A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007)

NCT05064059 | Completed Phase 3 Results DMC FDA Drug

• 6 other identifiers: 4280A-007MK-4280A-007jRCT20312104822024-511043-25-00U1111-1302-99332021-001309-60
• Study Type: interventional
• Target: 441
• Locations: 21 countries
• Sites: 152

Brief Summary

The purpose of this study is to assess the safety and efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) in participants with metastatic colorectal cancer. The study will also compare MK-4280A with the standard of care treatment of regorafenib and TAS-102 (trifluridine and tipiracil). The primary study hypothesis is that coformulated favezelimab/pembrolizumab (MK-4280A) is superior to standard of care with respect to overall survival.

Conditions

Colorectal Cancer

Keywords

Programmed Cell Death-1 (PD1, PD-1),; Programmed Cell Death Receptor Ligand 1 (PDL1, PD-L1); Programmed Cell Death Receptor Ligand 2 (PDL2, PD-L2)

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  OS was defined as the time from randomization to death due to any cause.

  Up to approximately 33 months

Secondary Outcomes (13)

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

  Up to approximately 21 months

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

  Up to approximately 21 months

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

  Up to approximately 21 months

• Number of Participants Who Experienced at Least One Adverse Event (AE)

  Up to approximately 31 months

• Number of Participants Who Discontinued Study Treatment Due to an AE

  Up to approximately 28 months

Study Arms (2)

Favezelimab/Pembrolizumab

EXPERIMENTAL

Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions.

Biological: favezelimab/pembrolizumab

Standard of Care (Regorafenib or TAS-102)

ACTIVE COMPARATOR

At the Investigator's choice, participants will receive 160 mg regorafenib orally daily on Days 1-12 of each 28-day cycle or 35 mg/m\^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle.

Drug: regorafenib; Drug: TAS-102

Interventions

favezelimab/pembrolizumab BIOLOGICAL

Coformulated favezelimab/pembrolizumab (800 mg/200 mg), IV infusion

Also known as: MK-4280A

Favezelimab/Pembrolizumab

regorafenib DRUG

Oral

Also known as: STIVARGA®, REGONIX®

Standard of Care (Regorafenib or TAS-102)

TAS-102 DRUG

Oral

Also known as: LONSURF®

Standard of Care (Regorafenib or TAS-102)

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 colorectal adenocarcinoma that is metastatic and unresectable.
• Has measurable disease per RECIST 1.1 as assessed by the local site investigator.
• Has been previously treated for the disease and radiographically progressed on or after or could not tolerate standard treatment.
• Submits an archival (≤ 5 years) or newly obtained tumor tissue sample or newly obtained tumor tissue sample that has not been previously irradiated.
• Has an Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 to 1 within 10 days prior to first dose of study intervention.
• Has a life expectancy of at least 3 months, based on the investigator assessment.
• Has the ability to swallow and retain oral medication and not have any clinically significant gastrointestinal abnormalities that might alter absorption.
• Has adequate organ function.

You may not qualify if:

• Has previously been found to have deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) tumor status.
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease.
• Has a history of acute or chronic pancreatitis.
• Has neuromuscular disorders associated with an elevated creatine kinase (eg, inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).
• Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.
• Has urine protein greater than or equal to 1g/24h.
• A woman of childbearing potential who has a positive urine/serum pregnancy test within 24/72 hours prior to the first dose of study intervention.
• Has received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2), anti-lymphocyte activation gene 3 (LAG-3) antibody, with a tyrosine kinase inhibitor (TKI; eg, lenvatinib) other than rapidly accelerated fibrosarcoma (RAF) inhibitors (binimetinib is permitted if combined with a RAF inhibitor), or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4, OX-40, cluster of differentiation \[CD\] 137).
• Has previously received regorafenib or TAS-102.
• Has received prior systemic anticancer therapy including investigational agents within 28 days before randomization.
• Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
• Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
• Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
• Has an active autoimmune disease that has required systemic treatment in past 2 years.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (152)

Georgetown University Hospital ( Site 1148)

Washington D.C., District of Columbia, 20007, United States

Location

Sibley Memorial Hospital ( Site 1143)

Washington D.C., District of Columbia, 20016, United States

Location

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1118)

Marietta, Georgia, 30060, United States

Location

Norton Cancer Institute ( Site 1139)

Louisville, Kentucky, 40217, United States

Location

Rutgers Cancer Institute of New Jersey ( Site 1105)

New Brunswick, New Jersey, 08903, United States

Location

Memorial Sloan Kettering Cancer Center ( Site 1703)

New York, New York, 10065, United States

Location

Oregon Health & Science University ( Site 1141)

Portland, Oregon, 97239, United States

Location

MUSC Hollings Cancer Center ( Site 1715)

Charleston, South Carolina, 29425, United States

Location

The West Clinic, PLLC dba West Cancer Center ( Site 1149)

Germantown, Tennessee, 38138, United States

Location

UT Southwestern Medical Center ( Site 1709)

Dallas, Texas, 75390-9063, United States

Location

Intermountain Medical Center ( Site 1707)

Murray, Utah, 84107, United States

Location

Inova Schar Cancer Institute ( Site 1130)

Fairfax, Virginia, 22031, United States

Location

VCU Health Adult Outpatient Pavillion ( Site 1712)

Richmond, Virginia, 23219, United States

Location

Blue Ridge Cancer Care ( Site 1718)

Roanoke, Virginia, 24014, United States

Location

Seattle Cancer Care Alliance ( Site 1107)

Seattle, Washington, 98109, United States

Location

Westmead Hospital ( Site 0057)

Westmead, New South Wales, 2145, Australia

Location

Royal Brisbane and Women s Hospital ( Site 0058)

Herston, Queensland, 4029, Australia

Location

Queen Elizabeth Hospital ( Site 0050)

Woodville South, South Australia, 5011, Australia

Location

Frankston Hospital ( Site 0056)

Frankston, Victoria, 3199, Australia

Location

Western Health-Sunshine & Footscray Hospitals ( Site 0052)

St Albans, Victoria, 3021, Australia

Location

St John of God Subiaco Hospital ( Site 0051)

Perth, Western Australia, 6008, Australia

Location

London Regional Cancer Program - London HSC ( Site 0154)

London, Ontario, N6A 5W9, Canada

Location

The Ottawa Hospital ( Site 0151)

Ottawa, Ontario, K1H 8L6, Canada

Location

Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0155)

Toronto, Ontario, M5G 2M9, Canada

Location

IC La Serena Research ( Site 0202)

La Serena, Coquimbo Region, 1720430, Chile

Location

Clinica Puerto Montt ( Site 0211)

Port Montt, Los Lagos Region, 5500656, Chile

Location

Fundacion Arturo Lopez Perez FALP ( Site 0208)

Santiago, Region M. de Santiago, 7500921, Chile

Location

Oncovida ( Site 0209)

Santiago, Region M. de Santiago, 7510032, Chile

Location

Clínica Vespucio ( Site 0205)

Santiago, Region M. de Santiago, 8241479, Chile

Location

Pontificia Universidad Catolica de Chile ( Site 0206)

Santiago, Region M. de Santiago, 8330032, Chile

Location

Bradfordhill ( Site 0200)

Santiago, Region M. de Santiago, 8420383, Chile

Location

Centro Investigacion Cancer James Lind ( Site 0204)

Temuco, Región de la Araucanía, 4800827, Chile

Location

The Second Affiliated Hospital of Anhui Medical University ( Site 1179)

Hefei, Anhui, 230601, China

Location

Chongqing Cancer Hospital ( Site 1151)

Chongqing, Chongqing Municipality, 400030, China

Location

Fujian Province Cancer Hospital ( Site 1178)

Fuzhou, Fujian, 350014, China

Location

Sun Yat-Sen University Cancer Center ( Site 1150)

Guangzhou, Guangdong, 510060, China

Location

Southern Medical University Nanfang Hospital ( Site 1154)

Guangzhou, Guangdong, 510515, China

Location

The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 1159)

Guangzhou, Guangdong, 510655, China

Location

Guangxi Medical University Affiliated Tumor Hospital ( Site 1158)

Nanning, Guangxi, 531021, China

Location

Hainan General Hospital ( Site 1177)

Haikou, Hainan, 570311, China

Location

Wuhan Union Hospital Cancer Center ( Site 1162)

Wuhan, Hubei, 430022, China

Location

Hubei Cancer Hospital ( Site 1152)

Wuhan, Hubei, 430079, China

Location

Xiangya Hospital Central South University ( Site 1171)

Changsha, Hunan, 410008, China

Location

Hunan Cancer Hospital ( Site 1174)

Changsha, Hunan, 410013, China

Location

The Third Xiangya Hospital of Central South University ( Site 1175)

Changsha, Hunan, 410013, China

Location

Changzhou Cancer Hospital-Department of Oncology ( Site 1183)

Changzhou, Jiangsu, 213000, China

Location

Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 1185)

Wuxi, Jiangsu, 214122, China

Location

Jilin Cancer Hospital ( Site 1163)

Changchun, Jilin, 130012, China

Location

Jinan Central Hospital ( Site 1167)

Jinan, Shandong, 250000, China

Location

Shanghai Tenth People's Hospital ( Site 1170)

Shanghai, Shanghai Municipality, 200072, China

Location

Fudan University Shanghai Cancer Center ( Site 1176)

Shanghai, Shanghai Municipality, 201321, China

Location

West China Hospital Sichuan University ( Site 1172)

Chengdu, Sichuan, 332001, China

Location

Tianjin Medical University Cancer Institute and Hospital ( Site 1161)

Tianjin, Tianjin Municipality, 300060, China

Location

Yunnan Province Cancer Hospital-Colorectal surgery ( Site 1169)

Kunming, Yunnan, 650106, China

Location

Zhejiang Cancer Hospital ( Site 1180)

Hangzhou, Zhejiang, 310005, China

Location

Sir Run Run Shaw Hospital-Medical Oncology ( Site 1173)

Hangzhou, Zhejiang, 310018, China

Location

Masarykuv onkologicky ustav ( Site 1203)

Brno, Brno-mesto, 656 53, Czechia

Location

Fakultni nemocnice v Motole ( Site 1201)

Prague, Praha, Hlavni Mesto, 150 06, Czechia

Location

Fakultni nemocnice Hradec Kralove ( Site 1207)

Hradec Králové, 500 05, Czechia

Location

Fakultni nemocnice Olomouc ( Site 1204)

Olomouc, 779 00, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady ( Site 1208)

Prague, 100 34, Czechia

Location

Fakultni Thomayerova nemocnice ( Site 1205)

Prague, 140 59, Czechia

Location

Fakultni nemocnice Na Bulovce ( Site 1202)

Prague, 180 81, Czechia

Location

CHU Bordeaux Haut-Leveque ( Site 0305)

Pessac, Gironde, 33604, France

Location

CHU Hotel Dieu Nantes ( Site 0303)

Nantes, Pays de la Loire Region, 44093, France

Location

Institut du Cancer Avignon-Provence ( Site 0306)

Avignon, Vaucluse, 84000, France

Location

CHU Poitiers ( Site 0304)

Poitiers, Vienne, 86021, France

Location

Hopital Europeen Georges Pompidou ( Site 0300)

Paris, 75015, France

Location

LMU Klinikum Grosshadern der Universitaet Muenchen ( Site 1253)

Munich, Bavaria, 81377, Germany

Location

Philipps-Universitaet Marburg. ( Site 1252)

Marburg, Hesse, 35043, Germany

Location

Klinikum Wolfsburg ( Site 1256)

Wolfsburg, Lower Saxony, 38440, Germany

Location

Johanniter Krankenhaus Bonn ( Site 1254)

Bonn, North Rhine-Westphalia, 53113, Germany

Location

Kliniken Maria Hilf GmbH ( Site 1255)

Mönchengladbach, North Rhine-Westphalia, 41063, Germany

Location

Universitätsklinikum Halle ( Site 1251)

Halle, Saxony-Anhalt, 06120, Germany

Location

Katholisches Marienkrankenhaus gGmbH ( Site 1257)

Hamburg, 22087, Germany

Location

Assuta Ashdod Public ( Site 0507)

Ashdod, 7747629, Israel

Location

Rambam Health Care Campus-Oncology Division ( Site 0500)

Haifa, 3109601, Israel

Location

Bnei Zion Medical Center ( Site 0506)

Haifa, 3339419, Israel

Location

Hadassa Ein Karem Medical Center ( Site 0504)

Jerusalem, 9112001, Israel

Location

Rabin Medical Center ( Site 0503)

Petah Tikva, 4941492, Israel

Location

Chaim Sheba Medical Center ( Site 0501)

Ramat Gan, 5262000, Israel

Location

Sourasky Medical Center ( Site 0502)

Tel Aviv, 6423906, Israel

Location

Policlinico Gemelli di Roma ( Site 0552)

Roma, Abruzzo, 00168, Italy

Location

IRCCS Casa Sollievo della Sofferenza ( Site 0554)

San Giovanni Rotondo, Foggia, 71013, Italy

Location

Istituto Clinico Humanitas - Cancer Center ( Site 0555)

Rozzano, Milano, 20089, Italy

Location

A.O. di Rilievo Nazionale e di alta Specializzazione Garibaldi ( Site 0553)

Catania, 95122, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda ( Site 0550)

Milan, 20162, Italy

Location

Universita degli Studi della Campania Luigi Vanvitelli-UOC Oncoematologia ( Site 0556)

Napoli, 80131, Italy

Location

National Cancer Center Hospital East ( Site 0600)

Kashiwa, Chiba, 277-8577, Japan

Location

Kagawa University Hospital ( Site 0608)

Kita-gun, Kagawa-ken, 761-0793, Japan

Location

Kindai University Hospital ( Site 0607)

Sayama, Osaka, 5898511, Japan

Location

Saitama Prefectural Cancer Center ( Site 0603)

Kitaadachi-gun, Saitama, 362-0806, Japan

Location

Shizuoka Cancer Center ( Site 0605)

Sunto-gun,, Shizuoka, 411-8777, Japan

Location

National Hospital Organization Kyushu Cancer Center ( Site 0609)

Fukuoka, 811-1395, Japan

Location

National Cancer Center Hospital ( Site 0601)

Tokyo, 104-0045, Japan

Location

Japanese Foundation for Cancer Research ( Site 0602)

Tokyo, 135-8550, Japan

Location

Pantai Hospital Kuala Lumpur ( Site 1303)

Bangsar, Kuala Lumpur, 59100, Malaysia

Location

Institut Kanser Negara - National Cancer Institute ( Site 1302)

Putrajaya, Putrajaya, 62250, Malaysia

Location

Beacon Hospital Sdn Bhd ( Site 1305)

Petaling Jaya, Selangor, 46050, Malaysia

Location

University Malaya Medical Centre ( Site 1301)

Kuala Lumpur, 59100, Malaysia

Location

Akershus universitetssykehus ( Site 1352)

Loerenskog, Akershus, 1478, Norway

Location

St Olavs Hospital ( Site 1354)

Trondheim, Sor-Trondelag, 7030, Norway

Location

Universitetssykehuset i Nord Norge. ( Site 1355)

Tromsø, Troms, 9019, Norway

Location

Helse Bergen HF - Haukeland univeritetssykehus ( Site 1353)

Bergen, Vestfold, 5053, Norway

Location

Oslo Universitetssykehus HF. Ulleval ( Site 1351)

Oslo, 0450, Norway

Location

Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 0871)

Ufa, Baskortostan, Respublika, 450054, Russia

Location

SRBHI of Kirov Region Center of Oncology and medical radiology ( Site 0854)

Kirov, Kirov Oblast, 105094, Russia

Location

Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 0870)

Moscow, Moscow, 105094, Russia

Location

FSBI-FRCC of Special Types Med. Care and Technologies FMBA of Russia ( Site 0851)

Moscow, Moscow, 115682, Russia

Location

City Hospital #40 ( Site 0853)

Saint Petersburg, Sankt-Peterburg, 197706, Russia

Location

Clinical Research Center of specialized types medical care-Oncology ( Site 0860)

Saint Petersburg, Sankt-Peterburg, 197758, Russia

Location

Tomsk National Research Medical Center of Russian Academy of Sciences ( Site 0872)

Tomsk, Tomsk Oblast, 634045, Russia

Location

Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 0850)

Yaroslavl, Yaroslavl Oblast, 150054, Russia

Location

SHBI "Leningrad Regional Clinical Oncology Dispensary n.a. L.D. Roman"-Clinical Trials Department (

Saint Petersburg, 188663, Russia

Location

Cancer Care Langenhoven Drive Oncology Centre ( Site 1504)

Port Elizabeth, Eastern Cape, 6045, South Africa

Location

Sandton Oncology Medical Group PTY LTD ( Site 1501)

Sandton, Gauteng, 2196, South Africa

Location

Cape Town Oncology Trials Pty Ltd ( Site 1506)

Kraaifontein, Western Cape, 7570, South Africa

Location

Cancercare Rondebosch Oncology ( Site 1509)

Rondebosch, Western Cape, 7700, South Africa

Location

Asan Medical Center ( Site 0650)

Songpagu, Seoul, 05505, South Korea

Location

Seoul National University Hospital ( Site 0653)

Seoul, 03080, South Korea

Location

Severance Hospital ( Site 0652)

Seoul, 03722, South Korea

Location

Samsung Medical Center ( Site 0651)

Seoul, 06351, South Korea

Location

Hospital Universitari Vall d Hebron ( Site 0900)

Barcelona, 08035, Spain

Location

Hospital Sant Pau i la Santa Creu ( Site 0905)

Barcelona, 08041, Spain

Location

Hospital Clinico San Carlos ( Site 0902)

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre ( Site 0901)

Madrid, 28041, Spain

Location

Hospital Universitario Virgen Macarena ( Site 0906)

Seville, 41009, Spain

Location

Chang Gung Medical Foundation - Kaohsiung ( Site 0956)

Kaohsiung City, Changhua, 833, Taiwan

Location

China Medical University Hospital ( Site 0953)

Taichung, 40447, Taiwan

Location

National Cheng Kung University Hospital ( Site 0955)

Tainan, 704, Taiwan

Location

National Taiwan University Hospital ( Site 0950)

Taipei, 10048, Taiwan

Location

Taipei Veterans General Hospital ( Site 0951)

Taipei, 11217, Taiwan

Location

Chang Gung Medical Foundation. Linkou ( Site 0952)

Taoyuan District, 333, Taiwan

Location

Baskent Universitesi Dr. Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 1007)

Adana, 01120, Turkey (Türkiye)

Location

Acibadem Adana Hastanesi ( Site 1008)

Adana, 01130, Turkey (Türkiye)

Location

Gulhane Egitim ve Arastirma Hastanesi ( Site 1009)

Ankara, 06010, Turkey (Türkiye)

Location

Hacettepe Universitesi Tip Fakultesi ( Site 1003)

Ankara, 06230, Turkey (Türkiye)

Location

Ankara Sehir Hastanesi ( Site 1005)

Ankara, 06800, Turkey (Türkiye)

Location

Antalya Egitim ve Arastirma Hastanesi ( Site 1010)

Antalya, 07100, Turkey (Türkiye)

Location

Goztepe Prof.Dr. Suleyman Yalcin Sehir Hastanesi ( Site 1002)

Istanbul, 34722, Turkey (Türkiye)

Location

Ege Universitesi Tip Fakultesi Hastanesi ( Site 1006)

Izmir, 35100, Turkey (Türkiye)

Location

Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council ( Site 1657)

Dnipro, Dnipropetrovsk Oblast, 49102, Ukraine

Location

MI Precarpathian Clinical Oncology Center ( Site 1654)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine

Location

Ukrainian Center of Tomotherapy ( Site 1658)

Kropyvnytskyi, Kirovohrad Oblast, 25011, Ukraine

Location

Odessa Regional Clinical Hospital ( Site 1664)

Odesa, Odesa Oblast, 65025, Ukraine

Location

University College London Hospitals NHS Foundation Trust ( Site 1056)

London, Camden, WC1E 6AG, United Kingdom

Location

Royal Marsden NHS Foundation Trust ( Site 1064)

London, London, City of, SW3 6JJ, United Kingdom

Location

Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 1052)

London, London, City of, W12 0HS, United Kingdom

Location

Royal Marsden NHS Trust ( Site 1063)

Sutton, London, City of, SM25PT, United Kingdom

Location

University Hospital Coventry & Warwickshire ( Site 1062)

Coventry, Warwickshire, CV2 2DX, United Kingdom

Location

Velindre Cancer Centre ( Site 1058)

Cardiff, United Kingdom

Location

Leeds Teaching Hospitals NHS Trust ( Site 1050)

Leeds, LS9 7TF, United Kingdom

Location

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Colorectal Neoplasms; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

pembrolizumab; regorafenib; trifluridine tipiracil drug combination

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

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
• Masking Details: None (Open-label)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 1, 2021
• Study Start: November 10, 2021
• Primary Completion: August 15, 2024
• Study Completion: February 21, 2025
• Last Updated: September 17, 2025
• Results First Posted: September 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

KR (4); TU (8); IL (7); CN (24); RU (9); CL (8); JP (8); UA (4); FR (5); ES (5); GB (7); CZ (7); MY (4); CA (3); DE (7); AU (6); ZA (4); NO (5); TW (6); US (15); IT (6)