Safety and Efficacy Study of Pembrolizumab (MK-3475) Combined With Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Advance Melanoma (MK-7902-003/E7080-G000-312/LEAP-003)

NCT03820986 | Completed Phase 3 Results DMC FDA Drug

• 5 other identifiers: 7902-003MK-7902-003E7080-G000-312LEAP-0032018-002520-16
• Study Type: interventional
• Target: 674
• Locations: 17 countries
• Sites: 117

Brief Summary

The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) as first-line treatment in adults with no prior systemic therapy for their advanced melanoma. The primary study hypotheses are that: 1) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), and 2) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Overall Survival (OS). For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.

Conditions

Malignant Melanoma

Keywords

programmed cell death 1 (PD-1, PD1); programmed cell death-ligand 1 (PD-L1, PDL1); programmed cell death-ligand 2 (PD-L2, PDL2)

Outcome Measures

Primary Outcomes (2)

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

  PFS is defined as the time from date of randomization to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1, PD is 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 is also considered PD. For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The final analysis for this outcome is presented here.

  Up to approximately 34 months

• Overall Survival (OS)

  OS is defined as the time from date of randomization to date of death from any cause. The final analysis for this outcome is presented here.

  Up to approximately 46 months

Secondary Outcomes (8)

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

  Up to approximately 46 months

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

  Up to approximately 46 months

• Number of Participants With Adverse Events (AEs)

  Up to approximately 67 months

• Number of Participants Who Discontinue Study Treatment Due to Adverse Events (AEs)

  Up to approximately 63 months

• Change From Baseline in European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire-Core 30 [QLQ-C30] Global Health Status (GHS)/Quality of Life (QoL) Score

  Baseline and Week 21

Study Arms (2)

Pembrolizumab+Lenvatinib

EXPERIMENTAL

Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule daily for up to at least 2 years.

Biological: Pembrolizumab; Drug: Lenvatinib

Pembrolizumab+Placebo

ACTIVE COMPARATOR

Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule daily for up to at least 2 years.

Biological: Pembrolizumab; Drug: Placebo for lenvatinib

Interventions

Pembrolizumab BIOLOGICAL

IV infusion

Also known as: MK-3475, KEYTRUDA®

Pembrolizumab+Lenvatinib; Pembrolizumab+Placebo

Lenvatinib DRUG

Oral capsule

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

Pembrolizumab+Lenvatinib

Placebo for lenvatinib DRUG

Oral capsule

Pembrolizumab+Placebo

Eligibility Criteria

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

You may qualify if:

• Has histologically or cytologically confirmed melanoma.
• Has unresectable Stage III or Stage IV melanoma, as per American Joint Committee on Cancer guidelines, not amenable to local therapy.
• Has been untreated for advanced or metastatic disease except as follows:
• Proto-oncogene B-Raf (BRAF) V600 mutation-positive melanoma may have received standard of care targeted therapy as first-line therapy for advanced or metastatic disease. Participants that do not have a BRAF V600 mutation but did receive BRAF or BRAF/mitogen-activated extracellular signal-regulated kinase 1/2 Inhibitor (MEKi) therapy are eligible to participate in this study after discussion with the medical monitor.
• Prior adjuvant or neoadjuvant therapy, with targeted therapy or immunotherapy (such as anti-cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], anti-programmed cell death 1 \[anti-PD-1\] therapy or interferon) will only be permitted if relapse did not occur during active treatment or within 6 months of treatment discontinuation.
• Have documentation of BRAF V600-activating mutation status or consent to BRAF V600 mutation testing during the Screening period (participants with BRAF mutation-positive melanoma as well as BRAF wild-type or unknown are eligible).
• Has an Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
• Has the presence of ≥1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1.
• Provides a tumor biopsy. Participants must submit tumor sample during Screening for confirmation of adequacy of tumor tissue at a central pathology laboratory. Participants who do not submit a tumor tissue sample will not be randomized. The tumor biopsy may not be obtained from a lone target lesion. Confirmation of presence of tumor tissue is not required prior to randomization.
• Has resolution of toxic effect(s) of the most recent prior therapy to Grade 1 or less (except alopecia). If participant received major surgery or radiation therapy of \>30 Gray (Gy), they must have recovered from the toxicity and/or complications from the intervention.
• Male participants must agree to use contraception during the treatment period and for at least 7 days after the last dose of study treatment and refrain from donating sperm during this period. Please note that 7 days after lenvatinib/placebo is stopped, if the participant is on pembrolizumab only, no male contraception measures are needed. Contraception use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed.
• Female participants must not be pregnant, not breastfeeding, and ≥1 of the following conditions applies:
• Not a woman of childbearing potential (WOCBP). OR
• A WOCBP who agrees to use study-approved contraception during the treatment period and for at least 120 days after the last dose of study treatment.
• The participant (or legally acceptable representative) has provided documented informed consent for the study.

You may not qualify if:

• Has a 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 before the first dose of study treatment.
• Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1, non-ulcerated primary melanoma \<1 mm in depth with no nodal involvement) treated with curative intent, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy.
• Has known active central nervous system metastases and/or carcinomatous meningitis.
• Has ocular melanoma.
• Has known hypersensitivity to active substances or any of their excipients including previous clinically significant hypersensitivity reaction to treatment with another monoclonal antibody.
• Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease-modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• Has an active infection requiring systemic therapy.
• Has known history of human immunodeficiency virus (HIV) infection
• Has known history of or is positive for hepatitis B virus or hepatitis C virus infection.
• Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
• Has a history of active tuberculosis (Bacillus tuberculosis).
• Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib.
• Has had a major surgery within 3 weeks prior to first dose of study intervention. Note: Adequate wound healing after major surgery must be assessed clinically independent of time elapsed for eligibility.
• Has a preexisting Grade ≥3 gastrointestinal or non-gastrointestinal fistula.
• Has radiographic evidence of encasement or invasion of major blood vessel, or of intratumoral cavitation.

Sponsors & Collaborators

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

Study Sites (119)

The Angeles Clinic and Research Institute ( Site 0707)

Los Angeles, California, 90025, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0704)

San Francisco, California, 30322, United States

Location

California Pacific Medical Center Research Institute ( Site 0705)

San Francisco, California, 94115, United States

Location

John Wayne Cancer Institute ( Site 0706)

Santa Monica, California, 90404, United States

Location

University of Colorado Cancer Center ( Site 0708)

Aurora, Colorado, 80045, United States

Location

Yale Cancer Center ( Site 0709)

New Haven, Connecticut, 06510, United States

Location

Baptist MD Anderson Cancer Center ( Site 0767)

Jacksonville, Florida, 32207, United States

Location

Mid-Florida Cancer Centers ( Site 0764)

Orange City, Florida, 32763, United States

Location

AMG Oncology ( Site 0714)

Park Ridge, Illinois, 60068, United States

Location

Illinois Cancer Care, PC ( Site 0765)

Peoria, Illinois, 61615, United States

Location

Minnesota Oncology Specialist, PA ( Site 0766)

Fridley, Minnesota, 55432, United States

Location

St. Vincent Frontier Cancer Center ( Site 0724)

Billings, Montana, 59102, United States

Location

Atlantic Health System ( Site 0768)

Morristown, New Jersey, 07960, United States

Location

Valley Hospital ( Site 0749)

Paramus, New Jersey, 07652, United States

Location

University of North Carolina - Cancer Hospital ( Site 0751)

Chapel Hill, North Carolina, 27514, United States

Location

OHSU Center for Health & Healing ( Site 0731)

Portland, Oregon, 97239, United States

Location

Inova Schar Cancer Institute ( Site 0739)

Fairfax, Virginia, 22031-4867, United States

Location

Lismore Base Hospital ( Site 0453)

Lismore, Australian Capital Territory, 2480, Australia

Location

Melanoma Institute Australia ( Site 0452)

North Sydney, New South Wales, 2060, Australia

Location

Westmead Hospital ( Site 0451)

Westmead, New South Wales, 2145, Australia

Location

Princess Alexandra Hospital ( Site 0454)

Wooloongabba, Queensland, 4102, Australia

Location

Eastern Health ( Site 0457)

Box Hill, Victoria, 3128, Australia

Location

Fiona Stanley Hospital ( Site 0456)

Murdoch, Western Australia, 6150, Australia

Location

LKH Universitatsklinikum Graz ( Site 0776)

Graz, Styria, 8036, Austria

Location

Medizinische Universitat Wien ( Site 0778)

Vienna, 1090, Austria

Location

PERSONAL - Oncologia de Precisao e Personalizada ( Site 0399)

Belo Horizonte, Minas Gerais, 30130-090, Brazil

Location

Hospital de Caridade de Ijui ( Site 0391)

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

Hospital Sao Vicente de Paulo ( Site 0396)

Passo Fundo, Rio Grande do Sul, 99010-080, Brazil

Location

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0397)

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Instituto Nacional de Cancer Hospital do Cancer II ( Site 0394)

Rio de Janeiro, 20220-410, Brazil

Location

BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 0661)

Kelowna, British Columbia, V1Y 5L3, Canada

Location

Lions Gate Hospital ( Site 0662)

North Vancouver, British Columbia, V7L 2L7, Canada

Location

Sunnybrook Research Institute ( Site 0654)

Toronto, Ontario, M4N 3M5, Canada

Location

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0652)

Montreal, Quebec, H2W 3E4, Canada

Location

McGill University Health Centre ( Site 0651)

Montreal, Quebec, H4A 3J1, Canada

Location

Fundacion Arturo Lopez Perez FALP ( Site 0421)

Santiago, Region M. de Santiago, 7500921, Chile

Location

Pontificia Universidad Catolica de Chile ( Site 0422)

Santiago, Region M. de Santiago, 8330024, Chile

Location

Sociedad Medica Aren y Bachero Limitada ( Site 0426)

Santiago, Region M. de Santiago, 8420383, Chile

Location

Centro Investigación del Cáncer James Lind ( Site 0425)

Temuco, Región de la Araucanía, 4780000, Chile

Location

Oncocentro ( Site 0424)

Viña del Mar, Región de Valparaíso, 2520598, Chile

Location

Beijing Cancer Hospital ( Site 0601)

Beijing, Beijing Municipality, 100036, China

Location

Fujian Provincial Cancer Hospital ( Site 0612)

Fuzhou, Fujian, 350014, China

Location

Sun Yat-Sen University Cancer Center ( Site 0602)

Guangzhou, Guangdong, 510000, China

Location

Henan Cancer Hospital ( Site 0610)

Zhengzhou, Henan, 450003, China

Location

Nanjing Drum Tower Hospital ( Site 0609)

Nanjing, Jiangsu, 210008, China

Location

The First Hospital Of Jilin University ( Site 0603)

Changchun, Jilin, 130021, China

Location

Fudan University Shanghai Cancer Center ( Site 0607)

Shanghai, Shanghai Municipality, 200032, China

Location

Tianjin Medical University Cancer Institute & Hospital ( Site 0606)

Tianjin, Tianjin Municipality, 300060, China

Location

Yunnan Cancer Hospital ( Site 0604)

Kunming, Yunnan, 430030, China

Location

Sir Run Run Shaw Hospital ( Site 0605)

Hangzhou, Zhejiang, 310018, China

Location

Zhejiang Cancer Hospital ( Site 0608)

Hangzhou, Zhejiang, 310022, China

Location

Hopital ARCHET 2 ( Site 0009)

Nice, Alpes-Maritimes, 06200, France

Location

Hopital La Timone ( Site 0002)

Marseille, Bouches-du-Rhone, 13385, France

Location

CHU Dijon Bourgogne ( Site 0010)

Dijon, Cote-d Or, 21079, France

Location

Institut Claudius Regaud IUCT Oncopole ( Site 0003)

Toulouse, Haute-Garonne, 31059, France

Location

Hopital Ambroise Pare Boulogne ( Site 0007)

Boulogne-Billancourt, Hauts-de-Seine, 92100, France

Location

CHRU Lille - Hopital Claude Huriez ( Site 0004)

Lille, Nord, 59037, France

Location

CHU de Rouen ( Site 0013)

Rouen, Seine-Maritime, 76000, France

Location

Centre Hospitalier Victor Dupouy ( Site 0012)

Argenteuil, Val-d Oise, 95100, France

Location

Institut Gustave Roussy ( Site 0001)

Villejuif, Val-de-Marne, 94805, France

Location

CHU de la Miletrie Poitiers ( Site 0011)

Poitiers, Vienne, 86021, France

Location

Klinik fur Dermatologie Allergologie und Venerologie ( Site 0035)

Hannover, Baden-Wurttemberg, 30625, Germany

Location

Universitaetsklinikum Erlangen ( Site 0044)

Erlangen, Bavaria, 91054, Germany

Location

Universitaetsklinikum Wuerzburg-Department of Dermatology ( Site 0036)

Würzburg, Bavaria, 97080, Germany

Location

Hautkrebszentrum Buxtehude ( Site 0037)

Buxtehude, Lower Saxony, 21614, Germany

Location

Universitaetsklinikum Carl Gustav Carus ( Site 0041)

Dresden, Saxony, 01307, Germany

Location

Universitaetsklinikum Leipzig ( Site 0040)

Leipzig, Saxony, 04103, Germany

Location

Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 0033)

Kiel, Schleswig-Holstein, 24105, Germany

Location

SRH Wald-Klinikum Gera GmbH ( Site 0042)

Gera, Thuringia, 07548, Germany

Location

HaEmek Medical Center ( Site 0306)

Afula, 1834111, Israel

Location

Soroka Medical Center ( Site 0303)

Beersheba, 8457108, Israel

Location

Rambam Medical Center ( Site 0301)

Haifa, 3109601, Israel

Location

Hadassah Ein Karem Hebrew University Medical Center ( Site 0305)

Jerusalem, 9112001, Israel

Location

Rabin Medical Center ( Site 0302)

Petah Tikva, 4941492, Israel

Location

Chaim Sheba Medical Center ( Site 0304)

Ramat Gan, 5262000, Israel

Location

Sourasky Medical Center ( Site 0307)

Tel Aviv, 6423906, Israel

Location

Shamir Medical Center-Assaf Harofeh ( Site 0308)

Ẕerifin, 70300, Israel

Location

ASST Papa Giovanni XXIII ( Site 0062)

Bergamo, Abruzzo, 24127, Italy

Location

Azienda Ospedaliera Universitaria Senese ( Site 0065)

Siena, Tuscany, 53100, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0064)

Milan, 20133, Italy

Location

Istituto Europeo di Oncologia ( Site 0067)

Milan, 20141, Italy

Location

Istituto Nazionale Tumori Fondazione Pascale ( Site 0061)

Naples, 80131, Italy

Location

Istituto Oncologico Veneto ( Site 0063)

Padua, 35128, Italy

Location

Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 0272)

Poznan, Greater Poland Voivodeship, 60-780, Poland

Location

Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 0273)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

Location

Pratia MCM Krakow ( Site 0280)

Krakow, Lesser Poland Voivodeship, 30-510, Poland

Location

Uniwersyteckie Centrum Kliniczne ( Site 0281)

Gdansk, Pomeranian Voivodeship, 80-214, Poland

Location

Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0278)

Gliwice, Silesian Voivodeship, 44-102, Poland

Location

Cancer Care Langenhoven Drive Oncology Centre ( Site 0805)

Port Elizabeth, Eastern Cape, 6045, South Africa

Location

Sandton Oncology Medical Group PTY LTD ( Site 0802)

Johannesburg, Gauteng, 2196, South Africa

Location

Cape Town Oncology Trials Pty Ltd ( Site 0803)

Kraaifontein, Western Cape, 7570, South Africa

Location

Kyungpook National University Chilgok Hospital ( Site 0553)

Daegu, Taegu-Kwangyokshi, 41404, South Korea

Location

Seoul National University Hospital ( Site 0554)

Seoul, 03080, South Korea

Location

Severance Hospital Yonsei University Health System ( Site 0552)

Seoul, 03722, South Korea

Location

Samsung Medical Center ( Site 0551)

Seoul, 06351, South Korea

Location

Hospital Duran i Reinals ICO de Hospitalet ( Site 0187)

Hospitalet Del Llobregat, Barcelona, 08908, Spain

Location

Hospital Universitario Marques de Valdecilla ( Site 0181)

Santander, Cantabria, 39008, Spain

Location

Complejo Hospitalario Universitario A Coruna. CHUAC ( Site 0182)

A Coruña, La Coruna, 15006, Spain

Location

Hospital Universitario Insular de Gran Canaria ( Site 0189)

Las Palmas de Gran Canaria, Las Palmas, 35001, Spain

Location

Hospital Clinic i Provincial Barcelona ( Site 0190)

Barcelona, 08036, Spain

Location

Hospital General Universitario Gregorio Maranon ( Site 0191)

Madrid, 28009, Spain

Location

Hospital Universitario Ramon y Cajal ( Site 0183)

Madrid, 28034, Spain

Location

Hospital Universitario La Paz ( Site 0184)

Madrid, 28046, Spain

Location

Hospital Universitario Carlos Haya ( Site 0186)

Málaga, 29010, Spain

Location

Laenssjukhuset Ryhov ( Site 0215)

Jönköping, Jönköping County, 551 85, Sweden

Location

Centrallasarettet Vaxjo ( Site 0214)

Vaxjo, Kronoberg County, 351 85, Sweden

Location

Skanes Universitetssjukhus ( Site 0213)

Lund, Skåne County, 221 85, Sweden

Location

Karolinska Universitetssjukhuset ( Site 0211)

Solna, Stockholm County, 171 64, Sweden

Location

Akademiska Sjukhuset ( Site 0218)

Uppsala, Uppsala County, 751 85, Sweden

Location

Norrlands Universitetssjukhus ( Site 0216)

Umeå, Västerbotten County, 901 85, Sweden

Location

Sahlgrenska Universitetssjukhuset ( Site 0212)

Gothenburg, Västra Götaland County, 413 45, Sweden

Location

Universitaetsspital Basel ( Site 0094)

Basel, Canton of Basel-City, 4031, Switzerland

Location

Kantonsspital Winterthur ( Site 0095)

Winterthur, Canton of Zurich, 8401, Switzerland

Location

Universitaetsspital Zuerich ( Site 0092)

Zuerich-Flughafen, Canton of Zurich, 8058, Switzerland

Location

Kantonsspital Graubuenden ( Site 0091)

Chur, Kanton Graubünden, 7000, Switzerland

Location

Western General Hospital ( Site 0121)

Edinburgh, Edinburgh, City of, EH4 2XU, United Kingdom

Location

Guys and St Thomas NHS Foundation Trust ( Site 0126)

London, London, City of, SE1 9RT, United Kingdom

Location

Derriford Hospital ( Site 0129)

Plymouth, PL6 8DH, United Kingdom

Location

Singleton Hospital ( Site 0131)

Swansea, SA2 8QA, United Kingdom

Location

Related Publications (1)

• Arance A, Berciano-Guerrero MA, Guo J, Carlino MS, Ascierto PA, Burotto M, Mortier L, Queirolo P, Chiarion-Sileni V, Schachter J, Zhang X, Martin-Liberal J, Del Vecchio M, Okpara CE, Dutcus C, Zhang J, Diede SJ, Neff T, Long GV. Randomized, double-blind, phase III LEAP-003 study of first-line lenvatinib plus pembrolizumab versus placebo plus pembrolizumab for unresectable or metastatic melanoma. Ann Oncol. 2025 Dec;36(12):1535-1546. doi: 10.1016/j.annonc.2025.08.008. Epub 2025 Aug 28.

  PMID: 40885529 RESULT

Related Links

• Merck Clinical Trial Information
• Plain Language Summary

MeSH Terms

Conditions

Melanoma; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

pembrolizumab; lenvatinib

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue 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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 29, 2019
• Study Start: March 12, 2019
• Primary Completion: January 18, 2023
• Study Completion: November 1, 2024
• Last Updated: February 9, 2026
• Results First Posted: January 17, 2024

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

FR (10); PL (5); CL (5); IT (6); US (17); SE (7); GB (4); BR (5); AU (6); CH (4); KR (4); DE (8); CN (11); ZA (3); CA (5); IL (8); ES (9)