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)

NCT ID: NCT04456699

Last Updated: 2024-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 335 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-19
• Study Completion Date: 2023-11-06

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Olaparib + bevacizumab

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.

Group Type: EXPERIMENTAL

Olaparib

Intervention Type: DRUG

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

Bevacizumab

Intervention Type: DRUG

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

Olaparib

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

Group Type: EXPERIMENTAL

Olaparib

Intervention Type: DRUG

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

Bevacizumab + chemotherapy

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.

Group Type: ACTIVE_COMPARATOR

5-FU

Intervention Type: 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

Bevacizumab

Intervention Type: DRUG

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

Capecitabine

Intervention Type: DRUG

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

Leucovorin/ levoleucovorin

Intervention Type: 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

Interventions

Olaparib

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

Intervention Type: 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

Intervention Type: DRUG

Bevacizumab

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

Intervention Type: DRUG

Capecitabine

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

LYNPARZA^TM; Fluorouracil; Adrucil; Efudex; MVASI^TM; Avastin; XELODA^®; Folinic Acid; Fusilev^®; Khapzory^TM

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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

Burbank, California, United States

St Joseph Heritage Healthcare-Oncology ( Site 1383)

Fullerton, California, United States

UC Health Memorial Hospital ( Site 1401)

Colorado Springs, Colorado, United States

Poudre Valley Health System ( Site 1402)

Fort Collins, Colorado, United States

University Cancer & Blood Center, LLC ( Site 1381)

Athens, Georgia, United States

University of Chicago ( Site 1357)

Chicago, Illinois, United States

Illinois Cancer Care, PC ( Site 1352)

Peoria, Illinois, United States

James Graham Brown Cancer Center ( Site 1393)

Louisville, Kentucky, United States

University Medical Center New Orleans ( Site 1365)

New Orleans, Louisiana, United States

New England Cancer Specialists ( Site 1422)

Scarborough, Maine, United States

Cancer & Hematology Centers of Western Michigan ( Site 1358)

Grand Rapids, Michigan, United States

Hattiesburg Clinic Hematology/Oncology ( Site 1418)

Hattiesburg, Mississippi, United States

Washington University in St. Louis ( Site 1384)

St Louis, Missouri, United States

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

Billings, Montana, United States

CHI Health St. Francis ( Site 1406)

Grand Island, Nebraska, United States

Cancer Partners of Nebraska ( Site 1353)

Lincoln, Nebraska, United States

Providence Portland Medical Center ( Site 1400)

Portland, Oregon, United States

Oregon Health & Science University ( Site 1411)

Portland, Oregon, United States

Allegheny Singer Research Institute ( Site 1364)

Pittsburgh, Pennsylvania, United States

West Cancer Center - East Campus ( Site 1396)

Germantown, Tennessee, United States

Vanderbilt University Medical Center ( Site 1362)

Nashville, Tennessee, United States

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

Temple, Texas, United States

Blue Ridge Cancer Care ( Site 1374)

Roanoke, Virginia, United States

St George Hospital ( Site 0052)

Kogarah, New South Wales, Australia

Liverpool Hospital ( Site 0055)

Liverpool, New South Wales, Australia

Royal Brisbane and Women s Hospital ( Site 0054)

Herston, Queensland, Australia

Queen Elizabeth Hospital ( Site 0053)

Woodville South, South Australia, Australia

Monash Health ( Site 0050)

Clayton, Victoria, Australia

Peninsula Health Frankston Hospital ( Site 0056)

Frankston, Victoria, Australia

Imelda vzw ( Site 0110)

Bonheiden, Antwerpen, Belgium

AZ Klina ( Site 0106)

Brasschaat, Antwerpen, Belgium

UZ Antwerpen ( Site 0108)

Edegem, Antwerpen, Belgium

UCL Saint Luc ( Site 0100)

Brussels, Bruxelles-Capitale, Region de, Belgium

OLV Ziekenhuis ( Site 0109)

Aalst, Oost-Vlaanderen, Belgium

UZ Gent ( Site 0101)

Ghent, Oost-Vlaanderen, Belgium

UZ Gasthuisberg ( Site 0102)

Leuven, Vlaams-Brabant, Belgium

AZ Groeninge ( Site 0105)

Kortrijk, West-Vlaanderen, Belgium

Dr. Everett Chalmers Regional Hospital ( Site 0204)

Fredericton, New Brunswick, Canada

Moncton Hospital - Horizon Health Network ( Site 0201)

Moncton, New Brunswick, Canada

Princess Margaret Cancer Centre ( Site 0209)

Toronto, Ontario, Canada

Hopital Cite de la Sante de Laval ( Site 0203)

Laval, Quebec, Canada

McGill University Health Centre ( Site 0207)

Montreal, Quebec, Canada

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

Sherbrooke, Quebec, Canada

Sociedad Oncovida S.A. ( Site 0250)

Santiago, Region M. de Santiago, Chile

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

Santiago, Region M. de Santiago, Chile

Centro Investigación del Cáncer James Lind ( Site 0251)

Temuco, Región de la Araucanía, Chile

Administradora Country SA - Clinica del Country ( Site 0350)

Bogotá, Bogota D.C., Colombia

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

Bogotá, Bogota D.C., Colombia

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

Valledupar, Cesar Department, Colombia

Oncomedica S.A. ( Site 0352)

Montería, Departamento de Córdoba, Colombia

Oncologos del Occidente ( Site 0364)

Pereira, Risaralda Department, Colombia

Fundacion Cardiovascular de Colombia ( Site 0360)

Bucaramanga, Santander Department, Colombia

Hemato Oncologos S.A. ( Site 0355)

Cali, Valle del Cauca Department, Colombia

Centre Leon Berard ( Site 0459)

Lyon, Auvergne-Rhône-Alpes, France

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

Strasbourg, Bas-Rhin, France

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

Saint-Herblain, Brittany Region, France

CHU Jean Minjoz ( Site 0450)

Besançon, Doubs, France

CHU Bordeaux Haut-Leveque ( Site 0457)

Pessac, Gironde, France

CHU Saint Eloi ( Site 0467)

Montpellier, Herault, France

Hopital Europeen Georges Pompidou ( Site 0452)

Paris, , France

Universitaetsklinikum Ulm ( Site 0500)

Ulm, Baden-Wurttemberg, Germany

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

Bochum, North Rhine-Westphalia, Germany

Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0504)

Berlin, , Germany

Facharztzentrum Eppendorf ( Site 0501)

Hamburg, , Germany

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

Gyula, Bekes County, Hungary

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

Miskolc, Borsod-Abauj Zemplen county, Hungary

Debreceni Egyetem Klinikai Kozpont ( Site 1426)

Debrecen, Hajdú-Bihar, Hungary

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

Szolnok, Jász-Nagykun-Szolnok, Hungary

Zala Megyei Szent Rafael Korhaz ( Site 1429)

Zalaegerszeg, Zala County, Hungary

Orszagos Onkologiai Intezet ( Site 1431)

Budapest, , Hungary

Aichi Cancer Center Hospital ( Site 0658)

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East ( Site 0650)

Kashiwa, Chiba, Japan

National Hospital Organization Shikoku Cancer Center ( Site 0652)

Matsuyama, Ehime, Japan

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

Kawasaki, Kanagawa, Japan

Saitama Cancer Center ( Site 0653)

Kitaadachi-gun, Saitama, Japan

Shizuoka Cancer Center Hospital and Research Institute ( Site 0655)

Sunto-gun, Shizuoka, Japan

Chiba Cancer Center ( Site 0656)

Chiba, , Japan

National Hospital Organization Kyushu Cancer Center ( Site 0654)

Fukuoka, , Japan

National Cancer Center Hospital ( Site 0651)

Tokyo, , Japan

The Cancer Institute Hospital of JFCR ( Site 0659)

Tokyo, , Japan

Daugavpils Regional Hospital ( Site 1502)

Daugavpils, , Latvia

P. Stradina Clinical University Hospital ( Site 1500)

Riga, , Latvia

Riga East Clinical University Hospital ( Site 1501)

Riga, , Latvia

LSMUL Kauno Klinikos ( Site 1528)

Kaunas, , Lithuania

Nacionalinis Vezio Institutas ( Site 1527)

Vilnius, , Lithuania

Vilniaus Universiteto Ligonine Santaros Klinikos ( Site 1526)

Vilnius, , Lithuania

Arkhangelsk Clinical Oncological Dispensary ( Site 1113)

Arkhangelsk, Arkhangelskaya oblast, Russia

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

Ufa, Baskortostan, Respublika, Russia

Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1121)

Krasnoyarsk, Krasnoyarsk Krai, Russia

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

Moscow, Moscow, Russia

N.N. Blokhin NMRCO ( Site 1106)

Moscow, Moscow, Russia

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

Moscow, Moscow, Russia

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

Moscow, Moscow, Russia

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

Krasnogorsk, Moscow Oblast, Russia

City Clinical Oncology Center ( Site 1114)

Saint Petersburg, Sankt-Peterburg, Russia

Sandton Oncology Medical Group PTY LTD ( Site 0900)

Sandton, Gauteng, South Africa

The Oncology Centre ( Site 0903)

Durban, Limpopo, South Africa

Cancercare Rondebosch Oncology ( Site 0904)

Rondebosch, Western Cape, South Africa

Asan Medical Center ( Site 0952)

Songpagu, Seoul, South Korea

Kyungpook National University Chilgok Hospital ( Site 0956)

Daegu, Taegu-Kwangyokshi, South Korea

Korea University Anam Hospital ( Site 0955)

Seoul, , South Korea

Seoul National University Hospital ( Site 0950)

Seoul, , South Korea

Severance Hospital Yonsei University Health System ( Site 0951)

Seoul, , South Korea

Samsung Medical Center ( Site 0954)

Seoul, , South Korea

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

Seoul, , South Korea

Hospital General Universitario de Elche ( Site 1155)

Elche, Alicante, Spain

Hospital Universitario Central de Asturias ( Site 1153)

Oviedo, Principality of Asturias, Spain

Hospital Vall D Hebron ( Site 1151)

Barcelona, , Spain

Hospital Universitario Gregorio Maranon ( Site 1152)

Madrid, , Spain

Hospital 12 de Octubre de Madrid ( Site 1150)

Madrid, , Spain

Inonu Universitesi Medical Fakultesi ( Site 1207)

Malatya, Adana, Turkey (Türkiye)

Baskent University Adana Training Hospital ( Site 1205)

Adana, , Turkey (Türkiye)

Hacettepe University Faculty of Medicine ( Site 1200)

Ankara, , Turkey (Türkiye)

Gazi Universitesi Tip Fakultesi ( Site 1215)

Ankara, , Turkey (Türkiye)

Trakya Universitesi Tip Fakultesi ( Site 1210)

Edirne, , Turkey (Türkiye)

Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1202)

Istanbul, , Turkey (Türkiye)

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

Istanbul, , Turkey (Türkiye)

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

Istanbul, , Turkey (Türkiye)

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

Istanbul, , Turkey (Türkiye)

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

Izmir, , Turkey (Türkiye)

Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 1203)

Konya, , Turkey (Türkiye)

Medical center Medikal Plaza of Ecodnipro LLC ( Site 1317)

Dnipro, Dnipropetrovsk Oblast, Ukraine

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

Kharkiv, Kharkivs’ka Oblast’, Ukraine

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

Kapitanivka Village, Kyivska Oblast, Ukraine

Medical Center Asklepion LLC ( Site 1309)

Khodosovka, Kyivska Oblast, Ukraine

Medical Center Verum ( Site 1318)

Kyiv, Kyivska Oblast, Ukraine

Shalimov s NI of Surgery and Transplantation ( Site 1321)

Kyiv, Kyivska Oblast, Ukraine

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

Zaporizhzhia, Zaporizhzhia Oblast, Ukraine

Dobrobut Medical Center ( Site 1320)

Kyiv, , Ukraine

Countries

United States; Australia; Belgium; Canada; Chile; Colombia; France; Germany; Hungary; Japan; Latvia; Lithuania; Russia; South Africa; South Korea; Spain; Turkey (Türkiye); Ukraine

References

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.

Reference Type: RESULT

PMID: 38749110 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34779646 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

https://msd.trialsummaries.com/Study/StudyDetails?id=26089&tenant=MT_MSD_9011

Plain Language Summary

Other Identifiers

MK-7339-003

Identifier Type: OTHER

Identifier Source: secondary_id

LYNK-003

Identifier Type: OTHER

Identifier Source: secondary_id

jRCT2031200146

Identifier Type: REGISTRY

Identifier Source: secondary_id

2019-000698-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

7339-003

Identifier Type: -

Identifier Source: org_study_id