed TTFields to be equivalent to active chemotherapy in extending survival, associated with minimal toxicity, good quality of life, and activity within the brain (14% response rate). Finally, a phase III trial of Optune® combined with maintenance temozolomide compared to maintenance temozolomide alone has shown that combined therapy led to a significant improvement in both progression free survival and overall survival in patients with newly diagnosed glioblastoma without the addition of high grade toxicity and without decline in quality of life.

DESCRIPTION OF THE TRIAL:

All patients included in this trial are patients with platinum-resistant ovarian carcinoma. In addition, all patients must meet all eligibility criteria.

Eligible patients will be randomly assigned to one of two groups:

Patients receive TTFields at 200 kHz to the abdomen and pelvis using the NovoTTF-100L(O) System together with weekly paclitaxel.
Patients receive weekly paclitaxel alone.

Patients will be randomized at a 1:1 ratio. Baseline tests will be performed in patients enrolled in both arms. If assigned to the NovoTTF-100L(O) group, the patients will be treated continuously with the device until progression in the abdomen/pelvis. On both arms, patients who have progression outside the abdomen/pelvis will switch to a second line treatment according to local practice.

SCIENTIFIC BACKGROUND:

Electric fields exert forces on electric charges similar to the way a magnet exerts forces on metallic particles within a magnetic field. These forces cause movement and rotation of electrically charged biological building blocks, much like the alignment of metallic particles seen along the lines of force radiating outwards from a magnet.

Electric fields can also cause muscles to twitch and if strong enough may heat tissues. TTFields are alternating electric fields of low intensity. This means that they change their direction repetitively many times a second. Since they change direction very rapidly (200 thousand times a second), they do not cause muscles to twitch, nor do they have any effects on other electrically activated tissues in the body (brain, nerves and heart). Since the intensities of TTFields in the body are very low, they do not cause heating.

The finding made by Novocure was that finely tuned alternating fields of very low intensity, now termed TTFields (Tumor Treating Fields), cause a significant slowing in the growth of cancer cells. Due to the unique geometric shape of cancer cells when they are multiplying, TTFields cause electrically-charged cellular components of these cells to change their location within the dividing cell, disrupting their normal function and ultimately leading to cell death. In addition, cancer cells also contain miniature building blocks which act as tiny motors in moving essential parts of the cells from place to place. TTFields interfere with the normal orientation of these tiny motors related to other cellular components since they are electrically-charged as well. As a result of these two effects, tumor cell division is slowed, results in cellular death or reverses after continuous exposure to TTFields.

Other cells in the body (normal healthy tissues) are affected much less than cancer cells since they multiply at a much slower rate if at all. In addition TTFields can be directed to a certain part of the body, leaving sensitive areas out of their reach. Finally, the frequency of TTFields applied to each type of cancer is specific and may not damage normally dividing cells in healthy tissues.

In conclusion, TTFields could potentially become treatment for ovarian cancer with very few side effects.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

18 years of age and older
Epithelial histology of ovarian/primary peritoneal or fallopian tube carcinoma at the time of diagnosis
Life expectancy of ≥ 12 weeks
Maximum two prior lines of systemic therapy following diagnosis of platinum-resistance
Maximum total of 5 prior lines of systemic therapy
Amenable to receive weekly paclitaxel and able to operate the NovoTTF-100L(O) System
ECOG 0-1
Evaluable (measurable or non-measurable) disease in the abdominal/pelvic region per RECIST V1.
Signed informed consent form for the study protocol

Exclusion Criteria:

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
Prior disease progression on a weekly paclitaxel for recurrent disease
Brain metastasis or leptomeningeal spread of the tumor
Albumin level <25 gram/liter (subjects should not receive total parenteral nutrition or albumin within 2 weeks of the test)
CTCAE V5.0 Grade 3 or higher peripheral neuropathy
Implantable electrical medical devices
Known allergies to medical adhesives or hydrogel
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
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
Serious co-morbidities
Concurrent anti-tumor therapy beyond weekly paclitaxel, excluding hormonal therapy for breast cancer
Concurrent active treatment in another clinical trial. However prior participation in clinical trials is allowed as well as participation during survival follow-up
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
Admitted to an institution by administrative or court order

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

540

Study ID:

NCT03940196

Recruitment Status:

Completed

Sponsor:

NovoCure Ltd.

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There are 115 Locations for this study

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Arizona Oncology- Biltmore Cancer Center
Phoenix Arizona, 85016, United States
Arizona Oncology
Tucson Arizona, 85711, United States
University of California
La Jolla California, 92093, United States
Hoag Memorial Hospital Presbyterian
Newport Beach California, 92663, United States
California Pacific Medical Center- Pacific Campus
San Francisco California, 94109, United States
Olive View - UCLA Medical Center
Sylmar California, 91342, United States
Rocky Mountain Cancer Centers
Aurora Colorado, 80012, United States
University of Colorado Denver
Aurora Colorado, 80045, United States
Rocky Mountain Cancer Centers
Boulder Colorado, 80303, United States
Rocky Mountain Cancer Centers
Colorado Springs Colorado, 80907, United States
Rocky Mountain Cancer Centers
Denver Colorado, 80218, United States
Rocky Mountain Cancer Centers
Denver Colorado, 80220, United States
Rocky Mountain Cancer Centers
Lakewood Colorado, 80228, United States
Rocky Mountain Cancer Centers
Littleton Colorado, 80120, United States
Rocky Mountain Cancer Centers
Lone Tree Colorado, 80124, United States
Rocky Mountain Cancer Centers
Longmont Colorado, 80501, United States
Rocky Mountain Cancer Centers
Parker Colorado, 80138, United States
Rocky Mountain Cancer Centers
Pueblo Colorado, 81008, United States
Rocky Mountain Cancer Centers
Thornton Colorado, 80260, United States
Broward Health Medical Center
Fort Lauderdale Florida, 33316, United States
AdventHealth Cancer Institute
Orlando Florida, 32804, United States
Northeast Georgia Medical Center
Gainesville Georgia, 30501, United States
Rush University Cancer Center - Chicago and Innovation
Chicago Illinois, 60612, United States
Des Moines Oncology Research Association
Des Moines Iowa, 50309, United States
Norton Cancer Institute
Louisville Kentucky, 40202, United States
Maryland Oncology Hematology, P.A.
Silver Spring Maryland, 20902, United States
Lahey Hospital & Medical Center
Burlington Massachusetts, 01805, United States
Minnesota Oncology Hematology, PA
Saint Paul Minnesota, 55102, United States
Washington University School of Medicine in St. Louis
Saint Louis Missouri, 63110, United States
Methodist Estabrook Cancer Center
Omaha Nebraska, 68114, United States
Women's Cancer Center of Nevada
Las Vegas Nevada, 89169, United States
Center of Hope at Renown Medical Center
Reno Nevada, 89502, United States
MD Anderson Cancer Center at Cooper
Camden New Jersey, 08103, United States
The Valley Hospital
Paramus New Jersey, 07652, United States
Wake Forest Baptist Medical Center
Winston-Salem North Carolina, 27157, United States
Miami Valley Hospital South
Centerville Ohio, 45459, United States
The Ohio State University Wexner Medical Center
Columbus Ohio, 43210, United States
Northwest Cancer Specialists, PC
Portland Oregon, 97227, United States
West Penn OB/GYN
Pittsburgh Pennsylvania, 15212, United States
UPMC Cancer Center
Pittsburgh Pennsylvania, 15232, United States
Abington Hospital- Asplundh Cancer Pavilion
Willow Grove Pennsylvania, 19001, United States
Women & Infants Hospital of Rhode Island
Providence Rhode Island, 02905, United States
Sanford Gynecologic Oncology Clinic
Sioux Falls South Dakota, 57104, United States
Texas Oncology Austin-Balcones
Austin Texas, 78731, United States
Texas Oncology Austin-Midtown
Austin Texas, 78745, United States
Texas Oncology Austin-North Austin
Austin Texas, 78758, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75216, United States
Texas Oncology
Dallas Texas, 75246, United States
Texas Oncology-Fort Worth
Fort Worth Texas, 76104, United States
The University of Texas Medical School at Houston
Houston Texas, 77030, United States
Texas Oncology-McAllen
McAllen Texas, 78503, United States
Texas Oncology San Antonio Medical Center
San Antonio Texas, 78240, United States
Texas Oncology - Sugar Land
Sugar Land Texas, 77479, United States
Texas Oncology
The Woodlands Texas, 77380, United States
Texas Oncology-Tyler
Tyler Texas, 75702, United States
Texas Oncology-Deke Slayton Cancer Center
Webster Texas, 77598, United States
Virginia Oncology Associates
Norfolk Virginia, 23502, United States
Carilion Clinic-Gynecologic Oncology
Roanoke Virginia, 24016, United States
Multicare Institute for Research and Innovation
Tacoma Washington, 98405, United States
KH der Barmherzigen Brüder Graz
Graz , 8020, Austria
Univ.-Klinik für Gynäkologie und Geburtshilfe
Graz , 8036, Austria
Univ.-Klinik für Gynäkologie und Geburtshilfe, Innsbruck
Innsbruck , , Austria
Landesfrauenklinik Salzburg
Salzburg , 5020, Austria
Imelda Ziekenhuis Bonheiden
Bonheiden , 2820, Belgium
Cliniques Universitaires Saint Luc, Institut Roi Albert II
Brussel , 1200, Belgium
Grand Hôpital de Charleroi, Oncologie-Hématologie
Charleroi , 6000, Belgium
AZ Maria Middelares, Clinical Trial Unit Medical Oncology - Integrated Cancer Center Ghent
Gent , 9000, Belgium
UZ Gent
Gent , 9000, Belgium
University Hospitals Leuven, Leuven Cancer Institute
Leuven , , Belgium
CHU Ambroise Paré
Mons , 7000, Belgium
CHU UCL Namur - Site Ste Elisabeth
Namur , 5000, Belgium
CancerCare Manitoba
Winnipeg Manitoba, R3E)V, Canada
Centre Hospitalie
Montréal Quebec, H2X 0, Canada
Tom Baker Cancer Center
Calgary , H2L 4, Canada
McGill University Health Centre
Montréal , H4A 3, Canada
Jewish General Hospital
Montréal , QC H3, Canada
Onkologická Klinika Fakultní nemocnice Olomouc
Olomouc , 779 0, Czechia
University Hospital Ostrava
Ostrava-Poruba , 708 5, Czechia
Gynekologicko-porodnická klinika, Fakultní nemocnice Královské Vinohrady
Praha 10 , 100 3, Czechia
Gynekologicko-porodnická klinika 1. LF UK a VFN
Praha 2 , 128 0, Czechia
Gynekologicko-porodnické oddělení - Nemocnice České Budějovice a.s.
České Budějovice , 370 0, Czechia
Charité Universitätsmedizin Berlin, Campus Virchow-Klinikum, Klinik für Gynäkologie
Berlin , 1200, Germany
Universitätsklinikum Carl Gustav Carus
Dresden , 01307, Germany
Horst-Schmidt-Kliniken, Gynecology and Gynecologic, Oncology Department
Wiesbaden , 65199, Germany
Semmelweis University
Budapest , 1085, Hungary
Nőgyógyászati Osztály, Országos Onkológiai Intézet
Budapest , 1122, Hungary
Szuleszeti és Nogyogyaszati Klinika
Debrecen , 4032, Hungary
Hillel Yaffe Medical Center
Hadera , 38100, Israel
Saare Zedek Medical Center - Gyneco-Oncology
Jerusalem , 91031, Israel
Oncology Institute, Galilee Medical Center
Nahariya , 22100, Israel
Gyneco-Oncology Chaim Sheba Medical Center
Ramat Gan , 52656, Israel
Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii
Bologna , 40138, Italy
Presidio Ospedaliero Antonio Perrino - ASL Brindisi
Brindisi , 72100, Italy
ASST Lecco - Ospedale Manzoni, Dipartimento Oncologico
Lecco , 23900, Italy
Dipartimento Medicina e Chirurgia, Università Milano-Bicocca, Direttore Programma Ginecologia Oncologica, Istituto Europeo Oncologia
Milano , 20141, Italy
IRCCS Ospedale San Raffaele, U.O. Ginecologia-Ematologia e TMO
Milano , 60 20, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Napoli , 80130, Italy
Fondazione Policlinico Universitario Gemelli
Roma , 00168, Italy
University Saint Anna
Torino , 10126, Italy
Amsterdam Universitair Medische centra
Amsterdam , 1105, Netherlands
University Medical Center Utrech
Utrecht , 3508, Netherlands
Szpitale Pomorskie Sp. z o.o.
Gdynia , 81-51, Poland
Oddział Kliniczny Chirurgii Ogólnej i Onkologicznej, Szpital Św. Rafała
Kraków , 30-69, Poland
Uniwersytet Medyczny w Lublinie, I Klinika Ginekologii Onkologicznej i Ginekologii
Lublin , 20-08, Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie, Oddział Kliniczny Onkologii i Immunoonkologii z Ośrodkiem Dziennym Terapii Onkologicznej
Olsztyn , 10-22, Poland
Oddział Ginekologii Onkologicznej Katedry i Kliniki Onkologii Uniwersytetu Medycznego w Poznaniu
Poznań , 60-56, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie, Klinika Ginekologii Operacyjnej i Onkologii Ginekologicznej Dorosłych i Dziewcząt
Szczecin , 70-11, Poland
Szpital Kliniczny im. ks. Anny Mazowieckiej
Warsaw , 00-31, Poland
Servicio de Oncología Médica, Hospital Universitario Quirón Dexeus
Barcelona , 08028, Spain
lnstitut Catala d'Oncologia, Hospital Universitario Dr. Josep Trueta, Servicio de Oncologia,
Girona , 17007, Spain
Clinica Universidad de Navarra en Madrid
Madrid , 28027, Spain
Hospital MD Anderson Cancer Center
Madrid , 28033, Spain
Hospital Universitario Ramon y Cajal, Servicio de Oncologia Médica
Madrid , 28034, Spain
Hospital 12 de Octubre. Servicio Oncología Médica
Madrid , 28041, Spain
Fundació Institut d'Investigació Sanitària Illes Balears - IdISBa, Hospital Universitari Son Espases
Palma De Mallorca , 07120, Spain
Gynecological Tumor Center, University Hospital Basel
Basel , 4031, Switzerland
IOSI Bellinzona, Oncology Institute of Southern Switzerland, Ospedale San Giovanni
Bellinzona , 6500, Switzerland
Kantonsspital Frauenfeld - Frauenklinik
Frauenfeld , 8501, Switzerland
UniversitätsSpital Zürich - Klinik für Gynäkologie
Zürich , 8091, Switzerland

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

540

Study ID:

NCT03940196

Recruitment Status:

Completed

Sponsor:


NovoCure Ltd.

How clear is this clinincal trial information?

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