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)

April 4, 2024 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

390

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 Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1118AAT
        • Recruiting
        • Hospital Aleman ( Site 2702)
        • Contact:
          • Study Coordinator
          • Phone Number: +54 11 4827-7000
      • Buenos Aires, Argentina, C1012AAR
        • Completed
        • Instituto de Investigaciones Metabolicas ( Site 2700)
    • Buenos Aires
      • Berazategui, Buenos Aires, Argentina, B1884BBF
        • Completed
        • Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 2703)
    • Caba
      • Ciudad de Buenos Aires, Caba, Argentina, C1280AEB
        • Completed
        • Hospital Britanico de Buenos Aires ( Site 2704)
  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Recruiting
        • Kinghorn Cancer Centre ( Site 2200)
        • Contact:
          • Study Coordinator
          • Phone Number: +61293555655
      • Port Macquarie, New South Wales, Australia, 2444
        • Completed
        • MNCCI Port Macquarie Base Hospital ( Site 2201)
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Completed
        • Linear Clinical Research Ltd ( Site 2202)
  • Canada
      • Quebec, Canada, G1J 1Z4
        • Completed
        • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Research Institute ( Site 0210)
        • Contact:
          • Study Coordinator
          • Phone Number: 4164805000
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Recruiting
        • Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0203)
        • Contact:
          • Study Coordinator
          • Phone Number: 51425234005853
      • Montreal, Quebec, Canada, H3T 1E2
        • Completed
        • Jewish General Hospital ( Site 0209)
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 050021
        • Completed
        • Fundacion Centro de Investigacion Clinica CIC ( Site 2812)
      • Medellin, Antioquia, Colombia, 050030
        • Completed
        • Rodrigo Botero SAS ( Site 2801)
    • Atlantico
      • Barranquilla, Atlantico, Colombia, 080001
        • Completed
        • Biomelab S A S ( Site 2800)
    • Cesar
      • Valledupar, Cesar, Colombia, 200001
        • Recruiting
        • Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 2808)
        • Contact:
          • Study Coordinator
          • Phone Number: +5755602310
    • Cordoba
      • Monteria, Cordoba, Colombia, 230002
        • Completed
        • Oncomedica S.A. ( Site 2806)
    • Distrito Capital De Bogota
      • Bogota, Distrito Capital De Bogota, Colombia, 110311
        • Completed
        • Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 2807)
      • Bogota, Distrito Capital De Bogota, Colombia, 111511
        • Completed
        • Instituto Nacional de Cancerologia E.S.E ( Site 2809)
      • Bogota, Distrito Capital De Bogota, Colombia, 110221
        • Completed
        • Administradora Country SA - Clinica del Country ( Site 2802)
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia, 760042
        • Completed
        • C. Medico Imbanaco Cali S.A. ( Site 2810)
  • Denmark
    • Hovedstaden
      • Copenhagen, Hovedstaden, Denmark, 2100
        • Completed
        • Rigshospitalet ( Site 0402)
      • Herlev, Hovedstaden, Denmark, 2730
        • Recruiting
        • Herlev og Gentofte Hospital. ( Site 0401)
        • Contact:
          • Study Coordinator
          • Phone Number: +45 38 68 38 68
    • Syddanmark
      • Odense, Syddanmark, Denmark, 5000
        • Completed
        • Odense Universitetshospital ( Site 0400)
  • France
    • Ain
      • Poitiers, Ain, France, 86021
        • Completed
        • CHU Poitiers ( Site 0612)
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06189
        • Completed
        • Centre Antoine Lacassagne ( Site 0610)
    • Alsace
      • Strasbourg, Alsace, France, 67200
        • Recruiting
        • Institut de Cancerologie Strasbourg Europe ( Site 0613)
        • Contact:
          • Study Coordinator
          • Phone Number: +33388252485
    • Bourgogne
      • Dijon, Bourgogne, France, 21000
        • Completed
        • Centre Georges Francois Leclerc ( Site 0608)
    • Gironde
      • Bordeaux, Gironde, France, 33076
        • Completed
        • Institut Bergonie ( Site 0603)
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94805
        • Recruiting
        • Institut Gustave Roussy ( Site 0601)
        • Contact:
          • Study Coordinator
          • Phone Number: +33142114296
  • Guatemala
      • Guatemala, Guatemala, 01010
        • Recruiting
        • Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 3004)
        • Contact:
          • Study Coordinator
          • Phone Number: +50259458053
      • Guatemala, Guatemala, 01010
        • Recruiting
        • Integra Cancer Institute ( Site 3006)
        • Contact:
          • Study Coordinator
          • Phone Number: +50222790939
      • Guatemala, Guatemala, 01015
        • Recruiting
        • Grupo Angeles SA ( Site 3001)
        • Contact:
          • Study Coordinator
          • Phone Number: +50240492110
    • Quetzaltenango
      • Guatemala, Quetzaltenango, Guatemala, 09001
        • Recruiting
        • Centro Regional de Sub Especialidades Medicas SA ( Site 3003)
        • Contact:
          • Study Coordinator
          • Phone Number: +50259450559
  • Ireland
      • Cork, Ireland, T12 DV56
        • Completed
        • Bon Secours Hospital ( Site 1656)
      • Dublin, Ireland, 00004
        • Recruiting
        • St. Vincent's University Hospital ( Site 1653)
        • Contact:
          • Study Coordinator
          • Phone Number: +35314144259
      • Dublin, Ireland, D24 NROA
        • Completed
        • Tallaght University Hospital ( Site 1652)
    • Carlow
      • Dublin, Carlow, Ireland, D07 WKW8
        • Completed
        • Mater Misericordiae University Hospital ( Site 1654)
  • Israel
      • Beer-Sheva, Israel, 8457108
        • Completed
        • Soroka Medical Center ( Site 0800)
      • Haifa, Israel, 3109601
        • Completed
        • Rambam Health Care Campus-Oncology Division ( Site 0801)
      • Jerusalem, Israel, 9112001
        • Active, not recruiting
        • Hadassah Ein Kerem Medical Center ( Site 0802)
      • Ramat Gan, Israel, 5262000
        • Recruiting
        • Chaim Sheba Medical Center ( Site 0803)
        • Contact:
          • Study Coordinator
          • Phone Number: +97235302243
      • Tel Aviv, Israel, 6423906
        • Completed
        • Sourasky Medical Center ( Site 0804)
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
        • Completed
        • Istituto Nazionale Tumori Fondazione Pascale ( Site 0700)
    • Lombardia
      • Rozzano, Lombardia, Italy, 20089
        • Completed
        • Istituto Clinico Humanitas Research Hospital ( Site 0703)
    • Toscana
      • Siena, Toscana, Italy, 53100
        • Completed
        • Policlinico Le Scotte di Siena ( Site 0704)
  • Japan
      • Tokyo, Japan, 135-8550
        • Active, not recruiting
        • The Cancer Institute Hospital of JFCR ( Site 2605)
      • Tokyo, Japan, 104-0045
        • Active, not recruiting
        • National Cancer Center Hospital ( Site 2601)
    • Aichi
      • Nagoya, Aichi, Japan, 464-8681
        • Active, not recruiting
        • Aichi Cancer Center Hospital ( Site 2602)
    • Chiba
      • Kashiwa, Chiba, Japan, 2778577
        • Active, not recruiting
        • National Cancer Center Hospital East ( Site 2600)
    • Kyoto
      • Kyoto-shi, Kyoto, Japan, 606-8507
        • Completed
        • Kyoto University Hospital ( Site 2603)
    • Osaka
      • Suita, Osaka, Japan, 565-0871
        • Completed
        • Osaka University Hospital ( Site 2604)
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital ( Site 2401)
        • Contact:
          • Study Coordinator
          • Phone Number: +82220720850
      • Seoul, Korea, Republic of, 03722
        • Completed
        • Severance Hospital Yonsei University Health System ( Site 2400)
    • Kyonggi-do
      • Seongnam-si, Kyonggi-do, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital ( Site 2402)
        • Contact:
          • Study Coordinator
          • Phone Number: +82317877022
  • Mexico
      • Chihuahua, Mexico, 31000
        • Completed
        • Centro Estatal de Cancerologia de Chihuahua ( Site 2907)
      • Mexico, Mexico, 03100
        • Recruiting
        • CENEIT Oncologicos ( Site 2904)
        • Contact:
          • Study Coordinator
          • Phone Number: +5215529009882
      • Mexico City, Mexico, 06100
        • Recruiting
        • CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 2900)
        • Contact:
          • Study Coordinator
          • Phone Number: +525555743589
      • Oaxaca, Mexico, 68000
        • Completed
        • Oaxaca Site Management Organization S.C. ( Site 2905)
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44680
        • Recruiting
        • Actualidad Basada en la Investigacion del Cancer ( Site 2903)
        • Contact:
          • Study Coordinator
          • Phone Number: +523313141707
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Completed
        • Unidad Biomedica Avanzada Monterrey S. A. ( Site 2902)
    • Queretaro
      • Santiago De Quetaro, Queretaro, Mexico, 76000
        • Completed
        • Cuidados Oncologicos ( Site 2908)
    • Tamaulipas
      • Madero, Tamaulipas, Mexico, 89440
        • Completed
        • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 2901)
  • Peru
      • Lima, Peru, 15036
        • Recruiting
        • Clinica Internacional Sede San Borja ( Site 3100)
        • Contact:
          • Study Coordinator
          • Phone Number: +51999611475
      • Lima, Peru, 15036
        • Recruiting
        • Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 3101)
        • Contact:
          • Study Coordinator
          • Phone Number: +5112241598 Ext.121
      • Lima, Peru, 15036
        • Recruiting
        • Oncosalud-Clinical Research ( Site 3108)
        • Contact:
          • Study Coordinator
          • Phone Number: +51971232095
      • Lima, Peru, 15076
        • Recruiting
        • Hospital Militar Central Coronel Luis Arias Schereiber ( Site 3105)
        • Contact:
          • Study Coordinator
          • Phone Number: +51997468543
      • Lima, Peru, 15082
        • Completed
        • Hospital Arzobispo Loayza ( Site 3103)
      • Lima, Peru, 15033
        • Completed
        • Hospital Nacional Guillermo Almenara Irigoyen ( Site 3107)
      • Lima, Peru, 15046
        • Completed
        • Hospital Central de la Fuerza Aerea del Peru ( Site 3104)
    • La Libertad
      • Trujillo, La Libertad, Peru, 13006
        • Recruiting
        • Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 3102)
        • Contact:
          • Study Coordinator
          • Phone Number: +51964820298
    • Muni Metro De Lima
      • Lima, Muni Metro De Lima, Peru, 15038
        • Completed
        • Instituto Nacional de Enfermedades Neoplasicas ( Site 3106)
  • Romania
      • Brasov, Romania, 500152
        • Completed
        • Spitalul PDR Medlife ( Site 1106)
      • Bucuresti, Romania, 031422
        • Completed
        • S.C.Gral Medical S.R.L ( Site 1104)
      • Bucuresti, Romania, 022548
        • Completed
        • S.C.Focus Lab Plus S.R.L ( Site 1101)
    • Bihor
      • Oradea, Bihor, Romania, 410469
        • Completed
        • S.C. Pelican Impex S.R.L Spitalul Clinic Pelican Oradea ( Site 1102)
    • Cluj
      • Cluj Napoca, Cluj, Romania, 400641
        • Completed
        • Medisprof ( Site 1107)
      • Comuna Floresti, Cluj, Romania, 407280
        • Completed
        • SC Radiotherapy Center Cluj SRL ( Site 1105)
    • Dolj
      • Craiova, Dolj, Romania, 200542
        • Completed
        • S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1103)
  • Russian Federation
    • Arkhangel Skaya Oblast
      • Arkhangelsk, Arkhangel Skaya Oblast, Russian Federation, 163045
        • Completed
        • Arkhangelsk Clinical Oncological Dispensary ( Site 1204)
    • Chelyabinskaya Oblast
      • Chelyabinsk, Chelyabinskaya Oblast, Russian Federation, 454087
        • Suspended
        • Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1212)
    • Moskovskaya Oblast
      • Krasnogorsk, Moskovskaya Oblast, Russian Federation, 143442
        • Completed
        • MEDSI Clinical Hospital on Pyatnitsky Highway-Departmentof Antitumor Drug therapy ( Site 1216)
    • Moskva
      • Moscow, Moskva, Russian Federation, 125284
        • Suspended
        • MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 1213)
      • Moscow, Moskva, Russian Federation, 115477
        • Completed
        • N.N. Blokhin NMRCO ( Site 1201)
    • Ryazanskaya Oblast
      • Ryazan, Ryazanskaya Oblast, Russian Federation, 390011
        • Completed
        • Ryazan Regional Clinical Oncology dispensary ( Site 1202)
    • Samarskaya Oblast
      • Samara, Samarskaya Oblast, Russian Federation, 443031
        • Completed
        • SBHI Samara Regional Clinical Oncology Dispensary ( Site 1211)
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 197758
        • Completed
        • Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1208)
      • Saint-Petersburg, Sankt-Peterburg, Russian Federation, 194044
        • Completed
        • Clinical Hospital Saint Luka ( Site 1205)
      • St.Petersburg, Sankt-Peterburg, Russian Federation, 194291
        • Completed
        • SBHI Leningrad Regional Clinical Hospital ( Site 1206)
    • Tatarstan, Respublika
      • Kazan, Tatarstan, Respublika, Russian Federation, 420029
        • Suspended
        • Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1207)
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d Hebron ( Site 1350)
        • Contact:
          • Study Coordinator
          • Phone Number: +34934894158
    • Madrid
      • Pozuelo de Alarcon, Madrid, Spain, 28223
        • Recruiting
        • Hospital Universitario Quiron Madrid ( Site 1352)
        • Contact:
          • Study Coordinator
          • Phone Number: +34914521987
  • Switzerland
    • Aargau
      • Zuerich, Aargau, Switzerland, 8091
        • Completed
        • Universitaetsspital Zuerich ( Site 1400)
    • Geneve
      • Geneva, Geneve, Switzerland, 1211
        • Completed
        • Hopitaux Universitaires de Geneve HUG. ( Site 1406)
    • Ticino
      • Bellinzona, Ticino, Switzerland, 6500
        • Recruiting
        • Ospedale Regionale di Bellinzona e Valli ( Site 1407)
        • Contact:
          • Study Coordinator
          • Phone Number: +41918118194
  • Turkey
      • Adana, Turkey, 01250
        • Recruiting
        • Baskent University Adana Training Hospital ( Site 1508)
        • Contact:
          • Study Coordinator
          • Phone Number: +905353067506
      • Ankara, Turkey, 06100
        • Completed
        • Hacettepe Universitesi Tıp Fakultesi ( Site 1503)
      • Antalya, Turkey, 07070
        • Recruiting
        • Akdeniz Universitesi Tip Fakultesi ( Site 1504)
        • Contact:
          • Study Coordinator
          • Phone Number: +905052312377
      • Edirne, Turkey, 22030
        • Recruiting
        • Trakya Universitesi Tip Fakultesi ( Site 1500)
        • Contact:
          • Study Coordinator
          • Phone Number: +905322480988
      • Istanbul, Turkey, 34098
        • Recruiting
        • Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1505)
        • Contact:
          • Study Coordinator
          • Phone Number: +905052312377
      • Istanbul, Turkey, 34722
        • Recruiting
        • Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 1506)
        • Contact:
          • Study Coordinator
          • Phone Number: +902165664000
      • Izmir, Turkey, 35100
        • Recruiting
        • Ege Universitesi Tip Fakultesi ( Site 1502)
        • Contact:
          • Study Coordinator
          • Phone Number: +902323903911
    • Adana
      • Konya, Adana, Turkey, 42080
        • Recruiting
        • Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 1507)
        • Contact:
          • Study Coordinator
          • Phone Number: +903322237000
  • United Kingdom
      • Manchester, United Kingdom, M20 4BX
        • Completed
        • Christie NHS Foundation Trust ( Site 1601)
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • Recruiting
        • Northern Centre for Cancer Care ( Site 1602)
        • Contact:
          • Study Coordinator
          • Phone Number: +441912138476
      • Sheffield, United Kingdom, S10 2SJ
        • Completed
        • Weston Park Hospital ( Site 1607)
    • Worcestershire
      • Oxford, Worcestershire, United Kingdom, OX3 7LE
        • Completed
        • Churchill Hospital ( Site 1606)
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85721
        • Completed
        • The University of Arizona Cancer Center - North Campus ( Site 0011)
    • California
      • Fullerton, California, United States, 92835
        • Completed
        • St Joseph Heritage Healthcare-Oncology ( Site 0056)
      • Los Angeles, California, United States, 90048
        • Completed
        • Cedars Sinai Medical Center ( Site 0002)
      • San Francisco, California, United States, 94158
        • Completed
        • UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0007)
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Completed
        • Rocky Mountain Regional Veterans Affairs Medical Center ( Site 0092)
    • Georgia
      • Atlanta, Georgia, United States, 30322-1013
        • Completed
        • Winship Cancer Institute of Emory University ( Site 0025)
      • Augusta, Georgia, United States, 30912
        • Completed
        • Augusta University ( Site 0028)
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Completed
        • Markey Cancer Center ( Site 0018)
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland ( Site 0050)
        • Contact:
          • Study Coordinator
          • Phone Number: 410-328-7224
      • Baltimore, Maryland, United States, 21237
        • Completed
        • Weinberg Cancer Institute at Franklin Square ( Site 0054)
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • Completed
        • University of Massachusetts ( Site 0017)
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Completed
        • Henry Ford Health System ( Site 0060)
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Completed
        • Cancer Partners of Nebraska ( Site 0051)
    • New Jersey
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0116)
        • Contact:
          • Study Coordinator
          • Phone Number: 646-888-5089
    • New York
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 0126)
        • Contact:
          • Study Coordinator
          • Phone Number: 646-888-5089
      • New York, New York, United States, 10010
        • Completed
        • VA New York Harbor Healthcare System Manhattan ( Site 0094)
      • New York, New York, United States, 10016
        • Completed
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0057)
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center ( Site 0026)
        • Contact:
          • Study Coordinator
          • Phone Number: 646-888-5089
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74133
        • Completed
        • Southwestern Regional Medical Center, Inc. ( Site 0079)
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19124
        • Completed
        • Eastern Regional Medical Center, Inc. ( Site 0077)
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Completed
        • Sanford Hematology Oncology-Sioux Falls SD ( Site 0012)
    • Utah
      • Saint George, Utah, United States, 84790
        • Completed
        • Intermountain Healthcare ( Site 0043)
    • Washington
      • Seattle, Washington, United States, 98101
        • Completed
        • Virginia Mason Medical Center ( Site 0052)
      • Seattle, Washington, United States, 98108
        • Recruiting
        • Veterans Affairs Puget Sound Health Care System [Seattle, WA] ( Site 0093)
        • Contact:
          • Study Coordinator
          • Phone Number: 206-277-3101

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 RECIST 1.1 or PCWG-modified RECIST 1.1 as assessed by the local site Investigator/radiology and confirmed by 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:

    1. Is not a woman of childbearing potential (WOCBP).
    2. 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 BRCA1/2 non-mutated and homologous recombination repair nonmutated:
  • 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.
  • Has either centrally-confirmed known or suspected deleterious mutations in at least 1 of the genes involved in HRR or centrally-confirmed HRD.
  • 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Olaparib
Participants with HRRm or HRD-positive advanced cancer will receive oral olaparib, 300 mg twice daily (BID).
Drug: Olaparib
Olaparib 300 mg administered BID as two, 150 mg oral tablets.
Other Names:
  • AZD2281
  • KU-0059436
  • MK-7339
  • LYNPARZA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to 53 months
ORR is defined as the percentage of participants who achieve a confirmed complete response ([CR]; disappearance of all target lesions) or partial response ([PR]: ≥30% decrease in the sum of diameters of target lesions) as assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors 1.1, modified to follow a maximum of 10 target lesions in total and a maximum of 5 target lesions per organ (modified RECIST 1.1). For participants with prostate cancer, ORR will be based on Prostate Cancer Working Group (PCWG)-modified RECIST 1.1 as assessed by BICR.
Up to 53 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Response (DOR)
Time Frame: Up to 53 months
DOR is defined as the time from first documented evidence of CR or PR until the first documented sign of disease progression or death due to any cause, whichever occurs first. DOR will be assessed by BICR according to either modified RECIST 1.1 or PCWG-modified RECIST 1.1 for participants with prostate cancer.
Up to 53 months
Overall Survival (OS)
Time Frame: Up to 53 months
OS is defined as the time from the date of the first dose to the date of death due to any cause.
Up to 53 months
Progression Free Survival (PFS)
Time Frame: Up to 53 months
PFS is defined as the time from the date of the first dose to either: 1) the first documented disease progression as assessed either by BICR according to modified RECIST 1.1 or PCWG-modified RECIST 1.1 for participants with prostate cancer; or 2) death due to any cause, whichever occurs first.
Up to 53 months
Number of Participants Experiencing an Adverse Event (AE)
Time Frame: Up to 53 months
An AE is any unfavorable and unintended sign, symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants experiencing an AE will be assessed.
Up to 53 months
Number of Participants Discontinuing Study Treatment due to an Adverse Event (AE)
Time Frame: Up to 52 months
The number of participants discontinuing study treatment due to an AE will be assessed.
Up to 52 months
Objective Response Rate (ORR) in Participants with HRRm or HRD Positive Cancer
Time Frame: Up to 53 months
For participants with homologous recombination repair mutation (HRRm) or homologous recombination deficiency (HRD) positive cancer, the ORR will be assessed. ORR is defined as the percentage of participants who achieve a confirmed complete response ([CR]; disappearance of all target lesions) or partial response ([PR]: ≥30% decrease in the sum of diameters of target lesions) as assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors 1.1, modified to follow a maximum of 10 target lesions in total and a maximum of 5 target lesions per organ (modified RECIST 1.1). For participants with prostate cancer, ORR will be based on Prostate Cancer Working Group (PCWG)-modified RECIST 1.1 as assessed by BICR.
Up to 53 months
Time to Earliest Progression by Cancer Antigen-125 (CA-125)
Time Frame: Up to 53 months
For participants with BRCA1/2 non-mutated ovarian cancer only, the time to earliest progression by CA-125 will be assessed. Progression by CA-125 is defined as an increase in CA-125 level ≥2x upper limit normal (ULN) on 2 occasions, 1 week apart. For participants with elevated CA-125 (≥ULN) at baseline, progression by CA-125 is defined as an increase in CA-125 level ≥2x the nadir value on 2 occasions, 1 week apart.
Up to 53 months
Prostate-specific Antigen (PSA) Response Rate in Participants with Prostate Cancer
Time Frame: Up to 53 months
For participants with prostate cancer, the PSA response rate will be presented. PSA response rate is defined as the percentage of participants in the analysis population with PSA reduction of ≥50% from baseline measured twice at least 3 weeks apart.
Up to 53 months
Progression-Free Survival After Next-Line Treatment in Participants with sBRCAm Breast Cancer
Time Frame: Up to 53 months
For participants with somatic BRCA mutated (sBRCAm) breast cancer, the PFS after next-line treatment will be presented. PFS is defined as the time from the date of the first dose to either: 1) the first documented disease progression on the next-line of treatment, as assessed by BICR according to modified RECIST 1.1; or 2) death due to any cause, whichever occurs first.
Up to 53 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Collaborators

AstraZeneca

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 (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

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)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7339-002
  • MK-7339-002 (Other Identifier: Merck Protocol Number)
  • LYNK-002 (Other Identifier: Merck)
  • 194694 (Registry Identifier: JAPIC-CTI)
  • 2018-003007-19 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/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.

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