Clinical trial NCT04123366: 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)
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Solid Tumors
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2019-10-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
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
timeFrame: Up to ~3 years
Secondary outcomes:
measure: Duration of Response (DOR) as Assessed by RECIST 1.1 or PCWG-modified RECIST 1.1 in Biomarker Subgroups
timeFrame: Up to ~3 years
measure: Progression-Free Survival (PFS) as Assessed by RECIST 1.1 or PCWG-modified RECIST 1.1 in Biomarker Subgroups
timeFrame: Up to ~3 years
measure: Overall Survival (OS) in Biomarker Subgroups
timeFrame: Up to ~3 years
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to ~3 years
measure: Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
timeFrame: Up to ~3 years
measure: 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
timeFrame: Up to ~3 years
measure: 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
timeFrame: Up to ~3 years
measure: 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
timeFrame: Up to ~3 years
measure: Overall Survival (OS) in Additional Biomarker Subpopulations
timeFrame: Up to ~3 years
measure: Number of Participants with Cancer Antigen-125 (CA-125) Level of ≥2 × Upper Limit of Normal (ULN) Among Participants with Ovarian Cancer
timeFrame: Up to ~3 years
measure: 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
timeFrame: Up to ~3 years
measure: Number of Participants with a Change from Baseline in Prostate-Specific Antigen (PSA) Level of ≥50% Among Participants with Prostate Cancer
timeFrame: Up to ~3 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The Kirklin Clinic ( Site 0086)
state: Alabama
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center ( Site 0049)
state: Arizona
city: Sacramento
country: United States
facility: UC Davis Comprehensive Cancer Center ( Site 0039)
state: California
city: San Francisco
country: United States
facility: San Francisco Oncology Associates ( Site 0085)
state: California
city: San Francisco
country: United States
facility: University of California San Francisco ( Site 0015)
state: California
city: Greeley
country: United States
facility: Banner MD Anderson Cancer Center ( Site 0092)
state: Colorado
city: Gainesville
country: United States
facility: University of Florida ( Site 0078)
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute of Emory University ( Site 0057)
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center ( Site 0026)
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers PC ( Site 0047)
state: Georgia
city: Louisville
country: United States
facility: Norton Cancer Institute - St. Matthews ( Site 0024)
state: Kentucky
city: Summit
country: United States
facility: Atlantic Health System ( Site 0046)
state: New Jersey
city: Port Jefferson Station
country: United States
facility: New York Cancer and Blood Specialists-Research Department ( Site 0080)
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center ( Site 0016)
state: Ohio
city: Oklahoma City
country: United States
facility: The University of Oklahoma Health Sciences Center ( Site 0050)
state: Oklahoma
city: Dallas
country: United States
facility: Parkland Health & Hospital System ( Site 0091)
state: Texas
city: Dallas
country: United States
facility: University of Texas, Southwestern Medical Center ( Site 0004)
state: Texas
city: Houston
country: United States
facility: University of Texas-MD Anderson Cancer Center ( Site 0087)
state: Texas
city: West Valley City
country: United States
facility: Utah Cancer Specialists ( Site 0038)
state: Utah
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute ( Site 0008)
state: Virginia
city: Tacoma
country: United States
facility: Northwest Medical Specialties, PLLC ( Site 0007)
state: Washington
city: Ciudad de Buenos Aires
country: Argentina
facility: Fundacion CIDEA ( Site 2704)
state: Caba
city: Ciudad de Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires ( Site 2705)
state: Caba
city: Buenos Aires
country: Argentina
facility: Centro Medico Dra De Salvo ( Site 2702)
city: Buenos Aires
country: Argentina
facility: CEMIC ( Site 2701)
city: La Rioja
country: Argentina
facility: Centro Oncologico Riojano Integral ( Site 2703)
city: Blacktown
country: Australia
facility: Blacktown Hospital ( Site 2202)
state: New South Wales
city: Southport
country: Australia
facility: Tasman Oncology Research Pty Ltd ( Site 2203)
state: Queensland
city: Clayton
country: Australia
facility: Monash Medical Centre ( Site 2205)
state: Victoria
city: Nedlands
country: Australia
facility: Linear Clinical Research Ltd ( Site 2206)
state: Western Australia
city: Vancouver
country: Canada
facility: BC Cancer-Vancouver Center ( Site 0203)
state: British Columbia
city: Moncton
country: Canada
facility: Moncton Hospital - Horizon Health Network ( Site 0206)
state: New Brunswick
city: Montreal
country: Canada
facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0201)
state: Quebec
city: Medellin
country: Colombia
facility: Fundación Colombiana de Cancerología Clínica Vida ( Site 2902)
state: Antioquia
city: Barranquilla
country: Colombia
facility: Clinica de la Costa S.A.S. ( Site 2900)
state: Atlantico
city: Piedecuesta
country: Colombia
facility: Fundacion Cardiovascular de Colombia ( Site 2907)
state: Santander
city: Cali
country: Colombia
facility: Hemato Oncologos S.A. ( Site 2910)
state: Valle Del Cauca
city: Cali
country: Colombia
facility: Fundacion Valle del Lili ( Site 2909)
state: Valle Del Cauca
city: Besancon
country: France
facility: CHU Jean Minjoz ( Site 0606)
state: Doubs
city: Montpellier
country: France
facility: Institut du Cancer de Montpellier ( Site 0610)
state: Herault
city: Rouen
country: France
facility: Centre Henri Becquerel ( Site 0607)
state: Seine-Maritime
city: Villejuif
country: France
facility: Institut Gustave Roussy ( Site 0602)
state: Val-de-Marne
city: La Roche sur Yon
country: France
facility: CHD Vendee ( Site 0604)
state: Vendee
city: Muenchen
country: Germany
facility: Universitaetsklinik der Ludwig-Maximilians-Universitaet Muenchen ( Site 0906)
state: Bayern
city: Koeln
country: Germany
facility: Universitaetsklinik Koeln ( Site 0903)
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Charite-Universitaetsmedizin Berlin-Campus Benjamin Franklin ( Site 0902)
city: Guatemala
country: Guatemala
facility: Oncologika S.A. ( Site 3003)
city: Guatemala
country: Guatemala
facility: Grupo Angeles SA ( Site 3004)
city: Guatemala
country: Guatemala
facility: Sanatorio Nuestra Senora del Pilar ( Site 3006)
city: Guatemala
country: Guatemala
facility: Medi-K Cayala ( Site 3005)
city: Quetzaltenango
country: Guatemala
facility: Centro Medico Integral De Cancerología (CEMIC) ( Site 3002)
city: Haifa
country: Israel
facility: Rambam Health Care Campus-Oncology Division ( Site 0801)
city: Jerusalem
country: Israel
facility: Hadassah Ein Kerem Medical Center ( Site 0802)
city: Kfar Saba
country: Israel
facility: Meir Medical Center ( Site 0804)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center ( Site 0806)
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center ( Site 0800)
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center ( Site 0805)
city: Modena
country: Italy
facility: Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0703)
state: Emilia-Romagna
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda ( Site 0700)
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Fondazione Pascale ( Site 0705)
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese ( Site 0704)
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital ( Site 2504)
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 2500)
state: Chiba
city: Sapporo
country: Japan
facility: Hokkaido University Hospital ( Site 2502)
state: Hokkaido
city: Fukuoka
country: Japan
facility: Kyushu University Hospital ( Site 2506)
city: Okayama
country: Japan
facility: Okayama University Hospital ( Site 2505)
city: Tokyo
country: Japan
facility: National Cancer Center Hospital ( Site 2501)
city: Tokyo
country: Japan
facility: Japanese Foundation for Cancer Research ( Site 2503)
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital ( Site 2403)
state: Kyonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 2402)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System ( Site 2400)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 2401)
city: Daugavpils
country: Latvia
facility: Daugavpils Regional Hospital ( Site 2104)
city: Liepaja
country: Latvia
facility: Liepaja Regional Hospital ( Site 2101)
city: Riga
country: Latvia
facility: Riga East Clinical University Hospital ( Site 2103)
city: Riga
country: Latvia
facility: P. Stradina Clinical University Hospital ( Site 2102)
city: León
country: Mexico
facility: Preparaciones Oncologicas ( Site 3102)
state: Guanajuato
city: Monterrey
country: Mexico
facility: Unidad Biomedica Avanzada Monterrey S. A. ( Site 3108)
state: Nuevo Leon
city: San Pedro Garza Garcia
country: Mexico
facility: Centro Medico Zambrano Hellion ( Site 3105)
state: Nuevo Leon
city: Santiago de Queretaro
country: Mexico
facility: Hospital H+ Queretaro ( Site 3104)
state: Queretaro
city: Madero
country: Mexico
facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 3101)
state: Tamaulipas
city: Ciudad de Mexico
country: Mexico
facility: CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 3103)
city: Puebla
country: Mexico
facility: Clinica Integral Internacional de Oncologia S. de R.L. de C.V. ( Site 3107)
city: Arequipa
country: Peru
facility: Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 3206)
state: Ariqipa
city: Bellavista
country: Peru
facility: Hospital Nacional Daniel Alcides Carrion ( Site 3207)
state: Qallaw
city: Cuzco
country: Peru
facility: Hospital Nacional Adolfo Guevara Velasco ( Site 3205)
state: Qusqu
city: Lima
country: Peru
facility: Oncosalud ( Site 3200)
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplasicas ( Site 3201)
city: Lima
country: Peru
facility: Hospital Nacional Arzobispo Loayza ( Site 3208)
city: Lima
country: Peru
facility: Clinica San Gabriel ( Site 3202)
city: Lima
country: Peru
facility: Hospital Nacional Cayetano Heredia ( Site 3203)
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
state: Mazowieckie
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne ( Site 1809)
state: Pomorskie
city: Manati
country: Puerto Rico
facility: Hematology and Oncology Institute ( Site 0504)
city: Ponce
country: Puerto Rico
facility: Ad-Vance Medical Research LLC ( Site 0505)
city: Rio Piedras
country: Puerto Rico
facility: Pan American Center for Oncology Trials LLC ( Site 0501)
city: San Juan
country: Puerto Rico
facility: FDI Clinical Research ( Site 0500)
city: Alba Iulia
country: Romania
facility: Spitalul Judetean de Urgenta Alba Iulia ( Site 1107)
state: Alba
city: Cluj Napoca
country: Romania
facility: Medisprof ( Site 1102)
state: Cluj
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1101)
state: Cluj
city: Craiova
country: Romania
facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1103)
state: Dolj
city: Timisoara
country: Romania
facility: Policlinica Oncomed SRL ( Site 1104)
state: Timis
city: Bloemfontein
country: South Africa
facility: Universitas Annex National Hospital ( Site 1902)
state: Free State
city: Parktown-Johannesburg
country: South Africa
facility: Wits Clinical Research ( Site 1906)
state: Gauteng
city: Pretoria
country: South Africa
facility: Mary Potter Oncology Centre, Little Company of Mary Hospital ( Site 1900)
state: Gauteng
city: Vereeniging
country: South Africa
facility: Vaal Triangle Oncology Centre ( Site 1905)
state: Gauteng
city: Durban
country: South Africa
facility: The Oncology Centre ( Site 1904)
state: Kwazulu-Natal
city: Rondebosch
country: South Africa
facility: Cancercare Rondebosch Oncology ( Site 1901)
state: Western Cape
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Quiron de Madrid ( Site 1301)
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial ( Site 1302)
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon ( Site 1300)
city: Lund
country: Sweden
facility: Skanes Universitetssjukhus Lund. ( Site 2001)
state: Skane Lan
city: Solna
country: Sweden
facility: Karolinska Universitetssjukhuset Solna ( Site 2000)
state: Stockholms Lan
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset ( Site 2002)
state: Uppsala Lan
city: Adana
country: Turkey
facility: Baskent University Adana Training Hospital ( Site 1509)
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1502)
city: Ankara
country: Turkey
facility: Gazi Universitesi Tip Fakultesi ( Site 1507)
city: Ankara
country: Turkey
facility: Ankara Sehir Hastanesi ( Site 1508)
city: Antalya
country: Turkey
facility: Akdeniz Universitesi Tıp Fakultesi ( Site 1503)
city: Edirne
country: Turkey
facility: Trakya University Medical Faculty Balkan Oncology Hospital ( Site 1500)
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1504)
city: Istanbul
country: Turkey
facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi ( Site 1505)
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi Tulay Aktas Onkoloji Hastanesi ( Site 1501)
city: Konya
country: Turkey
facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 1510)
city: Malatya
country: Turkey
facility: Inonu Universitesi Medical Fakultesi ( Site 1506)
city: Cherkasy
country: Ukraine
facility: Cherkasy Regional Oncology Dispensary ( Site 1702)
state: Cherkaska Oblast
city: Dnipro
country: Ukraine
facility: Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council ( Site 1700)
state: Dnipropetrovska Oblast
city: Ivano-Frankivsk
country: Ukraine
facility: Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Department for daily treated patient (
state: Ivano-Frankivska Oblast
city: Kharkiv
country: Ukraine
facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 1704)
state: Kharkivska Oblast
city: Khmelnitskiy
country: Ukraine
facility: Khmelnitskiy Regional Onkology Dispensary ( Site 1705)
state: Khmelnytska Oblast
city: Kropyvnytsky
country: Ukraine
facility: Kirovograd Regional oncology Dispensary ( Site 1716)
state: Kirovohradska Oblast
city: Kyiv
country: Ukraine
facility: Medical Centre Consilium Medical ( Site 1712)
state: Kyivska Oblast
city: Vinnytsia
country: Ukraine
facility: Podillya Regional Center of Oncology ( Site 1708)
state: Vinnytska Oblast
city: Zaporizhzhia
country: Ukraine
facility: Medical center of the Limited Liability Company Yulis ( Site 1714)
state: Zaporizka Oblast
city: Zhytomyr
country: Ukraine
facility: Zhytomyr Regional Oncology Center ( Site 1710)
state: Zhytomyrska Oblast
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.