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)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Solid Tumors
• Intervention / Treatment: Biological: Pembrolizumab; Drug: Olaparib

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Toll Free Number; Phone Number: 1-888-577-8839; Email: Trialsites@merck.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1426ABP
    • Centro Medico Dra De Salvo ( Site 2702)
  • Buenos Aires, Argentina, C1431FWO
    • CEMIC ( Site 2701)
  • La Rioja, Argentina, F5300COE
    • Centro Oncologico Riojano Integral ( Site 2703)
  • Caba
    • Ciudad de Buenos Aires, Caba, Argentina, C1121ABE
      • Fundacion CIDEA ( Site 2704)
    • Ciudad de Buenos Aires, Caba, Argentina, C1280AEB
      • Hospital Britanico de Buenos Aires ( Site 2705)
• Australia
  • New South Wales
    • Blacktown, New South Wales, Australia, 2148
      • Blacktown Hospital ( Site 2202)
  • Queensland
    • Southport, Queensland, Australia, 4215
      • Tasman Oncology Research Pty Ltd ( Site 2203)
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Medical Centre ( Site 2205)
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Linear Clinical Research Ltd ( Site 2206)
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • BC Cancer-Vancouver Center ( Site 0203)
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 6Z8
      • Moncton Hospital - Horizon Health Network ( Site 0206)
  • Quebec
    • Montreal, Quebec, Canada, H2X 1R9
      • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0201)
• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia, 050030
      • Fundación Colombiana de Cancerología Clínica Vida ( Site 2902)
  • Atlantico
    • Barranquilla, Atlantico, Colombia, 080020
      • Clinica de la Costa S.A.S. ( Site 2900)
  • Santander
    • Piedecuesta, Santander, Colombia, 68017
      • Fundacion Cardiovascular de Colombia ( Site 2907)
  • Valle Del Cauca
    • Cali, Valle Del Cauca, Colombia, 76001
      • Hemato Oncologos S.A. ( Site 2910)
    • Cali, Valle Del Cauca, Colombia, 760032
      • Fundacion Valle del Lili ( Site 2909)
• France
  • Doubs
    • Besancon, Doubs, France, 25030
      • CHU Jean Minjoz ( Site 0606)
  • Herault
    • Montpellier, Herault, France, 34298
      • Institut du Cancer de Montpellier ( Site 0610)
  • Seine-Maritime
    • Rouen, Seine-Maritime, France, 76038
      • Centre Henri Becquerel ( Site 0607)
  • Val-de-Marne
    • Villejuif, Val-de-Marne, France, 94800
      • Institut Gustave Roussy ( Site 0602)
  • Vendee
    • La Roche sur Yon, Vendee, France, 85925
      • CHD Vendee ( Site 0604)
• Germany
  • Berlin, Germany, 12203
    • Charite-Universitaetsmedizin Berlin-Campus Benjamin Franklin ( Site 0902)
  • Bayern
    • Muenchen, Bayern, Germany, 81377
      • Universitaetsklinik der Ludwig-Maximilians-Universitaet Muenchen ( Site 0906)
  • Nordrhein-Westfalen
    • Koeln, Nordrhein-Westfalen, Germany, 50937
      • Universitaetsklinik Koeln ( Site 0903)
• Guatemala
  • Guatemala, Guatemala, 01010
    • Oncologika S.A. ( Site 3003)
  • Guatemala, Guatemala, 01015
    • Grupo Angeles SA ( Site 3004)
  • Guatemala, Guatemala, 01015
    • Sanatorio Nuestra Senora del Pilar ( Site 3006)
  • Guatemala, Guatemala, 01016
    • Medi-K Cayala ( Site 3005)
  • Quetzaltenango, Guatemala, 09002
    • Centro Medico Integral De Cancerología (CEMIC) ( Site 3002)
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus-Oncology Division ( Site 0801)
  • Jerusalem, Israel, 9112001
    • Hadassah Ein Kerem Medical Center ( Site 0802)
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center ( Site 0804)
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center ( Site 0806)
  • Ramat Gan, Israel, 5262000
    • Chaim Sheba Medical Center ( Site 0800)
  • Tel Aviv, Israel, 6423906
    • Sourasky Medical Center ( Site 0805)
• Italy
  • Milano, Italy, 20162
    • ASST Grande Ospedale Metropolitano Niguarda ( Site 0700)
  • Napoli, Italy, 80131
    • Istituto Nazionale Tumori Fondazione Pascale ( Site 0705)
  • Siena, Italy, 53100
    • Azienda Ospedaliera Universitaria Senese ( Site 0704)
  • Emilia-Romagna
    • Modena, Emilia-Romagna, Italy, 41124
      • Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0703)
• Japan
  • Fukuoka, Japan, 812-8582
    • Kyushu University Hospital ( Site 2506)
  • Okayama, Japan, 700-8558
    • Okayama University Hospital ( Site 2505)
  • Tokyo, Japan, 104-0045
    • National Cancer Center Hospital ( Site 2501)
  • Tokyo, Japan, 135-8550
    • Japanese Foundation for Cancer Research ( Site 2503)
  • Aichi
    • Nagoya, Aichi, Japan, 464-8681
      • Aichi Cancer Center Hospital ( Site 2504)
  • Chiba
    • Kashiwa, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East ( Site 2500)
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital ( Site 2502)
• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital Yonsei University Health System ( Site 2400)
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center ( Site 2401)
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital ( Site 2402)
  • Kyonggi-do
    • Seongnam-si, Kyonggi-do, Korea, Republic of, 13605
      • Seoul National University Bundang Hospital ( Site 2403)
• Latvia
  • Daugavpils, Latvia, 5417
    • Daugavpils Regional Hospital ( Site 2104)
  • Liepaja, Latvia, 3414
    • Liepaja Regional Hospital ( Site 2101)
  • Riga, Latvia, 1079
    • Riga East Clinical University Hospital ( Site 2103)
  • Riga, Latvia, LV-1002
    • P. Stradina Clinical University Hospital ( Site 2102)
• Mexico
  • Ciudad de Mexico, Mexico, 06100
    • CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 3103)
  • Puebla, Mexico, 72530
    • Clinica Integral Internacional de Oncologia S. de R.L. de C.V. ( Site 3107)
  • Guanajuato
    • León, Guanajuato, Mexico, 37178
      • Preparaciones Oncologicas ( Site 3102)
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64460
      • Unidad Biomedica Avanzada Monterrey S. A. ( Site 3108)
    • San Pedro Garza Garcia, Nuevo Leon, Mexico, 66278
      • Centro Medico Zambrano Hellion ( Site 3105)
  • Queretaro
    • Santiago de Queretaro, Queretaro, Mexico, 76000
      • Hospital H+ Queretaro ( Site 3104)
  • Tamaulipas
    • Madero, Tamaulipas, Mexico, 89440
      • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 3101)
• Peru
  • Lima, Peru, 15036
    • Oncosalud ( Site 3200)
  • Lima, Peru, 15038
    • Instituto Nacional de Enfermedades Neoplasicas ( Site 3201)
  • Lima, Peru, 15082
    • Hospital Nacional Arzobispo Loayza ( Site 3208)
  • Lima, Peru, 15088
    • Clinica San Gabriel ( Site 3202)
  • Lima, Peru, 15102
    • Hospital Nacional Cayetano Heredia ( Site 3203)
  • Ariqipa
    • Arequipa, Ariqipa, Peru, 04001
      • Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 3206)
  • Qallaw
    • Bellavista, Qallaw, Peru, 07021
      • Hospital Nacional Daniel Alcides Carrion ( Site 3207)
  • Qusqu
    • Cuzco, Qusqu, Peru, 08003
      • Hospital Nacional Adolfo Guevara Velasco ( Site 3205)
• Poland
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 02-781
      • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
  • Pomorskie
    • Gdansk, Pomorskie, Poland, 80-214
      • Uniwersyteckie Centrum Kliniczne ( Site 1809)
• Puerto Rico
  • Manati, Puerto Rico, 00674
    • Hematology and Oncology Institute ( Site 0504)
  • Ponce, Puerto Rico, 00717
    • Ad-Vance Medical Research LLC ( Site 0505)
  • Rio Piedras, Puerto Rico, 00935
    • Pan American Center for Oncology Trials LLC ( Site 0501)
  • San Juan, Puerto Rico, 00927
    • FDI Clinical Research ( Site 0500)
• Romania
  • Alba
    • Alba Iulia, Alba, Romania, 510007
      • Spitalul Judetean de Urgenta Alba Iulia ( Site 1107)
  • Cluj
    • Cluj Napoca, Cluj, Romania, 400641
      • Medisprof ( Site 1102)
    • Cluj-Napoca, Cluj, Romania, 400015
      • Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1101)
  • Dolj
    • Craiova, Dolj, Romania, 200542
      • S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1103)
  • Timis
    • Timisoara, Timis, Romania, 300239
      • Policlinica Oncomed SRL ( Site 1104)
• South Africa
  • Free State
    • Bloemfontein, Free State, South Africa, 9301
      • Universitas Annex National Hospital ( Site 1902)
  • Gauteng
    • Parktown-Johannesburg, Gauteng, South Africa, 2193
      • Wits Clinical Research ( Site 1906)
    • Pretoria, Gauteng, South Africa, 0181
      • Mary Potter Oncology Centre, Little Company of Mary Hospital ( Site 1900)
    • Vereeniging, Gauteng, South Africa, 1930
      • Vaal Triangle Oncology Centre ( Site 1905)
  • Kwazulu-Natal
    • Durban, Kwazulu-Natal, South Africa, 4091
      • The Oncology Centre ( Site 1904)
  • Western Cape
    • Rondebosch, Western Cape, South Africa, 7700
      • Cancercare Rondebosch Oncology ( Site 1901)
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic i Provincial ( Site 1302)
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon ( Site 1300)
  • Madrid
    • Pozuelo de Alarcon, Madrid, Spain, 28223
      • Hospital Quiron de Madrid ( Site 1301)
• Sweden
  • Skane Lan
    • Lund, Skane Lan, Sweden, 221 85
      • Skanes Universitetssjukhus Lund. ( Site 2001)
  • Stockholms Lan
    • Solna, Stockholms Lan, Sweden, 171 76
      • Karolinska Universitetssjukhuset Solna ( Site 2000)
  • Uppsala Lan
    • Uppsala, Uppsala Lan, Sweden, 751 85
      • Akademiska Sjukhuset ( Site 2002)
• Turkey
  • Adana, Turkey, 01250
    • Baskent University Adana Training Hospital ( Site 1509)
  • Ankara, Turkey, 06100
    • Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1502)
  • Ankara, Turkey, 06500
    • Gazi Universitesi Tip Fakultesi ( Site 1507)
  • Ankara, Turkey, 06800
    • Ankara Sehir Hastanesi ( Site 1508)
  • Antalya, Turkey, 07070
    • Akdeniz Universitesi Tıp Fakultesi ( Site 1503)
  • Edirne, Turkey, 22030
    • Trakya University Medical Faculty Balkan Oncology Hospital ( Site 1500)
  • Istanbul, Turkey, 34098
    • Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1504)
  • Istanbul, Turkey, 34722
    • Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi ( Site 1505)
  • Izmir, Turkey, 35040
    • Ege Universitesi Tip Fakultesi Tulay Aktas Onkoloji Hastanesi ( Site 1501)
  • Konya, Turkey, 42080
    • Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 1510)
  • Malatya, Turkey, 44280
    • Inonu Universitesi Medical Fakultesi ( Site 1506)
• Ukraine
  • Cherkaska Oblast
    • Cherkasy, Cherkaska Oblast, Ukraine, 18009
      • Cherkasy Regional Oncology Dispensary ( Site 1702)
  • Dnipropetrovska Oblast
    • Dnipro, Dnipropetrovska Oblast, Ukraine, 49102
      • Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council ( Site 1700)
  • Ivano-Frankivska Oblast
    • Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine, 76018
      • Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Department for daily treated patient (
  • Kharkivska Oblast
    • Kharkiv, Kharkivska Oblast, Ukraine, 61070
      • Communal non profit enterprise Regional Clinical Oncology Center ( Site 1704)
  • Khmelnytska Oblast
    • Khmelnitskiy, Khmelnytska Oblast, Ukraine, 29009
      • Khmelnitskiy Regional Onkology Dispensary ( Site 1705)
  • Kirovohradska Oblast
    • Kropyvnytsky, Kirovohradska Oblast, Ukraine, 25011
      • Kirovograd Regional oncology Dispensary ( Site 1716)
  • Kyivska Oblast
    • Kyiv, Kyivska Oblast, Ukraine, 04050
      • Medical Centre Consilium Medical ( Site 1712)
  • Vinnytska Oblast
    • Vinnytsia, Vinnytska Oblast, Ukraine, 21029
      • Podillya Regional Center of Oncology ( Site 1708)
  • Zaporizka Oblast
    • Zaporizhzhia, Zaporizka Oblast, Ukraine, 69035
      • Medical center of the Limited Liability Company Yulis ( Site 1714)
  • Zhytomyrska Oblast
    • Zhytomyr, Zhytomyrska Oblast, Ukraine, 10002
      • Zhytomyr Regional Oncology Center ( Site 1710)
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • The Kirklin Clinic ( Site 0086)
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Banner MD Anderson Cancer Center ( Site 0049)
  • California
    • Sacramento, California, United States, 95817
      • UC Davis Comprehensive Cancer Center ( Site 0039)
    • San Francisco, California, United States, 94115
      • San Francisco Oncology Associates ( Site 0085)
    • San Francisco, California, United States, 94158
      • University of California San Francisco ( Site 0015)
  • Colorado
    • Greeley, Colorado, United States, 80631
      • Banner MD Anderson Cancer Center ( Site 0092)
  • Florida
    • Gainesville, Florida, United States, 32608
      • University of Florida ( Site 0078)
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute of Emory University ( Site 0057)
    • Gainesville, Georgia, United States, 30501
      • Northeast Georgia Medical Center ( Site 0026)
    • Marietta, Georgia, United States, 30060
      • Northwest Georgia Oncology Centers PC ( Site 0047)
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Norton Cancer Institute - St. Matthews ( Site 0024)
  • New Jersey
    • Summit, New Jersey, United States, 07901
      • Atlantic Health System ( Site 0046)
  • New York
    • Port Jefferson Station, New York, United States, 11776
      • New York Cancer and Blood Specialists-Research Department ( Site 0080)
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center ( Site 0016)
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • The University of Oklahoma Health Sciences Center ( Site 0050)
  • Texas
    • Dallas, Texas, United States, 75235
      • Parkland Health & Hospital System ( Site 0091)
    • Dallas, Texas, United States, 75390
      • University of Texas, Southwestern Medical Center ( Site 0004)
    • Houston, Texas, United States, 77030
      • University of Texas-MD Anderson Cancer Center ( Site 0087)
  • Utah
    • West Valley City, Utah, United States, 84119
      • Utah Cancer Specialists ( Site 0038)
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Inova Schar Cancer Institute ( Site 0008)
  • Washington
    • Tacoma, Washington, United States, 98405
      • Northwest Medical Specialties, PLLC ( Site 0007)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Biological: Pembrolizumab; Intravenous infusion; Other Names: MK-3475; KEYTRUDA®; Drug: Olaparib; Oral tablet; Other Names: MK-7339; LYNPARZA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or Prostate Cancer Working Group (PCWG)-modified RECIST 1.1 in Biomarker Subgroups	ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The ORR for all participants will be presented by biomarker subgroup.	Up to ~3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Response (DOR) as Assessed by RECIST 1.1 or PCWG-modified RECIST 1.1 in Biomarker Subgroups	For participants who demonstrate a confirmed complete response (CR: Disappearance of all target lesions) or confirmed Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death. The DOR for all participants who experience a CR or PR will be presented by biomarker subgroup.	Up to ~3 years
Progression-Free Survival (PFS) as Assessed by RECIST 1.1 or PCWG-modified RECIST 1.1 in Biomarker Subgroups	PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more lesions is also considered PD. The PFS for all participants will be presented by biomarker subgroup.	Up to ~3 years
Overall Survival (OS) in Biomarker Subgroups	OS is the time from randomization to death due to any cause. The OS for all participants will be presented by biomarker subgroup.	Up to ~3 years
Number of Participants Who Experience an Adverse Event (AE)	An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented.	Up to ~3 years
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)	An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment will be presented.	Up to ~3 years
Objective Response Rate (ORR) Based on Tumor Biomarker Status as Assessed by RECIST 1.1 or PCWG-modified RECIST 1.1 in Additional Biomarker Subpopulations	ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR will be presented by biomarker subpopulation.	Up to ~3 years
Duration of Response (DOR) Based on Tumor Biomarker Status as Assessed by RECIST 1.1 or PCWG-modified RECIST 1.1 in Additional Biomarker Subpopulations	For participants who demonstrate a confirmed complete response (CR: Disappearance of all target lesions) or confirmed Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death. The DOR for all participants who experience a CR or PR will be presented by biomarker subpopulation.	Up to ~3 years
Progression-Free Survival (PFS) Based on Tumor Biomarker Status as Assessed by RECIST 1.1 or PCWG-modified RECIST 1.1 in Additional Biomarker Subpopulations	PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more lesions is also considered PD. PFS will be presented by biomarker subpopulation.	Up to ~3 years
Overall Survival (OS) in Additional Biomarker Subpopulations	OS is the time from randomization to death due to any cause. OS will be presented by biomarker subpopulation.	Up to ~3 years
Number of Participants with Cancer Antigen-125 (CA-125) Level of ≥2 × Upper Limit of Normal (ULN) Among Participants with Ovarian Cancer	The number of participants who have ovarian cancer and have a CA-125 level ≥2 × upper limit of normal (ULN) at 2 different assessments that are measured at least 1 week apart will be presented.	Up to ~3 years
Number of Participants with Cancer Antigen-125 (CA-125) Level ≥2 × Nadir (Lowest) Value Among Participants with Ovarian Cancer Who Had Elevated CA-125 Levels ≥ULN at Baseline	The number of participants who have ovarian cancer with an elevated CA-125 level ≥ ULN at Baseline and have a CA-125 level ≥2 × the nadir (lowest) value at 2 different assessments that are measured at least 1 week apart will be presented.	Up to ~3 years
Number of Participants with a Change from Baseline in Prostate-Specific Antigen (PSA) Level of ≥50% Among Participants with Prostate Cancer	A PSA response is defined as a reduction in the PSA level of ≥50% from Baseline measured at 2 different times at least 3 weeks apart. The number of participants who have prostate cancer and have a change from Baseline in PSA level ≥50% will be presented.	Up to ~3 years

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• 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.

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2019
• Primary Completion (Estimated): July 24, 2025
• Study Completion (Estimated): July 24, 2025

Study Registration Dates

• First Submitted: October 9, 2019
• First Submitted That Met QC Criteria: October 9, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Immunological; Poly(ADP-ribose) Polymerase Inhibitors; Immune Checkpoint Inhibitors; Olaparib; Pembrolizumab
• Other Study ID Numbers: 7339-007; MK-7339-007 (Other Identifier: Merck); KEYLYNK-007 (Other Identifier: Merck); jRCT2011200025 (Registry Identifier: jRCT); 2019-001745-40 (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