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ACTIVE NOT RECRUITING

NCT03742895

PHASE2

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)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

326

Start Date

2018-12-12

Completion Date

2026-06-30

Last Updated

2026-02-18

Healthy Volunteers

Conditions

Advanced Solid Neoplasms

Interventions

DRUG

Olaparib

Olaparib 300 mg administered BID as two, 150 mg oral tablets.

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.

Locations (130)

The University of Arizona Cancer Center - North Campus ( Site 0011)

Tucson, Arizona, United States

St Joseph Heritage Healthcare-Oncology ( Site 0056)

Fullerton, California, United States

Cedars Sinai Medical Center ( Site 0002)

Los Angeles, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0007)

San Francisco, California, United States

Rocky Mountain Regional Veterans Affairs Medical Center ( Site 0092)

Aurora, Colorado, United States

Winship Cancer Institute of Emory University ( Site 0025)

Atlanta, Georgia, United States

Augusta University ( Site 0028)

Augusta, Georgia, United States

Markey Cancer Center ( Site 0018)

Lexington, Kentucky, United States

University of Maryland ( Site 0050)

Baltimore, Maryland, United States

Weinberg Cancer Institute at Franklin Square ( Site 0054)

Baltimore, Maryland, United States

University of Massachusetts ( Site 0017)

Worcester, Massachusetts, United States

Henry Ford Health System ( Site 0060)

Detroit, Michigan, United States

Cancer Partners of Nebraska ( Site 0051)

Lincoln, Nebraska, United States

Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0116)

Middletown, New Jersey, United States

Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 0126)

Harrison, New York, United States

VA New York Harbor Healthcare System Manhattan ( Site 0094)

New York, New York, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0057)

New York, New York, United States

Memorial Sloan Kettering Cancer Center ( Site 0026)

New York, New York, United States

Southwestern Regional Medical Center, Inc. ( Site 0079)

Tulsa, Oklahoma, United States

Eastern Regional Medical Center, Inc. ( Site 0077)

Philadelphia, Pennsylvania, United States

Sanford Hematology Oncology-Sioux Falls SD ( Site 0012)

Sioux Falls, South Dakota, United States

Intermountain Healthcare ( Site 0043)

St. George, Utah, United States

Virginia Mason Medical Center ( Site 0052)

Seattle, Washington, United States

Veterans Affairs Puget Sound Health Care System [Seattle, WA] ( Site 0093)

Seattle, Washington, United States

Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 2703)

Berazategui, Buenos Aires, Argentina

Hospital Britanico de Buenos Aires ( Site 2704)

Ciudad de Buenos Aires, Buenos Aires F.D., Argentina

Instituto de Investigaciones Metabolicas ( Site 2700)

Buenos Aires, Argentina

Hospital Aleman ( Site 2702)

Buenos Aires, Argentina

Kinghorn Cancer Centre ( Site 2200)

Darlinghurst, New South Wales, Australia

MNCCI Port Macquarie Base Hospital ( Site 2201)

Port Macquarie, New South Wales, Australia

Linear Clinical Research Ltd ( Site 2202)

Nedlands, Western Australia, Australia

Sunnybrook Research Institute ( Site 0210)

Toronto, Ontario, Canada

Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0203)

Montreal, Quebec, Canada

Jewish General Hospital ( Site 0209)

Montreal, Quebec, Canada

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0

Québec, Quebec, Canada

Fundacion Centro de Investigacion Clinica CIC ( Site 2812)

Medellín, Antioquia, Colombia

Rodrigo Botero SAS ( Site 2801)

Medellín, Antioquia, Colombia

Biomelab S A S ( Site 2800)

Barranquilla, Atlántico, Colombia

Administradora Country SA - Clinica del Country ( Site 2802)

Bogotá, Bogota D.C., Colombia

Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 2807)

Bogotá, Bogota D.C., Colombia

Instituto Nacional de Cancerologia E.S.E ( Site 2809)

Bogotá, Bogota D.C., Colombia

Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 2808)

Valledupar, Cesar Department, Colombia

Oncomedica S.A. ( Site 2806)

Montería, Departamento de Córdoba, Colombia

C. Medico Imbanaco Cali S.A. ( Site 2810)

Cali, Valle del Cauca Department, Colombia

Rigshospitalet ( Site 0402)

Copenhagen, Capital Region, Denmark

Herlev og Gentofte Hospital. ( Site 0401)

Herlev, Capital Region, Denmark

Odense Universitetshospital ( Site 0400)

Odense, Region Syddanmark, Denmark

CHU Poitiers ( Site 0612)

Poitiers, Ain, France

Centre Antoine Lacassagne ( Site 0610)

Nice, Alpes-Maritimes, France

Institut de Cancerologie Strasbourg Europe ( Site 0613)

Strasbourg, Alsace, France

Centre Georges Francois Leclerc ( Site 0608)

Dijon, Bourgogne-Franche-Comté, France

Institut Bergonie ( Site 0603)

Bordeaux, Gironde, France

Institut Gustave Roussy ( Site 0601)

Villejuif, Val-de-Marne, France

Centro Regional de Sub Especialidades Medicas SA ( Site 3003)

Guatemala, Departamento de Quetzaltenango, Guatemala

Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 3004)

Guatemala City, Guatemala

Integra Cancer Institute ( Site 3006)

Guatemala City, Guatemala

Grupo Angeles SA ( Site 3001)

Guatemala City, Guatemala

Mater Misericordiae University Hospital ( Site 1654)

Dublin, Carlow, Ireland

Bon Secours Hospital ( Site 1656)

Cork, Ireland

St. Vincent's University Hospital ( Site 1653)

Dublin, Ireland

Tallaght University Hospital ( Site 1652)

Dublin, Ireland

Soroka Medical Center ( Site 0800)

Beersheba, Israel

Rambam Health Care Campus-Oncology Division ( Site 0801)

Haifa, Israel

Hadassah Ein Kerem Medical Center ( Site 0802)

Jerusalem, Israel

Chaim Sheba Medical Center ( Site 0803)

Ramat Gan, Israel

Sourasky Medical Center ( Site 0804)

Tel Aviv, Israel

Istituto Nazionale Tumori Fondazione Pascale ( Site 0700)

Naples, Campania, Italy

Istituto Clinico Humanitas Research Hospital ( Site 0703)

Rozzano, Lombardy, Italy

Policlinico Le Scotte di Siena ( Site 0704)

Siena, Tuscany, Italy

Aichi Cancer Center Hospital ( Site 2602)

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East ( Site 2600)

Kashiwa, Chiba, Japan

Kyoto University Hospital ( Site 2603)

Kyoto, Kyoto, Japan

Osaka University Hospital ( Site 2604)

Suita, Osaka, Japan

National Cancer Center Hospital ( Site 2601)

Tokyo, Japan

The Cancer Institute Hospital of JFCR ( Site 2605)

Tokyo, Japan

Actualidad Basada en la Investigacion del Cancer ( Site 2903)

Guadalajara, Jalisco, Mexico

Unidad Biomedica Avanzada Monterrey S. A. ( Site 2902)

Monterrey, Nuevo León, Mexico

Cuidados Oncologicos ( Site 2908)

Santiago de Quetaro, Querétaro, Mexico

Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 2901)

Madero, Tamaulipas, Mexico

Centro Estatal de Cancerologia de Chihuahua ( Site 2907)

Chihuahua City, Mexico

CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 2900)

Mexico City, Mexico

CENEIT Oncologicos ( Site 2904)

México, Mexico

Oaxaca Site Management Organization S.C. ( Site 2905)

Oaxaca City, Mexico

Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 3102)

Trujillo, La Libertad, Peru

Instituto Nacional de Enfermedades Neoplasicas ( Site 3106)

Lima, Muni Metro de Lima, Peru

Hospital Nacional Guillermo Almenara Irigoyen ( Site 3107)

Lima, Peru

Clinica Internacional Sede San Borja ( Site 3100)

Lima, Peru

Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 3101)

Lima, Peru

Oncosalud-Clinical Research ( Site 3108)

Lima, Peru

Hospital Central de la Fuerza Aerea del Peru ( Site 3104)

Lima, Peru

Hospital Militar Central Coronel Luis Arias Schereiber ( Site 3105)

Lima, Peru

Hospital Arzobispo Loayza ( Site 3103)

Lima, Peru

S.C. Pelican Impex S.R.L Spitalul Clinic Pelican Oradea ( Site 1102)

Oradea, Bihor County, Romania

Medisprof ( Site 1107)

Cluj-Napoca, Cluj, Romania

SC Radiotherapy Center Cluj SRL ( Site 1105)

Comuna Floresti, Cluj, Romania

S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1103)

Craiova, Dolj, Romania

Spitalul PDR Medlife ( Site 1106)

Brasov, Romania

S.C.Focus Lab Plus S.R.L ( Site 1101)

Bucharest, Romania

S.C.Gral Medical S.R.L ( Site 1104)

Bucharest, Romania

Arkhangelsk Clinical Oncological Dispensary ( Site 1204)

Arkhangelsk, Arkhangelskaya oblast, Russia

Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1212)

Chelyabinsk, Chelyabinsk Oblast, Russia

N.N. Blokhin NMRCO ( Site 1201)

Moscow, Moscow, Russia

MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 1213)

Moscow, Moscow, Russia

MEDSI Clinical Hospital on Pyatnitsky Highway-Departmentof Antitumor Drug therapy ( Site 1216)

Krasnogorsk, Moscow Oblast, Russia

Ryazan Regional Clinical Oncology dispensary ( Site 1202)

Ryazan, Ryazan Oblast, Russia

SBHI Samara Regional Clinical Oncology Dispensary ( Site 1211)

Samara, Samara Oblast, Russia

Clinical Hospital Saint Luka ( Site 1205)

Saint Petersburg, Sankt-Peterburg, Russia

SBHI Leningrad Regional Clinical Hospital ( Site 1206)

Saint Petersburg, Sankt-Peterburg, Russia

Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1208)

Saint Petersburg, Sankt-Peterburg, Russia

Republican Clinical Oncology Dispensary of Tatarstan MoH named after professor M.Z. Sigal ( Site 120

Kazan', Tatarstan, Respublika, Russia

Seoul National University Bundang Hospital ( Site 2402)

Seongnam-si, Kyonggi-do, South Korea

Seoul National University Hospital ( Site 2401)

Seoul, South Korea

Severance Hospital Yonsei University Health System ( Site 2400)

Seoul, South Korea

Hospital Universitario Quiron Madrid ( Site 1352)

Pozuelo de Alarcón, Madrid, Spain

Hospital Universitari Vall d Hebron ( Site 1350)

Barcelona, Spain

Universitaetsspital Zuerich ( Site 1400)

Zuerich, Canton of Aargau, Switzerland

Hopitaux Universitaires de Geneve HUG. ( Site 1406)

Geneva, Canton of Geneva, Switzerland

Ospedale Regionale di Bellinzona e Valli ( Site 1407)

Bellinzona, Canton Ticino, Switzerland

Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 1507)

Konya, Adana, Turkey (Türkiye)

Baskent University Adana Training Hospital ( Site 1508)

Adana, Turkey (Türkiye)

Hacettepe Universitesi Tıp Fakultesi ( Site 1503)

Ankara, Turkey (Türkiye)

Akdeniz Universitesi Tip Fakultesi ( Site 1504)

Antalya, Turkey (Türkiye)

Trakya Universitesi Tip Fakultesi ( Site 1500)

Edirne, Turkey (Türkiye)

Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1505)

Istanbul, Turkey (Türkiye)

Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 1506)

Istanbul, Turkey (Türkiye)

Ege Universitesi Tip Fakultesi ( Site 1502)

Izmir, Turkey (Türkiye)

Churchill Hospital ( Site 1606)

Oxford, Worcestershire, United Kingdom

Christie NHS Foundation Trust ( Site 1601)

Manchester, United Kingdom

Northern Centre for Cancer Care ( Site 1602)

Newcastle upon Tyne, United Kingdom

Weston Park Hospital ( Site 1607)

Sheffield, United Kingdom

Clinical Research Directory

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)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (130)