Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005)

NCT03797326 | Completed Phase 2 Results FDA Drug

• 5 other identifiers: 7902-005MK-7902-005E7080-G000-224LEAP-0052018-003747-37
• Study Type: interventional
• Target: 611
• Locations: 17 countries
• Sites: 88

Brief Summary

The purpose of this study is to determine the safety and efficacy of combination therapy with pembrolizumab (MK-3475) and lenvatinib (E7080/MK-7902) in participants with triple negative breast cancer (TNBC), ovarian cancer, gastric cancer, colorectal cancer (CRC), glioblastoma (GBM), biliary tract cancers (BTC), or pancreatic cancer.

Conditions

Advanced Solid Tumors; Ovarian Cancer; Biliary Tract Cancers; Triple Negative Breast Cancer; Gastric Cancer; Colorectal Cancer; Glioblastoma; Pancreatic Cancer

Keywords

programmed cell death 1 (PD-1, PD1); programmed cell death ligand 1 (PD-L1, PDL1); programmed cell death ligand 2 (PD-L2, PDL2); tyrosine kinase inhibitor (TKI); multiple TKI; Vascular Endothelial Growth Factor Receptor (VEFG); Fibroblast Growth Factor (FGF); Platelet-Derived Growth Factor (PDGF)

Outcome Measures

Primary Outcomes (4)

• Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Investigator Assessment

  ORR was defined as the percentage of participants who had a best overall response of either Complete Response (CR): Disappearance of all target lesions or Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions as assessed by RECIST 1.1. The percentage of participants who experienced a CR or PR as assessed by RECIST 1.1 by investigator assessment was presented. Per protocol, only data for Cohorts A and B were presented for this endpoint.

  Up to approximately 66 months

• Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for Glioblastoma Multiforma [GBM] Only), by Blinded Independent Central Review (BICR)

  ORR was defined as the percentage of participants who had a best overall response of either Complete Response (CR): Disappearance of all target lesions or Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions as assessed by RECIST 1.1. For participants with GBM, response was assessed according to RANO criteria whereby ORR was defined as the percentage of participants who had a best overall response of either Complete response (CR): Disappearance of all target lesions or Partial response (PR): sum of products of diameters decreased by ≥50% from baseline value. The percentage of participants who experienced a CR or PR as assessed by RECIST 1.1 or RANO by BICR was presented. Per protocol, only data for Cohorts C, D1, D2, E, F, and G were presented for this endpoint.

  Up to approximately 66 months

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

  An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with at least one or more AE is presented.

  Up to approximately 66 months

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

  An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued from study treatment due to an AE is presented.

  Up to approximately 62 months

Secondary Outcomes (8)

• Disease Control Rate (DCR) Per RECIST 1.1 by Investigator Assessment

  Up to approximately 66 months

• Disease Control Rate (DCR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR

  Up to approximately 66 months

• Duration of Response (DOR) Per RECIST 1.1 by Investigator Assessment

  Up to approximately 66 months

• Duration of Response (DOR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR

  Up to approximately 66 months

• Progression-Free Survival (PFS) Per RECIST 1.1 by Investigator Assessment

  Up to approximately 66 months

Study Arms (2)

Pembrolizumab + Lenvatinib (Arm 1)

EXPERIMENTAL

Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) plus lenvatinib 20 mg via oral capsule once a day (QD). Pembrolizumab will be administered for up to 35 cycles (up to 2 years). Lenvatinib will be administered until progressive disease or unacceptable toxicity (up to at least 2 years).

Biological: Pembrolizumab; Drug: Lenvatinib

Lenvatinib Monotherapy (Arm 2)

EXPERIMENTAL

Participants receive lenvatinib 24 mg via oral capsule QD, to be administered until progressive disease or unacceptable toxicity (up to at least 2 years).

Drug: Lenvatinib

Interventions

Pembrolizumab BIOLOGICAL

Administered as an IV infusion on Day 1 Q3W.

Also known as: MK-3475, Keytruda®

Pembrolizumab + Lenvatinib (Arm 1)

Lenvatinib DRUG

Administered orally once a day during each 21-day cycle.

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

Lenvatinib Monotherapy (Arm 2); Pembrolizumab + Lenvatinib (Arm 1)

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 or cytologically-documented, advanced (metastatic and/or unresectable) solid tumor that is incurable and for which prior standard systemic therapy has failed in one of the following cohorts: TNBC, Ovarian Cancer, Gastric Cancer, Colorectal Cancer, GBM, BTC (intrahepatic, extrahepatic cholangiocarcinoma and gall bladder cancer; excludes Ampulla of Vater), Pancreatic Cancer
• Must have progressed on or since the last treatment
• Has measurable disease per RECIST 1.1 (RANO for the GBM cohort) as assessed by the local site investigator/radiology and confirmed by BICR
• Has provided a PD-L1 evaluable archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
• Male participants agree to use approved contraception during the treatment period for at least 7 days after the last dose of lenvatinib, or refrain from heterosexual intercourse during this period
• Female participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period (or 14 days prior to the initiation of study treatment for oral contraception) and for at least 120 days post pembrolizumab, or 30 days post lenvatinib, whichever occurs last
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 3 days of study treatment initiation
• Has adequate organ function
• For Triple Negative Breast Cancer Participants:
• Has received one or 2 prior lines of therapy
• Has Lactate Dehydrogenase (LDH) \<2.0 x Upper Limit of Normal (ULN)
• Has locally determined results for estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 tumor analyses
• For Ovarian Cancer Participants:
• \- Has primary ovarian cancer and has received 3 prior lines of therapy.
• For Gastric Cancer Participants:

You may not qualify if:

• Has gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib
• Has present or progressive accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment (applies to all cohorts except the ovarian cancer cohort)
• Has radiographic evidence of encasement or invasion of a major blood vessel or of intratumoral cavitation. Participants with portal vein invasion (Vp4), inferior vena cava, or cardiac involvement based on imaging in the BTC cohort are not eligible for enrollment
• Has clinical significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study treatment
• Has significant cardiovascular impairment within 12 months of the first dose of study treatment, such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident (CVA), or cardiac arrhythmia associated with hemodynamic instability
• Has a history of arterial thromboembolism within 12 months of start of study treatment
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
• Has a serious nonhealing wound, ulcer or bone fracture
• Has had major surgery within 3 weeks prior to first dose of study interventions
• Has biologic response modifiers therapy (e.g. granulocyte colony-stimulating factor) within 4 weeks before study entry
• Has preexisting ≥Grade 3 gastrointestinal (GI) or non-gastrointestinal fistula
• Has received prior therapy with lenvatinib, an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], Tumor necrosis factor receptor superfamily, member 4 \[OX 40\], tumor necrosis factor receptor superfamily member 9 \[CD137\])
• Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study treatment start
• If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment
• Has received prior radiotherapy within 2 weeks of start of study treatment. 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-central nervous system (CNS) disease

Sponsors & Collaborators

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

Study Sites (88)

City of Hope ( Site 0002)

Duarte, California, 91010, United States

Location

Cedars Sinai Medical Center ( Site 0003)

Los Angeles, California, 90048, United States

Location

University of California Davis Comprehensive Cancer Center ( Site 0005)

Sacramento, California, 95817, United States

Location

University of Colorado, Anschutz Cancer Pavilion ( Site 0007)

Aurora, Colorado, 80045, United States

Location

University of Florida-Health Cancer Center-Orlando ( Site 0015)

Orlando, Florida, 32806, United States

Location

Rutgers Cancer Institute of New Jersey ( Site 0009)

New Brunswick, New Jersey, 08901, United States

Location

Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0023)

New York, New York, 10016, United States

Location

Sanford Fargo Medical Center ( Site 0059)

Fargo, North Dakota, 58102, United States

Location

Lehigh Valley Hospital- Cedar Crest ( Site 0047)

Allentown, Pennsylvania, 18103, United States

Location

Sanford Cancer Center ( Site 0058)

Sioux Falls, South Dakota, 57104, United States

Location

West Cancer Center - East Campus ( Site 0018)

Germantown, Tennessee, 38138, United States

Location

Mary Crowley Cancer Research Centers - Medical City Hospital ( Site 0049)

Dallas, Texas, 75230, United States

Location

Swedish Medical Center ( Site 0021)

Seattle, Washington, 98104, United States

Location

University of Wisconsin Carbone Cancer Center ( Site 0017)

Madison, Wisconsin, 53792-0001, United States

Location

Fundacion Favaloro para la Docencia e Investigacion Medica ( Site 2106)

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1078AAI, Argentina

Location

Hospital Aleman ( Site 2100)

Buenos Aires, Buenos Aires F.D., 1118, Argentina

Location

Hospital Britanico de Buenos Aires ( Site 2109)

Ciudad de Buenos Aires, Buenos Aires F.D., C1280AEB, Argentina

Location

Instituto de Oncologia de Rosario ( Site 2105)

Rosario, Santa Fe Province, S2000KZE, Argentina

Location

CEMIC ( Site 2104)

Buenos Aires, C1431FWO, Argentina

Location

IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 2101)

Caba, C1012AAR, Argentina

Location

Royal Brisbane and Women s Hospital ( Site 0901)

Herston, Queensland, 4029, Australia

Location

Alfred Health ( Site 0902)

Melbourne, Victoria, 3004, Australia

Location

Sir Charles Gairdner Hospital ( Site 0903)

Nedlands, Western Australia, 6009, Australia

Location

BC Cancer - Abbotsford ( Site 0200)

Abbotsford British Columbia, British Columbia, V2S 0C2, Canada

Location

CancerCare Manitoba ( Site 0201)

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0208)

Hamilton, Ontario, L8V 4X2, Canada

Location

Sunnybrook Research Institute ( Site 0207)

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Cancer Centre ( Site 0202)

Toronto, Ontario, M5G 2M9, Canada

Location

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0210)

Montreal, Quebec, H2X 3E4, Canada

Location

CHU de Quebec Universite de Laval ( Site 0206)

Québec, Quebec, G1R 2J6, Canada

Location

Centro Investigación del Cáncer James Lind ( Site 1203)

Temuco, Araucania, 4780000, Chile

Location

Fundacion Arturo Lopez Perez ( Site 1201)

Santiago, Region M. de Santiago, 7500921, Chile

Location

Pontificia Universidad Catolica de Chile ( Site 1202)

Santiago, Region M. de Santiago, 8330024, Chile

Location

Hospital Clinico Universidad de Chile ( Site 1200)

Santiago, Region M. de Santiago, 8380456, Chile

Location

Fundacion Colombiana de Cancerologia Clinica Vida ( Site 1105)

Medellín, Antioquia, 050030, Colombia

Location

Instituto Nacional de Cancerologia E.S.E ( Site 1102)

Bogotá, Bogota D.C., 110321, Colombia

Location

Oncologos del Occidente S.A. ( Site 1106)

Pereira, Risaralda Department, 660001, Colombia

Location

Fundacion Valle del Lili ( Site 1101)

Cali, Valle del Cauca Department, 760032, Colombia

Location

Centre Antoine Lacassagne ( Site 0404)

Nice, Alpes-Maritimes, 06189, France

Location

Centre Leon Berard ( Site 0405)

Lyon, Auvergne, 69373, France

Location

Institut Claudius Regaud IUCT Oncopole ( Site 0403)

Toulouse, Haute-Garonne, 31059, France

Location

Centre Oscar Lambret ( Site 0401)

Lille, Nord, 59000, France

Location

Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0402)

Saint-Herblain, Val-de-Marne, 44805, France

Location

Institut Gustave Roussy ( Site 0400)

Villejuif, Val-de-Marne, 94800, France

Location

Robert Bosch GmbH ( Site 0307)

Stuttgart, Baden-Wurttemberg, 70376, Germany

Location

Universitaetsklinikum Regensburg ( Site 0304)

Regensburg, Bavaria, 93053, Germany

Location

Universitaetsklinikum Frankfurt ( Site 0306)

Frankfurt am Main, Hesse, 60528, Germany

Location

HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 0301)

Wiesbaden, Hesse, 65199, Germany

Location

SRH Wald-Klinikum Gera GmbH ( Site 0309)

Gera, Thuringia, 07548, Germany

Location

Universitaetsklinikum Jena ( Site 0302)

Jena, Thuringia, 07740, Germany

Location

Soroka Medical Center ( Site 0601)

Beersheba, 8457108, Israel

Location

Rambam Medical Center ( Site 0602)

Haifa, 3109601, Israel

Location

Hadassah Ein Kerem Medical Center ( Site 0604)

Jerusalem, 9112001, Israel

Location

Chaim Sheba Medical Center ( Site 0600)

Ramat Gan, 5262000, Israel

Location

Sourasky Medical Center ( Site 0603)

Tel Aviv, 6423906, Israel

Location

Istituto Clinico Humanitas Research Hospital ( Site 1402)

Rozzano, Milano, Italy

Location

Policlinico Le Scotte - A.O. Senese ( Site 1401)

Siena, Tuscany, 53100, Italy

Location

Istituto Nazionale Tumori Fondazione Pascale ( Site 1400)

Naples, 80131, Italy

Location

Fondazione Policlinico Universitario A. Gemelli ( Site 1403)

Roma, 00168, Italy

Location

Arkhangelsk Clinical Oncological Dispensary ( Site 1600)

Arkhangelsk, Arkhangelskaya oblast, 163045, Russia

Location

Russian Oncological Research Center n.a. N.N. Blokhin ( Site 1604)

Moscow, Moscow, 115478, Russia

Location

Leningrad Regional Oncology Center ( Site 1609)

Saint Petersburg, Sankt-Peterburg, 188663, Russia

Location

Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1610)

Saint Petersburg, Sankt-Peterburg, 197758, Russia

Location

City Clinical Oncology Center ( Site 1608)

Saint Petersburg, Sankt-Peterburg, 198255, Russia

Location

Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1603)

Kazan', Tatarstan, Respublika, 420029, Russia

Location

Asan Medical Center ( Site 1002)

Songpagu, Seoul, 05505, South Korea

Location

Seoul National University Hospital ( Site 1000)

Seoul, 03080, South Korea

Location

Severance Hospital Yonsei University Health System ( Site 1001)

Seoul, 03722, South Korea

Location

Hospital Clinic i Provincial ( Site 0703)

Barcelona, 08036, Spain

Location

Hospital Universitario Gregorio Maranon ( Site 0701)

Madrid, 28009, Spain

Location

Clinica Universitaria de Navarra ( Site 0704)

Madrid, 28027, Spain

Location

Hospital Ramon y Cajal ( Site 0702)

Madrid, 28034, Spain

Location

Inselspital Universitaetsspital Bern ( Site 1705)

Bern, Canton of Bern, 3010, Switzerland

Location

Kantonsspital St. Gallen ( Site 1702)

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

Ospedale Regionale di Bellinzona e Valli ( Site 1703)

Bellinzona, Canton Ticino, 6500, Switzerland

Location

Kantonsspital Graubuenden ( Site 1704)

Chur, Kanton Graubünden, 7000, Switzerland

Location

Hopitaux Universitaires de Geneve HUG ( Site 1701)

Geneva, 1211, Switzerland

Location

Universitaetsspital Zurich ( Site 1700)

Zurich, 8091, Switzerland

Location

National Cheng Kung University Hospital ( Site 3003)

Tainan, 704, Taiwan

Location

National Taiwan University Hospital ( Site 3000)

Taipei, 10002, Taiwan

Location

Chulalongkorn University ( Site 5001)

Bangkok, Bangkok, 10330, Thailand

Location

Ramathibodi Hospital. ( Site 5002)

Bangkok, Bangkok, 10400, Thailand

Location

Siriraj Hospital ( Site 5003)

Bangkok, Bangkok, 10700, Thailand

Location

Cambridge University Hospitals NHS Trust ( Site 0803)

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

Leicester Royal Infirmary. Univ. Hosp. of Leicester NHS Trust ( Site 0804)

Leicester, Leicestershire, LE1 5WW, United Kingdom

Location

Guy's Hospital ( Site 0806)

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

Location

Royal Marsden Hospital (Sutton) ( Site 0800)

London, Surrey, SM3 5PT, United Kingdom

Location

Christie NHS Foundation Trust ( Site 0805)

Manchester, M20 4BX, United Kingdom

Location

Related Publications (5)

• Gonzalez-Martin A, Chung HC, Saada-Bouzid E, Yanez E, Senellart H, Cassier PA, Basu B, Corr BR, Girda E, Dutcus C, Okpara CE, Ghori R, Jin F, Groisberg R, Lwin Z. Lenvatinib plus pembrolizumab for patients with previously treated advanced ovarian cancer: Results from the phase 2 multicohort LEAP-005 study. Gynecol Oncol. 2024 Jul;186:182-190. doi: 10.1016/j.ygyno.2024.04.011. Epub 2024 May 7.

  PMID: 38718741 RESULT

• Chung HC, Saada-Bouzid E, Longo F, Yanez E, Im SA, Castanon E, Desautels DN, Graham DM, Garcia-Corbacho J, Lopez J, Dutcus C, Okpara CE, Ghori R, Jin F, Groisberg R, Korakis I. Lenvatinib plus pembrolizumab for patients with previously treated, advanced, triple-negative breast cancer: Results from the triple-negative breast cancer cohort of the phase 2 LEAP-005 Study. Cancer. 2024 Oct 1;130(19):3278-3288. doi: 10.1002/cncr.35387. Epub 2024 Jun 21.

  PMID: 39031824 RESULT

• Ponz-Sarvise M, Rha SY, Gomez-Roca CA, Ortega Moran L, Gill S, Tortora G, Geva R, Saada-Bouzid E, Santoro A, Kim TW, Heudobler D, Dutcus CE, Okpara CE, Ghori R, Zhang Y, Vajdi A, Dettman EJ, Jin F, Groisberg R, Shapira-Frommer R. Lenvatinib plus Pembrolizumab for Patients with Previously Treated Advanced Gastric, Biliary Tract, or Pancreatic Cancer: Results from the Phase II LEAP-005 Study. Cancer Res Commun. 2026 Mar 1;6(3):673-686. doi: 10.1158/2767-9764.CRC-26-0018.

  PMID: 41747221 RESULT

• Victoria Ruiz I, Uboha NV, Jamal R, Mejia FC, Ahumada M, Im SA, Gomez-Roca C, Shapira-Frommer R, Perets R, Yanez E, Dutcus C, Okpara CE, Ghori R, Jin F, Groisberg R, Castanon E. Lenvatinib Plus Pembrolizumab for Patients With Previously Treated Advanced Colorectal Cancer: Results From the Phase II LEAP-005 Study. Clin Colorectal Cancer. 2026 Jan 22:S1533-0028(26)00005-8. doi: 10.1016/j.clcc.2026.01.003. Online ahead of print.

  PMID: 41763955 DERIVED

• Rha SY, Castanon E, Gill S, Senellart H, Lopez J, Marquez-Rodas I, Victoria I, Kim TM, Lwin Z, Burger MC, Simonelli M, Cassier PA, Hendifar AE, Ascierto PA, Dutcus C, Okpara CE, Ghori R, Jin F, Groisberg R, Villanueva L. Lenvatinib plus pembrolizumab for patients with previously treated select solid tumors: Results from the phase 2 LEAP-005 study recurrent glioblastoma cohort. Cancer. 2025 Aug 15;131(16):e70015. doi: 10.1002/cncr.70015.

  PMID: 40808295 DERIVED

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Ovarian Neoplasms; Stomach Neoplasms; Colorectal Neoplasms; Glioblastoma; Biliary Tract Neoplasms; Pancreatic Neoplasms; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

pembrolizumab; lenvatinib

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Biliary Tract Diseases; Pancreatic 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 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 9, 2019
• Study Start: February 12, 2019
• Primary Completion: October 28, 2024
• Study Completion: October 28, 2024
• Last Updated: May 4, 2026
• Results First Posted: November 17, 2025

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

IL (5); RU (6); DE (6); CA (7); CH (6); US (14); AU (3); TW (2); TH (3); IT (4); FR (6); ES (4); AR (6); GB (5); CL (4); CO (4); KR (3)