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)
NCT ID: NCT04123366
Last Updated: 2025-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
300 participants
INTERVENTIONAL
2019-11-18
2026-07-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Olaparib+Pembrolizumab
Participants receive olaparib 300 mg via oral tablet 2 times each day PLUS pembrolizumab 200 mg via intravenous infusion on Day 1 of each 21-day cycle. Participants may receive olaparib+pembrolizumab for up to approximately 2 years.
Olaparib
Oral tablet
Pembrolizumab
Intravenous infusion
Interventions
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Olaparib
Oral tablet
Pembrolizumab
Intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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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)
Napoli, , 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
Countries
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References
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Cannon TL, Randall JN BA, Sokol ES, Alexander SM, Wadlow RC, Winer AA, Barnett DM, Rayes DL BS, Nimeiri HS, McGregor KA. Concurrent BRAFV600E and BRCA Mutations in MSS Metastatic Colorectal Cancer: Prevalence and Case Series of mCRC patients with prolonged OS. Cancer Treat Res Commun. 2022;32:100569. doi: 10.1016/j.ctarc.2022.100569. Epub 2022 Apr 30.
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-7339-007
Identifier Type: OTHER
Identifier Source: secondary_id
KEYLYNK-007
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2011200025
Identifier Type: REGISTRY
Identifier Source: secondary_id
2023-503831-17
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1288-1642
Identifier Type: REGISTRY
Identifier Source: secondary_id
2019-001745-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
7339-007
Identifier Type: -
Identifier Source: org_study_id
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