A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy

Fallopian Tube Cancer Clinical Trial

— ATHENA  

Official title:

ATHENA (A Multicenter, Randomized, Double-Blind, Placebo- Controlled Phase 3 Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03522246
• Other study ID #: CO-338-087/GOG-3020/ENGOT-ov45
• Secondary ID: 2017-004557-17
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 14, 2018
• Est. completion date: December 30, 2030

Study information

• Verified date: September 2023
• Source: pharmaand GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 3, randomized, multinational, double-blind, dual placebo-controlled, 4-arm study evaluating rucaparib and nivolumab as maintenance treatment following response to front-line treatment in newly diagnosed ovarian cancer patients. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: December 30, 2030
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Newly diagnosed advanced (FIGO stage III-IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.
• Completed cytoreductive surgery, including at least a bilateral salpingo-oophorectomy and partial omentectomy, either prior to chemotherapy (primary surgery) or following neoadjuvant chemotherapy (interval debulking)
• Completed first-line platinum-based chemotherapy and surgery with a response, in the opinion of the Investigator
• Sufficient tumor tissue for planned analysis
• ECOG performance status of 0 or 1
• Patients must be 20 years of age to consent in Japan, Taiwan and South Korea; in all other participating countries patients must be 18 years of age to consent

Exclusion Criteria:

• Pure sarcomas or borderline tumors or mucinous tumors
• Active second malignancy
• Known central nervous system brain metastases
• Any prior treatment for ovarian cancer, other than the first-line platinum regimen
• Evidence of interstitial lung disease or active pneumonitis
• Active, known or suspected autoimmune disease
• Condition requiring active systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Complete Response
• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• FIGO Stage III-IV
• Newly Diagnosed
• Ovarian Neoplasms
• Partial Response
• Primary Peritoneal

Intervention

Drug:
• Rucaparib
Oral rucaparib will be administered twice daily
• Nivolumab
IV nivolumab will be administered once every 4 weeks
• Placebo Oral Tablet
Placebo tablets will be administered twice daily
• Placebo IV Infusion
IV placebo will be administered once every 4 weeks

Locations

Country	Name	City	State
Australia	Royal Brisbane and Women's Hospital	Brisbane	Queensland
Australia	Peter MacCallum Cancer Center	Melbourne	Victoria
Australia	Newcastle Private Hospital	New Lambton Heights	New South Wales
Australia	Northern Cancer Institute St Leonards	Saint Leonards	New South Wales
Australia	St John of God Subiaco Hospital	Subiaco	Western Australia
Australia	Prince of Wales Hospital	Sydney	New South Wales
Australia	Brian Fricker Oncology Centre, Burnside Hospital	Toorak Gardens	South Australia
Australia	Westmead Hospital	Westmead	New South Wales
Belgium	UZ Leven	Leuven
Canada	BC Cancer - Abbotsford	Abbotsford	British Columbia
Canada	Alberta Health Services - University of Calgary	Calgary	Alberta
Canada	Alberta Health Services and The University of Alberta	Edmonton	Alberta
Canada	Nsha-Qeii Hsc	Halifax	Nova Scotia
Canada	Juravinski Cancer Center	Hamilton	Ontario
Canada	BC Cancer - Kelowna	Kelowna	British Columbia
Canada	London Health Sciences Center	London	Ontario
Canada	Centre Hospitalier de l'Université de Montreal	Montréal	Quebec
Canada	McGill University Health Center	Montréal	Quebec
Canada	Ottawa Hospital Cancer Centre	Ottawa	Ontario
Canada	Centre Integre Universitaire de sante et de service sociaux de l'Estri-Centre hospitalier univeritaire de Sherbrooke	Sherbrooke	Quebec
Canada	BC Cancer - Surrey	Surrey	British Columbia
Canada	CancerCare Manitoba	Winnipeg	Manitoba
Czechia	Masaryk Memorial Cancer Institute	Brno
Czechia	Department of Gynecology and Obstetrics, Oncogynecological center U hiversity Hospital Kralovske Vinohrady	Prague
Czechia	KOC KNTB a.s. Zlfn, Hvalfckovo nabrezf 600, 76001	Zlín
Denmark	Aalborg University Hospital	Aalborg
Denmark	Odense University Hospital	Odense
Finland	Kuopio University Hospital	Kuopio
Germany	Klinik für Frauenheilkunde und Geburtshilfe	Dessau
Germany	Universitaetsklinikum Duesseldorf / Klinik fur Frauenheilkunde & Geburtshilfe	Duesseldorf
Germany	Universitatsklinikum National Centrum for Tumor Disease (NCT)	Heidelberg
Germany	Universitätslinikum Mannheim, Frauenklinik	Mannheim
Germany	Kliniken Suedostbayern AG, Klinikum Traunstein	Traunstein
Greece	Alexandra Hospital	Athens
Greece	Attikon General University Hospital	Chaidari	Athens
Greece	University Hospital Attikon	Chaidari	Athens
Greece	General Hospital of Patras	Patra
Greece	Euromedica General Clinic, B' Oncology Clinic	Thessaloniki
Ireland	Bon Secours Hospital	Cork
Ireland	Cork University Hospital	Cork
Ireland	University Hospital Limerick	Limerick
Ireland	University Hospital Waterford	Waterford
Israel	Shaare Zedek Medical Oncology	Jerusalem
Israel	Meir Medical Center	Kfar Saba
Israel	Galilee Medical Center	Nahariya
Israel	Sheba Medical Center	Ramat Gan
Israel	Ziv Medical Center	Safed
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Italy	Centro di Riferimento Oncologico, CRO-IRCCS	Aviano
Italy	Candiolo Cancer Institute - IRCCS	Candiolo
Italy	Arnas Garibaldi	Catania
Italy	University G, D'Annunuzio-Chieti	Chieti
Italy	IRCCS Instituto Nazionale Tumori	Napoli
Italy	Azienda Ospedaliera Universitaria Policlinico Umberto I	Roma
Italy	Ospedale S. Giovanni Calibita Fatebenefratelli	Roma
Italy	Policlinico Agostino Gemelli	Roma
Italy	Ospedale San Bortolo	Vicenza
Japan	Hyogo Cancer Center	Akashi	Hyogo
Japan	Osaka International Cancer Institute	Chuo	Osaka
Japan	Saitama Medical University International Medical Center	Hidaka	Saitama
Japan	National Cancer Center Hospital East	Kashiwa	Chiba
Japan	Nippon Medical School Musashikosugi Hospital	Kawasaki-shi	Kanagawa
Japan	The Cancer Institute Hospital of JFCR	Koto-Ku	Tokyo
Japan	Kurume University Hospital	Kurume	Fukuoka
Japan	Gunma University Hospital	Maebashi	Gunma
Japan	Iwate Medical University	Morioka	Iwate
Japan	Hiroshima City Hiroshima Citizens Hospital	Naka	Hiroshima
Japan	Kindai University Hospital	Osaka-sayama	Osaka
Japan	Gunma Prefectural Cancer Center	Ota-shi	Gunma
Japan	Saitama Cancer Center	Saitama
Japan	Keio University Hospital	Shinjuku-Ku	Shinanomachi
Japan	Kagawa Prefectural Central Hospital	Takamatsu
Japan	National Defense Medical College Hospital	Tokorozawa	Namiki
Japan	National Cancer Center Hospital	Tokyo
Japan	University of Tsukuba Hospital	Tsukuba	Amakubo
Japan	Kanagawa Cancer Center	Yokohama	Kanagawa
Japan	Yokohama City University Hospital	Yokohama	Fukuura
Korea, Republic of	SoonChunHyang Univeristy Cheonan Hosptial	Cheonan
Korea, Republic of	National Cancer Center	Goyang-si	Gyeonggi-do
Korea, Republic of	Gachon University Gil Medical Center	Incheon	Seoul
Korea, Republic of	CHA Bundang Medical Center	Seongnam	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Korea Cancer Center Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital,Yonsei University Health System	Seoul
Korea, Republic of	Ajou University Hospital	Suwon-si
New Zealand	Auckland City Hospital	Auckland
New Zealand	Christchurch Hospital	Christchurch
New Zealand	Waikato Hospital	Hamilton
New Zealand	Palmerston North Hospital	Palmerston North
New Zealand	Tauranga Hospital	Tauranga
Poland	Bialostockie Centrum Onkologii Oddzial Onkologii Ginekologicznej	Bialystok
Poland	University Hospital of Bialystok	Bialystok
Poland	Szpitale Pomorskie sp zoo	Gdynia
Poland	Medical University of Lublin	Lublin
Poland	Wielkopolskie Centrum Onkologii	Poznan
Poland	Pomeranian Medical University	Szczecin
Poland	Chair & department of Obsterics, Gynaecology and Oncology (previous site)	Warsaw	Kondratowicza
Romania	Oncopremium Team	Baia Mare
Romania	SC Quantum Medical Center SRL	Bucuresti
Romania	Instiute of Oncology - Medical Oncology	Cluj-Napoca
Romania	S.C. Medisprof S.R.L.	Cluj-Napoca	Jud. Cluj
Romania	Centrul de Oncologie Sf.Nectarie	Craiova
Romania	S.C Oncolab S.R.L	Craiova
Romania	Institutul Regional de Oncologie Iasi	Iasi
Romania	Spitalul Clinic Municipal "Dr. Gavril Curteanu"	Oradea	Jud. Bihor
Romania	Spital Municipal Ploiesti	Ploiesti
Romania	Spitalul Judetean de Urgenta "Sfantul Ioan cel Nou" Suceava	Suceava
Romania	ONCOMED Timisoara	Timisoara
Russian Federation	Arkhangelsk Clinical Oncological Dispensary	Arkhangel'sk
Russian Federation	BHI of Omsk Region Clinical Oncology Dispensary	Omsk
Russian Federation	Orenburg Regional Clinical Oncological Dispensary	Orenburg
Russian Federation	SBHI Saint Petersburg Research Center specialized types of medical care (Oncology)	Pesochnyy
Russian Federation	SBHI SR Pyatigorsk Interdistrict Oncology Dispensary	Pyatigorsk
Russian Federation	1st Medical University	Saint Petersburg
Russian Federation	FSBEI HE I.P. Pavlov SPbSMU MoH Russia	Saint Petersburg
Russian Federation	Limited Liability Company MedPomosch	Saint Petersburg
Russian Federation	Saint-Petersburg State Budget Institution of Healthcare City Clinical Oncology Dispensary	Saint Petersburg
Russian Federation	Federa; State Budgetary Educational Institution of Higher Education National Research Ogarev Mordovia State University	Saransk
Russian Federation	State Medical Institution "Oncology Center #2" under the Krasnodar Region Healthcare Department	Sotchi
Singapore	National Cancer Center Singapore	Singapore
Singapore	National University Hospital	Singapore
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Vall d'Hebron Institute of Oncology	Barcelona
Spain	Hospital Universitario Basurto	Bilbao
Spain	Consorcio Hospitalario Provincial Castellon	Castillón
Spain	Hospital Virgen de la Arrixaca	El Palmar
Spain	Hospital de Jerez	Jerez de la Frontera
Spain	Hospital Universitario Puerta de Hierro - Majadahonda	Madrid
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	Hospital Son Llatzer	Palma De Mallorca
Spain	Hospital Nuestra Señora de Valme	Sevilla
Sweden	Onkologiska Kliniken	Linköping
Sweden	Onkologiska Kliniken	Lund
Sweden	Karolinska Universitetssjukhuset	Stockholm
Taiwan	Hualien Tzu Chi Hospital	Hualien City
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung
Taiwan	Far Eastern Memorial Hospital	New Taipei City
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Chi Mei Hospital, Liouying (CMHLY)	Tainan
Taiwan	Chi Mei Medical Center (CMMC)	Tainan
Taiwan	Mackay Memorial Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Medical Univeristy Hopsital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Taiwan	Chang Gung Medical Foundation- Linkou Branch	Taoyuan
Turkey	Dr. Abdurrahman Yurtaslan Ankara Women's Health Education and Research Hospital	Ankara
Turkey	Istanbul University-cerrahpasa, Cerrahpasa School of Medicine	Istanbul
Turkey	Koc University School of Medicine, Koc University Hospital	Istanbul
Turkey	Celal Bayar University Faculty of Medicine	Manisa
Turkey	Baskent University Hospital	Yuregir
United Kingdom	Royal Sussex County Hospital	Brighton
United Kingdom	Bristol Cancer Institute Medical Oncology	Bristol
United Kingdom	Addenbrookes Hospital	Cambridge
United Kingdom	East Kent Hospitals University NHS Foundation trust Medical Oncology	Canterbury	Kent
United Kingdom	Northampton General Hospital	Cliftonville	Northampton
United Kingdom	Western General Hospital	Edinburgh
United Kingdom	University Hospitals of Morecambe Bay NHS Foundation Trust	Lancaster
United Kingdom	St. James University Hospital	Leeds
United Kingdom	Barts and the London NHS Trust	London
United Kingdom	Guy's & St Thomas' NHS Foundation Trust (Guy's Cancer Centre)	London
United Kingdom	Imperial College London	London
United Kingdom	The Royal Marsden NHS Foundation Trust	London
United Kingdom	University of College London Hospital	London
United Kingdom	The James Cook University Hospital	Middlesbrough
United Kingdom	Poole Hospital NHS Foundation Trust	Poole
United Kingdom	South West Wales Cancer Centre - Singleton Hospital	Swansea
United Kingdom	Musgrove Park Hospital	Taunton
United States	Women's Cancer Care Associates	Albany	New York
United States	Northside Hospital	Atlanta	Georgia
United States	Augusta University	Augusta	Georgia
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	Texas Oncology - Austin Central	Austin	Texas
United States	SKCCC at Johns Hopkins	Baltimore	Maryland
United States	Texas Oncology - Bedford	Bedford	Texas
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	MD Anderson Cancer Center at Cooper	Camden	New Jersey
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	Oncology Hematology Care, Inc	Cincinnati	Ohio
United States	University of Cincinnati	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	MD Anderson Cancer Center - Ohio Health	Columbus	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	John Muir Clinical Research Center	Concord	California
United States	Texas Oncology - Dallas Presbyterian Hospital	Dallas	Texas
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Oncology Associates of Oregon, P.C.	Eugene	Oregon
United States	Summit Medical Group	Florham Park	New Jersey
United States	Florida Gynecologic Oncology	Fort Myers	Florida
United States	Texas Oncology - Fort Worth	Fort Worth	Texas
United States	Dr. Sudarshan K. Sharma, Ltd - Gynecologic Oncology	Hinsdale	Illinois
United States	Memorial Hermann	Houston	Texas
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Community Health Network	Indianapolis	Indiana
United States	University of Iowa Hospitals	Iowa City	Iowa
United States	MD Anderson Cancer Center-Baptist	Jacksonville	Florida
United States	Broome Oncology, LLC	Johnson City	New York
United States	Northwell Health Monter Cancer Center	Lake Success	New York
United States	Rocky Mountain Cancer Centers	Lakewood	Colorado
United States	Women's Cancer Center of Nevada	Las Vegas	Nevada
United States	University of Kentucky	Lexington	Kentucky
United States	UCLA Women's Health Clinical Research Unit	Los Angeles	California
United States	Norton Cancer Institute	Louisville	Kentucky
United States	Baptist Health Medical Group Oncology, LLC	Miami	Florida
United States	Froedtert and Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Yale University	New Haven	Connecticut
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	New York University Medical Center	New York	New York
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	University of Oklahoma Health Science Center	Oklahoma City	Oklahoma
United States	Florida Hospital	Orlando	Florida
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Arizona Oncology Associates, PC - HAL	Phoenix	Arizona
United States	UPMC Magee-Womens Hospital	Pittsburgh	Pennsylvania
United States	LMG Gynecologic Oncology	Portland	Oregon
United States	Northwest Cancer Specialists, P.C.	Portland	Oregon
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Metro Minnesota Community Oncology Research Consortium	Saint Louis Park	Minnesota
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Texas Oncology - San Antonio Medical Center	San Antonio	Texas
United States	Kaiser Permanente Northern California	San Francisco	California
United States	Maine Medical Center	Scarborough	Maine
United States	Avera Gynecologic Oncology	Sioux Falls	South Dakota
United States	Van le	Springfield	Illinois
United States	Texas Oncology - The Woodlands, Gynecologic Oncology	The Woodlands	Texas
United States	Arizona Oncology Associates, PC - HOPE	Tucson	Arizona
United States	The University of Arizona Cancer Center	Tucson	Arizona
United States	Oklahoma Cancer Specialists and Research Institute	Tulsa	Oklahoma
United States	University of Kansas Cancer Center	Westwood	Kansas
United States	Abington Memorial Hospital	Willow Grove	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
pharmaand GmbH	Bristol-Myers Squibb, European Network of Gynaecological Oncological Trial Groups (ENGOT), Foundation Medicine, Gynecologic Oncology Group

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Czechia,  Denmark,  Finland,  Germany,  Greece,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  New Zealand,  Poland,  Romania,  Russian Federation,  Singapore,  Spain,  Sweden,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator assessed Progression-free survival (PFS)		From randomization until disease progression (up to approximately 7 years)
Secondary	Blinded independent central review (BICR) PFS		Every ~12 weeks after the start of combination treatment for ~3 years, then every ~24 weeks thereafter until disease progression. Study data collection expected to last for ~7 years
Secondary	Overall Survival (OS)		From enrollment to primary study completion of study (up to approximately 10 years)
Secondary	Objective response rate (ORR)		For patients with measurable disease, every ~12 weeks after the start of combination treatment for ~3 years, then every ~24 weeks thereafter until disease progression. Study data collection expected to last for ~7 years
Secondary	Duration of response (DOR)		For patients with measurable disease, every ~12 weeks after the start of combination treatment for ~3 years, then every ~24 weeks thereafter until disease progression. Study data collection expected to last for ~7 years
Secondary	Number of participants with treatment-emergent Adverse Events (AEs) as assessed by CTCAE v4 (or higher) as a measure of safety and tolerability		Collected from the time patient receives first dose of study drug until post treatment safety follow-up period (up to approximately 10 years)
Secondary	Number of participants with serious AEs as a measure of safety and tolerability		Collected from the time patient receives first dose of study drug until post treatment safety follow-up period (up to approximately 10 years)
Secondary	Number of participants with laboratory abnormalities as a measure of safety and tolerability		Collected from the time patient receives first dose of study drug until post treatment safety follow-up period (up to approximately 10 years)