AzTrials
AzTrials

Solid TumorsPhase 2NCT04123366

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 testing Olaparib and Pembrolizumab in people with Solid Tumors, run by Merck Sharp & Dohme LLC at 135 sites in 23 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors
What is being tested?
Olaparib and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
333 participants
Where
135 sitesin 23 countries
Study dates
18 Nov 2019to 8 Jun 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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]).
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  • 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.

Trial locations and contacts

135 sites in 23 countries.

135 sites in 23 countries

United States21 sites

  • Winship Cancer Institute of Emory University ( Site 0057)

    Atlanta, Georgia, 30322

  • The Kirklin Clinic ( Site 0086)

    Birmingham, Alabama, 35233

  • University Hospitals Cleveland Medical Center ( Site 0016)

    Cleveland, Ohio, 44106

  • Parkland Health & Hospital System ( Site 0091)

    Dallas, Texas, 75235

  • University of Texas, Southwestern Medical Center ( Site 0004)

    Dallas, Texas, 75390

  • Inova Schar Cancer Institute ( Site 0008)

    Fairfax, Virginia, 22031

  • University of Florida ( Site 0078)

    Gainesville, Florida, 32608

  • Northeast Georgia Medical Center ( Site 0026)

    Gainesville, Georgia, 30501

  • Banner MD Anderson Cancer Center ( Site 0049)

    Gilbert, Arizona, 85234

  • Banner MD Anderson Cancer Center ( Site 0092)

    Greeley, Colorado, 80631

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

    Houston, Texas, 77030

  • Norton Cancer Institute - St. Matthews ( Site 0024)

    Louisville, Kentucky, 40207

  • Northwest Georgia Oncology Centers PC ( Site 0047)

    Marietta, Georgia, 30060

  • The University of Oklahoma Health Sciences Center ( Site 0050)

    Oklahoma City, Oklahoma, 73104

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

    Port Jefferson Station, New York, 11776

  • UC Davis Comprehensive Cancer Center ( Site 0039)

    Sacramento, California, 95817

  • San Francisco Oncology Associates ( Site 0085)

    San Francisco, California, 94115

  • University of California San Francisco ( Site 0015)

    San Francisco, California, 94158

  • Atlantic Health System ( Site 0046)

    Summit, New Jersey, 07901

  • Northwest Medical Specialties, PLLC ( Site 0007)

    Tacoma, Washington, 98405

  • Utah Cancer Specialists ( Site 0038)

    West Valley City, Utah, 84119

Other trials in United States

Turkey (Türkiye)11 sites

  • Baskent University Adana Training Hospital ( Site 1509)

    Adana, 01250

  • Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1502)

    Ankara, 06100

  • Gazi Universitesi Tip Fakultesi ( Site 1507)

    Ankara, 06500

  • Ankara Sehir Hastanesi ( Site 1508)

    Ankara, 06800

  • Akdeniz Universitesi Tıp Fakultesi ( Site 1503)

    Antalya, 07070

  • Trakya University Medical Faculty Balkan Oncology Hospital ( Site 1500)

    Edirne, 22030

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1504)

    Istanbul, 34098

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

    Istanbul, 34722

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

    Izmir, 35040

  • Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 1510)

    Konya, 42080

  • Inonu Universitesi Medical Fakultesi ( Site 1506)

    Malatya, 44280

Other trials in Turkey (Türkiye)

Ukraine10 sites

  • Cherkasy Regional Oncology Dispensary ( Site 1702)

    Cherkasy, Cherkasy Oblast, 18009

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

    Dnipro, Dnipropetrovsk Oblast, 49102

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

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018

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

    Kharkiv, Kharkiv Oblast, 61070

  • Khmelnitskiy Regional Onkology Dispensary ( Site 1705)

    Khmelnitskiy, Khmelnytskyi Oblast, 29009

  • Kirovograd Regional oncology Dispensary ( Site 1716)

    Kropyvnytsky, Kirovohrad Oblast, 25011

  • Medical Centre Consilium Medical ( Site 1712)

    Kyiv, Kyivska Oblast, 04050

  • Podillya Regional Center of Oncology ( Site 1708)

    Vinnytsia, Vinnytsia Oblast, 21029

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

    Zaporizhzhya, Zaporizhzhia Oblast, 69035

  • Zhytomyr Regional Oncology Center ( Site 1710)

    Zhytomyr, Zhytomyr Oblast, 10002

Other trials in Ukraine

Peru8 sites

  • Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 3206)

    Arequipa, Ariqipa, 04001

  • Hospital Nacional Daniel Alcides Carrion ( Site 3207)

    Bellavista, Qallaw, 07021

  • Hospital Nacional Adolfo Guevara Velasco ( Site 3205)

    Cuzco, Qusqu, 08003

  • Oncosalud ( Site 3200)

    Lima, 15036

  • Instituto Nacional de Enfermedades Neoplasicas ( Site 3201)

    Lima, 15038

  • Hospital Nacional Arzobispo Loayza ( Site 3208)

    Lima, 15082

  • Clinica San Gabriel ( Site 3202)

    Lima, 15088

  • Hospital Nacional Cayetano Heredia ( Site 3203)

    Lima, 15102

Other trials in Peru

Japan7 sites

  • Kyushu University Hospital ( Site 2506)

    Fukuoka, 812-8582

  • National Cancer Center Hospital East ( Site 2500)

    Kashiwa, Chiba, 277-8577

  • Aichi Cancer Center Hospital ( Site 2504)

    Nagoya, Aichi-ken, 464-8681

  • Okayama University Hospital ( Site 2505)

    Okayama, 700-8558

  • Hokkaido University Hospital ( Site 2502)

    Sapporo, Hokkaido, 060-8648

  • National Cancer Center Hospital ( Site 2501)

    Tokyo, 104-0045

  • Japanese Foundation for Cancer Research ( Site 2503)

    Tokyo, 135-8550

Other trials in Japan

Mexico7 sites

  • Preparaciones Oncologicas ( Site 3102)

    León, Guanajuato, 37178

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

    Madero, Tamaulipas, 89440

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

    Mexico City, 06100

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

    Monterrey, Nuevo León, 64460

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

    Puebla City, 72530

  • Hospital H+ Queretaro ( Site 3104)

    Querétaro City, Querétaro, 76000

  • Centro Medico Zambrano Hellion ( Site 3105)

    San Pedro Garza García, Nuevo León, 66278

Other trials in Mexico

Israel6 sites

  • Rambam Health Care Campus-Oncology Division ( Site 0801)

    Haifa, 3109601

  • Hadassah Ein Kerem Medical Center ( Site 0802)

    Jerusalem, 9112001

  • Meir Medical Center ( Site 0804)

    Kfar Saba, 4428164

  • Rabin Medical Center ( Site 0806)

    Petah Tikva, 4941492

  • Chaim Sheba Medical Center ( Site 0800)

    Ramat Gan, 5262000

  • Sourasky Medical Center ( Site 0805)

    Tel Aviv, 6423906

Other trials in Israel

South Africa6 sites

  • Universitas Annex National Hospital ( Site 1902)

    Bloemfontein, Free State, 9301

  • The Oncology Centre ( Site 1904)

    Durban, KwaZulu-Natal, 4091

  • Wits Clinical Research ( Site 1906)

    Parktown-Johannesburg, Gauteng, 2193

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

    Pretoria, Gauteng, 0181

  • Cancercare Rondebosch Oncology ( Site 1901)

    Rondebosch, Western Cape, 7700

  • Vaal Triangle Oncology Centre ( Site 1905)

    Vereeniging, Gauteng, 1930

Other trials in South Africa

Argentina5 sites

  • Centro Medico Dra De Salvo ( Site 2702)

    Buenos Aires, C1426ABP

  • CEMIC ( Site 2701)

    Buenos Aires, C1431FWO

  • Fundacion CIDEA ( Site 2704)

    Ciudad de Buenos Aires, Buenos Aires F.D., C1121ABE

  • Hospital Britanico de Buenos Aires ( Site 2705)

    Ciudad de Buenos Aires, Buenos Aires F.D., C1280AEB

  • Centro Oncologico Riojano Integral ( Site 2703)

    La Rioja, F5300COE

Other trials in Argentina

Colombia5 sites

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

    Barranquilla, Atlántico, 080020

  • Hemato Oncologos S.A. ( Site 2910)

    Cali, Valle del Cauca Department, 76001

  • Fundacion Valle del Lili ( Site 2909)

    Cali, Valle del Cauca Department, 760032

  • Fundación Colombiana de Cancerología Clínica Vida ( Site 2902)

    Medellín, Antioquia, 050030

  • Fundacion Cardiovascular de Colombia ( Site 2907)

    Piedecuesta, Santander Department, 68017

Other trials in Colombia

France5 sites

  • CHU Jean Minjoz ( Site 0606)

    Besançon, Doubs, 25030

  • CHD Vendee ( Site 0604)

    La Roche-sur-Yon, Vendee, 85925

  • Institut du Cancer de Montpellier ( Site 0610)

    Montpellier, Herault, 34298

  • Centre Henri Becquerel ( Site 0607)

    Rouen, Seine-Maritime, 76038

  • Institut Gustave Roussy ( Site 0602)

    Villejuif, Val-de-Marne, 94800

Other trials in France

Guatemala5 sites

  • Oncologika S.A. ( Site 3003)

    Guatemala City, 01010

  • Grupo Angeles SA ( Site 3004)

    Guatemala City, 01015

  • Sanatorio Nuestra Senora del Pilar ( Site 3006)

    Guatemala City, 01015

  • Medi-K Cayala ( Site 3005)

    Guatemala City, 01016

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

    Quetzaltenango, 09002

Other trials in Guatemala

Romania5 sites

  • Spitalul Judetean de Urgenta Alba Iulia ( Site 1107)

    Alba Iulia, Alba, 510007

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

    Cluj-Napoca, Cluj, 400015

  • Medisprof ( Site 1102)

    Cluj-Napoca, Cluj, 400641

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

    Craiova, Dolj, 200542

  • Policlinica Oncomed SRL ( Site 1104)

    Timișoara, Timiș County, 300239

Other trials in Romania

Australia4 sites

  • Blacktown Hospital ( Site 2202)

    Blacktown, New South Wales, 2148

  • Monash Medical Centre ( Site 2205)

    Clayton, Victoria, 3168

  • Linear Clinical Research Ltd ( Site 2206)

    Nedlands, Western Australia, 6009

  • Tasman Oncology Research Pty Ltd ( Site 2203)

    Southport, Queensland, 4215

Other trials in Australia

Italy4 sites

  • ASST Grande Ospedale Metropolitano Niguarda ( Site 0700)

    Milan, 20162

  • Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0703)

    Modena, Emilia-Romagna, 41124

  • Istituto Nazionale Tumori Fondazione Pascale ( Site 0705)

    Naples, 80131

  • Azienda Ospedaliera Universitaria Senese ( Site 0704)

    Siena, 53100

Other trials in Italy

Latvia4 sites

  • Daugavpils Regional Hospital ( Site 2104)

    Daugavpils, 5417

  • Liepaja Regional Hospital ( Site 2101)

    Liepāja, 3414

  • Riga East Clinical University Hospital ( Site 2103)

    Riga, 1079

  • P. Stradina Clinical University Hospital ( Site 2102)

    Riga, LV-1002

Other trials in Latvia

Puerto Rico4 sites

  • Hematology and Oncology Institute ( Site 0504)

    Manati, 00674

  • Ad-Vance Medical Research LLC ( Site 0505)

    Ponce, 00717

  • Pan American Center for Oncology Trials LLC ( Site 0501)

    Rio Piedras, 00935

  • FDI Clinical Research ( Site 0500)

    San Juan, 00927

Other trials in Puerto Rico

South Korea4 sites

  • Seoul National University Bundang Hospital ( Site 2403)

    Seongnam-si, Kyonggi-do, 13605

  • Seoul National University Hospital ( Site 2402)

    Seoul, 03080

  • Severance Hospital Yonsei University Health System ( Site 2400)

    Seoul, 03722

  • Samsung Medical Center ( Site 2401)

    Seoul, 06351

Other trials in South Korea

Canada3 sites

  • Moncton Hospital - Horizon Health Network ( Site 0206)

    Moncton, New Brunswick, E1C 6Z8

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

    Montreal, Quebec, H2X 1R9

  • BC Cancer-Vancouver Center ( Site 0203)

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Germany3 sites

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

    Berlin, 12203

  • Universitaetsklinik Koeln ( Site 0903)

    Cologne, North Rhine-Westphalia, 50937

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

    Munich, Bavaria, 81377

Other trials in Germany

Spain3 sites

  • Hospital Clinic i Provincial ( Site 1302)

    Barcelona, 08036

  • Hospital General Universitario Gregorio Maranon ( Site 1300)

    Madrid, 28007

  • Hospital Quiron de Madrid ( Site 1301)

    Pozuelo de Alarcón, Madrid, 28223

Other trials in Spain

Sweden3 sites

  • Skanes Universitetssjukhus Lund. ( Site 2001)

    Lund, Skåne County, 221 85

  • Karolinska Universitetssjukhuset Solna ( Site 2000)

    Solna, Stockholm County, 171 76

  • Akademiska Sjukhuset ( Site 2002)

    Uppsala, Uppsala County, 751 85

Other trials in Sweden

Poland2 sites

  • Uniwersyteckie Centrum Kliniczne ( Site 1809)

    Gdansk, Pomeranian Voivodeship, 80-214

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

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

About this study

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

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.

Conditions
Solid Tumors
Being tested
Olaparib, Pembrolizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OlaparibDrug

    Also called MK-7339, LYNPARZA®

    Oral tablet

  • PembrolizumabBiological

    Also called MK-3475, KEYTRUDA®

    Intravenous infusion

Study groups in NCT04123366
Study groupRoleWhat they receive
Olaparib+PembrolizumabExperimentalParticipants 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.
Receives: Drug: Olaparib; Biological: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to ~3 years

Secondary outcomes (12)

  1. 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.

    Measured: Up to ~3 years

  2. 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.

    Measured: Up to ~3 years

  3. 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.

    Measured: Up to ~3 years

  4. 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.

    Measured: Up to ~3 years

  5. 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.

    Measured: Up to ~3 years

  6. 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.

    Measured: Up to ~3 years

  7. 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.

    Measured: Up to ~3 years

  8. 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.

    Measured: Up to ~3 years

  9. 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.

    Measured: Up to ~3 years

  10. 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.

    Measured: Up to ~3 years

  11. 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.

    Measured: Up to ~3 years

  12. 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.

    Measured: Up to ~3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2019
  2. Study start18 Nov 2019
  3. Primary completion8 Jun 2026
  4. Study completion8 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
333 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04123366
Sponsor's protocol ID
7339-007
Other IDs
MK-7339-007, KEYLYNK-007, jRCT2011200025, 2023-503831-17-00, U1111-1288-1642, 2019-001745-40, 2019, 2023
Status last verified
Jun 2026
First submitted
9 Oct 2019
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

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.

    PubMed 35567913

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Olaparib and Pembrolizumab in people with Solid Tumors, run by Merck Sharp & Dohme LLC at 135 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 135 sites in United States, Turkey (Türkiye), Ukraine, Peru, Japan and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Up to ~3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04123366, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.

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