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ACTIVE NOT RECRUITING

NCT04123366

PHASE2

Study of Olaparib (MK-7339) in Combination With Pembrolizumab (MK-3475) in the Treatment of Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer (MK-7339-007/KEYLYNK-007)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the efficacy and safety of treatment with olaparib (MK-7339) in combination with pembrolizumab (MK-3475) in adults with previously treated, advanced (metastatic and/or unresectable) Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-positive solid tumors.

Official title: A Phase 2 Study of Olaparib in Combination With Pembrolizumab in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2019-11-18

Completion Date

2026-07-23

Last Updated

2025-03-17

Healthy Volunteers

Conditions

Solid Tumors

Interventions

DRUG

Olaparib

Oral tablet

BIOLOGICAL

Pembrolizumab

Intravenous infusion

Inclusion Criteria: * Has a histologically- or cytologically-confirmed advanced (metastatic and/or unresectable) solid tumor (except breast or ovarian cancers whose tumor has a germline or somatic 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 ≥1 of the specified 15 genes involved in HRR or centrally-confirmed HRD based on the Lynparza HRR-HRD assay. * Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology and confirmed in real time by blinded independent central review (BICR). BICR must confirm the presence of radiologically measurable disease per RECIST 1.1 for the participant to be eligible for the study. * Has a life expectancy of ≥3 months. * Must have had CR or PR while on the last treatment with prior cisplatin or carboplatin, or if received only oxaliplatin had CR, PR, or stable disease (SD) while on the last treatment with prior oxaliplatin (either as monotherapy or in combination) for advanced (metastatic and/or unresectable) solid tumor. Participant must also not have been refractory to prior platinum-containing therapy. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1, as assessed within 3 days of study treatment initiation. * Male participants must agree to use contraception during the treatment period and for ≥90 days (3 months) after the last dose of olaparib and refrain from donating sperm during this period. * Female participants must not be pregnant or breastfeeding, and ≥1 of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP who agrees to use contraception during the treatment period and for ≥120 days (3 months) after the last dose of pembrolizumab and 180 days (6 months) after the last dose of olaparib, has a highly sensitive pregnancy test within 24 hours for urine or within 72 hours for serum before the first dose of study intervention, and abstains from breastfeeding during the study intervention period and for at least 120 days after the last dose of the study intervention. * Has adequate organ function Exclusion Criteria: * Has a known additional malignancy that is progressing or has required active treatment in the last 3 years. 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 a history of non-infectious pneumonitis/interstitial lung disease that required treatment with steroids or currently has pneumonitis/interstitial lung disease. * 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. * Has an active infection requiring systemic therapy. * Has active tuberculosis (Bacillus tuberculosis \[TB\]). * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing \>10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. * Has an active autoimmune disease that has required systemic treatment in the past 2 years. * 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 B or hepatitis C. * Is unable to swallow orally administered medication or has a gastrointestinal (GI) disorder affecting absorption (e.g. gastrectomy, partial bowel obstruction, malabsorption). * Has received prior therapy with an anti-programmed death-1 (anti-PD-1), anti-programmed death-ligand 1 (anti-PD-L1), or anti-programmed death-ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX 40 \[Tumor necrosis factor receptor superfamily, member 4 (TNFRSF4)\], CD137 \[tumor necrosis factor receptor superfamily member 9 (TNFRSF9)\]). * Has received prior therapy with olaparib or with any other polyadenosine 5' diphosphoribose (poly\[ADP ribose\]) polymerization (PARP) inhibitor. * Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to administration of study treatment. * Must have recovered from all adverse events (AEs) due to previous therapies, excluding alopecia, to ≤Grade 1 or Baseline. * Has a known hypersensitivity to the study treatments and/or any of their excipients. * Is currently receiving either strong inhibitors of cytochrome P450 (CYP)3A4 (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate inhibitors of CYP3A4 (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil) that cannot be discontinued for the duration of the study. The required washout period prior to starting olaparib is 2 weeks. * Is currently receiving either strong inducers of CYP3A4 (phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate inducers of CYP3A4 (e.g. bosentan, efavirenz, modafinil) that cannot be discontinued for the duration of the study. The required washout period prior to starting olaparib is 5 weeks for phenobarbital and 3 weeks for other agents. * 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. * Has received prior radiotherapy within 2 weeks of start of study treatment. * Is currently enrolled in and receiving study therapy, was enrolled in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks (28 days) of the first dose of study treatment. * The presence of uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g. unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, corrected QT interval by Fredericia \[QTcF\] prolongation \>500 msec, electrolyte disturbances), or participant has congenital long QT syndrome. * Has either had major surgery within 2 weeks of starting study treatment or has not recovered from any effects of any major surgery. * Has received a live vaccine within 30 days prior to the first dose of study treatment. * Has had an allogenic tissue/solid tumor organ transplant.

Locations (135)

The Kirklin Clinic ( Site 0086)

Birmingham, Alabama, United States

Banner MD Anderson Cancer Center ( Site 0049)

Gilbert, Arizona, United States

UC Davis Comprehensive Cancer Center ( Site 0039)

Sacramento, California, United States

San Francisco Oncology Associates ( Site 0085)

San Francisco, California, United States

University of California San Francisco ( Site 0015)

San Francisco, California, United States

Banner MD Anderson Cancer Center ( Site 0092)

Greeley, Colorado, United States

University of Florida ( Site 0078)

Gainesville, Florida, United States

Winship Cancer Institute of Emory University ( Site 0057)

Atlanta, Georgia, United States

Northeast Georgia Medical Center ( Site 0026)

Gainesville, Georgia, United States

Northwest Georgia Oncology Centers PC ( Site 0047)

Marietta, Georgia, United States

Norton Cancer Institute - St. Matthews ( Site 0024)

Louisville, Kentucky, United States

Atlantic Health System ( Site 0046)

Summit, New Jersey, United States

New York Cancer and Blood Specialists-Research Department ( Site 0080)

Port Jefferson Station, New York, United States

University Hospitals Cleveland Medical Center ( Site 0016)

Cleveland, Ohio, United States

The University of Oklahoma Health Sciences Center ( Site 0050)

Oklahoma City, Oklahoma, United States

Parkland Health & Hospital System ( Site 0091)

Dallas, Texas, United States

University of Texas, Southwestern Medical Center ( Site 0004)

Dallas, Texas, United States

University of Texas-MD Anderson Cancer Center ( Site 0087)

Houston, Texas, United States

Utah Cancer Specialists ( Site 0038)

West Valley City, Utah, United States

Inova Schar Cancer Institute ( Site 0008)

Fairfax, Virginia, United States

Northwest Medical Specialties, PLLC ( Site 0007)

Tacoma, Washington, United States

Fundacion CIDEA ( Site 2704)

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

Hospital Britanico de Buenos Aires ( Site 2705)

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

Centro Medico Dra De Salvo ( Site 2702)

Buenos Aires, Argentina

CEMIC ( Site 2701)

Buenos Aires, Argentina

Centro Oncologico Riojano Integral ( Site 2703)

La Rioja, Argentina

Blacktown Hospital ( Site 2202)

Blacktown, New South Wales, Australia

Tasman Oncology Research Pty Ltd ( Site 2203)

Southport, Queensland, Australia

Monash Medical Centre ( Site 2205)

Clayton, Victoria, Australia

Linear Clinical Research Ltd ( Site 2206)

Nedlands, Western Australia, Australia

BC Cancer-Vancouver Center ( Site 0203)

Vancouver, British Columbia, Canada

Moncton Hospital - Horizon Health Network ( Site 0206)

Moncton, New Brunswick, Canada

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0201)

Montreal, Quebec, Canada

Fundación Colombiana de Cancerología Clínica Vida ( Site 2902)

Medellín, Antioquia, Colombia

Clinica de la Costa S.A.S. ( Site 2900)

Barranquilla, Atlántico, Colombia

Fundacion Cardiovascular de Colombia ( Site 2907)

Piedecuesta, Santander Department, Colombia

Hemato Oncologos S.A. ( Site 2910)

Cali, Valle del Cauca Department, Colombia

Fundacion Valle del Lili ( Site 2909)

Cali, Valle del Cauca Department, Colombia

CHU Jean Minjoz ( Site 0606)

Besançon, Doubs, France

Institut du Cancer de Montpellier ( Site 0610)

Montpellier, Herault, France

Centre Henri Becquerel ( Site 0607)

Rouen, Seine-Maritime, France

Institut Gustave Roussy ( Site 0602)

Villejuif, Val-de-Marne, France

CHD Vendee ( Site 0604)

La Roche-sur-Yon, Vendee, France

Universitaetsklinik der Ludwig-Maximilians-Universitaet Muenchen ( Site 0906)

Munich, Bavaria, Germany

Universitaetsklinik Koeln ( Site 0903)

Cologne, North Rhine-Westphalia, Germany

Charite-Universitaetsmedizin Berlin-Campus Benjamin Franklin ( Site 0902)

Berlin, Germany

Oncologika S.A. ( Site 3003)

Guatemala City, Guatemala

Grupo Angeles SA ( Site 3004)

Guatemala City, Guatemala

Sanatorio Nuestra Senora del Pilar ( Site 3006)

Guatemala City, Guatemala

Medi-K Cayala ( Site 3005)

Guatemala City, Guatemala

Centro Medico Integral De Cancerología (CEMIC) ( Site 3002)

Quetzaltenango, Guatemala

Rambam Health Care Campus-Oncology Division ( Site 0801)

Haifa, Israel

Hadassah Ein Kerem Medical Center ( Site 0802)

Jerusalem, Israel

Meir Medical Center ( Site 0804)

Kfar Saba, Israel

Rabin Medical Center ( Site 0806)

Petah Tikva, Israel

Chaim Sheba Medical Center ( Site 0800)

Ramat Gan, Israel

Sourasky Medical Center ( Site 0805)

Tel Aviv, Israel

Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0703)

Modena, Emilia-Romagna, Italy

ASST Grande Ospedale Metropolitano Niguarda ( Site 0700)

Milan, Italy

Istituto Nazionale Tumori Fondazione Pascale ( Site 0705)

Naples, Italy

Azienda Ospedaliera Universitaria Senese ( Site 0704)

Siena, Italy

Aichi Cancer Center Hospital ( Site 2504)

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East ( Site 2500)

Kashiwa, Chiba, Japan

Hokkaido University Hospital ( Site 2502)

Sapporo, Hokkaido, Japan

Kyushu University Hospital ( Site 2506)

Fukuoka, Japan

Okayama University Hospital ( Site 2505)

Okayama, Japan

National Cancer Center Hospital ( Site 2501)

Tokyo, Japan

Japanese Foundation for Cancer Research ( Site 2503)

Tokyo, Japan

Daugavpils Regional Hospital ( Site 2104)

Daugavpils, Latvia

Liepaja Regional Hospital ( Site 2101)

Liepāja, Latvia

Riga East Clinical University Hospital ( Site 2103)

Riga, Latvia

P. Stradina Clinical University Hospital ( Site 2102)

Riga, Latvia

Preparaciones Oncologicas ( Site 3102)

León, Guanajuato, Mexico

Unidad Biomedica Avanzada Monterrey S. A. ( Site 3108)

Monterrey, Nuevo León, Mexico

Centro Medico Zambrano Hellion ( Site 3105)

San Pedro Garza García, Nuevo León, Mexico

Hospital H+ Queretaro ( Site 3104)

Querétaro City, Querétaro, Mexico

Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 3101)

Madero, Tamaulipas, Mexico

CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 3103)

Mexico City, Mexico

Clinica Integral Internacional de Oncologia S. de R.L. de C.V. ( Site 3107)

Puebla City, Mexico

Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 3206)

Arequipa, Ariqipa, Peru

Hospital Nacional Daniel Alcides Carrion ( Site 3207)

Bellavista, Qallaw, Peru

Hospital Nacional Adolfo Guevara Velasco ( Site 3205)

Cuzco, Qusqu, Peru

Oncosalud ( Site 3200)

Lima, Peru

Instituto Nacional de Enfermedades Neoplasicas ( Site 3201)

Lima, Peru

Hospital Nacional Arzobispo Loayza ( Site 3208)

Lima, Peru

Clinica San Gabriel ( Site 3202)

Lima, Peru

Hospital Nacional Cayetano Heredia ( Site 3203)

Lima, Peru

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

Warsaw, Masovian Voivodeship, Poland

Uniwersyteckie Centrum Kliniczne ( Site 1809)

Gdansk, Pomeranian Voivodeship, Poland

Hematology and Oncology Institute ( Site 0504)

Manatí, Puerto Rico

Ad-Vance Medical Research LLC ( Site 0505)

Ponce, Puerto Rico

Pan American Center for Oncology Trials LLC ( Site 0501)

Rio Piedras, Puerto Rico

FDI Clinical Research ( Site 0500)

San Juan, Puerto Rico

Spitalul Judetean de Urgenta Alba Iulia ( Site 1107)

Alba Iulia, Alba, Romania

Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1101)

Cluj-Napoca, Cluj, Romania

Medisprof ( Site 1102)

Cluj-Napoca, Cluj, Romania

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

Craiova, Dolj, Romania

Policlinica Oncomed SRL ( Site 1104)

Timișoara, Timiș County, Romania

Universitas Annex National Hospital ( Site 1902)

Bloemfontein, Free State, South Africa

Wits Clinical Research ( Site 1906)

Parktown-Johannesburg, Gauteng, South Africa

Mary Potter Oncology Centre, Little Company of Mary Hospital ( Site 1900)

Pretoria, Gauteng, South Africa

Vaal Triangle Oncology Centre ( Site 1905)

Vereeniging, Gauteng, South Africa

The Oncology Centre ( Site 1904)

Durban, KwaZulu-Natal, South Africa

Cancercare Rondebosch Oncology ( Site 1901)

Rondebosch, Western Cape, South Africa

Seoul National University Bundang Hospital ( Site 2403)

Seongnam-si, Kyonggi-do, South Korea

Seoul National University Hospital ( Site 2402)

Seoul, South Korea

Severance Hospital Yonsei University Health System ( Site 2400)

Seoul, South Korea

Samsung Medical Center ( Site 2401)

Seoul, South Korea

Hospital Quiron de Madrid ( Site 1301)

Pozuelo de Alarcón, Madrid, Spain

Hospital Clinic i Provincial ( Site 1302)

Barcelona, Spain

Hospital General Universitario Gregorio Maranon ( Site 1300)

Madrid, Spain

Skanes Universitetssjukhus Lund. ( Site 2001)

Lund, Skåne County, Sweden

Karolinska Universitetssjukhuset Solna ( Site 2000)

Solna, Stockholm County, Sweden

Akademiska Sjukhuset ( Site 2002)

Uppsala, Uppsala County, Sweden

Baskent University Adana Training Hospital ( Site 1509)

Adana, Turkey (Türkiye)

Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1502)

Ankara, Turkey (Türkiye)

Gazi Universitesi Tip Fakultesi ( Site 1507)

Ankara, Turkey (Türkiye)

Ankara Sehir Hastanesi ( Site 1508)

Ankara, Turkey (Türkiye)

Akdeniz Universitesi Tıp Fakultesi ( Site 1503)

Antalya, Turkey (Türkiye)

Trakya University Medical Faculty Balkan Oncology Hospital ( Site 1500)

Edirne, Turkey (Türkiye)

Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1504)

Istanbul, Turkey (Türkiye)

Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi ( Site 1505)

Istanbul, Turkey (Türkiye)

Ege Universitesi Tip Fakultesi Tulay Aktas Onkoloji Hastanesi ( Site 1501)

Izmir, Turkey (Türkiye)

Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 1510)

Konya, Turkey (Türkiye)

Inonu Universitesi Medical Fakultesi ( Site 1506)

Malatya, Turkey (Türkiye)

Cherkasy Regional Oncology Dispensary ( Site 1702)

Cherkasy, Cherkasy Oblast, Ukraine

Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council ( Site 1700)

Dnipro, Dnipropetrovsk Oblast, Ukraine

Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Department for daily treated patient (

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

Communal non profit enterprise Regional Clinical Oncology Center ( Site 1704)

Kharkiv, Kharkivs’ka Oblast’, Ukraine

Khmelnitskiy Regional Onkology Dispensary ( Site 1705)

Khmelnitskiy, Khmelnytskyi Oblast, Ukraine

Kirovograd Regional oncology Dispensary ( Site 1716)

Kropyvnytsky, Kirovohrad Oblast, Ukraine

Medical Centre Consilium Medical ( Site 1712)

Kyiv, Kyivska Oblast, Ukraine

Podillya Regional Center of Oncology ( Site 1708)

Vinnytsia, Vinnytsia Oblast, Ukraine

Medical center of the Limited Liability Company Yulis ( Site 1714)

Zaporizhzhia, Zaporizhzhia Oblast, Ukraine

Zhytomyr Regional Oncology Center ( Site 1710)

Zhytomyr, Zhytomyr Oblast, Ukraine

Clinical Research Directory

Study of Olaparib (MK-7339) in Combination With Pembrolizumab (MK-3475) in the Treatment of Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer (MK-7339-007/KEYLYNK-007)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (135)