Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009)

NCT04428151 | Completed Phase 2 Results DMC FDA Drug

• 7 other identifiers: 7902-009LEAP-009E7080-G000-228MK-7902-0092022-500820-31-00U1111-1278-27072019-000569-19
• Study Type: interventional
• Target: 408
• Locations: 15 countries
• Sites: 120

Brief Summary

Researchers are looking for new ways to treat people with head and neck cancer whose cancer has come back after treatment (recurrent) or whose cancer has spread to other parts of the body (metastatic). Some people with recurrent or metastatic head and neck cancer are treated with chemotherapy and immunotherapy, but the cancer gets worse. The goal of this study is to learn if more people who receive lenvatinib and pembrolizumab have a better overall survival rate than people who receive standard chemotherapy treatment.

Conditions

Squamous Cell Carcinoma of Head and Neck

Keywords

Programmed Cell Death-1 (PD1, PD-1); Programmed Death-Ligand 1 (PDL1, PD-L1)

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 45 months

Secondary Outcomes (5)

• Progression-Free Survival (PFS)

  Up to approximately 45 months

• Objective Response Rate (ORR)

  Up to approximately 45 months

• Duration of Response (DOR)

  Up to approximately 45 months

• Number of Participants Who Experienced One or More Adverse Events (AEs)

  Up to approximately 5 years

• Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)

  Up to approximately 5 years

Study Arms (3)

Lenvatinib + Pembrolizumab

EXPERIMENTAL

Participants will be treated with the combination of lenvatinib (once daily 20 mg oral dose) plus pembrolizumab (200 mg 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle for 35 cycles), until centrally verified disease progression, or until a protocol-specified discontinuation criterion is met. Participants may receive up to an additional 17 cycles of pembrolizumab as Second Course treatment, with or without lenvatinib.

Drug: Lenvatinib; Biological: Pembrolizumab

SOC Chemotherapy

ACTIVE COMPARATOR

Participants will be treated with investigator's choice of standard of care (SOC) chemotherapy (docetaxel, paclitaxel, cetuximab, or capecitabine) until centrally verified disease progression, or until a protocol-specified discontinuation criterion is met.

Drug: Docetaxel; Drug: Capecitabine; Drug: Paclitaxel; Drug: Cetuximab

Lenvatinib Monotherapy

ACTIVE COMPARATOR

Participants will be treated with lenvatinib monotherapy (once daily 24 mg oral dose) until centrally verified disease progression, or until a protocol-specified discontinuation criterion is met.

Drug: Lenvatinib

Interventions

Pembrolizumab BIOLOGICAL

200 mg 30-minute IV infusion on day 1 of each 21-day cycle

Also known as: KEYTRUDA®, MK-3475, SCH 900475

Lenvatinib + Pembrolizumab

Docetaxel DRUG

75 mg/m\^2 administered as an IV infusion on day 1 of each 21-day cycle

Also known as: TAXOTERE®

SOC Chemotherapy

Capecitabine DRUG

1250 mg/m\^2 twice daily on days 1-14 of each 21-day cycle, taken as oral tablets

Also known as: Xeloda®

SOC Chemotherapy

Paclitaxel DRUG

80 mg/m\^2 administered as an IV infusion on days 1, 8, and 15 of each 21-day cycle

Also known as: Taxol

SOC Chemotherapy

Cetuximab DRUG

400 mg/m\^2 loading dose, followed by 250 mg/m\^2 administered as an IV infusion on days 1, 8, and 15 of each 21-day cycle

Also known as: ERBITUX®

SOC Chemotherapy

Lenvatinib DRUG

20 mg once daily, taken as oral capsules

Also known as: LENVIMA®, MK-7902, E7080

Lenvatinib + Pembrolizumab

Eligibility Criteria

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

You may qualify if:

• Pathologically confirmed recurrent (not amenable to curative treatment with local and/or systemic therapies) or metastatic (disseminated) head and neck squamous cell carcinoma (HNSCC) of the oral cavity, oropharynx, hypopharynx, and/or larynx that is considered incurable by local therapies
• Disease progression at any time during or after treatment with a platinum-containing (e.g., carboplatin or cisplatin) regimen
• Disease progression on or after treatment with a programmed cell death protein 1/programmed death-ligand 1 monoclonal antibody (anti-PD-1/PD-L1 mAb)
• Pre-study imaging that demonstrates evidence of disease progression based on investigator review of at least 2 pre-study images per RECIST 1.1, following initiation of treatment with a PD-1/PD-L1 inhibitor
• Measurable disease by computed tomography scan (CT) or magnetic resonance imaging (MRI) based on Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as verified by blinded independent central review (BICR). Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of the first dose of study intervention
• Male participants are eligible to participate if they agree to the following during the intervention period and for at least 1 week after the last dose of lenvatinib, 3 months after the last dose of capecitabine and paclitaxel, and 6 months after the last dose of docetaxel:
• Refrain from donating sperm
• Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; or must agree to use contraception unless confirmed to be azoospermic
• Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
• A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
• Is not a woman of childbearing potential (WOCBP)
• Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), with low user dependency or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 120 days post pembrolizumab or 1 month post lenvatinib, whichever occurs last (Arms 1 and 3), or during the intervention period and for at least 6 months after the last dose of capecitabine, docetaxel, paclitaxel; and 2 months after the last dose of cetuximab (Arm 2)
• Female participants who randomize to Arm 2 must also agree not to donate or freeze/store eggs during the intervention period and for at least 6 months after the last dose of capecitabine, docetaxel, paclitaxel; and 2 months after the last dose of cetuximab
• Adequately controlled blood pressure (BP) with or without antihypertensive medications

You may not qualify if:

• Disease that is suitable for local therapy administered with curative intent
• Life expectancy of less than 3 months and/or has rapidly progressing disease in the opinion of the treating investigator
• History of (noninfectious) pneumonitis/interstitial lung disease that required steroids, or has current pneumonitis/interstitial lung disease
• Active infection requiring systemic therapy
• Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
• Known additional malignancy that is progressing or has required active systemic treatment within the past 3 years, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ that have undergone potentially curative therapy
• Active autoimmune disease that has required systemic treatment in the past 2 years
• Had an allogeneic tissue/solid organ transplant
• Known history of human immunodeficiency virus (HIV) infection
• History of any contraindication or has a severe hypersensitivity to any components of pembrolizumab, lenvatinib or SOC chemotherapy.
• Pre-existing ≥Grade 3 gastrointestinal or non-gastrointestinal fistula
• History of a gastrointestinal malabsorption or any other condition or procedure that may affect oral study drug absorption
• Had major surgery within 3 weeks prior to first dose of study interventions
• Clinically significant cardiovascular impairment within 12 months of the first dose of study drug

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Eisai Inc.: collaborator

Study Sites (120)

City of Hope ( Site 1519)

Duarte, California, 91010, United States

Location

UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1568)

Los Angeles, California, 90095, United States

Location

Yale-New Haven Hospital-Yale Cancer Center ( Site 1505)

New Haven, Connecticut, 06510, United States

Location

Georgetown University Medical Center ( Site 1520)

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

Location

UF Health ( Site 1554)

Gainesville, Florida, 32608, United States

Location

Mid Florida Hematology and Oncology Center ( Site 1606)

Orange City, Florida, 32763, United States

Location

Cleveland Clinic Florida ( Site 1596)

Weston, Florida, 33331, United States

Location

Georgia Cancer Center at Augusta University ( Site 1575)

Augusta, Georgia, 30912, United States

Location

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1521)

Marietta, Georgia, 30060, United States

Location

Memorial Health University Medical Center ( Site 1626)

Savannah, Georgia, 31404, United States

Location

Beacon Cancer Care ( Site 1599)

Post Falls, Idaho, 83854, United States

Location

Rush University Medical Center ( Site 1560)

Chicago, Illinois, 60607, United States

Location

NorthShore University HealthSystem - Evanston Hospital ( Site 1614)

Evanston, Illinois, 60201, United States

Location

IU Health Ball Memorial Hospital, Inc.-IU Health Ball Memorial Cancer Center ( Site 1612)

Muncie, Indiana, 47303, United States

Location

University of Iowa ( Site 1572)

Iowa City, Iowa, 52242, United States

Location

University of Kansas Cancer Center ( Site 1538)

Westwood, Kansas, 66205, United States

Location

Norton Hospital-Norton Cancer Institute - Downtown ( Site 1601)

Louisville, Kentucky, 40205, United States

Location

Mercy Health-Paducah Cancer Center ( Site 1623)

Paducah, Kentucky, 42003, United States

Location

Our Lady of the Lake RMC-Clinical Research ( Site 1624)

Baton Rouge, Louisiana, 70808, United States

Location

Mary Bird Perkins Cancer Center Baton Rouge ( Site 1622)

Baton Rouge, Louisiana, 70809, United States

Location

University of Maryland Greenebaum Cancer Center ( Site 1522)

Baltimore, Maryland, 21201, United States

Location

Boston Medical Center ( Site 1605)

Boston, Massachusetts, 02118, United States

Location

University of Massachusetts Chan Medical School ( Site 1616)

Worcester, Massachusetts, 01655, United States

Location

VA Ann Arbor Healthcare System ( Site 1584)

Ann Arbor, Michigan, 48105, United States

Location

Barbara Ann Karmanos Cancer Institute ( Site 1566)

Detroit, Michigan, 48201, United States

Location

Henry Ford Health System ( Site 1544)

Detroit, Michigan, 48202, United States

Location

Hattiesburg Clinic ( Site 1515)

Hattiesburg, Mississippi, 39401, United States

Location

Jackson Oncology Associates, PLLC-Clinical Trials ( Site 1625)

Jackson, Mississippi, 39202, United States

Location

Washington University School of Medicine ( Site 1500)

St Louis, Missouri, 63110, United States

Location

St. Vincent Frontier Cancer Center ( Site 1507)

Billings, Montana, 59102, United States

Location

University Of Nebraska Medical Center ( Site 1570)

Omaha, Nebraska, 68105, United States

Location

Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 1627)

Omaha, Nebraska, 68130, United States

Location

John Theurer Cancer Center at Hackensack University Medical Center ( Site 1555)

Hackensack, New Jersey, 07601, United States

Location

Rutgers Cancer Institute of New Jersey ( Site 1523)

New Brunswick, New Jersey, 08901, United States

Location

Perlmutter Cancer Center at Winthrop Oncology Hematology Associates NYU Langone Health ( Site 1597)

Mineola, New York, 11501, United States

Location

Laura and Isaac Perlmutter Cancer Center ( Site 1582)

New York, New York, 10016, United States

Location

Levine Cancer Institute ( Site 1590)

Charlotte, North Carolina, 28204, United States

Location

Duke Cancer Institute ( Site 1541)

Durham, North Carolina, 27710, United States

Location

University of Cincinnati Medical Center ( Site 1567)

Cincinnati, Ohio, 45219, United States

Location

University Hospital Cleveland ( Site 1578)

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Main ( Site 1598)

Cleveland, Ohio, 44195, United States

Location

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 1558)

Columbus, Ohio, 43210, United States

Location

Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1508)

Tulsa, Oklahoma, 74146, United States

Location

Gettysburg Cancer Center ( Site 1594)

Gettysburg, Pennsylvania, 17325, United States

Location

Penn State Hershey Medical Center ( Site 1561)

Hershey, Pennsylvania, 17033, United States

Location

Fox Chase Cancer Center ( Site 1502)

Philadelphia, Pennsylvania, 19111, United States

Location

Medical University of South Carolina ( Site 1579)

Charleston, South Carolina, 29425, United States

Location

St Francis Cancer Center-Research Office ( Site 1607)

Greenville, South Carolina, 29607, United States

Location

The Center For Cancer And Blood Disorders ( Site 1569)

Fort Worth, Texas, 76104, United States

Location

Utah Cancer Specialists ( Site 1621)

Salt Lake City, Utah, 84106, United States

Location

Huntsman Cancer Institute ( Site 1532)

Salt Lake City, Utah, 84112, United States

Location

Inova Schar Cancer Institute ( Site 1550)

Fairfax, Virginia, 22031-4867, United States

Location

Hematology Oncology Associates of Fredericksburg ( Site 1537)

Fredericksburg, Virginia, 22408, United States

Location

MultiCare Health System-MultiCare Oncology - Puget Sound ( Site 1609)

Tacoma, Washington, 98405, United States

Location

Medical College of Wisconsin Clinical Cancer Center ( Site 1574)

Milwaukee, Wisconsin, 53226, United States

Location

Mid North Coast Cancer Institute ( Site 0109)

Port Macquarie, New South Wales, 2444, Australia

Location

Blacktown Hospital ( Site 0101)

Sydney, New South Wales, 2148, Australia

Location

The Townsville Hospital ( Site 0107)

Douglas, Queensland, 4814, Australia

Location

Gallipoli Medical Research Ltd-GMRF CTU ( Site 0105)

Greenslopes, Queensland, 4120, Australia

Location

Royal Adelaide Hospital ( Site 0110)

Adelaide, South Australia, 5000, Australia

Location

Monash Health ( Site 0102)

Clayton, Victoria, 3168, Australia

Location

Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0806)

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

A. C. Camargo Cancer Center ( Site 0809)

São Paulo, 01509-010, Brazil

Location

Arthur J.E. Child Comprehensive Cancer Centre ( Site 0304)

Calgary, Alberta, T2N 5G2, Canada

Location

BC Cancer-Vancouver Center ( Site 0306)

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0307)

Hamilton, Ontario, L8V 5C2, Canada

Location

Sunnybrook Research Institute ( Site 0308)

Toronto, Ontario, M4N 3M5, Canada

Location

Instituto de Cancerología ( Site 0408)

Medellín, Antioquia, 50034, Colombia

Location

Sociedad De Oncologia Y Hematologia Del Cesar ( Site 0404)

Valledupar, Cesar Department, 200001, Colombia

Location

Administradora Country S.A.S - Clínica del Country ( Site 0407)

Bogotá, Cundinamarca, 110221, Colombia

Location

IMAT S.A.S ( Site 0409)

Montería, Departamento de Córdoba, 230002, Colombia

Location

Rigshospitalet University Hospital Copenhagen ( Site 1000)

Copenhagen, Capital Region, 2100, Denmark

Location

Hopital La Timone ( Site 0503)

Marseille, Bouches-du-Rhone, 13385, France

Location

Centre de Cancerologie du Grand Montpellier ( Site 0508)

Montpellier, Herault, 34070, France

Location

Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne-ONCOLOGY ( Site 0510)

Clermont-Ferrand, Puy-de-Dome, 63003, France

Location

Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen ( Site 0509)

Rouen, Seine-Maritime, 76038, France

Location

Institut Gustave Roussy ( Site 0505)

Villejuif, Val-de-Marne, 94800, France

Location

Institut Curie ( Site 0500)

Paris, 75005, France

Location

Soroka Medical Center-Oncology ( Site 0604)

Beersheba, 8400000, Israel

Location

Rambam Health Care Campus-Oncology Division ( Site 0602)

Haifa, 3109601, Israel

Location

Hadassah Medical Center. Ein Kerem ( Site 0601)

Jerusalem, 9112001, Israel

Location

Chaim Sheba Medical Center ( Site 0600)

Ramat Gan, 5265601, Israel

Location

Oslo universitetssykehus, Radiumhospitalet ( Site 1102)

Oslo, 0379, Norway

Location

Unidade Local de Saude Gaia/Espinho - Hospital Eduardo Santos Silva ( Site 1401)

Vila Nova de Gaia, Porto District, 4434-502, Portugal

Location

Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 1400)

Porto, 4200-072, Portugal

Location

MEMORIAL HEALTHCARE INTERNATIONAL S.R.L. ( Site 1703)

Bucharest, București, 013823, Romania

Location

Spitalul Clinic Colțea ( Site 1708)

Bucharest, București, 030171, Romania

Location

Cardiomed SRL Cluj-Napoca ( Site 1701)

Cluj-Napoca, Cluj, 400015, Romania

Location

Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1702)

Cluj-Napoca, Cluj, 400015, Romania

Location

S.C. Radiotherapy Center Cluj S.R.L ( Site 1706)

Floreşti, Cluj, 407280, Romania

Location

S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1704)

Craiova, Dolj, 200542, Romania

Location

Cabinet Medical Oncomed ( Site 1707)

Timișoara, Timiș County, 300239, Romania

Location

Seoul National University Bundang Hospital ( Site 1801)

Seongnam, Kyonggi-do, 13620, South Korea

Location

Ajou University Hospital ( Site 1802)

Suwon, Kyonggi-do, 16499, South Korea

Location

Severance Hospital Yonsei University Health System ( Site 1800)

Seoul, 03722, South Korea

Location

Samsung Medical Center ( Site 1803)

Seoul, 06351, South Korea

Location

Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 0700)

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

HOSPITAL CLÍNIC DE BARCELONA ( Site 0707)

Barcelona, Catalonia, 08036, Spain

Location

Centro Oncologico de Galicia ( Site 0706)

A Coruña, Galicia, 15009, Spain

Location

Hospital General de Valencia ( Site 0703)

Valencia, Valenciana, Comunitat, 46014, Spain

Location

Hospital Universitari Vall d Hebron ( Site 0701)

Barcelona, 08035, Spain

Location

Hospital Ramon y Cajal ( Site 0705)

Madrid, 28034, Spain

Location

Hospital Virgen de la Victoria ( Site 0702)

Málaga, 29010, Spain

Location

Chang Gung Medical Foundation - Kaohsiung ( Site 1204)

Kaohsiung City, 83301, Taiwan

Location

China Medical University Hospital ( Site 1205)

Taichung, 404332, Taiwan

Location

Taichung Veterans General Hospital ( Site 1206)

Taichung, 407, Taiwan

Location

National Cheng Kung University Hospital ( Site 1202)

Tainan, 704, Taiwan

Location

National Taiwan University Hospital ( Site 1200)

Taipei, 10048, Taiwan

Location

Taipei Veterans General Hospital ( Site 1201)

Taipei, 11217, Taiwan

Location

Chang Gung Memorial Hospital - Linkou Branch ( Site 1203)

Taoyuan District, 333, Taiwan

Location

Aberdeen Royal Infirmary ( Site 0911)

Aberdeen, Aberdeen City, AB25 2ZN, United Kingdom

Location

Castle Hill Hospital ( Site 0910)

Cottingham, East Riding Of Yorkshire, HU16 5JQ, United Kingdom

Location

The Beatson West of Scotland Cancer Centre ( Site 0909)

Glasgow, Glasgow City, G12 0YN, United Kingdom

Location

Guy s and St Thomas Hospital NHS Foundation Trust ( Site 0903)

London, Great Britain, SE1 9RT, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust ( Site 0905)

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Royal Marsden Hospital ( Site 0902)

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

Location

Charing Cross Hospital ( Site 0908)

London, London, City of, W6 8RF, United Kingdom

Location

Musgrove Park Hospital ( Site 0904)

Taunton, Somerset, TA1 5DA, United Kingdom

Location

Royal Marsden Hospital. ( Site 0901)

Sutton, Surrey, SM2 5PT, United Kingdom

Location

The Christie NHS Foundation Trust ( Site 0907)

Manchester, m20 4bx, United Kingdom

Location

Related Publications (1)

• Taylor MH, Schmidt EV, Dutcus C, Pinheiro EM, Funahashi Y, Lubiniecki G, Rasco D. The LEAP program: lenvatinib plus pembrolizumab for the treatment of advanced solid tumors. Future Oncol. 2021 Feb;17(6):637-648. doi: 10.2217/fon-2020-0937. Epub 2020 Dec 10.

  PMID: 33300372 DERIVED

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

lenvatinib; pembrolizumab; Docetaxel; Capecitabine; Paclitaxel; Cetuximab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

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 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 11, 2020
• Study Start: August 6, 2020
• Primary Completion: May 31, 2024
• Study Completion: October 30, 2025
• Last Updated: December 4, 2025
• Results First Posted: May 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

TW (7); US (55); BR (2); AU (6); IL (4); KR (4); DK (1); NO (1); CO (4); CA (4); ES (7); FR (6); PT (2); RO (7); GB (10)