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

Recruitment Status
ACTIVE, NOT RECRUITING - HAS RESULTS
(See Contacts and Locations)Verified May 2025 by pharmaand GmbH
Sponsor
pharmaand GmbH
Information Provided by (Responsible Party)
pharmaand GmbH
Clinicaltrials.gov Identifier
NCT03522246
Other Study ID Numbers:
CO-338-087/GOG-3020/ENGOT-ov45
First Submitted
April 8, 2018
First Posted
May 10, 2018
Results First Posted
May 12, 2025
Last Update Posted
June 23, 2025
Last Verified
May 2025

ClinicalTrials.gov processed this data on June 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Epithelial Ovarian CancerPrimary PeritonealFallopian Tube CancerNewly DiagnosedFIGO Stage III-IVPartial ResponseComplete Response
Drug: RucaparibDrug: RucaparibDrug: NivolumabDrug: Placebo Oral TabletDrug: Rucaparib

Study Design

Study TypeInterventional
Actual Enrollment1097 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleATHENA (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 Start DateMay 13, 2018
Actual Primary Completion DateMay 19, 2024
Actual Study Completion Date4yrs 7mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Arm A
Oral rucaparib + intravenous (IV) nivolumab
Drug: Rucaparib
Oral rucaparib will be administered twice daily
Arm B
Oral rucaparib + IV placebo
Drug: Rucaparib
Oral rucaparib will be administered twice daily
Arm C
Oral placebo + IV nivolumab
Drug: Nivolumab
IV nivolumab will be administered once every 4 weeks
Arm D
Oral placebo + IV placebo
Drug: Placebo Oral Tablet
Placebo tablets will be administered twice daily
Japanese Open-label Safety Cohort
Oral rucaparib + IV nivolumab
Drug: Rucaparib
Oral rucaparib will be administered twice daily

Outcome Measures

Primary Outcome Measures
  1. Monotherapy Arm B and Arm D: Investigator Assessed Progression-free Survival (PFS)
    PFS by investigator was defined as the time from randomization to disease progression, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
  2. Monotherapy Arm B and Arm D: Investigator Assessed PFS
    PFS by investigator was defined as the time from randomization to disease progression, according to RECIST v1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
  3. Combination Therapy Arm A and Arm B: Investigator Assessed PFS
    PFS by investigator was defined as the time from randomization to disease progression, according to RECIST v1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
Secondary Outcome Measures
  1. Monotherapy Arm B and Arm D: Blinded Independent Central Review (BICR) PFS
    PFS was assessed by BICR per RECIST v1.1 as the time from randomization to disease progression, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
  2. Monotherapy Arm B and Arm D: BICR PFS
    PFS was assessed by BICR per RECIST v1.1 as the time from randomization to disease progression, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
  3. Combination Therapy Arm A and Arm B: BICR PFS
    PFS was assessed by BICR per RECIST v1.1 as the time from randomization to disease progression, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
  4. Monotherapy Arm B and Arm D: Overall Survival (OS)
    OS was defined as the number of days (measured in months) from the date of randomization to the date of death due to any cause.
  5. Monotherapy Arm B and Arm D: OS
    OS was defined as the number of days (measured in months) from the date of randomization to the date of death due to any cause.
  6. Combination Therapy Arm A and Arm B: OS
    OS was defined as the number of days (measured in months) from the date of randomization to the date of death due to any cause.
  7. Monotherapy Arm B and Arm D: Objective Response Rate (ORR)
    ORR was defined as the percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR) as assessed by the Investigator per RECIST 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
  8. Monotherapy Arm B and Arm D: ORR
    ORR was defined as the percentage of participants with CR or PR as assessed by the Investigator per RECIST 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
  9. Combination Therapy Arm A and Arm B: ORR
    ORR was defined as the percentage of participants with CR or PR as assessed by the Investigator per RECIST 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
  10. Monotherapy Arm B and Arm D: Duration of Response (DOR)
    DOR was assessed by the investigator and defined as the interval from the first documentation of objective response (CR or PR per RECIST v1.1) to the earlier of the first documentation of progressive disease (PD) or death from any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD: 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
  11. Monotherapy Arm B and Arm D: DOR
    DOR was assessed by the investigator and defined as the interval from the first documentation of objective response (CR or PR per RECIST v1.1) to the earlier of the first documentation of PD or death from any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD: 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
  12. Combination Therapy Arm A and Arm B: DOR
    DOR was assessed by the investigator and defined as the interval from the first documentation of objective response (CR or PR per RECIST v1.1) to the earlier of the first documentation of PD or death from any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD: 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyFemale
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and Collaboratorspharmaand GmbH
Locations
Arizona Oncology Associates, PC - HAL | Phoenix Arizona, United States, 85016Arizona Oncology Associates, PC - HOPE | Tucson Arizona, United States, 85711The University of Arizona Cancer Center | Tucson Arizona, United States, 85724John Muir Clinical Research Center | Concord California, United States, 94520UCLA Women's Health Clinical Research Unit | Los Angeles California, United States, 90095Kaiser Permanente Northern California | San Francisco California, United States, 94589University of Colorado Cancer Center | Aurora Colorado, United States, 80045Rocky Mountain Cancer Centers | Lakewood Colorado, United States, 80228Yale University | New Haven Connecticut, United States, 06520Florida Gynecologic Oncology | Fort Myers Florida, United States, 33905MD Anderson Cancer Center-Baptist | Jacksonville Florida, United States, 32207Baptist Health Medical Group Oncology, LLC | Miami Florida, United States, 33176Florida Hospital | Orlando Florida, United States, 32804Northside Hospital | Atlanta Georgia, United States, 30342Augusta University | Augusta Georgia, United States, 30912Rush University Medical Center | Chicago Illinois, United States, 60612Dr. Sudarshan K. Sharma, Ltd - Gynecologic Oncology | Hinsdale Illinois, United States, 60521Ferrell-Duncan Clinic | Springfield Illinois, United States, 62769Community Health Network | Indianapolis Indiana, United States, 46250University of Iowa Hospitals | Iowa City Iowa, United States, 52242University of Kansas Cancer Center | Westwood Kansas, United States, 66205University of Kentucky | Lexington Kentucky, United States, 40536Norton Cancer Institute | Louisville Kentucky, United States, 40241Ochsner Medical Center | New Orleans Louisiana, United States, 70121Maine Medical Center | Scarborough Maine, United States, 04074SKCCC at Johns Hopkins | Baltimore Maryland, United States, 21287Massachusetts General Hospital | Boston Massachusetts, United States, 02114Karmanos Cancer Institute | Detroit Michigan, United States, 48201Metro Minnesota Community Oncology Research Consortium | Saint Louis Park Minnesota, United States, 55416Washington University School of Medicine | St Louis Missouri, United States, 63110Women's Cancer Center of Nevada | Las Vegas Nevada, United States, 89169MD Anderson Cancer Center at Cooper | Camden New Jersey, United States, 08103Summit Medical Group | Florham Park New Jersey, United States, 07932Women's Cancer Care Associates | Albany New York, United States, 12008Broome Oncology, LLC | Johnson City New York, United States, 13790Northwell Health Monter Cancer Center | Lake Success New York, United States, 11042New York University Medical Center | New York New York, United States, 10016University of North Carolina | Chapel Hill North Carolina, United States, 27707University of Cincinnati | Cincinnati Ohio, United States, 45221Oncology Hematology Care, Inc | Cincinnati Ohio, United States, 45242Cleveland Clinic | Cleveland Ohio, United States, 44106The Ohio State University | Columbus Ohio, United States, 43210MD Anderson Cancer Center - Ohio Health | Columbus Ohio, United States, 44907University of Oklahoma Health Science Center | Oklahoma City Oklahoma, United States, 73104Oklahoma Cancer Specialists and Research Institute | Tulsa Oklahoma, United States, 74146Oncology Associates of Oregon, P.C. | Eugene Oregon, United States, 97401LMG Gynecologic Oncology | Portland Oregon, United States, 97210Northwest Cancer Specialists, P.C. | Portland Oregon, United States, 97225University of Pennsylvania | Philadelphia Pennsylvania, United States, 19104Thomas Jefferson University | Philadelphia Pennsylvania, United States, 19107UPMC Magee-Womens Hospital | Pittsburgh Pennsylvania, United States, 15213Abington Memorial Hospital | Willow Grove Pennsylvania, United States, 19090Avera Gynecologic Oncology | Sioux Falls South Dakota, United States, 57105Texas Oncology - Austin Central | Austin Texas, United States, 78731Texas Oncology - Bedford | Bedford Texas, United States, 76022Texas Oncology - Dallas Presbyterian Hospital | Dallas Texas, United States, 75231Texas Oncology - Fort Worth | Fort Worth Texas, United States, 76104Memorial Hermann | Houston Texas, United States, 77030University of Texas MD Anderson Cancer Center | Houston Texas, United States, 77030Texas Oncology - San Antonio Medical Center | San Antonio Texas, United States, 78240Texas Oncology - The Woodlands, Gynecologic Oncology | The Woodlands Texas, United States, 77380Huntsman Cancer Institute | Salt Lake City Utah, United States, 84112Virginia Oncology Associates | Norfolk Virginia, United States, 23502Froedtert and Medical College of Wisconsin | Milwaukee Wisconsin, United States, 53226Newcastle Private Hospital | New Lambton Heights New South Wales, Australia, 2145Northern Cancer Institute St Leonards | Saint Leonards New South Wales, Australia, 2065Prince of Wales Hospital | Sydney New South Wales, Australia, 2031Westmead Hospital | Westmead New South Wales, Australia, 2145Royal Brisbane and Women's Hospital | Brisbane Queensland, Australia, 4020Brian Fricker Oncology Centre, Burnside Hospital | Toorak Gardens South Australia, Australia, 5065Peter MacCallum Cancer Center | Melbourne Victoria, Australia, 3000St John of God Subiaco Hospital | Subiaco Western Australia, Australia, 6005UZ Leven | Leuven , Belgium, 3000Alberta Health Services - University of Calgary | Calgary Alberta, Canada, T2N 1N4Alberta Health Services and The University of Alberta | Edmonton Alberta, Canada, T6G 2B7BC Cancer - Abbotsford | Abbotsford British Columbia British Columbia, Canada, V2S 0C2BC Cancer - Kelowna | Kelowna British Columbia, Canada, V1Y 5L3BC Cancer - Surrey | Surrey British Columbia, Canada, V3V 1Z2CancerCare Manitoba | Winnipeg Manitoba, Canada, R3E 0V9Nsha-Qeii Hsc | Halifax Nova Scotia, Canada, B3H 2Y9Juravinski Cancer Center | Hamilton Ontario, Canada, LbV 5C2London Health Sciences Center | London Ontario, Canada, N6A 5W9Ottawa Hospital Cancer Centre | Ottawa Ontario, Canada, K1H 8L6Centre Hospitalier de l'Université de Montreal | Montreal Quebec, Canada, H2X 0C2McGill University Health Center | Montreal Quebec, Canada, H4A 3J1Centre Integre Universitaire de sante et de service sociaux de l'Estri-Centre hospitalier univeritaire de Sherbrooke | Sherbrooke Quebec, Canada, J1H 5N4Masaryk Memorial Cancer Institute | Brno , Czechia, 65653Department of Gynecology and Obstetrics, Oncogynecological center U hiversity Hospital Kralovske Vinohrady | Prague , Czechia, KOC KNTB a.s. Zlfn, Hvalfckovo nabrezf 600, 76001 | Zlín , Czechia, Aalborg University Hospital | Aalborg , Denmark, 9000Odense University Hospital | Odense , Denmark, 5000Kuopio University Hospital | Kuopio , Finland, 70210Klinik für Frauenheilkunde und Geburtshilfe | Dessau , Germany, Universitaetsklinikum Duesseldorf / Klinik fur Frauenheilkunde & Geburtshilfe | Düsseldorf , Germany, Universitatsklinikum National Centrum for Tumor Disease (NCT) | Heidelberg , Germany, Universitätslinikum Mannheim, Frauenklinik | Mannheim , Germany, Kliniken Suedostbayern AG, Klinikum Traunstein | Traunstein , Germany, Attikon General University Hospital | Chaïdári Athens, Greece, 12462University Hospital Attikon | Chaïdári Athens, Greece, 12462Alexandra Hospital | Athens , Greece, 11528General Hospital of Patras | Pátrai , Greece, 26335Euromedica General Clinic, B' Oncology Clinic | Thessaloniki , Greece, 5465Cork University Hospital | Cork , Ireland, T12 DC4ABon Secours Hospital | Cork , Ireland, University Hospital Limerick | Limerick , Ireland, V94 F858University Hospital Waterford | Waterford , Ireland, X91 ER8EShaare Zedek Medical Oncology | Jerusalem , Israel, Meir Medical Center | Kfar Saba , Israel, 4428164Galilee Medical Center | Nahariya , Israel, 2210001Sheba Medical Center | Ramat Gan , Israel, 5265601Ziv Medical Center | Safed , Israel, 13100Tel Aviv Sourasky Medical Center | Tel Aviv , Israel, 6423906Centro di Riferimento Oncologico, CRO-IRCCS | Aviano , Italy, 33081Candiolo Cancer Institute - IRCCS | Candiolo , Italy, 10060Arnas Garibaldi | Catania , Italy, 95122University G, D'Annunuzio-Chieti | Chieti , Italy, IRCCS Instituto Nazionale Tumori | Naples , Italy, 80131Azienda Ospedaliera Universitaria Policlinico Umberto I | Roma , Italy, 00161Policlinico Agostino Gemelli | Roma , Italy, 00168Ospedale S. Giovanni Calibita Fatebenefratelli | Roma , Italy, 00186Ospedale San Bortolo | Vicenza , Italy, 36100University of Tsukuba Hospital | Tsukuba Amakubo, Japan, National Cancer Center Hospital East | Kashiwa Chiba, Japan, 277-8577Kurume University Hospital | Kurume Fukuoka, Japan, 830-0011Yokohama City University Hospital | Yokohama Fukuura, Japan, Gunma University Hospital | Maebashi Gunma, Japan, 371-8511Gunma Prefectural Cancer Center | Ota-shi Gunma, Japan, 373-8550Hiroshima City Hiroshima Citizens Hospital | Naka Hiroshima, Japan, 730-0844,Hyogo Cancer Center | Akashi Hyōgo, Japan, 673-0021Iwate Medical University | Morioka Iwate, Japan, Nippon Medical School Musashikosugi Hospital | Kawasaki-shi Kanagawa, Japan, 211-8533Kanagawa Cancer Center | Yokohama Kanagawa, Japan, 241-8515National Defense Medical College Hospital | Tokorozawa Namiki, Japan, Osaka International Cancer Institute | Chuo Osaka, Japan, 541-8567Kindai University Hospital | Ōsaka-sayama Osaka, Japan, 589-8511Saitama Medical University International Medical Center | Hidaka Saitama, Japan, 350-1298Keio University Hospital | Shinjuku-Ku Shinanomachi, Japan, The Cancer Institute Hospital of JFCR | Koto-Ku Tokyo, Japan, Saitama Cancer Center | Saitama , Japan, 362-0806Kagawa Prefectural Central Hospital | Takamatsu , Japan, National Cancer Center Hospital | Tokyo , Japan, 104-0045Auckland City Hospital | Auckland , New Zealand, 1023Christchurch Hospital | Christchurch , New Zealand, 8011Waikato Hospital | Hamilton , New Zealand, 3204Palmerston North Hospital | Palmerston North , New Zealand, 4442Tauranga Hospital | Tauranga , New Zealand, 3112Chair & department of Obsterics, Gynaecology and Oncology (previous site) | Warsaw Kondratowicza, Poland, Bialostockie Centrum Onkologii Oddzial Onkologii Ginekologicznej | Bialystok , Poland, 20-081University Hospital of Bialystok | Bialystok , Poland, Szpitale Pomorskie sp zoo | Gdynia , Poland, 81-519Medical University of Lublin | Lublin , Poland, 20-081Wielkopolskie Centrum Onkologii | Poznan , Poland, 61-866Pomeranian Medical University | Szczecin , Poland, Spitalul Clinic Municipal "Dr. Gavril Curteanu" | Oradea Jud. Bihor, Romania, 410469S.C. Medisprof S.R.L. | Cluj-Napoca Jud. Cluj, Romania, 400641Oncopremium Team | Baia Mare , Romania, SC Quantum Medical Center SRL | Bucharest , Romania, Instiute of Oncology - Medical Oncology | Cluj-Napoca , Romania, Centrul de Oncologie Sf.Nectarie | Craiova , Romania, 200347S.C Oncolab S.R.L | Craiova , Romania, Institutul Regional de Oncologie Iasi | Iași , Romania, 700489Spital Municipal Ploiesti | Ploieşti , Romania, Spitalul Judetean de Urgenta "Sfantul Ioan cel Nou" Suceava | Suceava , Romania, 720237ONCOMED Timisoara | Timișoara , Romania, 300239Arkhangelsk Clinical Oncological Dispensary | Arkhangelsk , Russia, 163045BHI of Omsk Region Clinical Oncology Dispensary | Omsk , Russia, 644013Orenburg Regional Clinical Oncological Dispensary | Orenburg , Russia, SBHI Saint Petersburg Research Center specialized types of medical care (Oncology) | Pesochnyy , Russia, 197758SBHI SR Pyatigorsk Interdistrict Oncology Dispensary | Pyatigorsk , Russia, 357502Limited Liability Company MedPomosch | Saint Petersburg , Russia, 194356FSBEI HE I.P. Pavlov SPbSMU MoH Russia | Saint Petersburg , Russia, 197022Saint-Petersburg State Budget Institution of Healthcare City Clinical Oncology Dispensary | Saint Petersburg , Russia, 1982551st Medical University | Saint Petersburg , Russia, Federa; State Budgetary Educational Institution of Higher Education National Research Ogarev Mordovia State University | Saransk , Russia, 430032State Medical Institution "Oncology Center #2" under the Krasnodar Region Healthcare Department | Sochi , Russia, 354057National University Hospital | Singapore , Singapore, 119082National Cancer Center Singapore | Singapore , Singapore, National Cancer Center | Goyang-si Gyeonggi-do, South Korea, 10408CHA Bundang Medical Center | Seongnam-si Gyeonggi-do, South Korea, 13496Seoul National University Bundang Hospital | Seongnam-si Gyeonggi-do, South Korea, 13620Gachon University Gil Medical Center | Incheon Seoul, South Korea, 21565SoonChunHyang University Cheonan Hospital | Cheonan , South Korea, Korea Cancer Center Hospital | Seoul , South Korea, 01812Seoul National University Hospital | Seoul , South Korea, 03080Severance Hospital, Yonsei University Health System | Seoul , South Korea, 03722Konkuk University Medical Center | Seoul , South Korea, 05030Asan Medical Center | Seoul , South Korea, 05505Samsung Medical Center | Seoul , South Korea, 06351Korea University Guro Hospital | Seoul , South Korea, Ajou University Hospital | Suwon , South Korea, Vall d'Hebron Institute of Oncology | Barcelona , Spain, 08035Hospital de la Santa Creu i Sant Pau | Barcelona , Spain, 08041Hospital Universitario Basurto | Bilbao , Spain, 48013Consorcio Hospitalario Provincial Castellon | Castillón , Spain, 12002Hospital Virgen de la Arrixaca | El Palmar , Spain, 30120Hospital de Jerez | Jerez de la Frontera , Spain, 11407Hospital Universitario Puerta de Hierro - Majadahonda | Madrid , Spain, 28222Hospital Universitario Central de Asturias | Oviedo , Spain, 33011Hospital Son Llatzer | Palma de Mallorca , Spain, 07198Hospital Nuestra Señora de Valme | Seville , Spain, 41014Onkologiska Kliniken | Linköping , Sweden, Onkologiska Kliniken | Lund , Sweden, Karolinska Universitetssjukhuset | Stockholm , Sweden, Hualien Tzu Chi Hospital | Hualien City , Taiwan, Kaohsiung Veterans General Hospital | Kaohsiung City , Taiwan, 81362Far Eastern Memorial Hospital | New Taipei City , Taiwan, 22060Taichung Veterans General Hospital | Taichung , Taiwan, 40705China Medical University Hospital | Taichung , Taiwan, Chi Mei Hospital, Liouying (CMHLY) | Tainan , Taiwan, Chi Mei Medical Center (CMMC) | Tainan , Taiwan, National Taiwan University Hospital | Taipei , Taiwan, 10048Mackay Memorial Hospital | Taipei , Taiwan, 10449Taipei Veterans General Hospital | Taipei , Taiwan, 11217Tri-Service General Hospital | Taipei , Taiwan, 11490Taipei Medical University Hospital | Taipei , Taiwan, Chang Gung Medical Foundation- Linkou Branch | Taoyuan , Taiwan, 33305Dr. Abdurrahman Yurtaslan Ankara Women's Health Education and Research Hospital | Ankara , Turkey (Türkiye), Istanbul University-cerrahpasa, Cerrahpasa School of Medicine | Istanbul , Turkey (Türkiye), Koc University School of Medicine, Koc University Hospital | Istanbul , Turkey (Türkiye), Celal Bayar University Faculty of Medicine | Manisa , Turkey (Türkiye), 45030Baskent University Hospital | Yüreğir , Turkey (Türkiye), East Kent Hospitals University NHS Foundation trust Medical Oncology | Canterbury Kent, United Kingdom, CT1 3NGNorthampton General Hospital | Cliftonville Northampton, United Kingdom, NN1 5BDRoyal Sussex County Hospital | Brighton , United Kingdom, BN2 3EHBristol Cancer Institute Medical Oncology | Bristol , United Kingdom, BS2 8HWAddenbrookes Hospital | Cambridge , United Kingdom, CB2 0QQWestern General Hospital | Edinburgh , United Kingdom, EH4 2XUUniversity Hospitals of Morecambe Bay NHS Foundation Trust | Lancaster , United Kingdom, LA1 4RPSt. James University Hospital | Leeds , United Kingdom, LS9 7TFBarts and the London NHS Trust | London , United Kingdom, EC1A 7BEUniversity of College London Hospital | London , United Kingdom, NW1 2PGGuy's & St Thomas' NHS Foundation Trust (Guy's Cancer Centre) | London , United Kingdom, SE1 9RTThe Royal Marsden NHS Foundation Trust | London , United Kingdom, SW3 6JJImperial College London | London , United Kingdom, W12 0HSThe James Cook University Hospital | Middlesbrough , United Kingdom, TS4 3BWPoole Hospital NHS Foundation Trust | Poole , United Kingdom, BH15 2JBSouth West Wales Cancer Centre - Singleton Hospital | Swansea , United Kingdom, SA2 8QAMusgrove Park Hospital | Taunton , United Kingdom, TA1 5DA
Study Documents (Full Text)
Documents provided by pharmaand GmbH: Study Protocol  June 15, 2023Documents provided by pharmaand GmbH: Statistical Analysis Plan  May 14, 2024