Clinical trial NCT04456699: Efficacy and Safety of Olaparib (MK-7339) With or Without Bevacizumab Compared to Bevacizumab With a Fluoropyrimidine in Unresectable or Metastatic Colorectal Cancer (CRC) (MK-7339-003/LYNK-003)
Official title: A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Olaparib Alone or in Combination With Bevacizumab Compared to Bevacizumab With a Fluoropyrimidine in Participants With Unresectable or Metastatic Colorectal Cancer Who Have Not Progressed Following First-line Induction (LYNK-003)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metastatic Colorectal Cancer
Keywords: colorectal cancer
CRC
Olaparib
Bevacizumab
FOLFOX
5-FU
fluorouracil
folinic acid
oxaliplatin
CAPOX
capecitabine
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2020-07-02
Enrollment: 335
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an efficacy and safety study of olaparib alone or in combination with bevacizumab being compared to bevacizumab with a fluoropyrimidine in participants with unresectable or metastatic colorectal cancer who have not progressed following first-line induction. The primary hypotheses are: Olaparib + Bevacizumab is superior to a fluoropyrimidine + Bevacizumab with respect to progression-free survival (PFS) using Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR); Olaparib is superior to a fluoropyrimidine + Bevacizumab with respect to PFS using RECIST 1.1 as assessed by BICR. As of amendment 5 study enrollment is being discontinued and study participants randomized to one of the two experimental arms (olaparib plus bevacizumab or olaparib monotherapy) must discontinue study intervention. Participants who are still on study treatment will no longer have tumor response assessments by BICR.


Eligibility criteria: Inclusion Criteria:

1. Has a histologically-confirmed metastatic or unresectable (Stage IV as defined by American Joint Committee on Cancer (AJCC eighth edition) colorectal adenocarcinoma (National Comprehensive Cancer Network \[NCCN\] 2018).
2. Has not progressed (ie, achieved a stable disease \[SD\], partial response \[PR\], or complete response \[CR\]) after a first-line induction course of at least 6 cycles of folinic acid/fluorouracil/oxaliplatin (FOLFOX) + bevacizumab or 4 cycles of capecitabine and oxaliplatin (CAPOX) + bevacizumab as first-line therapy.

   * Participants must not have received an investigational agent during their induction course.
   * Determination of best overall response (SD/PR/CR) will be made by the investigator.
   * Non-Progressive Disease (PD) will be verified by BICR prior to randomization based on the images submitted to imaging contract research organization (iCRO) as described in inclusion criterion 4.
   * "First-line therapy" is defined as the first systemic chemotherapy regimen given for the diagnosis of unresectable or metastatic colorectal cancer (CRC). Participants may have received prior adjuvant/neoadjuvant chemotherapy for CRC, as long as it was completed at least 6 months prior to initiation of first-line CAPOX + bevacizumab or FOLFOX + bevacizumab induction treatment.
3. Has experienced unacceptable toxicity to oxaliplatin that, in the opinion of the treating physician, requires/required the discontinuation of oxaliplatin. Note: As an example, unacceptable toxicity may include (but is not limited to) severe or prolonged neurotoxicity.

   • Participants must be randomized within a minimum of 2 weeks and a maximum of 6 weeks after their last dose of CAPOX + bevacizumab or FOLFOX + bevacizumab (last dose is the day of the last infusion that contained oxaliplatin).
4. Has provided to the iCRO 1 set of baseline radiographic images taken before or during the CAPOX + bevacizumab or FOLFOX + bevacizumab induction period and at least 42 days prior to the imaging performed during Screening. Tumor imaging at Screening must be performed within 28 days prior to the date of randomization.
5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days prior to randomization.

Exclusion Criteria:

1. Has known hypersensitivity to the components and/or excipients in bevacizumab, 5-FU, capecitabine, or olaparib.
2. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression for at least 28 days by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid intervention for at least 14 days prior to first dose of study intervention.
3. Has an active infection requiring systemic therapy.
4. Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority.
5. Has a known history of or is positive for hepatitis B surface antigen (HBsAg reactive) or hepatitis C ribonucleic acid (HCV RNA \[qualitative\]) is detected). Note: No testing for hepatitis B and hepatitis C is required unless mandated by local health authority.
6. Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
7. Has myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) or with features suggestive of MDS/AML.
8. Has hemoptysis or hematemesis within 28 days prior to randomization.
9. Has evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation).
10. Has clinically significant bleeding within 28 days prior to randomization.
11. Is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on high-resolution computed tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.
12. Has 1 or more conditions that, in the opinion of the treating physician, make the participant ineligible for treatment with bevacizumab. These conditions may include:

    * Uncontrolled hypertension (systolic blood pressure \[SBP\] \>150 mm Hg or diastolic blood pressure \[DBP\] \>100 mm Hg) or a history of hypertensive crisis or hypertensive encephalopathy
    * Arterial thromboembolic events (eg, myocardial infarction, cerebral infarction)
    * History of nephrotic syndrome or moderate proteinuria
    * History of gastrointestinal perforation
    * History of non-gastrointestinal fistula formation
    * History of possible reversible encephalopathy syndrome (RPLS)
13. Has received prior systemic anticancer therapy (other than CAPOX + bevacizumab or FOLFOX + bevacizumab induction) including investigational agents within 28 days prior to randomization. Note: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with persistent alopecia or Grade ≤3 neuropathy are eligible.
14. Has received prior therapy with olaparib or with any other polyadenosine 5'-diphosphoribose polymerase (PARP) inhibitor.
15. Is currently receiving either strong (eg, itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate (eg, ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil) inhibitors of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of the study. The required washout period prior to randomization is 2 weeks.
16. Is currently receiving either strong (phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate (eg. bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued for the duration of the study. The required washout period prior to randomization is 5 weeks for phenobarbital and 3 weeks for other agents.
17. Has undergone major surgery within 2 weeks of randomization or has not recovered adequately from toxicities and/or complications from any major surgery prior to randomization.

Primary outcomes:
measure: Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)
timeFrame: Up to approximately 30 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 30 months
measure: Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR
timeFrame: Up to approximately 30 months
measure: Number of Participants With One or More Adverse Events (AE)
timeFrame: Up to approximately 30 months
measure: Number of Participants Discontinuing Study Intervention Due to an AE
timeFrame: Up to approximately 30 months
measure: Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
timeFrame: Up to approximately 30 months
Other outcomes:
Locations:
city: Burbank
country: United States
facility: Providence Saint Joseph Medical Center, Disney Family Cancer ( Site 1392)
state: California
city: Fullerton
country: United States
facility: St Joseph Heritage Healthcare-Oncology ( Site 1383)
state: California
city: Colorado Springs
country: United States
facility: UC Health Memorial Hospital ( Site 1401)
state: Colorado
city: Fort Collins
country: United States
facility: Poudre Valley Health System ( Site 1402)
state: Colorado
city: Athens
country: United States
facility: University Cancer & Blood Center, LLC ( Site 1381)
state: Georgia
city: Chicago
country: United States
facility: University of Chicago ( Site 1357)
state: Illinois
city: Peoria
country: United States
facility: Illinois Cancer Care, PC ( Site 1352)
state: Illinois
city: Louisville
country: United States
facility: James Graham Brown Cancer Center ( Site 1393)
state: Kentucky
city: New Orleans
country: United States
facility: University Medical Center New Orleans ( Site 1365)
state: Louisiana
city: Scarborough
country: United States
facility: New England Cancer Specialists ( Site 1422)
state: Maine
city: Grand Rapids
country: United States
facility: Cancer & Hematology Centers of Western Michigan ( Site 1358)
state: Michigan
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic Hematology/Oncology ( Site 1418)
state: Mississippi
city: Saint Louis
country: United States
facility: Washington University in St. Louis ( Site 1384)
state: Missouri
city: Billings
country: United States
facility: St. Vincent Frontier Cancer Center-Research ( Site 1414)
state: Montana
city: Grand Island
country: United States
facility: CHI Health St. Francis ( Site 1406)
state: Nebraska
city: Lincoln
country: United States
facility: Cancer Partners of Nebraska ( Site 1353)
state: Nebraska
city: Portland
country: United States
facility: Providence Portland Medical Center ( Site 1400)
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University ( Site 1411)
state: Oregon
city: Pittsburgh
country: United States
facility: Allegheny Singer Research Institute ( Site 1364)
state: Pennsylvania
city: Germantown
country: United States
facility: West Cancer Center - East Campus ( Site 1396)
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center ( Site 1362)
state: Tennessee
city: Temple
country: United States
facility: Baylor Scott & White Medical Center - Temple ( Site 1397)
state: Texas
city: Roanoke
country: United States
facility: Blue Ridge Cancer Care ( Site 1374)
state: Virginia
city: Kogarah
country: Australia
facility: St George Hospital ( Site 0052)
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital ( Site 0055)
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women s Hospital ( Site 0054)
state: Queensland
city: Woodville South
country: Australia
facility: Queen Elizabeth Hospital ( Site 0053)
state: South Australia
city: Clayton
country: Australia
facility: Monash Health ( Site 0050)
state: Victoria
city: Frankston
country: Australia
facility: Peninsula Health Frankston Hospital ( Site 0056)
state: Victoria
city: Bonheiden
country: Belgium
facility: Imelda vzw ( Site 0110)
state: Antwerpen
city: Brasschaat
country: Belgium
facility: AZ Klina ( Site 0106)
state: Antwerpen
city: Edegem
country: Belgium
facility: UZ Antwerpen ( Site 0108)
state: Antwerpen
city: Brussels
country: Belgium
facility: UCL Saint Luc ( Site 0100)
state: Bruxelles-Capitale, Region De
city: Aalst
country: Belgium
facility: OLV Ziekenhuis ( Site 0109)
state: Oost-Vlaanderen
city: Gent
country: Belgium
facility: UZ Gent ( Site 0101)
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Gasthuisberg ( Site 0102)
state: Vlaams-Brabant
city: Kortrijk
country: Belgium
facility: AZ Groeninge ( Site 0105)
state: West-Vlaanderen
city: Fredericton
country: Canada
facility: Dr. Everett Chalmers Regional Hospital ( Site 0204)
state: New Brunswick
city: Moncton
country: Canada
facility: Moncton Hospital - Horizon Health Network ( Site 0201)
state: New Brunswick
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre ( Site 0209)
state: Ontario
city: Laval
country: Canada
facility: Hopital Cite de la Sante de Laval ( Site 0203)
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre ( Site 0207)
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0202)
state: Quebec
city: Temuco
country: Chile
facility: Centro Investigación del Cáncer James Lind ( Site 0251)
state: Araucania
city: Santiago
country: Chile
facility: Sociedad Oncovida S.A. ( Site 0250)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Clínica San Carlos de Apoquindo Red Salud UC Christus ( Site 0252)
state: Region M. De Santiago
city: Valledupar
country: Colombia
facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0353)
state: Cesar
city: Monteria
country: Colombia
facility: Oncomedica S.A. ( Site 0352)
state: Cordoba
city: Bogota
country: Colombia
facility: Administradora Country SA - Clinica del Country ( Site 0350)
state: Distrito Capital De Bogota
city: Bogota
country: Colombia
facility: Instituto Nacional de Cancerologia E.S.E ( Site 0362)
state: Distrito Capital De Bogota
city: Pereira
country: Colombia
facility: Oncologos del Occidente ( Site 0364)
state: Risaralda
city: Bucaramanga
country: Colombia
facility: Fundacion Cardiovascular de Colombia ( Site 0360)
state: Santander
city: Cali
country: Colombia
facility: Hemato Oncologos S.A. ( Site 0355)
state: Valle Del Cauca
city: Strasbourg
country: France
facility: C.H.U. de Strasbourg Hopital de Hautepierre ( Site 0464)
state: Bas-Rhin
city: Saint-Herblain
country: France
facility: Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0455)
state: Bretagne
city: Besancon
country: France
facility: CHU Jean Minjoz ( Site 0450)
state: Doubs
city: Pessac Cedex
country: France
facility: CHU Bordeaux Haut-Leveque ( Site 0457)
state: Gironde
city: Montpellier
country: France
facility: CHU Saint Eloi ( Site 0467)
state: Herault
city: Lyon
country: France
facility: Centre Leon Berard ( Site 0459)
state: Rhone-Alpes
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou ( Site 0452)
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm ( Site 0500)
state: Baden-Wurttemberg
city: Bochum
country: Germany
facility: St. Josef und St. Elisabeth Hospital gGmbH-Hematology, oncology and palliative medicine ( Site 0503)
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0504)
city: Hamburg
country: Germany
facility: Facharztzentrum Eppendorf ( Site 0501)
city: Gyula
country: Hungary
facility: Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 1432)
state: Bekes
city: Miskolc
country: Hungary
facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás Ce
state: Borsod-Abauj-Zemplen
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont ( Site 1426)
state: Hajdu-Bihar
city: Szolnok
country: Hungary
facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1427)
state: Jasz-Nagykun-Szolnok
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Szent Rafael Korhaz ( Site 1429)
state: Zala
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet ( Site 1431)
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital ( Site 0658)
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 0650)
state: Chiba
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center ( Site 0652)
state: Ehime
city: Kawasaki
country: Japan
facility: St. Marianna University School of Medicine Hospital ( Site 0657)
state: Kanagawa
city: Kitaadachi-gun
country: Japan
facility: Saitama Cancer Center ( Site 0653)
state: Saitama
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 0655)
state: Shizuoka
city: Chiba
country: Japan
facility: Chiba Cancer Center ( Site 0656)
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center ( Site 0654)
city: Tokyo
country: Japan
facility: National Cancer Center Hospital ( Site 0651)
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR ( Site 0659)
city: Songpagu
country: Korea, Republic of
facility: Asan Medical Center ( Site 0952)
state: Seoul
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital ( Site 0956)
state: Taegu-Kwangyokshi
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital ( Site 0955)
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 0950)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System ( Site 0951)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 0954)
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea St. Mary s Hospital ( Site 0953)
city: Daugavpils
country: Latvia
facility: Daugavpils Regional Hospital ( Site 1502)
city: Riga
country: Latvia
facility: P. Stradina Clinical University Hospital ( Site 1500)
city: Riga
country: Latvia
facility: Riga East Clinical University Hospital ( Site 1501)
city: Kaunas
country: Lithuania
facility: LSMUL Kauno Klinikos ( Site 1528)
city: Vilnius
country: Lithuania
facility: Nacionalinis Vezio Institutas ( Site 1527)
city: Vilnius
country: Lithuania
facility: Vilniaus Universiteto Ligonine Santaros Klinikos ( Site 1526)
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Clinical Oncological Dispensary ( Site 1113)
state: Arkhangel Skaya Oblast
city: Ufa
country: Russian Federation
facility: GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 1130)
state: Baskortostan, Respublika
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1121)
state: Krasnoyarskiy Kray
city: Krasnogorsk
country: Russian Federation
facility: MEDSI Clinical Hospital on Pyatnitsky Highway-Departmentof Antitumor Drug therapy ( Site 1129)
state: Moskovskaya Oblast
city: Moscow
country: Russian Federation
facility: National Medical and Surgical Center n.a. N.I.Pirogov ( Site 1126)
state: Moskva
city: Moscow
country: Russian Federation
facility: N.N. Blokhin NMRCO ( Site 1106)
state: Moskva
city: Moscow
country: Russian Federation
facility: First Moscow State Medical University n.a. I.M.Sechenov ( Site 1127)
state: Moskva
city: Moscow
country: Russian Federation
facility: MROI n.a. P.A. Herzen - branch of FSBI NMICR of MoH of Russia ( Site 1128)
state: Moskva
city: Saint Petersburg
country: Russian Federation
facility: City Clinical Oncology Center ( Site 1114)
state: Sankt-Peterburg
city: Sandton
country: South Africa
facility: Sandton Oncology Medical Group PTY LTD ( Site 0900)
state: Gauteng
city: Durban
country: South Africa
facility: The Oncology Centre ( Site 0903)
state: Limpopo
city: Rondebosch
country: South Africa
facility: Cancercare Rondebosch Oncology ( Site 0904)
state: Western Cape
city: Elche
country: Spain
facility: Hospital General Universitario de Elche ( Site 1155)
state: Alicante
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias ( Site 1153)
state: Asturias
city: Barcelona
country: Spain
facility: Hospital Vall D Hebron ( Site 1151)
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Maranon ( Site 1152)
city: Madrid
country: Spain
facility: Hospital 12 de Octubre de Madrid ( Site 1150)
city: Malatya
country: Turkey
facility: Inonu Universitesi Medical Fakultesi ( Site 1207)
state: Adana
city: Adana
country: Turkey
facility: Baskent University Adana Training Hospital ( Site 1205)
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Medicine ( Site 1200)
city: Ankara
country: Turkey
facility: Gazi Universitesi Tip Fakultesi ( Site 1215)
city: Edirne
country: Turkey
facility: Trakya Universitesi Tip Fakultesi ( Site 1210)
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1202)
city: Istanbul
country: Turkey
facility: Prof. Dr. Cemil Tascioglu Sehir Hastanesi ( Site 1216)
city: Istanbul
country: Turkey
facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 1214)
city: Istanbul
country: Turkey
facility: Kartal Dr. Lutfi Kirdar Egitim ve Arast Hast ( Site 1211)
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi Tulay Aktas Onkoloji Hastanesi ( Site 1204)
city: Konya
country: Turkey
facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 1203)
city: Dnipro
country: Ukraine
facility: Medical center Medikal Plaza of Ecodnipro LLC ( Site 1317)
state: Dnipropetrovska Oblast
city: Kharkiv
country: Ukraine
facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 1304)
state: Kharkivska Oblast
city: Kapitanivka Village
country: Ukraine
facility: Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 1319)
state: Kyivska Oblast
city: Khodosivka
country: Ukraine
facility: Medical Center Asklepion LLC ( Site 1309)
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: Medical Center Verum ( Site 1318)
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: Shalimov s NI of Surgery and Transplantation ( Site 1321)
state: Kyivska Oblast
city: Zaporizhzhia
country: Ukraine
facility: Medical center of the Limited Liability Company Yulis ( Site 1314)
state: Zaporizka Oblast
city: Kyiv
country: Ukraine
facility: Dobrobut Medical Center ( Site 1320)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Takashima A, Garcia-Alfonso P, Manneh R, Besen AA, Hong YS, Cuyle PJ, Yanez P, Burge M, Yoshino T, Kim TW, Cui K, Li C, Jain R, Adelberg D, Taieb J. Olaparib with or without bevacizumab versus bevacizumab plus a fluoropyrimidine as maintenance therapy in advanced colorectal cancer: The randomized phase 3 LYNK-003 study. Eur J Cancer. 2024 Jul;205:114036. doi: 10.1016/j.ejca.2024.114036. Epub 2024 Mar 21.
citation: Kim TW, Taieb J, Gurary EB, Lerman N, Cui K, Yoshino T. Olaparib with or without bevacizumab or bevacizumab and 5-fluorouracil in advanced colorectal cancer: Phase III LYNK-003. Future Oncol. 2021 Dec;17(36):5013-5022. doi: 10.2217/fon-2021-0899. Epub 2021 Nov 15.