Efficacy and Safety of Olaparib (MK-7339) in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer (MK-7339-002 / LYNK-002)
July 22, 2026 updated by: Merck Sharp & Dohme LLC
A Phase 2 Study of Olaparib Monotherapy in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer
This study will evaluate the efficacy and safety of olaparib (MK-7339) monotherapy in participants with multiple types of advanced cancer (unresectable and/or metastatic) that: 1) have progressed or been intolerant to standard of care therapy; and 2) are positive for homologous recombination repair mutation (HRRm) or homologous recombination deficiency (HRD).
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
329
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Buenos Aires, Argentina, C1012AAR
- Instituto de Investigaciones Metabolicas ( Site 2700)
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Buenos Aires, Argentina, C1118AAT
- Hospital Aleman ( Site 2702)
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Buenos Aires
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Berazategui, Buenos Aires, Argentina, B1884BBF
- Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 2703)
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Buenos Aires F.D.
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Ciudad de Buenos Aires, Buenos Aires F.D., Argentina, C1280AEB
- Hospital Britanico de Buenos Aires ( Site 2704)
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New South Wales
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Darlinghurst, New South Wales, Australia, 2010
- Kinghorn Cancer Centre ( Site 2200)
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Port Macquarie, New South Wales, Australia, 2444
- MNCCI Port Macquarie Base Hospital ( Site 2201)
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Linear Clinical Research Ltd ( Site 2202)
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Ontario
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Research Institute ( Site 0210)
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Quebec
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Montreal, Quebec, Canada, H1T 2M4
- Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0203)
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Montreal, Quebec, Canada, H3T 1E2
- Jewish General Hospital ( Site 0209)
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Québec, Quebec, Canada, G1J 1Z4
- Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
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Antioquia
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Medellín, Antioquia, Colombia, 050021
- Fundacion Centro de Investigacion Clinica CIC ( Site 2812)
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Medellín, Antioquia, Colombia, 050030
- Rodrigo Botero SAS ( Site 2801)
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Atlántico
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Barranquilla, Atlántico, Colombia, 080001
- Biomelab S A S ( Site 2800)
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Bogota D.C.
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Bogotá, Bogota D.C., Colombia, 110221
- Administradora Country SA - Clinica del Country ( Site 2802)
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Bogotá, Bogota D.C., Colombia, 110311
- Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 2807)
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Bogotá, Bogota D.C., Colombia, 111511
- Instituto Nacional de Cancerologia E.S.E ( Site 2809)
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Cesar Department
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Valledupar, Cesar Department, Colombia, 200001
- Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 2808)
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Departamento de Córdoba
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Montería, Departamento de Córdoba, Colombia, 230002
- Oncomedica S.A. ( Site 2806)
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Valle del Cauca Department
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Cali, Valle del Cauca Department, Colombia, 760042
- C. Medico Imbanaco Cali S.A. ( Site 2810)
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Capital Region
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Copenhagen, Capital Region, Denmark, 2100
- Rigshospitalet ( Site 0402)
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Herlev, Capital Region, Denmark, 2730
- Herlev og Gentofte Hospital. ( Site 0401)
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Region Syddanmark
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Odense, Region Syddanmark, Denmark, 5000
- Odense Universitetshospital ( Site 0400)
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Ain
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Poitiers, Ain, France, 86021
- CHU Poitiers ( Site 0612)
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Alpes-Maritimes
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Nice, Alpes-Maritimes, France, 06189
- Centre Antoine Lacassagne ( Site 0610)
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Alsace
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Strasbourg, Alsace, France, 67033
- Institut de Cancerologie Strasbourg Europe ( Site 0613)
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Bourgogne-Franche-Comté
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Dijon, Bourgogne-Franche-Comté, France, 21000
- Centre Georges Francois Leclerc ( Site 0608)
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Gironde
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Bordeaux, Gironde, France, 33076
- Institut Bergonie ( Site 0603)
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Val-de-Marne
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Villejuif, Val-de-Marne, France, 94805
- Institut Gustave Roussy ( Site 0601)
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Guatemala City, Guatemala, 01010
- Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 3004)
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Guatemala City, Guatemala, 01010
- Integra Cancer Institute ( Site 3006)
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Guatemala City, Guatemala, 01015
- Grupo Angeles SA ( Site 3001)
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Departamento de Quetzaltenango
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Guatemala, Departamento de Quetzaltenango, Guatemala, 09001
- Centro Regional de Sub Especialidades Medicas SA ( Site 3003)
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Cork, Ireland, T12 DV56
- Bon Secours Hospital ( Site 1656)
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Dublin, Ireland, 00004
- St. Vincent's University Hospital ( Site 1653)
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Dublin, Ireland, D24 NROA
- Tallaght University Hospital ( Site 1652)
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Carlow
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Dublin, Carlow, Ireland, D07 WKW8
- Mater Misericordiae University Hospital ( Site 1654)
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Beersheba, Israel, 8457108
- Soroka Medical Center ( Site 0800)
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Haifa, Israel, 3109601
- Rambam Health Care Campus-Oncology Division ( Site 0801)
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Jerusalem, Israel, 9112001
- Hadassah Ein Kerem Medical Center ( Site 0802)
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Ramat Gan, Israel, 5262000
- Chaim Sheba Medical Center ( Site 0803)
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Tel Aviv, Israel, 6423906
- Sourasky Medical Center ( Site 0804)
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Campania
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Naples, Campania, Italy, 80131
- Istituto Nazionale Tumori Fondazione Pascale ( Site 0700)
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Lombardy
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Rozzano, Lombardy, Italy, 20089
- Istituto Clinico Humanitas Research Hospital ( Site 0703)
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Tuscany
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Siena, Tuscany, Italy, 53100
- Policlinico Le Scotte di Siena ( Site 0704)
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Tokyo, Japan, 135-8550
- The Cancer Institute Hospital of JFCR ( Site 2605)
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Tokyo, Japan, 104-0045
- National Cancer Center Hospital ( Site 2601)
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Aichi-ken
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Nagoya, Aichi-ken, Japan, 464-8681
- Aichi Cancer Center Hospital ( Site 2602)
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Chiba
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Kashiwa, Chiba, Japan, 2778577
- National Cancer Center Hospital East ( Site 2600)
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Kyoto
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Kyoto, Kyoto, Japan, 606-8507
- Kyoto University Hospital ( Site 2603)
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Osaka
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Suita, Osaka, Japan, 565-0871
- Osaka University Hospital ( Site 2604)
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Chihuahua City, Mexico, 31000
- Centro Estatal de Cancerologia de Chihuahua ( Site 2907)
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Mexico City, Mexico, 06100
- CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 2900)
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México, Mexico, 03100
- CENEIT Oncologicos ( Site 2904)
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Oaxaca City, Mexico, 68000
- Oaxaca Site Management Organization S.C. ( Site 2905)
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Jalisco
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Guadalajara, Jalisco, Mexico, 44680
- Actualidad Basada en la Investigacion del Cancer ( Site 2903)
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Nuevo León
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Monterrey, Nuevo León, Mexico, 64460
- Unidad Biomedica Avanzada Monterrey S. A. ( Site 2902)
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Querétaro
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Santiago de Quetaro, Querétaro, Mexico, 76000
- Cuidados Oncologicos ( Site 2908)
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Tamaulipas
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Madero, Tamaulipas, Mexico, 89440
- Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 2901)
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Lima, Peru, 15033
- Hospital Nacional Guillermo Almenara Irigoyen ( Site 3107)
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Lima, Peru, 15036
- Clinica Internacional Sede San Borja ( Site 3100)
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Lima, Peru, 15036
- Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 3101)
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Lima, Peru, 15036
- Oncosalud-Clinical Research ( Site 3108)
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Lima, Peru, 15046
- Hospital Central de la Fuerza Aerea del Peru ( Site 3104)
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Lima, Peru, 15076
- Hospital Militar Central Coronel Luis Arias Schereiber ( Site 3105)
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Lima, Peru, 15082
- Hospital Arzobispo Loayza ( Site 3103)
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La Libertad
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Trujillo, La Libertad, Peru, 13006
- Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 3102)
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Muni Metro de Lima
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Lima, Muni Metro de Lima, Peru, 15038
- Instituto Nacional de Enfermedades Neoplasicas ( Site 3106)
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Brasov, Romania, 500152
- Spitalul PDR Medlife ( Site 1106)
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Bucharest, Romania, 022548
- S.C.Focus Lab Plus S.R.L ( Site 1101)
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Bucharest, Romania, 031422
- S.C.Gral Medical S.R.L ( Site 1104)
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Bihor County
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Oradea, Bihor County, Romania, 410469
- S.C. Pelican Impex S.R.L Spitalul Clinic Pelican Oradea ( Site 1102)
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Cluj
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Cluj-Napoca, Cluj, Romania, 400641
- Medisprof ( Site 1107)
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Comuna Floresti, Cluj, Romania, 407280
- SC Radiotherapy Center Cluj SRL ( Site 1105)
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Dolj
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Craiova, Dolj, Romania, 200542
- S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1103)
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Arkhangelskaya oblast
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Arkhangelsk, Arkhangelskaya oblast, Russia, 163045
- Arkhangelsk Clinical Oncological Dispensary ( Site 1204)
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Chelyabinsk Oblast
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Chelyabinsk, Chelyabinsk Oblast, Russia, 454087
- Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1212)
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Moscow
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Moscow, Moscow, Russia, 115477
- N.N. Blokhin NMRCO ( Site 1201)
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Moscow, Moscow, Russia, 125284
- MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 1213)
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Moscow Oblast
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Krasnogorsk, Moscow Oblast, Russia, 143442
- MEDSI Clinical Hospital on Pyatnitsky Highway-Departmentof Antitumor Drug therapy ( Site 1216)
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Ryazan Oblast
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Ryazan, Ryazan Oblast, Russia, 390011
- Ryazan Regional Clinical Oncology dispensary ( Site 1202)
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Samara Oblast
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Samara, Samara Oblast, Russia, 443031
- SBHI Samara Regional Clinical Oncology Dispensary ( Site 1211)
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Sankt-Peterburg
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Saint Petersburg, Sankt-Peterburg, Russia, 194044
- Clinical Hospital Saint Luka ( Site 1205)
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Saint Petersburg, Sankt-Peterburg, Russia, 194291
- SBHI Leningrad Regional Clinical Hospital ( Site 1206)
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Saint Petersburg, Sankt-Peterburg, Russia, 197758
- Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1208)
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Tatarstan, Respublika
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Kazan', Tatarstan, Respublika, Russia, 420029
- Republican Clinical Oncology Dispensary of Tatarstan MoH named after professor M.Z. Sigal ( Site 120
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Seoul, South Korea, 03722
- Severance Hospital Yonsei University Health System ( Site 2400)
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Seoul, South Korea, 03080
- Seoul National University Hospital ( Site 2401)
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Kyonggi-do
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Seongnam-si, Kyonggi-do, South Korea, 13620
- Seoul National University Bundang Hospital ( Site 2402)
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Barcelona, Spain, 08035
- Hospital Universitari Vall d Hebron ( Site 1350)
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Madrid
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Pozuelo de Alarcón, Madrid, Spain, 28223
- Hospital Universitario Quiron Madrid ( Site 1352)
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Canton Ticino
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Bellinzona, Canton Ticino, Switzerland, 6500
- Ospedale Regionale di Bellinzona e Valli ( Site 1407)
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Canton of Aargau
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Zuerich, Canton of Aargau, Switzerland, 8091
- Universitaetsspital Zuerich ( Site 1400)
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Canton of Geneva
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Geneva, Canton of Geneva, Switzerland, 1211
- Hopitaux Universitaires de Geneve HUG. ( Site 1406)
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Adana, Turkey (Türkiye), 01250
- Baskent University Adana Training Hospital ( Site 1508)
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Ankara, Turkey (Türkiye), 06100
- Hacettepe Universitesi Tıp Fakultesi ( Site 1503)
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Antalya, Turkey (Türkiye), 07070
- Akdeniz Universitesi Tip Fakultesi ( Site 1504)
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Edirne, Turkey (Türkiye), 22030
- Trakya Universitesi Tip Fakultesi ( Site 1500)
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Istanbul, Turkey (Türkiye), 34098
- Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1505)
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Istanbul, Turkey (Türkiye), 34722
- Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 1506)
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Izmir, Turkey (Türkiye), 35100
- Ege Universitesi Tip Fakultesi ( Site 1502)
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Adana
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Konya, Adana, Turkey (Türkiye), 42080
- Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 1507)
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Manchester, United Kingdom, M20 4BX
- Christie NHS Foundation Trust ( Site 1601)
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Newcastle upon Tyne, United Kingdom, NE7 7DN
- Northern Centre for Cancer Care ( Site 1602)
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Sheffield, United Kingdom, S10 2SJ
- Weston Park Hospital ( Site 1607)
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Worcestershire
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Oxford, Worcestershire, United Kingdom, OX3 7LE
- Churchill Hospital ( Site 1606)
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Arizona
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Tucson, Arizona, United States, 85719
- The University of Arizona Cancer Center - North Campus ( Site 0011)
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California
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Fullerton, California, United States, 92835
- St Joseph Heritage Healthcare-Oncology ( Site 0056)
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Los Angeles, California, United States, 90048
- Cedars Sinai Medical Center ( Site 0002)
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San Francisco, California, United States, 94158
- UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0007)
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Colorado
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Aurora, Colorado, United States, 80045
- Rocky Mountain Regional Veterans Affairs Medical Center ( Site 0092)
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Georgia
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Atlanta, Georgia, United States, 30322-1013
- Winship Cancer Institute of Emory University ( Site 0025)
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Augusta, Georgia, United States, 30912
- Augusta University ( Site 0028)
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Kentucky
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Lexington, Kentucky, United States, 40536
- Markey Cancer Center ( Site 0018)
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland ( Site 0050)
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Baltimore, Maryland, United States, 21237
- Weinberg Cancer Institute at Franklin Square ( Site 0054)
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Massachusetts
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Worcester, Massachusetts, United States, 01655
- University of Massachusetts ( Site 0017)
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Health System ( Site 0060)
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Nebraska
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Lincoln, Nebraska, United States, 68510
- Cancer Partners of Nebraska ( Site 0051)
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New Jersey
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Middletown, New Jersey, United States, 07748
- Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0116)
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New York
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Harrison, New York, United States, 10604
- Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 0126)
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New York, New York, United States, 10010
- VA New York Harbor Healthcare System Manhattan ( Site 0094)
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New York, New York, United States, 10016
- Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0057)
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center ( Site 0026)
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Oklahoma
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Tulsa, Oklahoma, United States, 74133
- Southwestern Regional Medical Center, Inc. ( Site 0079)
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19124
- Eastern Regional Medical Center, Inc. ( Site 0077)
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South Dakota
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Sioux Falls, South Dakota, United States, 57104
- Sanford Hematology Oncology-Sioux Falls SD ( Site 0012)
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Utah
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St. George, Utah, United States, 84790
- Intermountain Healthcare ( Site 0043)
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Washington
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Seattle, Washington, United States, 98101
- Virginia Mason Medical Center ( Site 0052)
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Seattle, Washington, United States, 98108
- Veterans Affairs Puget Sound Health Care System [Seattle, WA] ( Site 0093)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- For all participants:
- Has measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or Prostate Cancer Working Group (PCWG)-modified RECIST 1.1 as assessed by the local site Investigator/radiology and confirmed by Blinded independent central review (BICR).
- Is able to provide a newly obtained core or excisional biopsy of a tumor lesion or either an archival formalin-fixed paraffin embedded (FFPE) tumor tissue block or slides.
- Has a life expectancy of at least 3 months.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1, as assessed within 7 days of treatment initiation.
- Male participants must agree to use contraception during the treatment period and for at least 95 days (3 months and 5 days) after the last dose of study treatment and refrain from donating sperm during this period.
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- Is not a woman of childbearing potential (WOCBP).
- Is a WOCBP and using a contraceptive method that is highly effective with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 180 days after the last dose of study intervention, AND agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. Abstains from breastfeeding during the study intervention period and for at least 30 days after the last dose of study intervention.
- Has adequate organ function.
- For participants who have non-breast or ovarian cancers that are breast cancer susceptibility gene 1/2 (BRCA1/2) mutated (BRCAm), or who have cancers that are homologous recombination repair mutated (HRRm) but BRCA1/2 non-mutated, or homologous recombination repair non-mutated but homologous recombination deficiency (HRD) positive as centrally-confirmed by the Lynparza HRR-HRD Assay:
- Has a histologically- or cytologically-confirmed advanced (metastatic and/or unresectable) solid tumor (except ovarian cancer whose tumor has a germline or somatic BRCA mutation and breast cancer whose tumor has a germline BRCA mutation) that is not eligible for curative treatment and for which standard of care therapy has failed. Participants must have progressed on or be intolerant to standard of care therapies that are known to provide clinical benefit. There is no limit on the number of prior treatment regimens.
- For participants receiving prior platinum (cisplatin, carboplatin, or oxaliplatin either as monotherapy or in combination) for advanced (metastatic and/or unresectable) solid tumor, have no evidence of disease progression during the platinum chemotherapy or ≤4 weeks of completing the platinum-containing regimen.
- For participants who have somatic BRCAm breast cancer:
- Has histologically- or cytologically-confirmed breast cancer with evidence of metastatic disease.
- Has a known or suspected deleterious mutation in breast cancer susceptibility gene (BRCA) 1 or BRCA2 and does not harbor a germline BRCA1 or BRCA2 mutation - testing can be done centrally or locally. Blood and tissue samples must be provided by all participants.
- Has received treatment with an anthracycline unless contraindicated and a taxane in either the neoadjuvant/adjuvant or metastatic setting.
- Participants with estrogen and/or progesterone receptor-positive disease must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy.
Exclusion Criteria:
- Has a known additional malignancy that is progressing or has required active treatment in the last 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, ductal carcinoma in situ, or cervical carcinoma in situ that has undergone potentially curative therapy are not excluded.
- Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
- Has known central nervous system (CNS) metastases and/or carcinomatous meningitis. Note: Participants with previously treated brain metastases may participate if radiologically stable, clinically stable, and without requirement for steroid treatment for at least 14 days prior to the first dose of study treatment.
- Has received colony-stimulating factors (e.g., granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF] or recombinant erythropoietin) within 28 days prior to the first dose of study treatment.
- Has a known history of human immunodeficiency virus (HIV) infection.
- Has known active hepatitis infection (i.e., Hepatitis B or C).
- Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (e.g., gastrectomy, partial bowel obstruction, malabsorption).
- Has received prior therapy with olaparib or with any other polyadenosine 5' diphosphoribose (poly[ADP ribose]) polymerization (PARP) inhibitor.
- Has a known hypersensitivity to the components or excipients in olaparib.
- Has received previous allogenic bone-marrow transplant or double umbilical cord transplantation (dUCBT).
- Has received a whole blood transfusion in the last 120 days prior to entry to the study. Packed red blood cells and platelet transfusions are acceptable if not performed within 28 days of the first dose of study treatment.
- Has received any anti-neoplastic systemic chemotherapy or biological therapy, targeted therapy, or an anticancer hormonal therapy within 3 weeks prior to the first dose of study intervention.
- Has a primary cancer of unknown origin.
- Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cohort 3: sBRCAm Breast Cancer
Per protocol, participants with breast cancer tumors that harbor known or suspected deleterious somatic mutations in BRCA1/2 and do not harbor a germline BRCA1/2 mutation were enrolled into Cohort 3: somatic BRCA1/2 mutations (sBRCAm).
Participants in Cohort3: sBRCAm Breast Cancer received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
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Olaparib 300 mg administered BID as two, 150 mg oral tablets.
Other Names:
|
|
Experimental: Cohort 1: BRCA1/2 Mutated
Per protocol, participants with tumors that harbor known or suspected deleterious mutations in breast cancer susceptibility gene 1 or gene 2 (BRCA1/2) based on the Lynparza homologous recombination repair-homologous recombination deficiency (HRR-HRD) Assay, excluding breast and ovarian cancers, were considered BRCA1/2 mutated and enrolled into Cohort 1: BRCA1/2.
Participants with known or suspected deleterious mutations in BRCA1/BRCA2 were enrolled into Cohort 1 whether or not they were homologous recombination repair mutated (HRRm) positive for the other protocol specified genes in the Lynparza HRR-HRD Assay, or whether they had loss of heterozygosity (LOH) protocol specified score of ≥16.
Participants in Cohort 1: BRCA1/2 received oral olaparib, 300 mg twice daily (BID) continuously until documented disease progression or discontinuation criteria were met.
|
Olaparib 300 mg administered BID as two, 150 mg oral tablets.
Other Names:
|
|
Experimental: Cohort 2: HRD+, HRR Non-mutated
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2, or any of the other protocol specified genes in the Lynparza HRR-HRD Assay (BRCA1/2 Non-mutated/HRR Non-mutated) but had a loss of heterozygosity (LOH) score greater than or equal to the protocol specified cutoff of 16, were considered homologous recombination deficiency positive (HRD+) and enrolled into Cohort 2: HRD+(BRCA1/2 non-mutated/HRR Non-mutated).
Participants in Cohort 2: HRD+ (BRCA1/2 Non-mutated/HRR Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
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Olaparib 300 mg administered BID as two, 150 mg oral tablets.
Other Names:
|
|
Experimental: Cohort 2: HRRm, BRCA1/2 Non-mutated
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2 but have known or suspected deleterious mutations in any of the other protocol specified genes in the Lynparza HRR-HRD Assay were considered homologous recombination repair mutated [HRRm] and were enrolled into Cohort 2: HRRm (BRCA1/2 Non-mutated).
Participants in Cohort 2: HRRm (BRCA1/2 Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
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Olaparib 300 mg administered BID as two, 150 mg oral tablets.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cohorts 1, 2, 3: Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR) Per Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or Prostate Cancer Working Group (PCWG)-Modified RECIST 1.1
Time Frame: Up to approximately 78 months
|
ORR was defined as the percentage of participants who have a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by the BICR per modified RECIST 1.1.
For participants with prostate cancer, response was assessed based on PCWG-modified RECIST 1.1 criteria (CR: soft tissue CR with no evidence of disease [NED] on bone scan; PR: soft tissue PR with non-progressive disease, non-evaluable [NE], or NED on bone scan, or soft tissue CR with non-progressive disease, or NE bone scan).
Per protocol, RECIST 1.1 was modified to follow a maximum of 10 target lesions in total and a maximum of 5 target lesions per organ.
The percentage of participants who experienced a CR or PR as assessed by BICR is presented.
|
Up to approximately 78 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cohorts 1, 2, 3: Duration of Response (DOR) as Assessed by BICR According to Modified RECIST 1.1 or PCWG-Modified RECIST 1.1
Time Frame: Up to approximately 78 months
|
For participants with confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in sum of diameters of target lesions) as assessed by BICR per modified RECIST; or, for participants with prostate cancer, per PCWG-modified RECIST 1.1 (CR: soft tissue CR with NED on bone scan; PR: soft tissue PR with non-progressive disease, NE, or NED on bone scan, or soft tissue CR with non-progressive disease, or NE bone scan) DOR was defined as time from first documented CR or PR to progressive disease (PD) or death.
Per protocol, RECIST 1.1 was modified to allow ≤10 target lesions total (up to 5 per organ).
Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions and absolute increase of ≥5 mm.
The appearance of ≥1 new lesions was also PD.
Per PCWG, PD was ≥2 new bone lesions (not tumor flare) persisting ≥6 weeks.
DOR is presented.
|
Up to approximately 78 months
|
|
Cohorts 1, 2, 3: Overall Survival (OS)
Time Frame: Up to approximately 78 months
|
OS was defined as the time from the date of the first dose of study treatment to the date of death due to any cause.
OS will be reported for all participants.
|
Up to approximately 78 months
|
|
Cohorts 1, 2, 3: Progression Free Survival (PFS) as Assessed by BICR Per Modified RECIST 1.1 or PCWG-Modified RECIST 1.1
Time Frame: Up to approximately 78 months
|
PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) as assessed by BICR per modified RECIST 1.1 or PCWG-modified RECIST 1.1 (for participants with prostate cancer), or death due to any cause, whichever occurred first.
Per protocol, RECIST 1.1 was modified to allow ≤10 target lesions total (up to 5 per organ).
Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions and the sum must also have demonstrated an absolute increase of ≥5 mm.
The appearance of one or more new lesions was also considered PD.
Per PCWG, PD was ≥2 new bone lesions, confirmed to not represent tumor flare, and persistent for ≥6 weeks.
The PFS per modified RECIST 1.1/PCWG-modified RECIST 1.1 as assessed by BICR is presented.
|
Up to approximately 78 months
|
|
Cohorts 1, 2, 3: Number of Participants Experiencing an Adverse Event (AE)
Time Frame: Up to approximately 78 months
|
An AE is any unfavorable and unintended sign, symptom, or disease (new or exacerbated) in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
The number of participants who experience an AE will be reported.
|
Up to approximately 78 months
|
|
Cohorts 1, 2, 3: Number of Participants Who Discontinue Study Treatment Due to an AE
Time Frame: Up to approximately 78 months
|
An AE is any unfavorable and unintended sign, symptom, or disease (new or exacerbated) in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
The number of participants who discontinue study treatment due to an AE will be reported.
|
Up to approximately 78 months
|
|
Combined Cohort 1+2: ORR as Assessed by BICR Per Modified RECIST 1.1 or PCWG-Modified RECIST 1.1 in Participants Who Are HRRm Positive
Time Frame: Up to approximately 78 months
|
ORR is defined as the percentage of participants who have a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by the BICR per modified RECIST 1.1.
For participants with prostate cancer, response will be assessed based on PCWG-modified RECIST 1.1 criteria (CR: soft tissue CR with NED on bone scan; PR: soft tissue PR with non-progressive disease, NE, or NED on bone scan, or soft tissue CR with non-progressive disease, or NE bone scan).
Per protocol, RECIST 1.1 was modified to follow a maximum of 10 target lesions in total and a maximum of 5 target lesions per organ.
Per protocol, the secondary ORR outcome measure analysis for HRRm positive participants in Cohort 1 (BRCA 1/2) & Cohort 2 [(HRRm, BRCA Non-mutated); (HRD+, HRR Non-mutated)] combined, is presented here.
Per protocol, Cohort 1 & 2 were combined as a pre-specified secondary efficacy analysis population.
|
Up to approximately 78 months
|
|
Combined Cohort 1+2: ORR as Assessed by BICR Per Modified RECIST 1.1 or PCWG-Modified RECIST 1.1 In Participants Who Are HRD Positive (HRD+)
Time Frame: Up to approximately 78 months
|
ORR is defined as the percentage of participants who have a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by the BICR per modified RECIST 1.1.
For participants with prostate cancer, response will be assessed based on PCWG-modified RECIST 1.1 criteria (CR: soft tissue CR with NED on bone scan; PR: soft tissue PR with non-progressive disease, NE, or NED on bone scan, or soft tissue CR with non-progressive disease, or NE bone scan).
Per protocol, RECIST 1.1 was modified to follow a maximum of 10 target lesions in total and a maximum of 5 target lesions per organ.
Per protocol, the secondary ORR outcome measure analysis for HRD+ participants in Cohort 1 (BRCA 1/2) and Cohort 2 [(HRRm, BRCA Non-mutated); (HRD+, HRR Non-mutated)] combined, is presented here.
Per protocol, Cohort 1 and Cohort 2 were combined as a pre-specified secondary efficacy analysis population.
|
Up to approximately 78 months
|
|
Combined Cohort 1+2: ORR as Assessed by BICR Per Modified RECIST 1.1 or PCWG-Modified RECIST 1.1 in All Combined Cohort 1+2 Participants Regardless of Biomarker Status
Time Frame: Up to approximately 78 months
|
ORR is defined as the percentage of participants who have a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by the BICR per modified RECIST 1.1.
For participants with prostate cancer, response will be assessed based on PCWG-modified RECIST 1.1 criteria (CR: soft tissue CR with no evidence of disease [NED] on bone scan; PR: soft tissue PR with non-progressive disease, non-evaluable [NE], or NED on bone scan, or soft tissue CR with non-progressive disease, or NE bone scan).
Per protocol, RECIST 1.1 was modified to follow a maximum of 10 target lesions in total and a maximum of 5 target lesions per organ.
Per protocol, the secondary ORR outcome measure analysis for all participants regardless of biomarker status in Cohort 1 (BRCA 1/2) and Cohort 2 ([HRRm, BRCA Non-mutated]; [HRD+, HRR Non-mutated]) combined, is presented here.
|
Up to approximately 78 months
|
|
Combined Cohort 1+2: DOR as Assessed by BICR Per Modified RECIST 1.1 or PCWG-Modified RECIST 1.1 in Participants Who Are HRRm Positive
Time Frame: Up to approximately 78 months
|
For participants with CR (disappearance of all target lesions) or PR (≥30% decrease in sum of diameters of target lesions) as assessed by BICR per modified RECIST; or, for participants with prostate cancer, per PCWG-modified RECIST 1.1 (CR: soft tissue CR with NED on bone scan; PR: soft tissue PR with non-progressive disease, NE, or NED on bone scan, or soft tissue CR with non-progressive disease, or NE bone scan) DOR was defined as time from first documented CR/PR to PD or death.
Per protocol, RECIST 1.1 was modified to allow ≤10 target lesions (up to 5 per organ).
Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions & absolute increase of ≥5 mm or appearance of ≥1 new lesion.
Per PCWG, PD was ≥2 new bone lesions (not tumor flare) persisting ≥6 weeks.
DOR for HRRm positive participants with CR/PR in Cohort 1 & 2 combined is presented.
|
Up to approximately 78 months
|
|
Combined Cohort 1+2: DOR as Assessed by BICR Per Modified RECIST 1.1 or PCWG-Modified RECIST 1.1 In Participants Who Are HRD Positive (HRD+)
Time Frame: Up to approximately 78 months
|
For participants with CR (disappearance of all target lesions) or PR (≥30% decrease in sum of diameters of target lesions) as assessed by BICR per modified RECIST; or, for participants with prostate cancer, per PCWG-modified RECIST 1.1 (CR: soft tissue CR with NED on bone scan; PR: soft tissue PR with non-progressive disease, NE, or NED on bone scan, or soft tissue CR with non-progressive disease, or NE bone scan) DOR was defined as time from first documented CR/PR to PD or death.
Per protocol, RECIST 1.1 was modified to allow ≤10 target lesions (up to 5 per organ).
Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions & absolute increase of ≥5 mm or appearance of ≥1 new lesion.
Per PCWG, PD was ≥2 new bone lesions (not tumor flare) persisting ≥6 weeks.
DOR for HRD+ participants with CR/PR in Cohort 1 & 2 combined is presented.
|
Up to approximately 78 months
|
|
Combined Cohort 1+2: DOR as Assessed by BICR Per Modified RECIST 1.1 or PCWG-modified RECIST 1.1 in All Combined Cohort 1+2 Participants Regardless of Biomarker Status
Time Frame: Up to approximately 78 months
|
For participants with CR (disappearance of all target lesions) or PR (≥30% decrease in sum of diameters of target lesions) as assessed by BICR per modified RECIST; or, for participants with prostate cancer, per PCWG-modified RECIST 1.1 (CR: soft tissue CR with NED on bone scan; PR: soft tissue PR with non-progressive disease, NE, or NED on bone scan, or soft tissue CR with non-progressive disease, or NE bone scan) DOR was defined as time from first documented CR/PR to PD or death.
Per protocol, RECIST 1.1 was modified to allow ≤10 target lesions (up to 5 per organ).
Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions & absolute increase of ≥5 mm or appearance of ≥1 new lesion.
Per PCWG, PD was ≥2 new bone lesions (not tumor flare) persisting ≥6 weeks.
DOR for all participants in Cohort 1 & 2 combined with CR/PR is presented.
|
Up to approximately 78 months
|
|
Combined Cohort 1+2: OS in Participants Who Are HRRm Positive
Time Frame: Up to approximately 78 months
|
OS was defined as the time from the date of the first dose of study treatment to the date of death due to any cause.
Per protocol, the secondary OS outcome measure analysis for HRRm positive participants in Cohort 1 (BRCA 1/2) and Cohort 2 [(HRRm, BRCA Non-mutated); (HRD+, HRR Non-mutated)] combined, will be presented.
Per protocol, Cohort 1 and Cohort 2 will be combined as a pre-specified secondary efficacy analysis.
|
Up to approximately 78 months
|
|
Combined Cohort 1+2: OS in Participants Who Are HRD Positive (HRD+)
Time Frame: Up to approximately 78 months
|
OS was defined as the time from the date of the first dose of study treatment to the date of death due to any cause.
Per protocol, the secondary OS outcome measure analysis for HRD+ participants in Cohort 1 (BRCA 1/2) and Cohort 2 [(HRRm, BRCA Non-mutated); (HRD+, HRR Non-mutated)] combined, will be presented.
Per protocol, Cohort 1 and Cohort 2 will be combined as a pre-specified secondary efficacy analysis.
|
Up to approximately 78 months
|
|
Combined Cohort 1+2: OS in All Combined Cohort 1+2 Participants Regardless of Biomarker Status
Time Frame: Up to approximately 78 months
|
OS was defined as the time from the date of the first dose of study treatment to the date of death due to any cause.
Per protocol, the secondary OS outcome measure analysis for all participants regardless of biomarker status in Cohort 1 (BRCA 1/2) and Cohort 2 [(HRRm, BRCA Non-mutated); (HRD+, HRR Non-mutated)] combined, will be presented.
Per protocol, Cohort 1 and Cohort 2 will be combined as a pre-specified secondary efficacy analysis.
|
Up to approximately 78 months
|
|
Combined Cohort 1+2: PFS as Assessed by BICR Per Modified RECIST 1.1 or PCWG-Modified RECIST 1.1 in Participants Who Are HRRm Positive
Time Frame: Up to approximately 78 months
|
PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) as assessed by BICR per modified RECIST 1.1 or PCWG-modified RECIST 1.1 (for participants with prostate cancer), or death due to any cause, whichever occurred first.
Per protocol, RECIST 1.1 was modified to allow ≤10 target lesions total (up to 5 per organ).
Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions and the sum must also have demonstrated an absolute increase of ≥5 mm.
The appearance of one or more new lesions was also considered PD.
Per PCWG, PD was ≥2 new bone lesions, confirmed to not represent tumor flare, and persistent for ≥6 weeks.
Per protocol, the PFS analysis for HRRm positive participants in Cohort 1 and Cohort 2 combined is presented here.
|
Up to approximately 78 months
|
|
Combined Cohort 1+2: PFS as Assessed by BICR Per Modified RECIST 1.1 or PCWG-Modified RECIST 1.1 in Participants Who Are HRD Positive (HRD+)
Time Frame: Up to approximately 78 months
|
PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) as assessed by BICR per modified RECIST 1.1 or PCWG-modified RECIST 1.1 (for participants with prostate cancer), or death due to any cause, whichever occurred first.
Per protocol, RECIST 1.1 was modified to allow ≤10 target lesions total (up to 5 per organ).
Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions and the sum must also have demonstrated an absolute increase of ≥5 mm.
The appearance of one or more new lesions was also considered PD.
Per PCWG, PD was ≥2 new bone lesions, confirmed to not represent tumor flare, and persistent for ≥6 weeks.
Per protocol, the PFS analysis for HRD+ participants in Cohort 1 and Cohort 2 combined is presented here.
|
Up to approximately 78 months
|
|
Combined Cohort 1+2: PFS as Assessed by BICR Per Modified RECIST 1.1 or PCWG-Modified RECIST 1.1 in All Combined Cohort 1+2 Participants Regardless of Biomarker Status
Time Frame: Up to approximately 78 months
|
PFS was defined as the time from first dose of study treatment to the first documented PD as assessed by BICR per modified RECIST 1.1 or PCWG-modified RECIST 1.1 (for participants with prostate cancer), or death due to any cause, whichever occurred first.
Per protocol, RECIST 1.1 was modified to allow ≤10 target lesions total (up to 5 per organ).
Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions and the sum must also have demonstrated an absolute increase of ≥5 mm.
The appearance of one or more new lesions was also considered PD.
Per PCWG, PD was ≥2 new bone lesions, confirmed to not represent tumor flare, and persistent for ≥6 weeks.
Per protocol, the PFS analysis for all participants regardless of biomarker status in Cohort 1 & 2 is presented here.
|
Up to approximately 78 months
|
|
Participants With BRCA1/2 Non-Mutated Ovarian Cancer: Time to Earliest Progression by Cancer Antigen-125 (CA-125)
Time Frame: Up to approximately 78 months
|
Time to earliest progression by CA-125 was defined as the time from first dose to progression based on CA-125.
For participants with BRCA1/2 non-mutated ovarian cancer only, progression by CA-125 was defined as either CA-125 ≥2× upper limit normal (ULN) on 2 occasions 1 week apart or, for participants with elevated CA-125 (≥ULN) at baseline, ≥2× the nadir value on 2 occasions 1 week apart.
Time to earliest progression based on CA-125 is presented.
|
Up to approximately 78 months
|
|
Participants With Prostate Cancer: Prostate-Specific Antigen (PSA) Response Rate
Time Frame: Up to approximately 78 months
|
PSA response was defined as a reduction in PSA level ≥50% from baseline measured twice at least 3 weeks apart.
For participants with prostate cancer with baseline PSA measurements available, the PSA response rate as assessed is presented.
|
Up to approximately 78 months
|
|
Cohort 3: PFS2 as Assessed by the Investigator in Participants With sBRCAm Breast Cancer
Time Frame: Up to approximately 78 months
|
PFS2 was defined as the time from the first dose of study medication to subsequent disease progression on next-line treatment or death due to any cause, whichever occurred first, as assessed by the investigator.
PFS2 for participants with sBRCAm breast cancer in Cohort 3 will be reported.
|
Up to approximately 78 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 12, 2018
Primary Completion (Actual)
August 12, 2025
Study Completion (Estimated)
June 30, 2027
Study Registration Dates
First Submitted
November 14, 2018
First Submitted That Met QC Criteria
November 14, 2018
First Posted (Actual)
November 15, 2018
Study Record Updates
Last Update Posted (Actual)
August 14, 2026
Last Update Submitted That Met QC Criteria
July 22, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7339-002
- MK-7339-002 (Other Identifier: MSD)
- LYNK-002 (Other Identifier: MSD)
- 194694 (Registry Identifier: JAPIC-CTI)
- 2018-003007-19 (EudraCT Number)
- 2022-500797-34-00 (Registry Identifier: EU CT)
- U1111-1278-1505 (Registry Identifier: UTN)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.