Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 99 of 532 for:    melanoma phase III

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03820986
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : February 17, 2020
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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 advance 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.


Condition or disease Intervention/treatment Phase
Malignant Melanoma Biological: Pembrolizumab Drug: Lenvatinib Drug: Placebo for lenvatinib Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 660 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) and Lenvatinib (E7080/MK-7902) Versus Pembrolizumab Alone as First-line Intervention in Participants With Advanced Melanoma (LEAP-003)
Actual Study Start Date : March 12, 2019
Estimated Primary Completion Date : April 6, 2024
Estimated Study Completion Date : April 6, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: Pembrolizumab+Lenvatinib
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
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®

Drug: Lenvatinib
Oral capsule
Other Names:
  • MK-7902
  • E7080
  • LENVIMA®

Active Comparator: Pembrolizumab+Placebo
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
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®

Drug: Placebo for lenvatinib
Oral capsule




Primary Outcome Measures :
  1. Progression-free Survival (PFS) as Assessed by Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: Up to approximately 2 years ]
    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. PFS as assessed by modified RECIST 1.1 will be presented.

  2. Overall Survival (OS) [ Time Frame: Up to approximately 2 years ]
    OS is defined as the time from date of randomization to date of death from any cause. OS will be presented.


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) as Assessed by Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: Up to approximately 2 years ]
    ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. 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. ORR as assessed by modified RECIST 1.1 will be presented.

  2. Duration of Response (DOR) as Assessed by Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: Up to approximately 2 years ]
    For participants who demonstrated CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), DOR is defined as the date of the first documented evidence of CR or PR until 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. DOR as assessed by modified RECIST 1.1 will be presented.

  3. Number of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 28 months ]
    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be presented.

  4. Number of Participants Who Discontinue Study Treatment Due to Adverse Events (AEs) [ Time Frame: Up to approximately 2 years ]
    The number of participants who discontinue study treatment due to an AE will be presented.

  5. 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) Score [ Time Frame: Baseline (Cycle 1 Day 1: Predose) and at designated time points: Predose; each cycle is 21 days (Up to approximately 2 years) ]
    The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The GHS Score consists of participant responses to questions regarding GHS (How would you rate your overall health during the past week?). For GHS, responses range in score from 0 to 100, with a higher score indicating a better outcome. The change from Baseline in GHS Score will be presented.

  6. Change from Baseline in European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire-Core 30 [QLQ-C30] Physical Function (PF) Score [ Time Frame: Baseline (Cycle 1 Day 1: Predose) and at designated time points: Predose; each cycle is 21 days (Up to approximately 2 years) ]
    The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The PF Score consists of participant responses to questions regarding PF (5 questions about daily activities [strenuous activities, long walks, short walks, bed/chair rest and needing help with eating, dressing, washing themselves or using the toilet]. For PF, responses range in score from 0 to 100, with a higher score indicating a better outcome. The change from Baseline in PF Score will be presented.

  7. Time to True Deterioration (TTD) Based on Change from Baseline in European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire-Core 30 [QLQ-C30] in Global Health Status (GHS) Score [ Time Frame: Up to approximately 2 years ]
    TTD is defined as the time from Baseline to 1st onset of a ≥10-point negative change (decrease) in EORTC-QLQ-C30 GHS Score. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The GHS Score consists of participant responses to questions regarding GHS (How would you rate your overall health during the past week?). For GHS, responses range in score from 0 to 100, with a higher score indicating a better outcome. TTD, based on a ≥10-point negative change (decrease) from Baseline in GHS Score will be presented.

  8. Time to True Deterioration (TTD) Based on Change from Baseline in European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire-Core 30 [QLQ-C30] in Physical Function (PF) Score [ Time Frame: Up to approximately 2 years ]
    TTD is defined as the time from Baseline to 1st onset of a ≥10-point negative change (decrease) in EORTC-QLQ-C30 PF Score. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The PF Score consists of participant responses to questions regarding PF (5 questions about daily activities [strenuous activities, long walks, short walks, bed/chair rest & needing help with eating, dressing, washing themselves or using the toilet]. For PF, responses range in score from 0 to 100, with a higher score indicating a better outcome. TTD, based on a ≥10-point negative change (decrease) from Baseline in PF Score will be presented.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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: a. 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. b. 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.
  • 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 120 days after the last dose of study treatment and refrain from donating sperm during this period
  • Female participants must not be pregnant, not breastfeeding, and ≥1 of the following conditions applies: a. Not a woman of childbearing potential (WOCBP) OR b. 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
  • Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mmHg at screening and no change in antihypertensive medications within 1 week before Cycle 1 Day 1
  • Has adequate organ function

Exclusion Criteria:

  • 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 that required steroids or current pneumonitis
  • Has a history of active tuberculosis (Bacillus tuberculosis)
  • Has presence of gastrointestinal condition including malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib
  • Has had a major surgery within 4 weeks prior to Cycle 1 Day 1. Adequate wound healing after major surgery must be assessed clinically and have resolved completely prior to Cycle 1 Day 1.
  • Has a pre-existing Grade ≥3 gastrointestinal or non-gastrointestinal fistula
  • Has radiographic evidence of major blood vessel invasion/infiltration
  • Has clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study treatment
  • Has clinically significant cardiovascular disease within 12 months of the first dose of study treatment 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 received prior systemic treatment for unresectable or metastatic melanoma other than targeted therapy as noted in Inclusion Criteria above
  • Has received prior therapy with a monoclonal antibody, chemotherapy, or an investigational agent or device within 4 weeks or 5 half-lives (whichever is longer) before administration of study treatment or not recovered (≤Grade 1 or at Baseline) from adverse events due to previously administered agents.

Exception to this rule would be use of denosumab, which is not excluded. Note: Participants with alopecia and ≤Grade 2 neuropathy are an exception and may enroll.

  • Has received prior radiotherapy within 2 weeks of first dose of study treatment (Cycle 1 Day 1) with the exception of palliative radiotherapy to bone lesions, which is allowed if completed 2 weeks prior to Cycle 1 Day 1. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
  • Has received live vaccine within 30 days before the first dose of study treatment
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
  • Has had an allogeneic tissue/solid organ transplant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820986


Contacts
Layout table for location contacts
Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
Hide Hide 88 study locations
Layout table for location information
United States, California
The Angeles Clinic and Research Institute ( Site 0707) Recruiting
Los Angeles, California, United States, 90025
Contact: Study Coordinator    310-231-2181      
California Pacific Medical Center Research Institute ( Site 0705) Recruiting
San Francisco, California, United States, 94115
Contact: Study Coordinator    415-600-3472      
UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0704) Recruiting
San Francisco, California, United States, 94115
Contact: Study Coordinator    813-745-8581      
John Wayne Cancer Institute ( Site 0706) Recruiting
Santa Monica, California, United States, 90404
Contact: Study Coordinator    310-582-7455      
United States, Colorado
University of Colorado Cancer Center ( Site 0708) Recruiting
Aurora, Colorado, United States, 80045
Contact: Study Coordinator    720-848-7135      
United States, Connecticut
Yale Cancer Center ( Site 0709) Recruiting
New Haven, Connecticut, United States, 06520-8063
Contact: Study Coordinator    203-737-5381      
United States, Illinois
AMG Oncology ( Site 0714) Recruiting
Niles, Illinois, United States, 60714
Contact: Study Coordinator    847-410-0658      
United States, Montana
St. Vincent Frontier Cancer Center ( Site 0724) Recruiting
Billings, Montana, United States, 59102
Contact: Study Coordinator    406-238-6290      
United States, North Carolina
University of North Carolina - Cancer Hospital ( Site 0751) Recruiting
Chapel Hill, North Carolina, United States, 28512
Contact: Study Coordinator    919-966-6416      
United States, Oregon
OHSU Center for Health & Healing ( Site 0731) Recruiting
Portland, Oregon, United States, 97239
Contact: Study Coordinator    503-494-1080      
United States, Virginia
Inova Schar Cancer Institute ( Site 0739) Recruiting
Fairfax, Virginia, United States, 22031-4867
Contact: Study Coordinator    571-472-0237      
Australia, New South Wales
Westmead Hospital ( Site 0451) Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Study Coordinator    +61298458543      
Melanoma Institute Australia ( Site 0452) Recruiting
Wollstonecraft, New South Wales, Australia, 2065
Contact: Study Coordinator    +61299117321      
Australia, Queensland
Princess Alexandra Hospital ( Site 0454) Recruiting
Wooloongabba, Queensland, Australia, 4102
Contact: Study Coordinator    +61731767825      
Australia, Victoria
Eastern Health ( Site 0457) Recruiting
Box Hill, Victoria, Australia, 3128
Contact: Study Coordinator    +61398953281      
Australia, Western Australia
Fiona Stanley Hospital ( Site 0456) Recruiting
Perth, Western Australia, Australia, 6150
Contact: Study Coordinator    +61861526530      
Australia
Lismore Base Hospital ( Site 0453) Recruiting
Lismore, Australia, 2480
Contact: Study Coordinator    +61266202416      
Brazil
PERSONAL - Oncologia de Precisao e Personalizada ( Site 0399) Recruiting
Belo Horizonte, Minas Gerais, Brazil, 30130-090
Contact: Study Coordinator    +553136576864      
Instituto Nacional de Cancer Hospital do Cancer II ( Site 0394) Recruiting
Rio de Janeiro, RJ, Brazil, 20220-410
Contact: Study Coordinator    +552122764964      
Hospital de Caridade de Ijui ( Site 0391) Recruiting
Ijui, RS, Brazil, 98700-000
Contact: Study Coordinator    +555533319393      
Hospital Sao Vicente de Paulo ( Site 0396) Recruiting
Passo Fundo, RS, Brazil, 99010-080
Contact: Study Coordinator    +555421034130      
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0397) Recruiting
Porto Alegre, RS, Brazil, 90610-000
Contact: Study Coordinator    +555133203039      
Canada, British Columbia
BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 0661) Recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
Contact: Study Coordinator    2507123966686740      
Lions Gate Hospital ( Site 0662) Completed
North Vancouver, British Columbia, Canada, V7L 2L7
Canada, Ontario
Sunnybrook Research Institute ( Site 0654) Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Study Coordinator    4164804662      
Canada, Quebec
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0652) Recruiting
Montreal, Quebec, Canada, H2X 3E4
Contact: Study Coordinator    514890800013680      
McGill University Health Centre ( Site 0651) Recruiting
Montreal, Quebec, Canada, H4A 3J1
Contact: Study Coordinator    514934193435033      
Chile
Fundacion Arturo Lopez Perez FALP ( Site 0421) Recruiting
Santiago, Chile, 7500921
Contact: Study Coordinator    +5624205100      
Pontificia Universidad Catolica de Chile ( Site 0422) Recruiting
Santiago, Chile, 8330024
Contact: Study Coordinator    +56996898431      
Sociedad Medica Aren y Bachero Limitada ( Site 0426) Recruiting
Santiago, Chile, 8420383
Contact: Study Coordinator    +56954240723      
Instituto Clinico Oncologico del Sur ( Site 0425) Recruiting
Temuco, Chile, 4810469
Contact: Study Coordinator    +56995579412      
Oncocentro ( Site 0424) Recruiting
Vina del Mar, Chile, 2520598
Contact: Study Coordinator    +56992369820      
France
Centre Hospitalier Victor Dupouy ( Site 0012) Recruiting
Argenteuil, France, 95100
Contact: Study Coordinator    +33134231445      
Hopital Ambroise Pare Boulogne ( Site 0007) Recruiting
Boulogne-Billancourt, France, 92100
Contact: Study Coordinator    +33149095771      
CHU Dijon Bourgogne ( Site 0010) Recruiting
Dijon, France, 21079
Contact: Study Coordinator    +33380293336      
CHRU Lille - Hopital Claude Huriez ( Site 0004) Recruiting
Lille, France, 59037
Contact: Study Coordinator    +33320444193      
Hopital La Timone ( Site 0002) Recruiting
Marseille, France, 13385
Contact: Study Coordinator    +33491388801      
Hopital ARCHET 2 ( Site 0009) Recruiting
Nice, France, 06200
Contact: Study Coordinator    +33492036223      
CHU de la Miletrie Poitiers ( Site 0011) Recruiting
Poitiers, France, 86021
Contact: Study Coordinator    +33549444459      
CHU de Rouen ( Site 0013) Recruiting
Rouen, France, 76000
Contact: Study Coordinator    +33232888141      
Institut Claudius Regaud IUCT Oncopole ( Site 0003) Recruiting
Toulouse, France, 31059
Contact: Study Coordinator    +33531155812      
Institut Gustave Roussy ( Site 0001) Recruiting
Villejuif, France, 94800
Contact: Study Coordinator    +33142114210      
Germany
Hautkrebszentrum Buxtehude ( Site 0037) Recruiting
Buxtehude, Germany, 21614
Contact: Study Coordinator    +4941617036250      
Universitaetsklinikum Carl Gustav Carus ( Site 0041) Recruiting
Dresden, Germany, 01307
Contact: Study Coordinator    +4935145819782      
Klinik fur Dermatologie Allergologie und Venerologie ( Site 0035) Recruiting
Hannover, Germany, 30625
Contact: Study Coordinator    +4951192460      
Universitaets-Hautklinik Kiel ( Site 0033) Recruiting
Kiel, Germany, 24105
Contact: Study Coordinator    +4943150021131      
Universitaetsklinikum Leipzig ( Site 0040) Recruiting
Leipzig, Germany, 04103
Contact: Study Coordinator    +493419718600      
Universitaetsklinikum Wuerzburg ( Site 0036) Recruiting
Wuerzburg, Germany, 97080
Contact: Study Coordinator    +4993120126779      
Israel
HaEmek Medical Center ( Site 0306) Recruiting
Afula, Israel, 1834111
Contact: Study Coordinator    +97246495723      
Soroka Medical Center ( Site 0303) Recruiting
Beer Sheva, Israel, 8457108
Contact: Study Coordinator    +97286400797      
Rambam Medical Center ( Site 0301) Recruiting
Haifa, Israel, 3109601
Contact: Study Coordinator    +97248543811      
Hadassah Ein Karem Hebrew University Medical Center ( Site 0305) Recruiting
Jerusalem, Israel, 9112001
Contact: Study Coordinator    +97226776781      
Rabin Medical Center ( Site 0302) Recruiting
Petah Tikva, Israel, 4941492
Contact: Study Coordinator    +97239378016      
Chaim Sheba Medical Center ( Site 0304) Recruiting
Ramat Gan, Israel, 5262000
Contact: Study Coordinator    +97235302243      
Italy
ASST Papa Giovanni XXIII ( Site 0062) Recruiting
Bergamo, Italy, 24127
Contact: Study Coordinator    +390352673687      
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0064) Recruiting
Milano, Italy, 20133
Contact: Study Coordinator    +390223902557      
Istituto Europeo di Oncologia ( Site 0067) Recruiting
Milano, Italy, 20141
Contact: Study Coordinator    +390257489459      
Istituto Nazionale Tumori Fondazione Pascale ( Site 0061) Recruiting
Napoli, Italy, 80131
Contact: Study Coordinator    +390815903236      
Istituto Oncologico Veneto ( Site 0063) Recruiting
Padova, Italy, 35128
Contact: Study Coordinator    +390498215931      
Azienda Ospedaliera Universitaria Senese ( Site 0065) Recruiting
Siena, Italy, 53100
Contact: Study Coordinator    +390577586303      
Korea, Republic of
Kyungpook National University Chilgok Hospital ( Site 0553) Recruiting
Daegu, Korea, Republic of, 41404
Contact: Study Coordinator    +82532003017      
Seoul National University Hospital ( Site 0554) Recruiting
Seoul, Korea, Republic of, 03080
Contact: Study Coordinator    +82220722216      
Severance Hospital Yonsei University Health System ( Site 0552) Recruiting
Seoul, Korea, Republic of, 03722
Contact: Study Coordinator    +82222288137      
Samsung Medical Center ( Site 0551) Recruiting
Seoul, Korea, Republic of, 06351
Contact: Study Coordinator    +82230101779      
Spain
Hospital Duran i Reinals ICO de Hospitalet ( Site 0187) Recruiting
Hospitalet del Llobregat, Barcelona, Spain, 08908
Contact: Study Coordinator    +34932607333      
Complejo Hospitalario Universitario A Coruna. CHUAC ( Site 0182) Recruiting
A Coruna, Galicia, Spain, 15006
Contact: Study Coordinator    +34981178000      
Hospital Universitario Insular de Gran Canaria ( Site 0189) Recruiting
Las Palmas de Gran Canaria, Gran Canaria, Spain, 35001
Contact: Study Coordinator    +34928444000      
Hospital Clinic i Provincial Barcelona ( Site 0190) Recruiting
Barcelona, Spain, 08036
Contact: Study Coordinator    +34932275402      
Hospital General Universitario Gregorio Maranon ( Site 0191) Recruiting
Madrid, Spain, 28009
Contact: Study Coordinator    +34914269394      
Hospital Universitario Ramon y Cajal ( Site 0183) Recruiting
Madrid, Spain, 28034
Contact: Study Coordinator    +34913368263      
Hospital Universitario La Paz ( Site 0184) Recruiting
Madrid, Spain, 28046
Contact: Study Coordinator    +34912071138      
Hospital Universitario Carlos Haya ( Site 0186) Recruiting
Malaga, Spain, 29010
Contact: Study Coordinator    +34951291425      
Hospital Universitario Marques de Valdecilla ( Site 0181) Recruiting
Santander, Spain, 39008
Contact: Study Coordinator    +34942202525      
Sweden
Sahlgrenska Universitetssjukhuset ( Site 0212) Recruiting
Goteborg, Sweden, 413 45
Contact: Study Coordinator    +46313428801      
Laenssjukhuset Ryhov ( Site 0215) Recruiting
Jonkoping, Sweden, 551 85
Contact: Study Coordinator    +46102422142      
Skanes Universitetssjukhus ( Site 0213) Recruiting
Lund, Sweden, 221 85
Contact: Study Coordinator    +4646177520      
Karolinska Universitetssjukhuset ( Site 0211) Recruiting
Solna, Sweden, 171 64
Contact: Study Coordinator    +46851770000      
Norrlands Universitetssjukhus ( Site 0216) Recruiting
Umea, Sweden, 901 85
Contact: Study Coordinator    +46907851993      
Akademiska Sjukhuset ( Site 0218) Recruiting
Uppsala, Sweden, 751 85
Contact: Study Coordinator    +46186110000      
Centrallasarettet Vaxjo ( Site 0214) Recruiting
Vaxjo, Sweden, 351 85
Contact: Study Coordinator    +46470588000      
Switzerland
Universitaetsspital Basel ( Site 0094) Recruiting
Basel, Switzerland, 4031
Contact: Study Coordinator    +41612655074      
Kantonsspital Graubuenden ( Site 0091) Recruiting
Chur, Switzerland, 7000
Contact: Study Coordinator    +41812566646      
Kantonsspital Winterthur ( Site 0095) Recruiting
Winterthur, Switzerland, 8401
Contact: Study Coordinator    +41522663065      
Universitaetsspital Zuerich ( Site 0092) Recruiting
Zuerich, Switzerland, 8091
Contact: Study Coordinator    +41442552588      
United Kingdom
Western General Hospital ( Site 0121) Recruiting
Edinburgh, United Kingdom, EH4 2XU
Contact: Study Coordinator    +441315373035      
Guys and St Thomas NHS Foundation Trust ( Site 0126) Recruiting
London, United Kingdom, SE1 9RT
Contact: Study Coordinator    +442071884244      
Derriford Hospital ( Site 0129) Recruiting
Plymouth, United Kingdom, PL6 8DH
Contact: Study Coordinator    +441752431957      
Singleton Hospital ( Site 0131) Recruiting
Swansea, United Kingdom, SA2 8QA
Contact: Study Coordinator    +441792285299      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Eisai Inc.
Investigators
Layout table for investigator information
Study Director: Medical Director Merck Sharp & Dohme Corp.

Additional Information:
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03820986    
Other Study ID Numbers: 7902-003
2018-002520-16 ( EudraCT Number )
MK-7902-003 ( Other Identifier: Merck Protocol Number )
E7080-G000-312 ( Other Identifier: Eisai Protocol Number )
LEAP-003 ( Other Identifier: Merck )
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Merck Sharp & Dohme Corp.:
programmed cell death 1 (PD-1, PD1)
programmed cell death-ligand 1 (PD-L1, PDL1)
programmed cell death-ligand 2 (PD-L2, PDL2)
Additional relevant MeSH terms:
Layout table for MeSH terms
Melanoma
Nevi and Melanomas
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Pembrolizumab
Lenvatinib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action