Clinical trial NCT03522246: A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Epithelial Ovarian Cancer
Primary Peritoneal
Fallopian Tube Cancer
Newly Diagnosed
FIGO Stage III-IV
Partial Response
Complete Response
Keywords: PARP inhibitor
PARPi
HRD
ATHENA
homologous recombination
DNA repair
LOH
DNA defect
DNA anomaly
Rucaparib
Nivolumab
PD-1
Immuno-
oncology
Tumor
mutational
burden
BRCA
First-line
Primary Therapy
Primary Treatment
Lead sponsor: pharmaand GmbH
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
name: Gynecologic Oncology Group
name: European Network of Gynaecological Oncological Trial Groups (ENGOT)
name: Foundation Medicine
First posted: 2018-05-11
Enrollment: 1097
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Investigator assessed Progression-free survival (PFS)
timeFrame: From randomization until disease progression (up to approximately 7 years)
Secondary outcomes:
measure: Blinded independent central review (BICR) PFS
timeFrame: 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
measure: Overall Survival (OS)
timeFrame: From enrollment to primary study completion of study (up to approximately 10 years)
measure: Objective response rate (ORR)
timeFrame: 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
measure: Duration of response (DOR)
timeFrame: 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
measure: Number of participants with treatment-emergent Adverse Events (AEs) as assessed by CTCAE v4 (or higher) as a measure of safety and tolerability
timeFrame: Collected from the time patient receives first dose of study drug until post treatment safety follow-up period (up to approximately 10 years)
measure: Number of participants with serious AEs as a measure of safety and tolerability
timeFrame: Collected from the time patient receives first dose of study drug until post treatment safety follow-up period (up to approximately 10 years)
measure: Number of participants with laboratory abnormalities as a measure of safety and tolerability
timeFrame: Collected from the time patient receives first dose of study drug until post treatment safety follow-up period (up to approximately 10 years)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Oncology Associates, PC - HAL
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates, PC - HOPE
state: Arizona
city: Tucson
country: United States
facility: The University of Arizona Cancer Center
state: Arizona
city: Concord
country: United States
facility: John Muir Clinical Research Center
state: California
city: Los Angeles
country: United States
facility: UCLA Women's Health Clinical Research Unit
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Northern California
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Lakewood
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Fort Myers
country: United States
facility: Florida Gynecologic Oncology
state: Florida
city: Jacksonville
country: United States
facility: MD Anderson Cancer Center-Baptist
state: Florida
city: Miami
country: United States
facility: Baptist Health Medical Group Oncology, LLC
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Hinsdale
country: United States
facility: Dr. Sudarshan K. Sharma, Ltd - Gynecologic Oncology
state: Illinois
city: Springfield
country: United States
facility: Van le
state: Illinois
city: Indianapolis
country: United States
facility: Community Health Network
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals
state: Iowa
city: Westwood
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Scarborough
country: United States
facility: Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: SKCCC at Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Saint Louis Park
country: United States
facility: Metro Minnesota Community Oncology Research Consortium
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Las Vegas
country: United States
facility: Women's Cancer Center of Nevada
state: Nevada
city: Camden
country: United States
facility: MD Anderson Cancer Center at Cooper
state: New Jersey
city: Florham Park
country: United States
facility: Summit Medical Group
state: New Jersey
city: Albany
country: United States
facility: Women's Cancer Care Associates
state: New York
city: Johnson City
country: United States
facility: Broome Oncology, LLC
state: New York
city: Lake Success
country: United States
facility: Northwell Health Monter Cancer Center
state: New York
city: New York
country: United States
facility: New York University Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Inc
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Columbus
country: United States
facility: MD Anderson Cancer Center - Ohio Health
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Science Center
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute
state: Oklahoma
city: Eugene
country: United States
facility: Oncology Associates of Oregon, P.C.
state: Oregon
city: Portland
country: United States
facility: LMG Gynecologic Oncology
state: Oregon
city: Portland
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Magee-Womens Hospital
state: Pennsylvania
city: Willow Grove
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Avera Gynecologic Oncology
state: South Dakota
city: Austin
country: United States
facility: Texas Oncology - Austin Central
state: Texas
city: Bedford
country: United States
facility: Texas Oncology - Bedford
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Dallas Presbyterian Hospital
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology - Fort Worth
state: Texas
city: Houston
country: United States
facility: Memorial Hermann
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology - San Antonio Medical Center
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology - The Woodlands, Gynecologic Oncology
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Milwaukee
country: United States
facility: Froedtert and Medical College of Wisconsin
state: Wisconsin
city: New Lambton Heights
country: Australia
facility: Newcastle Private Hospital
state: New South Wales
city: Saint Leonards
country: Australia
facility: Northern Cancer Institute St Leonards
state: New South Wales
city: Sydney
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Toorak Gardens
country: Australia
facility: Brian Fricker Oncology Centre, Burnside Hospital
state: South Australia
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Center
state: Victoria
city: Subiaco
country: Australia
facility: St John of God Subiaco Hospital
state: Western Australia
city: Leuven
country: Belgium
facility: UZ Leven
city: Calgary
country: Canada
facility: Alberta Health Services - University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: Alberta Health Services and The University of Alberta
state: Alberta
city: Abbotsford
country: Canada
facility: BC Cancer - Abbotsford
state: British Columbia
city: Kelowna
country: Canada
facility: BC Cancer - Kelowna
state: British Columbia
city: Surrey
country: Canada
facility: BC Cancer - Surrey
state: British Columbia
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
state: Manitoba
city: Halifax
country: Canada
facility: Nsha-Qeii Hsc
state: Nova Scotia
city: Hamilton
country: Canada
facility: Juravinski Cancer Center
state: Ontario
city: London
country: Canada
facility: London Health Sciences Center
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Cancer Centre
state: Ontario
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montreal
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Center
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Integre Universitaire de sante et de service sociaux de l'Estri-Centre hospitalier univeritaire de Sherbrooke
state: Quebec
city: Brno
country: Czechia
facility: Masaryk Memorial Cancer Institute
city: Prague
country: Czechia
facility: Department of Gynecology and Obstetrics, Oncogynecological center U hiversity Hospital Kralovske Vinohrady
city: Zlín
country: Czechia
facility: KOC KNTB a.s. Zlfn, Hvalfckovo nabrezf 600, 76001
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Dessau
country: Germany
facility: Klinik für Frauenheilkunde und Geburtshilfe
city: Duesseldorf
country: Germany
facility: Universitaetsklinikum Duesseldorf / Klinik fur Frauenheilkunde & Geburtshilfe
city: Heidelberg
country: Germany
facility: Universitatsklinikum National Centrum for Tumor Disease (NCT)
city: Mannheim
country: Germany
facility: Universitätslinikum Mannheim, Frauenklinik
city: Traunstein
country: Germany
facility: Kliniken Suedostbayern AG, Klinikum Traunstein
city: Chaidari
country: Greece
facility: Attikon General University Hospital
state: Athens
city: Chaidari
country: Greece
facility: University Hospital Attikon
state: Athens
city: Athens
country: Greece
facility: Alexandra Hospital
city: Patra
country: Greece
facility: General Hospital of Patras
city: Thessaloniki
country: Greece
facility: Euromedica General Clinic, B' Oncology Clinic
city: Cork
country: Ireland
facility: Cork University Hospital
city: Cork
country: Ireland
facility: Bon Secours Hospital
city: Limerick
country: Ireland
facility: University Hospital Limerick
city: Waterford
country: Ireland
facility: University Hospital Waterford
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Oncology
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Nahariya
country: Israel
facility: Galilee Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Safed
country: Israel
facility: Ziv Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico, CRO-IRCCS
city: Candiolo
country: Italy
facility: Candiolo Cancer Institute - IRCCS
city: Catania
country: Italy
facility: Arnas Garibaldi
city: Chieti
country: Italy
facility: University G, D'Annunuzio-Chieti
city: Napoli
country: Italy
facility: IRCCS Instituto Nazionale Tumori
city: Roma
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Umberto I
city: Roma
country: Italy
facility: Policlinico Agostino Gemelli
city: Roma
country: Italy
facility: Ospedale S. Giovanni Calibita Fatebenefratelli
city: Vicenza
country: Italy
facility: Ospedale San Bortolo
city: Tsukuba
country: Japan
facility: University of Tsukuba Hospital
state: Amakubo
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Kurume
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
state: Fukuura
city: Maebashi
country: Japan
facility: Gunma University Hospital
state: Gunma
city: Ota-shi
country: Japan
facility: Gunma Prefectural Cancer Center
state: Gunma
city: Naka
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital
state: Hiroshima
city: Akashi
country: Japan
facility: Hyogo Cancer Center
state: Hyogo
city: Morioka
country: Japan
facility: Iwate Medical University
state: Iwate
city: Kawasaki-shi
country: Japan
facility: Nippon Medical School Musashikosugi Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Tokorozawa
country: Japan
facility: National Defense Medical College Hospital
state: Namiki
city: Chuo
country: Japan
facility: Osaka International Cancer Institute
state: Osaka
city: Ōsaka-sayama
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center
state: Saitama
city: Shinjuku-Ku
country: Japan
facility: Keio University Hospital
state: Shinanomachi
city: Koto-Ku
country: Japan
facility: The Cancer Institute Hospital of JFCR
state: Tokyo
city: Saitama
country: Japan
facility: Saitama Cancer Center
city: Takamatsu
country: Japan
facility: Kagawa Prefectural Central Hospital
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center
state: Gyeonggi-do
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Seoul
city: Cheonan
country: Korea, Republic of
facility: SoonChunHyang University Cheonan Hospital
city: Seoul
country: Korea, Republic of
facility: Korea Cancer Center Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Palmerston North
country: New Zealand
facility: Palmerston North Hospital
city: Tauranga
country: New Zealand
facility: Tauranga Hospital
city: Warsaw
country: Poland
facility: Chair & department of Obsterics, Gynaecology and Oncology (previous site)
state: Kondratowicza
city: Bialystok
country: Poland
facility: Bialostockie Centrum Onkologii Oddzial Onkologii Ginekologicznej
city: Białystok
country: Poland
facility: University Hospital of Bialystok
city: Gdynia
country: Poland
facility: Szpitale Pomorskie sp zoo
city: Lublin
country: Poland
facility: Medical University of Lublin
city: Poznań
country: Poland
facility: Wielkopolskie Centrum Onkologii
city: Szczecin
country: Poland
facility: Pomeranian Medical University
city: Oradea
country: Romania
facility: Spitalul Clinic Municipal "Dr. Gavril Curteanu"
state: Jud. Bihor
city: Cluj-Napoca
country: Romania
facility: S.C. Medisprof S.R.L.
state: Jud. Cluj
city: Baia Mare
country: Romania
facility: Oncopremium Team
city: Bucuresti
country: Romania
facility: SC Quantum Medical Center SRL
city: Cluj-Napoca
country: Romania
facility: Instiute of Oncology - Medical Oncology
city: Craiova
country: Romania
facility: Centrul de Oncologie Sf.Nectarie
city: Craiova
country: Romania
facility: S.C Oncolab S.R.L
city: Iaşi
country: Romania
facility: Institutul Regional de Oncologie Iasi
city: Ploieşti
country: Romania
facility: Spital Municipal Ploiesti
city: Suceava
country: Romania
facility: Spitalul Judetean de Urgenta "Sfantul Ioan cel Nou" Suceava
city: Timişoara
country: Romania
facility: ONCOMED Timisoara
city: Arkhangel'sk
country: Russian Federation
facility: Arkhangelsk Clinical Oncological Dispensary
city: Omsk
country: Russian Federation
facility: BHI of Omsk Region Clinical Oncology Dispensary
city: Orenburg
country: Russian Federation
facility: Orenburg Regional Clinical Oncological Dispensary
city: Pesochnyy
country: Russian Federation
facility: SBHI Saint Petersburg Research Center specialized types of medical care (Oncology)
city: Pyatigorsk
country: Russian Federation
facility: SBHI SR Pyatigorsk Interdistrict Oncology Dispensary
city: Saint Petersburg
country: Russian Federation
facility: Limited Liability Company MedPomosch
city: Saint Petersburg
country: Russian Federation
facility: FSBEI HE I.P. Pavlov SPbSMU MoH Russia
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg State Budget Institution of Healthcare City Clinical Oncology Dispensary
city: Saint Petersburg
country: Russian Federation
facility: 1st Medical University
city: Saransk
country: Russian Federation
facility: Federa; State Budgetary Educational Institution of Higher Education National Research Ogarev Mordovia State University
city: Sotchi
country: Russian Federation
facility: State Medical Institution "Oncology Center #2" under the Krasnodar Region Healthcare Department
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National Cancer Center Singapore
city: Barcelona
country: Spain
facility: Vall d'Hebron Institute of Oncology
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Bilbao
country: Spain
facility: Hospital Universitario Basurto
city: Castillón
country: Spain
facility: Consorcio Hospitalario Provincial Castellon
city: El Palmar
country: Spain
facility: Hospital Virgen de la Arrixaca
city: Jerez de la Frontera
country: Spain
facility: Hospital de Jerez
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro - Majadahonda
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Palma De Mallorca
country: Spain
facility: Hospital Son Llatzer
city: Sevilla
country: Spain
facility: Hospital Nuestra Señora de Valme
city: Linköping
country: Sweden
facility: Onkologiska Kliniken
city: Lund
country: Sweden
facility: Onkologiska Kliniken
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset
city: Hualien City
country: Taiwan
facility: Hualien Tzu Chi Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: Chi Mei Hospital, Liouying (CMHLY)
city: Tainan
country: Taiwan
facility: Chi Mei Medical Center (CMMC)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation- Linkou Branch
city: Ankara
country: Turkey
facility: Dr. Abdurrahman Yurtaslan Ankara Women's Health Education and Research Hospital
city: Istanbul
country: Turkey
facility: Istanbul University-cerrahpasa, Cerrahpasa School of Medicine
city: Istanbul
country: Turkey
facility: Koc University School of Medicine, Koc University Hospital
city: Manisa
country: Turkey
facility: Celal Bayar University Faculty of Medicine
city: Yuregir
country: Turkey
facility: Baskent University Hospital
city: Canterbury
country: United Kingdom
facility: East Kent Hospitals University NHS Foundation trust Medical Oncology
state: Kent
city: Cliftonville
country: United Kingdom
facility: Northampton General Hospital
state: Northampton
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: Bristol
country: United Kingdom
facility: Bristol Cancer Institute Medical Oncology
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: Lancaster
country: United Kingdom
facility: University Hospitals of Morecambe Bay NHS Foundation Trust
city: Leeds
country: United Kingdom
facility: St. James University Hospital
city: London
country: United Kingdom
facility: Barts and the London NHS Trust
city: London
country: United Kingdom
facility: University of College London Hospital
city: London
country: United Kingdom
facility: Guy's & St Thomas' NHS Foundation Trust (Guy's Cancer Centre)
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
city: London
country: United Kingdom
facility: Imperial College London
city: Middlesbrough
country: United Kingdom
facility: The James Cook University Hospital
city: Poole
country: United Kingdom
facility: Poole Hospital NHS Foundation Trust
city: Swansea
country: United Kingdom
facility: South West Wales Cancer Centre - Singleton Hospital
city: Taunton
country: United Kingdom
facility: Musgrove Park Hospital
Study officials:
References:
citation: Monk BJ, Parkinson C, Lim MC, O'Malley DM, Oaknin A, Wilson MK, Coleman RL, Lorusso D, Bessette P, Ghamande S, Christopoulou A, Provencher D, Prendergast E, Demirkiran F, Mikheeva O, Yeku O, Chudecka-Glaz A, Schenker M, Littell RD, Safra T, Chou HH, Morgan MA, Drochytek V, Barlin JN, Van Gorp T, Ueland F, Lindahl G, Anderson C, Collins DC, Moore K, Marme F, Westin SN, McNeish IA, Shih D, Lin KK, Goble S, Hume S, Fujiwara K, Kristeleit RS. A Randomized, Phase III Trial to Evaluate Rucaparib Monotherapy as Maintenance Treatment in Patients With Newly Diagnosed Ovarian Cancer (ATHENA-MONO/GOG-3020/ENGOT-ov45). J Clin Oncol. 2022 Dec 1;40(34):3952-3964. doi: 10.1200/JCO.22.01003. Epub 2022 Jun 6.
citation: Monk BJ, Coleman RL, Fujiwara K, Wilson MK, Oza AM, Oaknin A, O'Malley DM, Lorusso D, Westin SN, Safra T, Herzog TJ, Marme F, N Eskander R, Lin KK, Shih D, Goble S, Grechko N, Hume S, Maloney L, McNeish IA, Kristeleit RS. ATHENA (GOG-3020/ENGOT-ov45): a randomized, phase III trial to evaluate rucaparib as monotherapy (ATHENA-MONO) and rucaparib in combination with nivolumab (ATHENA-COMBO) as maintenance treatment following frontline platinum-based chemotherapy in ovarian cancer. Int J Gynecol Cancer. 2021 Dec;31(12):1589-1594. doi: 10.1136/ijgc-2021-002933. Epub 2021 Sep 30.