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)

PHASE3CompletedINTERVENTIONAL
Enrollment

335

Participants

Timeline

Start Date

August 19, 2020

Primary Completion Date

March 27, 2023

Study Completion Date

November 6, 2023

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

Olaparib

300 mg BID, oral until progressive disease or end of study

DRUG

5-FU

2400 mg/m\^2 over 46 to 48 hours Q2W IV infusion until disease progression or end of study; bolus 5-FU (400mg/m2) can be added prior to infusional 5-FU, per local standards and at the investigator's discretion

DRUG

Bevacizumab

5 mg/kg or 7.5 mg/kg Q2W or Q3W IV infusion until progressive disease or end of study

DRUG

Capecitabine

1000 mg/m\^2 oral capsule BID for 14 days, then 7 days off, Q3W) until progressive disease or end of study

DRUG

Leucovorin/ levoleucovorin

400 mg/m\^2 (leucovorin) or 200 mg/m\^2 (levoleucovorin) may be added to Bevacizumab + 5-FU per investigator's discretion Q2W IV infusion until progressive disease or end of study

Trial Locations (129)

1122

Orszagos Onkologiai Intezet ( Site 1431), Budapest

1200

UCL Saint Luc ( Site 0100), Brussels

2170

Liverpool Hospital ( Site 0055), Liverpool

2196

Sandton Oncology Medical Group PTY LTD ( Site 0900), Sandton

2217

St George Hospital ( Site 0052), Kogarah

2650

UZ Antwerpen ( Site 0108), Edegem

2820

Imelda vzw ( Site 0110), Bonheiden

2930

AZ Klina ( Site 0106), Brasschaat

3000

UZ Gasthuisberg ( Site 0102), Leuven

3168

Monash Health ( Site 0050), Clayton

3199

Peninsula Health Frankston Hospital ( Site 0056), Frankston

3526

Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás Ce, Miskolc

4001

The Oncology Centre ( Site 0903), Durban

4029

Royal Brisbane and Women s Hospital ( Site 0054), Herston

4032

Debreceni Egyetem Klinikai Kozpont ( Site 1426), Debrecen

5000

Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1427), Szolnok

5011

Queen Elizabeth Hospital ( Site 0053), Woodville South

5417

Daugavpils Regional Hospital ( Site 1502), Daugavpils

5700

Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 1432), Gyula

7700

Cancercare Rondebosch Oncology ( Site 0904), Rondebosch

8500

AZ Groeninge ( Site 0105), Kortrijk

8900

Zala Megyei Szent Rafael Korhaz ( Site 1429), Zalaegerszeg

9000

UZ Gent ( Site 0101), Ghent

9300

OLV Ziekenhuis ( Site 0109), Aalst

10117

Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0504), Berlin

15212

Allegheny Singer Research Institute ( Site 1364), Pittsburgh

20249

Facharztzentrum Eppendorf ( Site 0501), Hamburg

22030

Trakya Universitesi Tip Fakultesi ( Site 1210), Edirne

24014

Blue Ridge Cancer Care ( Site 1374), Roanoke

25000

CHU Jean Minjoz ( Site 0450), Besançon

28009

Hospital Universitario Gregorio Maranon ( Site 1152), Madrid

28041

Hospital 12 de Octubre de Madrid ( Site 1150), Madrid

30607

University Cancer & Blood Center, LLC ( Site 1381), Athens

33011

Hospital Universitario Central de Asturias ( Site 1153), Oviedo

33604

CHU Bordeaux Haut-Leveque ( Site 0457), Pessac

34098

Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1202), Istanbul

34295

CHU Saint Eloi ( Site 0467), Montpellier

34384

Prof. Dr. Cemil Tascioglu Sehir Hastanesi ( Site 1216), Istanbul

34722

Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 1214), Istanbul

34890

Kartal Dr. Lutfi Kirdar Egitim ve Arast Hast ( Site 1211), Istanbul

35040

Ege Universitesi Tip Fakultesi Tulay Aktas Onkoloji Hastanesi ( Site 1204), Izmir

37232

Vanderbilt University Medical Center ( Site 1362), Nashville

38138

West Cancer Center - East Campus ( Site 1396), Germantown

39401

Hattiesburg Clinic Hematology/Oncology ( Site 1418), Hattiesburg

40202

James Graham Brown Cancer Center ( Site 1393), Louisville

41404

Kyungpook National University Chilgok Hospital ( Site 0956), Daegu

42080

Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 1203), Konya

44280

Inonu Universitesi Medical Fakultesi ( Site 1207), Malatya

44791

St. Josef und St. Elisabeth Hospital gGmbH-Hematology, oncology and palliative medicine ( Site 0503), Bochum

44805

Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0455), Saint-Herblain

49055

Medical center Medikal Plaza of Ecodnipro LLC ( Site 1317), Dnipro

49503

Cancer & Hematology Centers of Western Michigan ( Site 1358), Grand Rapids

50161

LSMUL Kauno Klinikos ( Site 1528), Kaunas

59102

St. Vincent Frontier Cancer Center-Research ( Site 1414), Billings

60637

University of Chicago ( Site 1357), Chicago

61070

Communal non profit enterprise Regional Clinical Oncology Center ( Site 1304), Kharkiv

61615

Illinois Cancer Care, PC ( Site 1352), Peoria

63110

Washington University in St. Louis ( Site 1384), St Louis

67098

C.H.U. de Strasbourg Hopital de Hautepierre ( Site 0464), Strasbourg

68510

Cancer Partners of Nebraska ( Site 1353), Lincoln

68803

CHI Health St. Francis ( Site 1406), Grand Island

69008

Centre Leon Berard ( Site 0459), Lyon

69035

Medical center of the Limited Liability Company Yulis ( Site 1314), Zaporizhzhia

70112

University Medical Center New Orleans ( Site 1365), New Orleans

75015

Hopital Europeen Georges Pompidou ( Site 0452), Paris

76508

Baylor Scott & White Medical Center - Temple ( Site 1397), Temple

80528

Poudre Valley Health System ( Site 1402), Fort Collins

80909

UC Health Memorial Hospital ( Site 1401), Colorado Springs

89081

Universitaetsklinikum Ulm ( Site 0500), Ulm

91505

Providence Saint Joseph Medical Center, Disney Family Cancer ( Site 1392), Burbank

92835

St Joseph Heritage Healthcare-Oncology ( Site 1383), Fullerton

97213

Providence Portland Medical Center ( Site 1400), Portland

97232

Oregon Health & Science University ( Site 1411), Portland

105203

National Medical and Surgical Center n.a. N.I.Pirogov ( Site 1126), Moscow

110221

Administradora Country SA - Clinica del Country ( Site 0350), Bogotá

110321

Instituto Nacional de Cancerologia E.S.E ( Site 0362), Bogotá

115478

N.N. Blokhin NMRCO ( Site 1106), Moscow

119991

First Moscow State Medical University n.a. I.M.Sechenov ( Site 1127), Moscow

125284

MROI n.a. P.A. Herzen - branch of FSBI NMICR of MoH of Russia ( Site 1128), Moscow

143442

MEDSI Clinical Hospital on Pyatnitsky Highway-Departmentof Antitumor Drug therapy ( Site 1129), Krasnogorsk

163045

Arkhangelsk Clinical Oncological Dispensary ( Site 1113), Arkhangelsk

198255

City Clinical Oncology Center ( Site 1114), Saint Petersburg

200001

Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0353), Valledupar

230002

Oncomedica S.A. ( Site 0352), Montería

450054

GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 1130), Ufa

660001

Oncologos del Occidente ( Site 0364), Pereira

660133

Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1121), Krasnoyarsk

681002

Fundacion Cardiovascular de Colombia ( Site 0360), Bucaramanga

760042

Hemato Oncologos S.A. ( Site 0355), Santiago de Cali

2778577

National Cancer Center Hospital East ( Site 0650), Kashiwa

4780000

Centro Investigación del Cáncer James Lind ( Site 0251), Temuco

7510032

Sociedad Oncovida S.A. ( Site 0250), Santiago

7620002

Clínica San Carlos de Apoquindo Red Salud UC Christus ( Site 0252), Santiago

04074

New England Cancer Specialists ( Site 1422), Scarborough

E3B 5N5

Dr. Everett Chalmers Regional Hospital ( Site 0204), Fredericton

E1C 6Z8

Moncton Hospital - Horizon Health Network ( Site 0201), Moncton

M5G 1X6

Princess Margaret Cancer Centre ( Site 0209), Toronto

H7M 3L9

Hopital Cite de la Sante de Laval ( Site 0203), Laval

H4A 3J1

McGill University Health Centre ( Site 0207), Montreal

J1H 5N4

CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0202), Sherbrooke

464-8681

Aichi Cancer Center Hospital ( Site 0658), Nagoya

791-0280

National Hospital Organization Shikoku Cancer Center ( Site 0652), Matsuyama

216-8511

St. Marianna University School of Medicine Hospital ( Site 0657), Kawasaki

362-0806

Saitama Cancer Center ( Site 0653), Kitaadachi-gun

411-8777

Shizuoka Cancer Center Hospital and Research Institute ( Site 0655), Sunto-gun

260-8717

Chiba Cancer Center ( Site 0656), Chiba

811-1395

National Hospital Organization Kyushu Cancer Center ( Site 0654), Fukuoka

104-0045

National Cancer Center Hospital ( Site 0651), Tokyo

135-8550

The Cancer Institute Hospital of JFCR ( Site 0659), Tokyo

LV-1002

P. Stradina Clinical University Hospital ( Site 1500), Riga

LV-1079

Riga East Clinical University Hospital ( Site 1501), Riga

08406

Nacionalinis Vezio Institutas ( Site 1527), Vilnius

08460

Vilniaus Universiteto Ligonine Santaros Klinikos ( Site 1526), Vilnius

05505

Asan Medical Center ( Site 0952), Songpagu

02841

Korea University Anam Hospital ( Site 0955), Seoul

03080

Seoul National University Hospital ( Site 0950), Seoul

03722

Severance Hospital Yonsei University Health System ( Site 0951), Seoul

06351

Samsung Medical Center ( Site 0954), Seoul

06591

The Catholic University of Korea St. Mary s Hospital ( Site 0953), Seoul

03203

Hospital General Universitario de Elche ( Site 1155), Elche

08035

Hospital Vall D Hebron ( Site 1151), Barcelona

01250

Baskent University Adana Training Hospital ( Site 1205), Adana

06230

Hacettepe University Faculty of Medicine ( Site 1200), Ankara

06500

Gazi Universitesi Tip Fakultesi ( Site 1215), Ankara

08111

Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 1319), Kapitanivka Village

08173

Medical Center Asklepion LLC ( Site 1309), Khodosovka

03039

Medical Center Verum ( Site 1318), Kyiv

03126

Shalimov s NI of Surgery and Transplantation ( Site 1321), Kyiv

03151

Dobrobut Medical Center ( Site 1320), Kyiv

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

Merck Sharp & Dohme LLC

INDUSTRY