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)

NCT04456699 | Completed Phase 3 Results DMC FDA Drug

• 5 other identifiers: 7339-003MK-7339-003LYNK-003jRCT20312001462019-000698-22
• Study Type: interventional
• Target: 335
• Locations: 18 countries
• Sites: 129

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.

Conditions

Metastatic Colorectal Cancer

Keywords

colorectal cancer; CRC; Olaparib; Bevacizumab; FOLFOX; 5-FU; fluorouracil; folinic acid; oxaliplatin; CAPOX; capecitabine

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)

  PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was 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. Note: The appearance of one or more new lesions was also considered PD. PFS using RECIST 1.1 as assessed by BICR is presented.

  Up to approximately 30 months

Secondary Outcomes (5)

• Overall Survival (OS)

  Up to approximately 30 months

• Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR

  Up to approximately 30 months

• Number of Participants With One or More Adverse Events (AE)

  Up to approximately 30 months

• Number of Participants Discontinuing Study Intervention Due to an AE

  Up to approximately 30 months

• Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR

  Up to approximately 30 months

Study Arms (3)

Olaparib + bevacizumab

EXPERIMENTAL

Participants will receive olaparib (300 mg twice daily \[BID\] oral) + Bevacizumab (5 mg/kg intravenous \[IV\] once every 2 weeks \[Q2W\]) until progressive disease or end of study.

Drug: Olaparib; Drug: Bevacizumab

Olaparib

EXPERIMENTAL

Participants will receive olaparib (300 mg BID) oral, until progressive disease or end of study.

Drug: Olaparib

Bevacizumab + chemotherapy

ACTIVE COMPARATOR

Participants will receive investigator's choice of either bevacizumab (7.5 mg/kg IV once every three weeks (Q3W)) + capecitabine (1000 mg/m\^2 BID for 14 days, then 7 days off, Q3W) or bevacizumab (5 mg/kg IV Q2W) + 5-FU (2400 mg/m2 IV over 46 to 48 hours Q2W; bolus 5-FU (400 mg/m2) can be added prior to infusional 5-FU, per local standards and at the investigator's discretion). Leucovorin or levoleucovorin 400 mg/m\^2 (leucovorin) or 200 mg/m\^2 (levoleucovorin) Q2W IV infusion may be added per investigator's discretion. Treatment will continue until progressive disease or end of study.

Drug: 5-FU; Drug: Bevacizumab; Drug: Capecitabine; Drug: Leucovorin/ levoleucovorin

Interventions

Olaparib DRUG

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

Also known as: LYNPARZA^TM

Olaparib; Olaparib + bevacizumab

5-FU DRUG

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

Also known as: Fluorouracil, Adrucil, Efudex

Bevacizumab + chemotherapy

Bevacizumab DRUG

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

Also known as: MVASI^TM, Avastin

Bevacizumab + chemotherapy; Olaparib + bevacizumab

Capecitabine DRUG

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

Also known as: XELODA^®

Bevacizumab + chemotherapy

Leucovorin/ levoleucovorin DRUG

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

Also known as: Folinic Acid, Fusilev^®, Khapzory^TM

Bevacizumab + chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.
• "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.
• 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).
• 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.
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days prior to randomization.

You may not qualify if:

• Has known hypersensitivity to the components and/or excipients in bevacizumab, 5-FU, capecitabine, or olaparib.
• 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.
• Has an active infection requiring systemic therapy.
• Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority.
• 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.
• Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
• Has myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) or with features suggestive of MDS/AML.
• Has hemoptysis or hematemesis within 28 days prior to randomization.
• Has evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation).
• Has clinically significant bleeding within 28 days prior to randomization.
• 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.
• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• AstraZeneca: collaborator

Study Sites (129)

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

Burbank, California, 91505, United States

Location

St Joseph Heritage Healthcare-Oncology ( Site 1383)

Fullerton, California, 92835, United States

Location

UC Health Memorial Hospital ( Site 1401)

Colorado Springs, Colorado, 80909, United States

Location

Poudre Valley Health System ( Site 1402)

Fort Collins, Colorado, 80528, United States

Location

University Cancer & Blood Center, LLC ( Site 1381)

Athens, Georgia, 30607, United States

Location

University of Chicago ( Site 1357)

Chicago, Illinois, 60637, United States

Location

Illinois Cancer Care, PC ( Site 1352)

Peoria, Illinois, 61615, United States

Location

James Graham Brown Cancer Center ( Site 1393)

Louisville, Kentucky, 40202, United States

Location

University Medical Center New Orleans ( Site 1365)

New Orleans, Louisiana, 70112, United States

Location

New England Cancer Specialists ( Site 1422)

Scarborough, Maine, 04074, United States

Location

Cancer & Hematology Centers of Western Michigan ( Site 1358)

Grand Rapids, Michigan, 49503, United States

Location

Hattiesburg Clinic Hematology/Oncology ( Site 1418)

Hattiesburg, Mississippi, 39401, United States

Location

Washington University in St. Louis ( Site 1384)

St Louis, Missouri, 63110, United States

Location

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

Billings, Montana, 59102, United States

Location

CHI Health St. Francis ( Site 1406)

Grand Island, Nebraska, 68803, United States

Location

Cancer Partners of Nebraska ( Site 1353)

Lincoln, Nebraska, 68510, United States

Location

Providence Portland Medical Center ( Site 1400)

Portland, Oregon, 97213, United States

Location

Oregon Health & Science University ( Site 1411)

Portland, Oregon, 97232, United States

Location

Allegheny Singer Research Institute ( Site 1364)

Pittsburgh, Pennsylvania, 15212, United States

Location

West Cancer Center - East Campus ( Site 1396)

Germantown, Tennessee, 38138, United States

Location

Vanderbilt University Medical Center ( Site 1362)

Nashville, Tennessee, 37232, United States

Location

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

Temple, Texas, 76508, United States

Location

Blue Ridge Cancer Care ( Site 1374)

Roanoke, Virginia, 24014, United States

Location

St George Hospital ( Site 0052)

Kogarah, New South Wales, 2217, Australia

Location

Liverpool Hospital ( Site 0055)

Liverpool, New South Wales, 2170, Australia

Location

Royal Brisbane and Women s Hospital ( Site 0054)

Herston, Queensland, 4029, Australia

Location

Queen Elizabeth Hospital ( Site 0053)

Woodville South, South Australia, 5011, Australia

Location

Monash Health ( Site 0050)

Clayton, Victoria, 3168, Australia

Location

Peninsula Health Frankston Hospital ( Site 0056)

Frankston, Victoria, 3199, Australia

Location

Imelda vzw ( Site 0110)

Bonheiden, Antwerpen, 2820, Belgium

Location

AZ Klina ( Site 0106)

Brasschaat, Antwerpen, 2930, Belgium

Location

UZ Antwerpen ( Site 0108)

Edegem, Antwerpen, 2650, Belgium

Location

UCL Saint Luc ( Site 0100)

Brussels, Bruxelles-Capitale, Region de, 1200, Belgium

Location

OLV Ziekenhuis ( Site 0109)

Aalst, Oost-Vlaanderen, 9300, Belgium

Location

UZ Gent ( Site 0101)

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

UZ Gasthuisberg ( Site 0102)

Leuven, Vlaams-Brabant, 3000, Belgium

Location

AZ Groeninge ( Site 0105)

Kortrijk, West-Vlaanderen, 8500, Belgium

Location

Dr. Everett Chalmers Regional Hospital ( Site 0204)

Fredericton, New Brunswick, E3B 5N5, Canada

Location

Moncton Hospital - Horizon Health Network ( Site 0201)

Moncton, New Brunswick, E1C 6Z8, Canada

Location

Princess Margaret Cancer Centre ( Site 0209)

Toronto, Ontario, M5G 1X6, Canada

Location

Hopital Cite de la Sante de Laval ( Site 0203)

Laval, Quebec, H7M 3L9, Canada

Location

McGill University Health Centre ( Site 0207)

Montreal, Quebec, H4A 3J1, Canada

Location

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

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Sociedad Oncovida S.A. ( Site 0250)

Santiago, Region M. de Santiago, 7510032, Chile

Location

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

Santiago, Region M. de Santiago, 7620002, Chile

Location

Centro Investigación del Cáncer James Lind ( Site 0251)

Temuco, Región de la Araucanía, 4780000, Chile

Location

Administradora Country SA - Clinica del Country ( Site 0350)

Bogotá, Bogota D.C., 110221, Colombia

Location

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

Bogotá, Bogota D.C., 110321, Colombia

Location

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

Valledupar, Cesar Department, 200001, Colombia

Location

Oncomedica S.A. ( Site 0352)

Montería, Departamento de Córdoba, 230002, Colombia

Location

Oncologos del Occidente ( Site 0364)

Pereira, Risaralda Department, 660001, Colombia

Location

Fundacion Cardiovascular de Colombia ( Site 0360)

Bucaramanga, Santander Department, 681002, Colombia

Location

Hemato Oncologos S.A. ( Site 0355)

Cali, Valle del Cauca Department, 760042, Colombia

Location

Centre Leon Berard ( Site 0459)

Lyon, Auvergne-Rhône-Alpes, 69008, France

Location

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

Strasbourg, Bas-Rhin, 67098, France

Location

Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0455)

Saint-Herblain, Brittany Region, 44805, France

Location

CHU Jean Minjoz ( Site 0450)

Besançon, Doubs, 25000, France

Location

CHU Bordeaux Haut-Leveque ( Site 0457)

Pessac, Gironde, 33604, France

Location

CHU Saint Eloi ( Site 0467)

Montpellier, Herault, 34295, France

Location

Hopital Europeen Georges Pompidou ( Site 0452)

Paris, 75015, France

Location

Universitaetsklinikum Ulm ( Site 0500)

Ulm, Baden-Wurttemberg, 89081, Germany

Location

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

Bochum, North Rhine-Westphalia, 44791, Germany

Location

Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0504)

Berlin, 10117, Germany

Location

Facharztzentrum Eppendorf ( Site 0501)

Hamburg, 20249, Germany

Location

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

Gyula, Bekes County, 5700, Hungary

Location

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

Miskolc, Borsod-Abauj Zemplen county, 3526, Hungary

Location

Debreceni Egyetem Klinikai Kozpont ( Site 1426)

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

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

Szolnok, Jász-Nagykun-Szolnok, 5000, Hungary

Location

Zala Megyei Szent Rafael Korhaz ( Site 1429)

Zalaegerszeg, Zala County, 8900, Hungary

Location

Orszagos Onkologiai Intezet ( Site 1431)

Budapest, 1122, Hungary

Location

Aichi Cancer Center Hospital ( Site 0658)

Nagoya, Aichi-ken, 464-8681, Japan

Location

National Cancer Center Hospital East ( Site 0650)

Kashiwa, Chiba, 2778577, Japan

Location

National Hospital Organization Shikoku Cancer Center ( Site 0652)

Matsuyama, Ehime, 791-0280, Japan

Location

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

Kawasaki, Kanagawa, 216-8511, Japan

Location

Saitama Cancer Center ( Site 0653)

Kitaadachi-gun, Saitama, 362-0806, Japan

Location

Shizuoka Cancer Center Hospital and Research Institute ( Site 0655)

Sunto-gun, Shizuoka, 411-8777, Japan

Location

Chiba Cancer Center ( Site 0656)

Chiba, 260-8717, Japan

Location

National Hospital Organization Kyushu Cancer Center ( Site 0654)

Fukuoka, 811-1395, Japan

Location

National Cancer Center Hospital ( Site 0651)

Tokyo, 104-0045, Japan

Location

The Cancer Institute Hospital of JFCR ( Site 0659)

Tokyo, 135-8550, Japan

Location

Daugavpils Regional Hospital ( Site 1502)

Daugavpils, 5417, Latvia

Location

P. Stradina Clinical University Hospital ( Site 1500)

Riga, LV-1002, Latvia

Location

Riga East Clinical University Hospital ( Site 1501)

Riga, LV-1079, Latvia

Location

LSMUL Kauno Klinikos ( Site 1528)

Kaunas, 50161, Lithuania

Location

Nacionalinis Vezio Institutas ( Site 1527)

Vilnius, 08406, Lithuania

Location

Vilniaus Universiteto Ligonine Santaros Klinikos ( Site 1526)

Vilnius, 08460, Lithuania

Location

Arkhangelsk Clinical Oncological Dispensary ( Site 1113)

Arkhangelsk, Arkhangelskaya oblast, 163045, Russia

Location

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

Ufa, Baskortostan, Respublika, 450054, Russia

Location

Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1121)

Krasnoyarsk, Krasnoyarsk Krai, 660133, Russia

Location

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

Moscow, Moscow, 105203, Russia

Location

N.N. Blokhin NMRCO ( Site 1106)

Moscow, Moscow, 115478, Russia

Location

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

Moscow, Moscow, 119991, Russia

Location

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

Moscow, Moscow, 125284, Russia

Location

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

Krasnogorsk, Moscow Oblast, 143442, Russia

Location

City Clinical Oncology Center ( Site 1114)

Saint Petersburg, Sankt-Peterburg, 198255, Russia

Location

Sandton Oncology Medical Group PTY LTD ( Site 0900)

Sandton, Gauteng, 2196, South Africa

Location

The Oncology Centre ( Site 0903)

Durban, Limpopo, 4001, South Africa

Location

Cancercare Rondebosch Oncology ( Site 0904)

Rondebosch, Western Cape, 7700, South Africa

Location

Asan Medical Center ( Site 0952)

Songpagu, Seoul, 05505, South Korea

Location

Kyungpook National University Chilgok Hospital ( Site 0956)

Daegu, Taegu-Kwangyokshi, 41404, South Korea

Location

Korea University Anam Hospital ( Site 0955)

Seoul, 02841, South Korea

Location

Seoul National University Hospital ( Site 0950)

Seoul, 03080, South Korea

Location

Severance Hospital Yonsei University Health System ( Site 0951)

Seoul, 03722, South Korea

Location

Samsung Medical Center ( Site 0954)

Seoul, 06351, South Korea

Location

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

Seoul, 06591, South Korea

Location

Hospital General Universitario de Elche ( Site 1155)

Elche, Alicante, 03203, Spain

Location

Hospital Universitario Central de Asturias ( Site 1153)

Oviedo, Principality of Asturias, 33011, Spain

Location

Hospital Vall D Hebron ( Site 1151)

Barcelona, 08035, Spain

Location

Hospital Universitario Gregorio Maranon ( Site 1152)

Madrid, 28009, Spain

Location

Hospital 12 de Octubre de Madrid ( Site 1150)

Madrid, 28041, Spain

Location

Inonu Universitesi Medical Fakultesi ( Site 1207)

Malatya, Adana, 44280, Turkey (Türkiye)

Location

Baskent University Adana Training Hospital ( Site 1205)

Adana, 01250, Turkey (Türkiye)

Location

Hacettepe University Faculty of Medicine ( Site 1200)

Ankara, 06230, Turkey (Türkiye)

Location

Gazi Universitesi Tip Fakultesi ( Site 1215)

Ankara, 06500, Turkey (Türkiye)

Location

Trakya Universitesi Tip Fakultesi ( Site 1210)

Edirne, 22030, Turkey (Türkiye)

Location

Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1202)

Istanbul, 34098, Turkey (Türkiye)

Location

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

Istanbul, 34384, Turkey (Türkiye)

Location

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

Istanbul, 34722, Turkey (Türkiye)

Location

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

Istanbul, 34890, Turkey (Türkiye)

Location

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

Izmir, 35040, Turkey (Türkiye)

Location

Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 1203)

Konya, 42080, Turkey (Türkiye)

Location

Medical center Medikal Plaza of Ecodnipro LLC ( Site 1317)

Dnipro, Dnipropetrovsk Oblast, 49055, Ukraine

Location

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

Kharkiv, Kharkivs’ka Oblast’, 61070, Ukraine

Location

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

Kapitanivka Village, Kyivska Oblast, 08111, Ukraine

Location

Medical Center Asklepion LLC ( Site 1309)

Khodosovka, Kyivska Oblast, 08173, Ukraine

Location

Medical Center Verum ( Site 1318)

Kyiv, Kyivska Oblast, 03039, Ukraine

Location

Shalimov s NI of Surgery and Transplantation ( Site 1321)

Kyiv, Kyivska Oblast, 03126, Ukraine

Location

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

Zaporizhzhia, Zaporizhzhia Oblast, 69035, Ukraine

Location

Dobrobut Medical Center ( Site 1320)

Kyiv, 03151, Ukraine

Location

Related Publications (2)

• 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.

  PMID: 38749110 RESULT

• 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.

  PMID: 34779646 DERIVED

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

olaparib; Fluorouracil; Bevacizumab; Capecitabine; Leucovorin; Levoleucovorin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 2, 2020
• Study Start: August 19, 2020
• Primary Completion: March 27, 2023
• Study Completion: November 6, 2023
• Last Updated: October 29, 2024
• Results First Posted: April 2, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

KR (7); FR (7); CA (6); RU (9); LI (3); DE (4); UA (8); TU (11); CL (3); LA (3); AU (6); JP (10); CO (7); ZA (3); BE (8); US (23); HU (6); ES (5)