Eficacia y seguridad de olaparib (MK-7339) en participantes con cáncer avanzado positivo previamente tratado, mutación en reparación de recombinación homóloga (HRRm) o deficiencia de recombinación homóloga (HRD) (MK-7339-002 / LYNK-002)
22 de julio de 2026 actualizado por: Merck Sharp & Dohme LLC
Un estudio de fase 2 de monoterapia con olaparib en participantes con cáncer avanzado positivo con mutación de reparación de recombinación homóloga (HRRm) o deficiencia de recombinación homóloga (HRD) previamente tratada
Este estudio evaluará la eficacia y seguridad de la monoterapia con olaparib (MK-7339) en participantes con múltiples tipos de cáncer avanzado (irresecable y/o metastásico) que: 1) han progresado o han sido intolerantes a la terapia de atención estándar; y 2) son positivos para mutación de reparación de recombinación homóloga (HRRm) o deficiencia de recombinación homóloga (HRD).
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
329
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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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, Canadá, M4N 3M5
- Sunnybrook Research Institute ( Site 0210)
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Quebec
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Montreal, Quebec, Canadá, H1T 2M4
- Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0203)
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Montreal, Quebec, Canadá, H3T 1E2
- Jewish General Hospital ( Site 0209)
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Québec, Quebec, Canadá, 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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Seoul, Corea del Sur, 03722
- Severance Hospital Yonsei University Health System ( Site 2400)
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Seoul, Corea del Sur, 03080
- Seoul National University Hospital ( Site 2401)
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Kyonggi-do
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Seongnam-si, Kyonggi-do, Corea del Sur, 13620
- Seoul National University Bundang Hospital ( Site 2402)
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Capital Region
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Copenhagen, Capital Region, Dinamarca, 2100
- Rigshospitalet ( Site 0402)
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Herlev, Capital Region, Dinamarca, 2730
- Herlev og Gentofte Hospital. ( Site 0401)
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Region Syddanmark
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Odense, Region Syddanmark, Dinamarca, 5000
- Odense Universitetshospital ( Site 0400)
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Barcelona, España, 08035
- Hospital Universitari Vall d Hebron ( Site 1350)
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Madrid
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Pozuelo de Alarcón, Madrid, España, 28223
- Hospital Universitario Quiron Madrid ( Site 1352)
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Arizona
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Tucson, Arizona, Estados Unidos, 85719
- The University of Arizona Cancer Center - North Campus ( Site 0011)
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California
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Fullerton, California, Estados Unidos, 92835
- St Joseph Heritage Healthcare-Oncology ( Site 0056)
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Los Angeles, California, Estados Unidos, 90048
- Cedars Sinai Medical Center ( Site 0002)
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San Francisco, California, Estados Unidos, 94158
- UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0007)
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- Rocky Mountain Regional Veterans Affairs Medical Center ( Site 0092)
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322-1013
- Winship Cancer Institute of Emory University ( Site 0025)
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Augusta, Georgia, Estados Unidos, 30912
- Augusta University ( Site 0028)
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40536
- Markey Cancer Center ( Site 0018)
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Maryland
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Baltimore, Maryland, Estados Unidos, 21201
- University of Maryland ( Site 0050)
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Baltimore, Maryland, Estados Unidos, 21237
- Weinberg Cancer Institute at Franklin Square ( Site 0054)
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Massachusetts
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Worcester, Massachusetts, Estados Unidos, 01655
- University of Massachusetts ( Site 0017)
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Michigan
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Detroit, Michigan, Estados Unidos, 48202
- Henry Ford Health System ( Site 0060)
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Nebraska
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Lincoln, Nebraska, Estados Unidos, 68510
- Cancer Partners of Nebraska ( Site 0051)
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New Jersey
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Middletown, New Jersey, Estados Unidos, 07748
- Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0116)
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New York
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Harrison, New York, Estados Unidos, 10604
- Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 0126)
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New York, New York, Estados Unidos, 10010
- VA New York Harbor Healthcare System Manhattan ( Site 0094)
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New York, New York, Estados Unidos, 10016
- Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0057)
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New York, New York, Estados Unidos, 10065
- Memorial Sloan Kettering Cancer Center ( Site 0026)
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Oklahoma
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Tulsa, Oklahoma, Estados Unidos, 74133
- Southwestern Regional Medical Center, Inc. ( Site 0079)
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19124
- Eastern Regional Medical Center, Inc. ( Site 0077)
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South Dakota
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Sioux Falls, South Dakota, Estados Unidos, 57104
- Sanford Hematology Oncology-Sioux Falls SD ( Site 0012)
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Utah
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St. George, Utah, Estados Unidos, 84790
- Intermountain Healthcare ( Site 0043)
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Washington
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Seattle, Washington, Estados Unidos, 98101
- Virginia Mason Medical Center ( Site 0052)
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Seattle, Washington, Estados Unidos, 98108
- Veterans Affairs Puget Sound Health Care System [Seattle, WA] ( Site 0093)
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Ain
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Poitiers, Ain, Francia, 86021
- CHU Poitiers ( Site 0612)
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Alpes-Maritimes
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Nice, Alpes-Maritimes, Francia, 06189
- Centre Antoine Lacassagne ( Site 0610)
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Alsace
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Strasbourg, Alsace, Francia, 67033
- Institut de Cancerologie Strasbourg Europe ( Site 0613)
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Bourgogne-Franche-Comté
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Dijon, Bourgogne-Franche-Comté, Francia, 21000
- Centre Georges Francois Leclerc ( Site 0608)
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Gironde
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Bordeaux, Gironde, Francia, 33076
- Institut Bergonie ( Site 0603)
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Val-de-Marne
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Villejuif, Val-de-Marne, Francia, 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, Irlanda, T12 DV56
- Bon Secours Hospital ( Site 1656)
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Dublin, Irlanda, 00004
- St. Vincent's University Hospital ( Site 1653)
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Dublin, Irlanda, D24 NROA
- Tallaght University Hospital ( Site 1652)
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Carlow
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Dublin, Carlow, Irlanda, 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, Italia, 80131
- Istituto Nazionale Tumori Fondazione Pascale ( Site 0700)
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Lombardy
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Rozzano, Lombardy, Italia, 20089
- Istituto Clinico Humanitas Research Hospital ( Site 0703)
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Tuscany
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Siena, Tuscany, Italia, 53100
- Policlinico Le Scotte di Siena ( Site 0704)
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Tokyo, Japón, 135-8550
- The Cancer Institute Hospital of JFCR ( Site 2605)
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Tokyo, Japón, 104-0045
- National Cancer Center Hospital ( Site 2601)
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Aichi-ken
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Nagoya, Aichi-ken, Japón, 464-8681
- Aichi Cancer Center Hospital ( Site 2602)
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Chiba
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Kashiwa, Chiba, Japón, 2778577
- National Cancer Center Hospital East ( Site 2600)
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Kyoto
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Kyoto, Kyoto, Japón, 606-8507
- Kyoto University Hospital ( Site 2603)
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Osaka
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Suita, Osaka, Japón, 565-0871
- Osaka University Hospital ( Site 2604)
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Chihuahua City, México, 31000
- Centro Estatal de Cancerologia de Chihuahua ( Site 2907)
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Mexico City, México, 06100
- CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 2900)
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México, México, 03100
- CENEIT Oncologicos ( Site 2904)
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Oaxaca City, México, 68000
- Oaxaca Site Management Organization S.C. ( Site 2905)
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Jalisco
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Guadalajara, Jalisco, México, 44680
- Actualidad Basada en la Investigacion del Cancer ( Site 2903)
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Nuevo León
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Monterrey, Nuevo León, México, 64460
- Unidad Biomedica Avanzada Monterrey S. A. ( Site 2902)
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Querétaro
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Santiago de Quetaro, Querétaro, México, 76000
- Cuidados Oncologicos ( Site 2908)
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Tamaulipas
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Madero, Tamaulipas, México, 89440
- Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 2901)
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Lima, Perú, 15033
- Hospital Nacional Guillermo Almenara Irigoyen ( Site 3107)
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Lima, Perú, 15036
- Clinica Internacional Sede San Borja ( Site 3100)
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Lima, Perú, 15036
- Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 3101)
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Lima, Perú, 15036
- Oncosalud-Clinical Research ( Site 3108)
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Lima, Perú, 15046
- Hospital Central de la Fuerza Aerea del Peru ( Site 3104)
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Lima, Perú, 15076
- Hospital Militar Central Coronel Luis Arias Schereiber ( Site 3105)
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Lima, Perú, 15082
- Hospital Arzobispo Loayza ( Site 3103)
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La Libertad
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Trujillo, La Libertad, Perú, 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, Perú, 15038
- Instituto Nacional de Enfermedades Neoplasicas ( Site 3106)
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Manchester, Reino Unido, M20 4BX
- Christie NHS Foundation Trust ( Site 1601)
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Newcastle upon Tyne, Reino Unido, NE7 7DN
- Northern Centre for Cancer Care ( Site 1602)
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Sheffield, Reino Unido, S10 2SJ
- Weston Park Hospital ( Site 1607)
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Worcestershire
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Oxford, Worcestershire, Reino Unido, OX3 7LE
- Churchill Hospital ( Site 1606)
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Brasov, Rumania, 500152
- Spitalul PDR Medlife ( Site 1106)
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Bucharest, Rumania, 022548
- S.C.Focus Lab Plus S.R.L ( Site 1101)
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Bucharest, Rumania, 031422
- S.C.Gral Medical S.R.L ( Site 1104)
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Bihor County
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Oradea, Bihor County, Rumania, 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, Rumania, 400641
- Medisprof ( Site 1107)
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Comuna Floresti, Cluj, Rumania, 407280
- SC Radiotherapy Center Cluj SRL ( Site 1105)
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Dolj
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Craiova, Dolj, Rumania, 200542
- S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1103)
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Arkhangelskaya oblast
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Arkhangelsk, Arkhangelskaya oblast, Rusia, 163045
- Arkhangelsk Clinical Oncological Dispensary ( Site 1204)
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Chelyabinsk Oblast
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Chelyabinsk, Chelyabinsk Oblast, Rusia, 454087
- Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1212)
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Moscow
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Moscow, Moscow, Rusia, 115477
- N.N. Blokhin NMRCO ( Site 1201)
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Moscow, Moscow, Rusia, 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, Rusia, 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, Rusia, 390011
- Ryazan Regional Clinical Oncology dispensary ( Site 1202)
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Samara Oblast
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Samara, Samara Oblast, Rusia, 443031
- SBHI Samara Regional Clinical Oncology Dispensary ( Site 1211)
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Sankt-Peterburg
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Saint Petersburg, Sankt-Peterburg, Rusia, 194044
- Clinical Hospital Saint Luka ( Site 1205)
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Saint Petersburg, Sankt-Peterburg, Rusia, 194291
- SBHI Leningrad Regional Clinical Hospital ( Site 1206)
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Saint Petersburg, Sankt-Peterburg, Rusia, 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, Rusia, 420029
- Republican Clinical Oncology Dispensary of Tatarstan MoH named after professor M.Z. Sigal ( Site 120
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Canton Ticino
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Bellinzona, Canton Ticino, Suiza, 6500
- Ospedale Regionale di Bellinzona e Valli ( Site 1407)
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Canton of Aargau
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Zuerich, Canton of Aargau, Suiza, 8091
- Universitaetsspital Zuerich ( Site 1400)
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Canton of Geneva
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Geneva, Canton of Geneva, Suiza, 1211
- Hopitaux Universitaires de Geneve HUG. ( Site 1406)
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Adana, Turquía (Türkiye), 01250
- Baskent University Adana Training Hospital ( Site 1508)
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Ankara, Turquía (Türkiye), 06100
- Hacettepe Universitesi Tıp Fakultesi ( Site 1503)
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Antalya, Turquía (Türkiye), 07070
- Akdeniz Universitesi Tip Fakultesi ( Site 1504)
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Edirne, Turquía (Türkiye), 22030
- Trakya Universitesi Tip Fakultesi ( Site 1500)
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Istanbul, Turquía (Türkiye), 34098
- Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1505)
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Istanbul, Turquía (Türkiye), 34722
- Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 1506)
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Izmir, Turquía (Türkiye), 35100
- Ege Universitesi Tip Fakultesi ( Site 1502)
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Adana
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Konya, Adana, Turquía (Türkiye), 42080
- Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 1507)
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Descripción
Criterios de inclusión:
- Para todos los participantes:
- Tiene una enfermedad medible según RECIST 1.1 o RECIST 1.1 modificado por PCWG según lo evaluado por el investigador/radiología del sitio local y confirmado por BICR.
- Es capaz de proporcionar una biopsia central o por escisión recién obtenida de una lesión tumoral o un bloque o portaobjetos de tejido tumoral fijado en formalina e incrustado en parafina (FFPE) de archivo.
- Tiene una esperanza de vida de al menos 3 meses.
- Tiene un estado funcional del Grupo Oncológico Cooperativo del Este (ECOG) de 0 o 1, según lo evaluado dentro de los 7 días posteriores al inicio del tratamiento.
- Los participantes masculinos deben aceptar usar métodos anticonceptivos durante el período de tratamiento y durante al menos 95 días (3 meses y 5 días) después de la última dosis del tratamiento del estudio y abstenerse de donar esperma durante este período.
Una participante femenina es elegible para participar si no está embarazada o amamantando, y se aplica al menos una de las siguientes condiciones:
- No es una mujer en edad fértil (WOCBP).
- Es un WOCBP y usa un método anticonceptivo que es altamente efectivo con baja dependencia del usuario, o se abstiene de tener relaciones heterosexuales como su estilo de vida preferido y habitual (abstinencia a largo plazo y persistente), durante el período de intervención y por al menos 180 días después de la última dosis de la intervención del estudio, Y acepta no donar óvulos (óvulos, ovocitos) a otros ni congelarlos/almacenarlos para su propio uso con fines de reproducción durante este período. Se abstiene de amamantar durante el período de intervención del estudio y durante al menos 30 días después de la última dosis de la intervención del estudio.
- Tiene función orgánica adecuada.
- Para las participantes que no tienen cáncer de mama o cáncer de ovario que tienen mutación del gen de susceptibilidad al cáncer de mama 1/2 (BRCA1/2) (BRCAm), o que tienen cánceres que no tienen mutación de BRCA1/2 y reparación de recombinación homóloga no mutada:
- Tiene un tumor sólido avanzado (metastásico y/o no resecable) confirmado histológica o citológicamente (excepto cáncer de ovario cuyo tumor tiene una mutación BRCA somática o de línea germinal y cáncer de mama cuyo tumor tiene una mutación BRCA de línea germinal) que no es elegible para tratamiento curativo y para los cuales la terapia estándar de atención ha fallado. Los participantes deben haber progresado o ser intolerantes a las terapias estándar de atención que se sabe que brindan un beneficio clínico. No hay límite en el número de regímenes de tratamiento previos.
- Tiene mutaciones nocivas conocidas o sospechosas confirmadas centralmente en al menos 1 de los genes involucrados en HRR o HRD confirmada centralmente.
- Para los participantes que recibieron platino previamente (cisplatino, carboplatino u oxaliplatino, ya sea como monoterapia o en combinación) para un tumor sólido avanzado (metastásico y/o no resecable), que no tengan evidencia de progresión de la enfermedad durante la quimioterapia con platino o ≤4 semanas de completar el tratamiento con platino. régimen contenedor.
- Para participantes que tienen cáncer de mama somático BRCAm:
- Tiene cáncer de mama confirmado histológica o citológicamente con evidencia de enfermedad metastásica.
- Tiene una mutación nociva conocida o sospechada en el gen de susceptibilidad al cáncer de mama (BRCA) 1 o BRCA2 y no alberga una mutación de línea germinal BRCA1 o BRCA2; las pruebas se pueden realizar de forma central o local. Todos los participantes deben proporcionar muestras de sangre y tejido.
- Ha recibido tratamiento con una antraciclina a menos que esté contraindicado y un taxano en el entorno neoadyuvante/adyuvante o metastásico.
- Las participantes con enfermedad positiva para receptores de estrógeno y/o progesterona deben haber recibido y progresado en al menos una terapia endocrina (adyuvante o metastásica), o tener una enfermedad que el médico tratante considere inapropiada para la terapia endocrina.
Criterio de exclusión:
- Tiene una neoplasia maligna adicional conocida que está progresando o ha requerido tratamiento activo en los últimos 5 años. Nota: No se excluyen los participantes con carcinoma de células basales de la piel, carcinoma de células escamosas de la piel, carcinoma ductal in situ o carcinoma de cuello uterino in situ que se haya sometido a una terapia potencialmente curativa.
- Tiene síndrome mielodisplásico (MDS)/leucemia mieloide aguda (AML) o con características sugestivas de MDS/AML.
- Tiene metástasis conocidas en el sistema nervioso central (SNC) y/o meningitis carcinomatosa. Nota: Los participantes con metástasis cerebrales previamente tratadas pueden participar si están radiológicamente estables, clínicamente estables y sin necesidad de tratamiento con esteroides durante al menos 14 días antes de la primera dosis del tratamiento del estudio.
- Ha recibido factores estimulantes de colonias (p. ej., factor estimulante de colonias de granulocitos [G-CSF], factor estimulante de colonias de granulocitos y macrófagos [GM-CSF] o eritropoyetina recombinante) dentro de los 28 días anteriores a la primera dosis del tratamiento del estudio.
- Tiene antecedentes conocidos de infección por el virus de la inmunodeficiencia humana (VIH).
- Tiene una infección de hepatitis activa conocida (es decir, hepatitis B o C).
- No puede tragar medicamentos administrados por vía oral o tiene un trastorno gastrointestinal que afecta la absorción (p. ej., gastrectomía, obstrucción intestinal parcial, malabsorción).
- Ha recibido tratamiento previo con olaparib o con cualquier otro inhibidor de la polimerización (PARP) de poliadenosina 5' difosforribosa (poli[ADP ribosa]).
- Tiene hipersensibilidad conocida a los componentes o excipientes de olaparib.
- Ha recibido trasplante alogénico de médula ósea o trasplante doble de cordón umbilical (dUCBT) previo.
- Ha recibido una transfusión de sangre completa en los últimos 120 días antes de ingresar al estudio. Las transfusiones de concentrados de glóbulos rojos y plaquetas son aceptables si no se realizan dentro de los 28 días posteriores a la primera dosis del tratamiento del estudio.
- Ha recibido quimioterapia sistémica antineoplásica o terapia biológica, terapia dirigida o terapia hormonal contra el cáncer dentro de las 3 semanas anteriores a la primera dosis de la intervención del estudio.
- Tiene un cáncer primario de origen desconocido.
- Ha recibido radioterapia previa dentro de las 2 semanas posteriores al inicio de la intervención del estudio. Los participantes deben haberse recuperado de todas las toxicidades relacionadas con la radiación, no requerir corticosteroides y no haber tenido neumonitis por radiación. Se permite un lavado de 1 semana para la radiación paliativa (≤2 semanas de radioterapia) para enfermedades que no pertenecen al SNC.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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 administrado dos veces al día en dos comprimidos orales de 150 mg.
Otros nombres:
|
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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.
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Olaparib 300 mg administrado dos veces al día en dos comprimidos orales de 150 mg.
Otros nombres:
|
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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.
|
Olaparib 300 mg administrado dos veces al día en dos comprimidos orales de 150 mg.
Otros nombres:
|
|
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.
|
Olaparib 300 mg administrado dos veces al día en dos comprimidos orales de 150 mg.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
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
Periodo de tiempo: 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.
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Up to approximately 78 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cohorts 1, 2, 3: Duration of Response (DOR) as Assessed by BICR According to Modified RECIST 1.1 or PCWG-Modified RECIST 1.1
Periodo de tiempo: 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.
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Up to approximately 78 months
|
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Cohorts 1, 2, 3: Overall Survival (OS)
Periodo de tiempo: Up to approximately 78 months
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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.
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Up to approximately 78 months
|
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Cohorts 1, 2, 3: Progression Free Survival (PFS) as Assessed by BICR Per Modified RECIST 1.1 or PCWG-Modified RECIST 1.1
Periodo de tiempo: 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.
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Up to approximately 78 months
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Cohorts 1, 2, 3: Number of Participants Experiencing an Adverse Event (AE)
Periodo de tiempo: Up to approximately 78 months
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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.
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Up to approximately 78 months
|
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Cohorts 1, 2, 3: Number of Participants Who Discontinue Study Treatment Due to an AE
Periodo de tiempo: Up to approximately 78 months
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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.
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Up to approximately 78 months
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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
Periodo de tiempo: 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.
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Up to approximately 78 months
|
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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+)
Periodo de tiempo: 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.
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Up to approximately 78 months
|
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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
Periodo de tiempo: 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.
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Up to approximately 78 months
|
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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
Periodo de tiempo: 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.
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Up to approximately 78 months
|
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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+)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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+)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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+)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Medical Director, Merck Sharp & Dohme LLC
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
12 de diciembre de 2018
Finalización primaria (Actual)
12 de agosto de 2025
Finalización del estudio (Estimado)
30 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
14 de noviembre de 2018
Primero enviado que cumplió con los criterios de control de calidad
14 de noviembre de 2018
Publicado por primera vez (Actual)
15 de noviembre de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
22 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 7339-002
- MK-7339-002 (Otro identificador: MSD)
- LYNK-002 (Otro identificador: MSD)
- 194694 (Identificador de registro: JAPIC-CTI)
- 2018-003007-19 (Número EudraCT)
- 2022-500797-34-00 (Identificador de registro: EU CT)
- U1111-1278-1505 (Identificador de registro: UTN)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .