Back to results

Study of First-line Pembrolizumab (MK-3475) With Lenvatinib (MK-7902/E7080) in Urothelial Carcinoma Cisplatin-ineligible Participants Whose Tumors Express Programmed Cell Death-Ligand 1 and in Participants Ineligible for Platinum-containing Chemotherapy (MK-7902-011/E7080-G000-317/ LEAP-011)

Primary Purpose

Urothelial Carcinoma

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Pembrolizumab

Lenvatinib

Placebo for lenvatinib

About this trial

This is an interventional treatment trial for Urothelial Carcinoma focused on measuring Advanced or metastatic urothelial cancer, Lenvatinib, Pembrolizumab, Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Has a histologically or cytologically confirmed diagnosis of advanced/unresectable (inoperable) or metastatic urothelial carcinoma (UC) of the renal pelvis, ureter (upper urinary tract), bladder, or urethra.
Has ≥1 measurable target lesion per RECIST 1.1 as assessed by the local site investigator/radiologist.
Has provided an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated and adequate for Programmed Death-Ligand 1 (PD-L1) evaluation.
Has received no prior systemic chemotherapy for advanced or metastatic UC with the following exceptions:
Neoadjuvant (prior to surgery) platinum-based chemotherapy for treatment of muscle-invasive bladder cancer with recurrence >12 months from completion of the therapy is permitted.
Adjuvant (following surgery) platinum-based chemotherapy following radical cystectomy, with recurrence >12 months from completion of the therapy, is permitted.
Meets criteria for either option a or option b (below):
a. Has a tumor(s) with PD-L1 combined positive score (CPS) ≥10 and is considered ineligible to receive cisplatin-based combination therapy, based on 1 of the following:
Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 2 within 7 days prior to randomization
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Grade ≥2 audiometric hearing loss
NCI CTCAE Version 4.0 Grade ≥2 peripheral neuropathy OR
b. In the opinion of the investigator, is considered ineligible to receive any platinum-based chemotherapy (i.e., ineligible for cisplatin and carboplatin) based on:
ECOG PS of 2 within 7 days prior to randomization. and ≥1 of the following:
Documented visceral metastatic disease
NCI CTCAE Version 4.0 Grade ≥2 audiometric hearing loss
NCI CTCAE Version 4.0 Grade ≥2 peripheral neuropathy
Other reason for the participant's being unable to receive both cisplatin and carboplatin safely. Additional criteria for platinum ineligibility will be considered and allowed on a case-by-case basis, following consultation with the Sponsor. Note: Participants considered ineligible for any platinum-based chemotherapy are eligible for this study regardless of their tumor PD-L1 status.
Has ECOG PS 0, 1, or 2 within 7 days prior to randomization and a life expectancy of ≥3 months.
Male participants are eligible to participate if they agree to the following during the treatment period and for ≥30 days after the last dose of pembrolizumab or lenvatinib/placebo:
Be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent, OR
Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause as detailed below:
Agrees to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.
A female participant is eligible to participate if she is not pregnant or breastfeeding and if she is not a WOCBP OR is a WOCBP and is using a contraceptive method that is highly effective (with a failure rate of <1% per year) with low user dependency, or is abstinent from heterosexual intercourse as her preferred and usual lifestyle during the intervention period and for ≥120 days post pembrolizumab or ≥30 days post lenvatinib/placebo.
Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mm Hg at screening and no change in antihypertensive medications within 1 week prior to randomization.
Has adequate organ function.

Exclusion Criteria:

Has disease that is suitable for local therapy administered with curative intent (e.g. chemotherapy and radiation for Stage 3 disease).
Has tumor with any neuroendocrine or small cell component.
Has a history of a gastrointestinal condition or procedure (e.g. gastric bypass, malabsorption) that, in the opinion of the investigator, may affect oral drug absorption.
Has had major surgery within 3 weeks prior to the first dose of study treatment
Has a pre-existing Grade ≥3 gastrointestinal or non-gastrointestinal fistula.
Has radiographic evidence of major blood vessel invasion/infiltration, or has had clinically significant hemoptysis (≥0.5 teaspoon of bright red blood) or tumor bleeding within 2 weeks prior to the first dose of study treatment.
Has had significant cardiovascular impairment within 12 months of the first dose of study treatment, such as history of New York Heart Association (NYHA) >Class II congestive heart failure, unstable angina, myocardial infarction or cerebrovascular accident (CVA)/stroke, cardiac revascularization procedure, or cardiac arrhythmia associated with hemodynamic instability.
Has known intolerance or severe hypersensitivity (Grade ≥3) to pembrolizumab or lenvatinib or any of their excipients
Has received lenvatinib as monotherapy or in combination with a programmed cell death-1/programmed cell death-ligand 1 (PD-1/PD-L1) inhibitor or has previously been enrolled in a clinical study evaluating lenvatinib for bladder cancer, regardless of the treatment received.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 inhibitor, indoleamine-pyrrole 2,3 dioxygenase (IDO1) inhibitor, or agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4], OX 40, CD137), or any other antibody or drug targeting T-cell costimulatory pathways in the adjuvant or advanced/metastatic setting.
Has received prior radiotherapy to a metastatic site without the use of chemotherapy radiosensitization within 3 weeks of the first dose of study treatment, with the exception of palliative radiotherapy to bone lesions, which is allowed if completed 2 weeks before the start of study treatment. Participants must have recovered from all radiation-related toxicities, and must not require corticosteroids.
Has received a live vaccine within 30 days prior to the first dose of study treatment.
In the investigator's judgment, has not recovered from toxicity or other complications from any major surgery prior to starting 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. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
Has history or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful.
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (at a dose exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization.
Has had an active malignancy (except locally advanced or metastatic UC) within the past 36 months. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) who have undergone potentially curative therapy are not excluded.
Has a history of prostate cancer (T2NXMX or lower with Gleason score ≤7) treated with definitive intent (surgically or with radiation therapy) ≥1 year prior to study entry is acceptable, provided that the participant is considered prostate cancer-free.
Has central nervous system (CNS) metastases, unless the participant has completed local therapy (e.g. whole brain radiation therapy, surgery, or radiosurgery) and has discontinued use of corticosteroids for this indication for ≥4 weeks before starting study treatment. Any signs (e.g. radiologic) or symptoms of CNS metastases must be stable for ≥4 weeks before starting study treatment.
Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e, with disease-modifying agents, corticosteroids, or immunosuppressive drugs).
Has a history of (non-infectious) pneumonitis that required systemic steroids, or current pneumonitis.
Has an active infection requiring systemic therapy.
Has a known history of human immunodeficiency virus (HIV) infection.
Has a known history of or is positive for active hepatitis B virus (HBV) or has active hepatitis C virus (HCV).
Has active tuberculosis (TB).
Is receiving hemodialysis.
Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of pembrolizumab and lenvatinib/placebo.
Has had an allogeneic tissue/solid organ transplant.

Sites / Locations

Banner MD Anderson Cancer Center ( Site 0016)
Community Cancer Institute ( Site 0777)
University of California Irvine Medical Center ( Site 0078)
John Wayne Cancer Institute ( Site 0017)
Northwest Georgia Oncology Centers PC ( Site 0707)
University of Chicago ( Site 0039)
Joliet Oncology Hematology ( Site 0091)
Quincy Medical Group ( Site 0022)
New England Cancer Specialists ( Site 0047)
Karmanos Cancer Institute ( Site 0712)
Mercy Hospital Saint Louis - David C. Pratt Cancer Center ( Site 0095)
Comprehensive Cancer Centers of Nevada ( Site 0005)
St. Peter's Hospital Cancer Care Center ( Site 0042)
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0002)
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0774)
Thomas Jefferson University Hospital ( Site 0051)
Medical University of South Carolina-Hollings Cancer Center ( Site 0029)
Baylor Scott & White Medical Center - Temple ( Site 0706)
Virginia Cancer Institute ( Site 0099)
Seattle Cancer Care Alliance ( Site 0003)
Cancer Care Northwest ( Site 0009)
Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0577)
Centro de Urología CDU ( Site 0590)
Instituto Medico Alexander Fleming ( Site 0578)
Centro de Investigaciones Clinicas - Clinica Viedma ( Site 0585)
Centro Oncológico de Rosario ( Site 0584)
Instituto de Investigaciones Metabolicas ( Site 0589)
Centro Medico Dra De Salvo ( Site 0593)
CEMAIC ( Site 0581)
Centro Oncologico de Integracion Regional. COIR ( Site 0576)
Macquarie University ( Site 0151)
Mater Misericordiae Ltd ( Site 0158)
Monash Health ( Site 0160)
Peninsula Health Frankston Hospital ( Site 0153)
Austin Health-Austin Hospital ( Site 0154)
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0101)
Lakeridge Health ( Site 0103)
Sunnybrook Research Institute ( Site 0106)
CIUSSS de l Estrie Centre Hospitalier Universitaire de Sherbrooke ( Site 0102)
CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0104)
Peking University First Hospital ( Site 0726)
Fifth Medical Center of CPLA General Hospital ( Site 0732)
Peking University Third Hospital ( Site 0727)
Chongqing Cancer Hospital ( Site 0741)
The First Affiliated Hospital of Xiamen University ( Site 0743)
Sun Yat-Sen University Cancer Center ( Site 0752)
The First Affiliated Hospital of Guangzhou Medical University ( Site 0749)
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ( Site 0746)
Harbin Medical University Cancer Hospital ( Site 0750)
Hubei Cancer Hospital ( Site 0744)
Hunan Cancer Hospital ( Site 0745)
Nanjing Drum Tower Hospital ( Site 0737)
Fudan University Shanghai Cancer Center ( Site 0721)
Zhongshan Hospital Fudan University ( Site 0725)
The First Affiliated Hospital of Xi an Jiaotong University ( Site 0738)
Cancer Hospital Affiliated to Xinjiang Medical University ( Site 0751)
Second Affiliated Hospital, Zhejiang University ( Site 0734)
Zhejiang Provincial People's Hospital ( Site 0735)
Rigshospitalet ( Site 0680)
Herlev Hospital ( Site 0681)
Aarhus Universitets hospital ( Site 0683)
Aalborg Universitets Hospital ( Site 0684)
Odense Universitetshospital ( Site 0682)
CHU Poitiers ( Site 0253)
Institut de Cancerologie Strasbourg Europe ( Site 0232)
Hopital de la Timone ( Site 0246)
CHIC Quimper ( Site 0245)
CHU de Bordeaux- Hopital Saint Andre ( Site 0235)
Clinique Pasteur ( Site 0252)
Centre de Cancerologie du Grand Montpellier ( Site 0249)
Centre Rene Gauducheau ICO ( Site 0250)
Institut de Cancerologie de l Ouest Site Paul Papin ( Site 0236)
Centre D Oncologie de Gentilly ( Site 0240)
Centre Hospitalier de la Cote Basque ( Site 0239)
Centre Leon Berard ( Site 0244)
Institut Gustave Roussy ( Site 0243)
CHD Vendee-onco-hematologie ( Site 0251)
Institut Curie ( Site 0237)
Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0271)
Universitaetsklinikum Giessen und Marburg GmbH ( Site 0284)
Helios Kliniken Schwerin GmbH ( Site 0278)
Universitaetsmedizin Goettingen ( Site 0281)
Universitaetsklinikum Essen ( Site 0274)
Staedtisches Krankenhaus Kiel GmbH ( Site 0285)
Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0277)
Universitaetsklinikum Hamburg-Eppendorf ( Site 0282)
Bacs-Kiskun Megyei Korhaz ( Site 0510)
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás Ce
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0507)
Markusovszky Egyetemi Oktatokorhaz ( Site 0502)
Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 0509)
Orszagos Onkologiai Intezet ( Site 0503)
Uzsoki Utcai Korhaz ( Site 0508)
Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 0504)
Ha Emek Medical Center ( Site 0560)
Assuta Ashdod Public ( Site 0562)
Rambam Medical Center ( Site 0552)
Shaare Zedek Medical Center ( Site 0559)
Hadassah Ein Kerem Medical Center ( Site 0558)
Meir Medical Center ( Site 0554)
Rabin Medical Center ( Site 0553)
Sheba Medical Center ( Site 0551)
Sourasky Medical Center ( Site 0561)
Assaf Harofeh Medical Center ( Site 0556)
Ospedale San Raffaele-Oncologia Medica ( Site 0309)
ASST Grande Ospedale Metropolitano Niguarda ( Site 0307)
Centro di Riferimento Oncologico CRO ( Site 0304)
Istituto Tumori Giovanni Paolo II ( Site 0306)
Policlinico S. Orsola - Malpighi (Bologna) ( Site 0302)
Azienda Ospedaliera per l Emergenza Cannizzaro ( Site 0305)
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0301)
Azienda Ospedaliera Santa Maria ( Site 0303)
Ospedale Borgo Roma-Oncologia ( Site 0308)
Hirosaki University Hospital ( Site 0123)
National Cancer Center Hospital East ( Site 0128)
Ehime University Hospital ( Site 0137)
Sapporo Medical University Hospital ( Site 0122)
University of Tsukuba Hospital ( Site 0126)
Kitasato University Hospital ( Site 0129)
Nara Medical University Hospital ( Site 0133)
Saitama Medical University International Medical Center ( Site 0125)
Yamaguchi University Hospital ( Site 0135)
Akita University Hospital ( Site 0124)
Chiba Cancer Center ( Site 0127)
Nagasaki University Hospital ( Site 0136)
Osaka City University Hospital ( Site 0132)
Tokushima University Hospital ( Site 0134)
Medical Hospital, Tokyo Medical And Dental University ( Site 0130)
Chonnam National University Hwasun Hospital ( Site 0194)
National Cancer Center ( Site 0196)
Chungnam National University Hospital ( Site 0195)
Korea University Anam Hospital ( Site 0197)
Seoul National University Hospital ( Site 0191)
Severance Hospital ( Site 0192)
Veterans Health Service Medical Center ( Site 0198)
Samsung Medical Center ( Site 0193)
Ziekenhuis Rijnstate ( Site 0342)
Maastricht Universitair Medisch Centrum - MUMC ( Site 0334)
VieCuri Medisch Centrum ( Site 0340)
Amphia Ziekenhuis Breda ( Site 0331)
Deventer Ziekenhuis ( Site 0341)
Haga Ziekenhuis ( Site 0333)
Erasmus MC ( Site 0332)
St. Antonius Ziekenhuis ( Site 0335)
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 0535)
Szpital Wojewodzki ( Site 1062)
Europejskie Centrum Zdrowia Otwock ( Site 0532)
Urologica Praktyka Lekarska Adam Marcheluk ( Site 0543)
Luxmed Onkologia sp. z o. o. ( Site 0541)
Szpital Miejski im. Jana Pawła II w Bielsku-Białej ( Site 0542)
GBUZ Leningrad Regional Clinical Oncology Dispensary ( Site 0426)
Russian Scientific Center of Roentgenoradiology ( Site 0424)
Central Clinical Hospital with Polyclinic ( Site 0415)
Medical Rehabilitation Center ( Site 0411)
Murmansk Regional Oncology Dispensary ( Site 0420)
Volga District Medical Center Federal Medical and Biological Agency ( Site 0413)
Omsk Clinical Oncology Dispensary ( Site 0418)
Clinical Hospital Saint Luka ( Site 0421)
Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 0414)
Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 0351)
ICO L Hospitalet ( Site 0361)
Xarxa Assistencial Universitaria Manresa ( Site 0354)
Hospital Teresa Herrera - Chuac ( Site 0357)
Hospital Universitario HM Sanchinarro ( Site 0356)
Hospital Infanta Cristina ( Site 0355)
Hospital General Universitari Vall d Hebron ( Site 0358)
Hospital La Princesa ( Site 0862)
Hospital Universitario Gregorio Maranon ( Site 0352)
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 0216)
Kaohsiung Chang Gung Memorial Hospital ( Site 0217)
China Medical University Hospital ( Site 0213)
Taichung Veterans General Hospital ( Site 0214)
National Cheng Kung University Hospital ( Site 0215)
National Taiwan University Hospital ( Site 0211)
Taipei Veterans General Hospital ( Site 0212)
Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi ( Site 0457)
Ankara Sehir Hastanesi ( Site 0455)
Antalya Memorial Hospital Department of Medical Oncology ( Site 0461)
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0454)
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0459)
Ege Universitesi Tulay Aktas Onkoloji Hastanesi ( Site 0462)
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0456)
Sakarya Universitesi Tip Fakultesi Arastirma Hastanesi ( Site 0460)
Weston Park Hospital ( Site 0387)
Queens Hospital-Purple Zone ( Site 0377)
Lister Hospital ( Site 0376)
Kent and Canterbury Hospital ( Site 0390)
Royal Preston Hospital ( Site 0379)
Saint Bartholomew s Hospital - London ( Site 0386)
University College London Hospital NHS Foundation Trust ( Site 0380)
Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 0378)
Nottingham University Hospital NHS Trust ( Site 0383)
Derriford Hospital ( Site 0388)
Royal Stoke University Hospital Univ. Hosps of North Midlands NHST ( Site 0392)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Pembrolizumab+Lenvatinib

Pembrolizumab+Placebo

Pembrolizumab monotherapy

Arm Description

Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) until progressive disease or discontinuation. Lenvatinib may be continued past 35 cycles until a discontinuation criterion is met.

Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD until progressive disease or discontinuation. Placebo may be continued past 35 cycles until a discontinuation criterion is met.

Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (approximately 2 years) until progressive disease or discontinuation.

Outcomes

Primary Outcome Measures

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

PFS is defined as the time from randomization to the first documented 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 ≥1 new lesions is also considered PD.

Overall Survival (OS)

OS is defined as the time from randomization to the date of death from any cause.

Secondary Outcome Measures

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1.

Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

DOR is defined as the time from the first documented evidence of Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) to the earliest date of progressive disease (PD; 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 ≥1 new lesions is also considered PD) or death due to any cause, whichever comes first, for participants with a confirmed CR or PR.

Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

DCR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. Note: The appearance of ≥1 new lesions is also considered PD.])

Change from Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score

The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life (QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in GHS (EORTC QLQ-C30 Item 29) and QoL (EORTC QLQ-C30 Item 30) combined score will be presented. A higher score indicates a better outcome.

Time to Deterioration (TTD) in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score

TTD is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) from baseline in Global Health Status (GHS; EORTC QLQ-C30 Item 29) & Quality of Life (QoL; EORTC QLQ-C30 Item 30) combined score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in GHS and QoL combined score, will be presented. A longer TTD indicates a better outcome.

Number of Participants Who Experience an Adverse Event (AE)

An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Number of Participants Who Discontinue Study Treatment Due to an AE

The number of participants who discontinue study treatment due to an AE will be presented.

Full Information

NCT ID

NCT03898180

First Posted

March 29, 2019

Last Updated

December 15, 2022

Sponsor

Merck Sharp & Dohme LLC

Collaborators

Eisai Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03898180

Brief Title

Study of First-line Pembrolizumab (MK-3475) With Lenvatinib (MK-7902/E7080) in Urothelial Carcinoma Cisplatin-ineligible Participants Whose Tumors Express Programmed Cell Death-Ligand 1 and in Participants Ineligible for Platinum-containing Chemotherapy (MK-7902-011/E7080-G000-317/ LEAP-011)

Official Title

A Phase 3, Randomized, Double-blind Study to Compare the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Lenvatinib (E7080/MK-7902) Versus Pembrolizumab and Placebo as First Line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma in Cisplatin-ineligible Participants Whose Tumors Express PD-L1, and in Participants Ineligible for Any Platinum-containing Chemotherapy Regardless of PD-L1 Expression (LEAP-011)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 6, 2019 (Actual)

Primary Completion Date

October 31, 2023 (Anticipated)

Study Completion Date

October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

Collaborators

Eisai Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of lenvatinib (MK-7902/E7080) in combination with pembrolizumab (MK-3475) in the treatment of cisplatin-ineligible participants with a Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10, or in participants ineligible for any platinum-containing chemotherapy regardless of CPS, with advanced/unresectable or metastatic urothelial carcinoma (UC). The primary hypotheses for this study are that: Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR), and Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Overall Survival (OS). With Amendment 3 study treatment with lenvatinib and placebo was discontinued, and all participants were unblinded and continued treatment with pembrolizumab monotherapy only. The pembrolizumab+lenvatinib and the pembrolizumab+placebo arms are no longer active for this study. With Amendment 3 the external Data Monitoring Committee was discontinued. With Amendment 4 Second Course will no longer be offered. Any participant receiving Second Course treatment prior to initiation of Amendment 4 will be able to complete treatment as planned. With Amendment 4 study participation will end after the final administration of pembrolizumab. Participants who either complete 35 administrations of pembrolizumab or discontinue pembrolizumab will discontinue from the study following the safety follow-up visit. AEs and spontaneously reported pregnancies will be reported and followed per protocol. All participants in efficacy follow-up prior to initiation of Amendment 4 will stop efficacy assessments and be discontinued from the study. All participants in survival follow-up prior to initiation of Amendment 4 are considered to have completed the study and should have a final survival contact. The overall study ends when the last participant completes the last study-related contact or visit, withdraws from the study, or is lost to follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urothelial Carcinoma

Keywords

Advanced or metastatic urothelial cancer, Lenvatinib, Pembrolizumab, Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

The study was unblinded with Amendment 3.

Allocation

Randomized

Enrollment

487 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pembrolizumab+Lenvatinib

Arm Type

Experimental

Arm Description

Arm Title

Pembrolizumab+Placebo

Arm Type

Active Comparator

Arm Description

Arm Title

Pembrolizumab monotherapy

Arm Type

Experimental

Arm Description

Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (approximately 2 years) until progressive disease or discontinuation.

Intervention Type

Biological

Intervention Name(s)

Pembrolizumab

Other Intervention Name(s)

MK-3475, KEYTRUDA®

Intervention Description

IV infusion

Intervention Type

Drug

Intervention Name(s)

Lenvatinib

Other Intervention Name(s)

MK-7902, E7080, LENVIMA®

Intervention Description

oral capsule

Intervention Type

Drug

Intervention Name(s)

Placebo for lenvatinib

Intervention Description

oral capsule

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Up to approximately 40 months

Title

Overall Survival (OS)

Description

OS is defined as the time from randomization to the date of death from any cause.

Time Frame

Up to approximately 40 months

Secondary Outcome Measure Information:

Title

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

Description

Time Frame

Up to approximately 40 months

Title

Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

Description

Time Frame

Up to approximately 40 months

Title

Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

Description

Time Frame

Up to approximately 40 months

Title

Description

Time Frame

Baseline and up to approximately 40 months

Title

Description

Time Frame

Up to approximately 40 months

Title

Number of Participants Who Experience an Adverse Event (AE)

Description

An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Time Frame

Up to approximately 40 months

Title

Number of Participants Who Discontinue Study Treatment Due to an AE

Description

The number of participants who discontinue study treatment due to an AE will be presented.

Time Frame

Up to approximately 40 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Has a histologically or cytologically confirmed diagnosis of advanced/unresectable (inoperable) or metastatic urothelial carcinoma (UC) of the renal pelvis, ureter (upper urinary tract), bladder, or urethra. Has ≥1 measurable target lesion per RECIST 1.1 as assessed by the local site investigator/radiologist. Has provided an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated and adequate for Programmed Death-Ligand 1 (PD-L1) evaluation. Has received no prior systemic chemotherapy for advanced or metastatic UC with the following exceptions: Neoadjuvant (prior to surgery) platinum-based chemotherapy for treatment of muscle-invasive bladder cancer with recurrence >12 months from completion of the therapy is permitted. Adjuvant (following surgery) platinum-based chemotherapy following radical cystectomy, with recurrence >12 months from completion of the therapy, is permitted. Meets criteria for either option a or option b (below): a. Has a tumor(s) with PD-L1 combined positive score (CPS) ≥10 and is considered ineligible to receive cisplatin-based combination therapy, based on 1 of the following: Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 2 within 7 days prior to randomization National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Grade ≥2 audiometric hearing loss NCI CTCAE Version 4.0 Grade ≥2 peripheral neuropathy OR b. In the opinion of the investigator, is considered ineligible to receive any platinum-based chemotherapy (i.e., ineligible for cisplatin and carboplatin) based on: ECOG PS of 2 within 7 days prior to randomization. and ≥1 of the following: Documented visceral metastatic disease NCI CTCAE Version 4.0 Grade ≥2 audiometric hearing loss NCI CTCAE Version 4.0 Grade ≥2 peripheral neuropathy Other reason for the participant's being unable to receive both cisplatin and carboplatin safely. Additional criteria for platinum ineligibility will be considered and allowed on a case-by-case basis, following consultation with the Sponsor. Note: Participants considered ineligible for any platinum-based chemotherapy are eligible for this study regardless of their tumor PD-L1 status. Has ECOG PS 0, 1, or 2 within 7 days prior to randomization and a life expectancy of ≥3 months. Male participants are eligible to participate if they agree to the following during the treatment period and for ≥30 days after the last dose of pembrolizumab or lenvatinib/placebo: Be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent, OR Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause as detailed below: Agrees to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration. A female participant is eligible to participate if she is not pregnant or breastfeeding and if she is not a WOCBP OR is a WOCBP and is using a contraceptive method that is highly effective (with a failure rate of <1% per year) with low user dependency, or is abstinent from heterosexual intercourse as her preferred and usual lifestyle during the intervention period and for ≥120 days post pembrolizumab or ≥30 days post lenvatinib/placebo. Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mm Hg at screening and no change in antihypertensive medications within 1 week prior to randomization. Has adequate organ function. Exclusion Criteria: Has disease that is suitable for local therapy administered with curative intent (e.g. chemotherapy and radiation for Stage 3 disease). Has tumor with any neuroendocrine or small cell component. Has a history of a gastrointestinal condition or procedure (e.g. gastric bypass, malabsorption) that, in the opinion of the investigator, may affect oral drug absorption. Has had major surgery within 3 weeks prior to the first dose of study treatment Has a pre-existing Grade ≥3 gastrointestinal or non-gastrointestinal fistula. Has radiographic evidence of major blood vessel invasion/infiltration, or has had clinically significant hemoptysis (≥0.5 teaspoon of bright red blood) or tumor bleeding within 2 weeks prior to the first dose of study treatment. Has had significant cardiovascular impairment within 12 months of the first dose of study treatment, such as history of New York Heart Association (NYHA) >Class II congestive heart failure, unstable angina, myocardial infarction or cerebrovascular accident (CVA)/stroke, cardiac revascularization procedure, or cardiac arrhythmia associated with hemodynamic instability. Has known intolerance or severe hypersensitivity (Grade ≥3) to pembrolizumab or lenvatinib or any of their excipients Has received lenvatinib as monotherapy or in combination with a programmed cell death-1/programmed cell death-ligand 1 (PD-1/PD-L1) inhibitor or has previously been enrolled in a clinical study evaluating lenvatinib for bladder cancer, regardless of the treatment received. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 inhibitor, indoleamine-pyrrole 2,3 dioxygenase (IDO1) inhibitor, or agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4], OX 40, CD137), or any other antibody or drug targeting T-cell costimulatory pathways in the adjuvant or advanced/metastatic setting. Has received prior radiotherapy to a metastatic site without the use of chemotherapy radiosensitization within 3 weeks of the first dose of study treatment, with the exception of palliative radiotherapy to bone lesions, which is allowed if completed 2 weeks before the start of study treatment. Participants must have recovered from all radiation-related toxicities, and must not require corticosteroids. Has received a live vaccine within 30 days prior to the first dose of study treatment. In the investigator's judgment, has not recovered from toxicity or other complications from any major surgery prior to starting 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. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent. Has history or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (at a dose exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization. Has had an active malignancy (except locally advanced or metastatic UC) within the past 36 months. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) who have undergone potentially curative therapy are not excluded. Has a history of prostate cancer (T2NXMX or lower with Gleason score ≤7) treated with definitive intent (surgically or with radiation therapy) ≥1 year prior to study entry is acceptable, provided that the participant is considered prostate cancer-free. Has central nervous system (CNS) metastases, unless the participant has completed local therapy (e.g. whole brain radiation therapy, surgery, or radiosurgery) and has discontinued use of corticosteroids for this indication for ≥4 weeks before starting study treatment. Any signs (e.g. radiologic) or symptoms of CNS metastases must be stable for ≥4 weeks before starting study treatment. Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e, with disease-modifying agents, corticosteroids, or immunosuppressive drugs). Has a history of (non-infectious) pneumonitis that required systemic steroids, or current pneumonitis. Has an active infection requiring systemic therapy. Has a known history of human immunodeficiency virus (HIV) infection. Has a known history of or is positive for active hepatitis B virus (HBV) or has active hepatitis C virus (HCV). Has active tuberculosis (TB). Is receiving hemodialysis. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of pembrolizumab and lenvatinib/placebo. Has had an allogeneic tissue/solid organ transplant.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

Facility Information:

Facility Name

Banner MD Anderson Cancer Center ( Site 0016)

City

Gilbert

State/Province

Arizona

ZIP/Postal Code

85234

Country

United States

Facility Name

Community Cancer Institute ( Site 0777)

City

Clovis

State/Province

California

ZIP/Postal Code

93611

Country

United States

Facility Name

University of California Irvine Medical Center ( Site 0078)

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

John Wayne Cancer Institute ( Site 0017)

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Northwest Georgia Oncology Centers PC ( Site 0707)

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

University of Chicago ( Site 0039)

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Joliet Oncology Hematology ( Site 0091)

City

Joliet

State/Province

Illinois

ZIP/Postal Code

60436

Country

United States

Facility Name

Quincy Medical Group ( Site 0022)

City

Quincy

State/Province

Illinois

ZIP/Postal Code

62301

Country

United States

Facility Name

New England Cancer Specialists ( Site 0047)

City

Scarborough

State/Province

Maine

ZIP/Postal Code

04074

Country

United States

Facility Name

Karmanos Cancer Institute ( Site 0712)

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Mercy Hospital Saint Louis - David C. Pratt Cancer Center ( Site 0095)

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Comprehensive Cancer Centers of Nevada ( Site 0005)

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89169

Country

United States

Facility Name

St. Peter's Hospital Cancer Care Center ( Site 0042)

City

Albany

State/Province

New York

ZIP/Postal Code

12208

Country

United States

Facility Name

Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0002)

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0774)

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74146

Country

United States

Facility Name

Thomas Jefferson University Hospital ( Site 0051)

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Medical University of South Carolina-Hollings Cancer Center ( Site 0029)

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Baylor Scott & White Medical Center - Temple ( Site 0706)

City

Temple

State/Province

Texas

ZIP/Postal Code

76508

Country

United States

Facility Name

Virginia Cancer Institute ( Site 0099)

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23230

Country

United States

Facility Name

Seattle Cancer Care Alliance ( Site 0003)

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Name

Cancer Care Northwest ( Site 0009)

City

Spokane

State/Province

Washington

ZIP/Postal Code

99218

Country

United States

Facility Name

Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0577)

City

Berazategui

State/Province

Buenos Aires

ZIP/Postal Code

B1884BBF

Country

Argentina

Facility Name

Centro de Urología CDU ( Site 0590)

City

Buenos Aires

State/Province

Caba

ZIP/Postal Code

C1120AAT

Country

Argentina

Facility Name

Instituto Medico Alexander Fleming ( Site 0578)

City

Buenos Aires

State/Province

Caba

ZIP/Postal Code

C1426ANZ

Country

Argentina

Facility Name

Centro de Investigaciones Clinicas - Clinica Viedma ( Site 0585)

City

Viedma

State/Province

Rio Negro

ZIP/Postal Code

R8500ACE

Country

Argentina

Facility Name

Centro Oncológico de Rosario ( Site 0584)

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000KZE

Country

Argentina

Facility Name

Instituto de Investigaciones Metabolicas ( Site 0589)

City

Buenos Aires

ZIP/Postal Code

C1012AAR

Country

Argentina

Facility Name

Centro Medico Dra De Salvo ( Site 0593)

City

Buenos Aires

ZIP/Postal Code

C1426ANZ

Country

Argentina

Facility Name

CEMAIC ( Site 0581)

City

Cordoba

ZIP/Postal Code

X5008HHW

Country

Argentina

Facility Name

Centro Oncologico de Integracion Regional. COIR ( Site 0576)

City

Mendoza

ZIP/Postal Code

M5500AYB

Country

Argentina

Facility Name

Macquarie University ( Site 0151)

City

North Ryde

State/Province

New South Wales

ZIP/Postal Code

2109

Country

Australia

Facility Name

Mater Misericordiae Ltd ( Site 0158)

City

South Brisbane

State/Province

Queensland

ZIP/Postal Code

4101

Country

Australia

Facility Name

Monash Health ( Site 0160)

City

Clayton

State/Province

Victoria

ZIP/Postal Code

3168

Country

Australia

Facility Name

Peninsula Health Frankston Hospital ( Site 0153)

City

Frankston

State/Province

Victoria

ZIP/Postal Code

3199

Country

Australia

Facility Name

Austin Health-Austin Hospital ( Site 0154)

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3084

Country

Australia

Facility Name

Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0101)

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8V 5C2

Country

Canada

Facility Name

Lakeridge Health ( Site 0103)

City

Oshawa

State/Province

Ontario

ZIP/Postal Code

L1G 2B9

Country

Canada

Facility Name

Sunnybrook Research Institute ( Site 0106)

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

CIUSSS de l Estrie Centre Hospitalier Universitaire de Sherbrooke ( Site 0102)

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H5N4

Country

Canada

Facility Name

CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0104)

City

Quebec

ZIP/Postal Code

G1R 2J6

Country

Canada

Facility Name

Peking University First Hospital ( Site 0726)

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100034

Country

China

Facility Name

Fifth Medical Center of CPLA General Hospital ( Site 0732)

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100071

Country

China

Facility Name

Peking University Third Hospital ( Site 0727)

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100089

Country

China

Facility Name

Chongqing Cancer Hospital ( Site 0741)

City

Chongging

State/Province

Chongqing

ZIP/Postal Code

400030

Country

China

Facility Name

The First Affiliated Hospital of Xiamen University ( Site 0743)

City

Xiamen

State/Province

Fujian

ZIP/Postal Code

361003

Country

China

Facility Name

Sun Yat-Sen University Cancer Center ( Site 0752)

City

Guangdong

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Facility Name

The First Affiliated Hospital of Guangzhou Medical University ( Site 0749)

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510230

Country

China

Facility Name

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ( Site 0746)

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510289

Country

China

Facility Name

Harbin Medical University Cancer Hospital ( Site 0750)

City

Harbin

State/Province

Heilongjiang

ZIP/Postal Code

150081

Country

China

Facility Name

Hubei Cancer Hospital ( Site 0744)

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430079

Country

China

Facility Name

Hunan Cancer Hospital ( Site 0745)

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410013

Country

China

Facility Name

Nanjing Drum Tower Hospital ( Site 0737)

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210008

Country

China

Facility Name

Fudan University Shanghai Cancer Center ( Site 0721)

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Name

Zhongshan Hospital Fudan University ( Site 0725)

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Name

The First Affiliated Hospital of Xi an Jiaotong University ( Site 0738)

City

Xian

State/Province

Shanxi

ZIP/Postal Code

710061

Country

China

Facility Name

Cancer Hospital Affiliated to Xinjiang Medical University ( Site 0751)

City

Urumqi

State/Province

Xinjiang

ZIP/Postal Code

830011

Country

China

Facility Name

Second Affiliated Hospital, Zhejiang University ( Site 0734)

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

Facility Name

Zhejiang Provincial People's Hospital ( Site 0735)

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310014

Country

China

Facility Name

Rigshospitalet ( Site 0680)

City

Copenhagen

State/Province

Hovedstaden

ZIP/Postal Code

2100

Country

Denmark

Facility Name

Herlev Hospital ( Site 0681)

City

Herlev

State/Province

Hovedstaden

ZIP/Postal Code

2730

Country

Denmark

Facility Name

Aarhus Universitets hospital ( Site 0683)

City

Aarhus N

State/Province

Midtjylland

ZIP/Postal Code

8200

Country

Denmark

Facility Name

Aalborg Universitets Hospital ( Site 0684)

City

Aalborg

State/Province

Nordjylland

ZIP/Postal Code

9000

Country

Denmark

Facility Name

Odense Universitetshospital ( Site 0682)

City

Odense

State/Province

Syddanmark

ZIP/Postal Code

5000

Country

Denmark

Facility Name

CHU Poitiers ( Site 0253)

City

Poitiers

State/Province

Ain

ZIP/Postal Code

86021

Country

France

Facility Name

Institut de Cancerologie Strasbourg Europe ( Site 0232)

City

Strasbourg

State/Province

Alsace

ZIP/Postal Code

67033

Country

France

Facility Name

Hopital de la Timone ( Site 0246)

City

Marseille

State/Province

Bouches-du-Rhone

ZIP/Postal Code

13005

Country

France

Facility Name

CHIC Quimper ( Site 0245)

City

Quimper

State/Province

Finistere

ZIP/Postal Code

29107

Country

France

Facility Name

CHU de Bordeaux- Hopital Saint Andre ( Site 0235)

City

Bordeaux

State/Province

Gironde

ZIP/Postal Code

33075

Country

France

Facility Name

Clinique Pasteur ( Site 0252)

City

Tolouse

State/Province

Haute-Garonne

ZIP/Postal Code

31076

Country

France

Facility Name

Centre de Cancerologie du Grand Montpellier ( Site 0249)

City

Montpellier

State/Province

Languedoc-Roussillon

ZIP/Postal Code

34070

Country

France

Facility Name

Centre Rene Gauducheau ICO ( Site 0250)

City

Saint Herblain

State/Province

Loire-Atlantique

ZIP/Postal Code

44805

Country

France

Facility Name

Institut de Cancerologie de l Ouest Site Paul Papin ( Site 0236)

City

Angers

State/Province

Maine-et-Loire

ZIP/Postal Code

49055

Country

France

Facility Name

Centre D Oncologie de Gentilly ( Site 0240)

City

Nancy

State/Province

Meurthe-et-Moselle

ZIP/Postal Code

54100

Country

France

Facility Name

Centre Hospitalier de la Cote Basque ( Site 0239)

City

Bayonne

State/Province

Pyrenees-Atlantiques

ZIP/Postal Code

64109

Country

France

Facility Name

Centre Leon Berard ( Site 0244)

City

Lyon

State/Province

Rhone

ZIP/Postal Code

69373

Country

France

Facility Name

Institut Gustave Roussy ( Site 0243)

City

Villejuif

State/Province

Val-de-Marne

ZIP/Postal Code

94805

Country

France

Facility Name

CHD Vendee-onco-hematologie ( Site 0251)

City

La Roche sur Yon

State/Province

Vendee

ZIP/Postal Code

85925

Country

France

Facility Name

Institut Curie ( Site 0237)

City

Paris

ZIP/Postal Code

75005

Country

France

Facility Name

Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0271)

City

Tuebingen

State/Province

Baden-Wurttemberg

ZIP/Postal Code

72076

Country

Germany

Facility Name

Universitaetsklinikum Giessen und Marburg GmbH ( Site 0284)

City

Marburg

State/Province

Hessen

ZIP/Postal Code

35032

Country

Germany

Facility Name

Helios Kliniken Schwerin GmbH ( Site 0278)

City

Schwerin

State/Province

Mecklenburg-Vorpommern

ZIP/Postal Code

19049

Country

Germany

Facility Name

Universitaetsmedizin Goettingen ( Site 0281)

City

Gottingen

State/Province

Niedersachsen

ZIP/Postal Code

37075

Country

Germany

Facility Name

Universitaetsklinikum Essen ( Site 0274)

City

Essen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Staedtisches Krankenhaus Kiel GmbH ( Site 0285)

City

Kiel

State/Province

Schleswig-Holstein

ZIP/Postal Code

24116

Country

Germany

Facility Name

Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0277)

City

Luebeck

State/Province

Schleswig-Holstein

ZIP/Postal Code

23538

Country

Germany

Facility Name

Universitaetsklinikum Hamburg-Eppendorf ( Site 0282)

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Bacs-Kiskun Megyei Korhaz ( Site 0510)

City

Kecskemet

State/Province

Bacs-Kiskun

ZIP/Postal Code

6000

Country

Hungary

Facility Name

Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás Ce

City

Miskolc

State/Province

Borsod-Abauj-Zemplen

ZIP/Postal Code

3526

Country

Hungary

Facility Name

Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0507)

City

Szolnok

State/Province

Jasz-Nagykun-Szolnok

ZIP/Postal Code

5000

Country

Hungary

Facility Name

Markusovszky Egyetemi Oktatokorhaz ( Site 0502)

City

Szombathely

State/Province

Vas

ZIP/Postal Code

9400

Country

Hungary

Facility Name

Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 0509)

City

Budapest

ZIP/Postal Code

1106

Country

Hungary

Facility Name

Orszagos Onkologiai Intezet ( Site 0503)

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

Uzsoki Utcai Korhaz ( Site 0508)

City

Budapest

ZIP/Postal Code

1145

Country

Hungary

Facility Name

Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 0504)

City

Kaposvar

ZIP/Postal Code

7400

Country

Hungary

Facility Name

Ha Emek Medical Center ( Site 0560)

City

Afula

ZIP/Postal Code

1834111

Country

Israel

Facility Name

Assuta Ashdod Public ( Site 0562)

City

Ashdod

ZIP/Postal Code

7747629

Country

Israel

Facility Name

Rambam Medical Center ( Site 0552)

City

Haifa

ZIP/Postal Code

3109601

Country

Israel

Facility Name

Shaare Zedek Medical Center ( Site 0559)

City

Jerusalem

ZIP/Postal Code

9103102

Country

Israel

Facility Name

Hadassah Ein Kerem Medical Center ( Site 0558)

City

Jerusalem

ZIP/Postal Code

9112001

Country

Israel

Facility Name

Meir Medical Center ( Site 0554)

City

Kfar Saba

ZIP/Postal Code

4428164

Country

Israel

Facility Name

Rabin Medical Center ( Site 0553)

City

Petach-Tikwa

ZIP/Postal Code

4941492

Country

Israel

Facility Name

Sheba Medical Center ( Site 0551)

City

Ramat Gan

ZIP/Postal Code

5265601

Country

Israel

Facility Name

Sourasky Medical Center ( Site 0561)

City

Tel Aviv

ZIP/Postal Code

6423906

Country

Israel

Facility Name

Assaf Harofeh Medical Center ( Site 0556)

City

Zerifin

ZIP/Postal Code

70300

Country

Israel

Facility Name

Ospedale San Raffaele-Oncologia Medica ( Site 0309)

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20132

Country

Italy

Facility Name

ASST Grande Ospedale Metropolitano Niguarda ( Site 0307)

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20162

Country

Italy

Facility Name

Centro di Riferimento Oncologico CRO ( Site 0304)

City

Aviano

State/Province

Pordenone

ZIP/Postal Code

33081

Country

Italy

Facility Name

Istituto Tumori Giovanni Paolo II ( Site 0306)

City

Bari

ZIP/Postal Code

70124

Country

Italy

Facility Name

Policlinico S. Orsola - Malpighi (Bologna) ( Site 0302)

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Azienda Ospedaliera per l Emergenza Cannizzaro ( Site 0305)

City

Catania

ZIP/Postal Code

95126

Country

Italy

Facility Name

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0301)

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Azienda Ospedaliera Santa Maria ( Site 0303)

City

Terni

ZIP/Postal Code

05100

Country

Italy

Facility Name

Ospedale Borgo Roma-Oncologia ( Site 0308)

City

Verona

ZIP/Postal Code

37134

Country

Italy

Facility Name

Hirosaki University Hospital ( Site 0123)

City

Hirosaki

State/Province

Aomori

ZIP/Postal Code

036-8563

Country

Japan

Facility Name

National Cancer Center Hospital East ( Site 0128)

City

Kashiwa

State/Province

Chiba

ZIP/Postal Code

277-8577

Country

Japan

Facility Name

Ehime University Hospital ( Site 0137)

City

Toon

State/Province

Ehime

ZIP/Postal Code

791-0295

Country

Japan

Facility Name

Sapporo Medical University Hospital ( Site 0122)

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

060-8543

Country

Japan

Facility Name

University of Tsukuba Hospital ( Site 0126)

City

Tsukuba

State/Province

Ibaraki

ZIP/Postal Code

305-8576

Country

Japan

Facility Name

Kitasato University Hospital ( Site 0129)

City

Sagamihara

State/Province

Kanagawa

ZIP/Postal Code

252-0375

Country

Japan

Facility Name

Nara Medical University Hospital ( Site 0133)

City

Kashihara

State/Province

Nara

ZIP/Postal Code

634-8522

Country

Japan

Facility Name

Saitama Medical University International Medical Center ( Site 0125)

City

Hidaka

State/Province

Saitama

ZIP/Postal Code

350-1298

Country

Japan

Facility Name

Yamaguchi University Hospital ( Site 0135)

City

Ube

State/Province

Yamaguchi

ZIP/Postal Code

755-8505

Country

Japan

Facility Name

Akita University Hospital ( Site 0124)

City

Akita

ZIP/Postal Code

010-8543

Country

Japan

Facility Name

Chiba Cancer Center ( Site 0127)

City

Chiba

ZIP/Postal Code

260-8717

Country

Japan

Facility Name

Nagasaki University Hospital ( Site 0136)

City

Nagasaki

ZIP/Postal Code

852-8501

Country

Japan

Facility Name

Osaka City University Hospital ( Site 0132)

City

Osaka

ZIP/Postal Code

545-8586

Country

Japan

Facility Name

Tokushima University Hospital ( Site 0134)

City

Tokushima

ZIP/Postal Code

770-8503

Country

Japan

Facility Name

Medical Hospital, Tokyo Medical And Dental University ( Site 0130)

City

Tokyo

ZIP/Postal Code

113-8519

Country

Japan

Facility Name

Chonnam National University Hwasun Hospital ( Site 0194)

City

Hwasun Gun

State/Province

Jeonranamdo

ZIP/Postal Code

58128

Country

Korea, Republic of

Facility Name

National Cancer Center ( Site 0196)

City

Goyang-si

State/Province

Kyonggi-do

ZIP/Postal Code

10408

Country

Korea, Republic of

Facility Name

Chungnam National University Hospital ( Site 0195)

City

Daejeon

State/Province

Taejon-Kwangyokshi

ZIP/Postal Code

35015

Country

Korea, Republic of

Facility Name

Korea University Anam Hospital ( Site 0197)

City

Seoul

ZIP/Postal Code

02841

Country

Korea, Republic of

Facility Name

Seoul National University Hospital ( Site 0191)

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Severance Hospital ( Site 0192)

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Veterans Health Service Medical Center ( Site 0198)

City

Seoul

ZIP/Postal Code

05368

Country

Korea, Republic of

Facility Name

Samsung Medical Center ( Site 0193)

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Ziekenhuis Rijnstate ( Site 0342)

City

Arnhem

State/Province

Gelderland

ZIP/Postal Code

6815 AD

Country

Netherlands

Facility Name

Maastricht Universitair Medisch Centrum - MUMC ( Site 0334)

City

Maastricht

State/Province

Limburg

ZIP/Postal Code

6229 HX

Country

Netherlands

Facility Name

VieCuri Medisch Centrum ( Site 0340)

City

Venlo

State/Province

Limburg

ZIP/Postal Code

5912 BL

Country

Netherlands

Facility Name

Amphia Ziekenhuis Breda ( Site 0331)

City

Breda

State/Province

Noord-Brabant

ZIP/Postal Code

4819 EV

Country

Netherlands

Facility Name

Deventer Ziekenhuis ( Site 0341)

City

Deventer

State/Province

Overijssel

ZIP/Postal Code

7416 SE

Country

Netherlands

Facility Name

Haga Ziekenhuis ( Site 0333)

City

Den Haag

State/Province

Zuid-Holland

ZIP/Postal Code

2545 AA

Country

Netherlands

Facility Name

Erasmus MC ( Site 0332)

City

Rotterdam

State/Province

Zuid-Holland

ZIP/Postal Code

3015 GD

Country

Netherlands

Facility Name

St. Antonius Ziekenhuis ( Site 0335)

City

Utrecht

ZIP/Postal Code

3543 AZ

Country

Netherlands

Facility Name

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 0535)

City

Wroclaw

State/Province

Dolnoslaskie

ZIP/Postal Code

50-556

Country

Poland

Facility Name

Szpital Wojewodzki ( Site 1062)

City

Tarnow

State/Province

Malopolskie

ZIP/Postal Code

33-100

Country

Poland

Facility Name

Europejskie Centrum Zdrowia Otwock ( Site 0532)

City

Otwock

State/Province

Mazowieckie

ZIP/Postal Code

05-400

Country

Poland

Facility Name

Urologica Praktyka Lekarska Adam Marcheluk ( Site 0543)

City

Siedlce

State/Province

Mazowieckie

ZIP/Postal Code

08-110

Country

Poland

Facility Name

Luxmed Onkologia sp. z o. o. ( Site 0541)

City

Warszawa

State/Province

Mazowieckie

ZIP/Postal Code

01-748

Country

Poland

Facility Name

Szpital Miejski im. Jana Pawła II w Bielsku-Białej ( Site 0542)

City

Bielsko-Biala

State/Province

Slaskie

ZIP/Postal Code

43-300

Country

Poland

Facility Name

GBUZ Leningrad Regional Clinical Oncology Dispensary ( Site 0426)

City

Kuzmolovskiy Settlement

State/Province

Leningradskaya Oblast

ZIP/Postal Code

188663

Country

Russian Federation

Facility Name

Russian Scientific Center of Roentgenoradiology ( Site 0424)

City

Moscow

State/Province

Moskva

ZIP/Postal Code

117485

Country

Russian Federation

Facility Name

Central Clinical Hospital with Polyclinic ( Site 0415)

City

Moscow

State/Province

Moskva

ZIP/Postal Code

121359

Country

Russian Federation

Facility Name

Medical Rehabilitation Center ( Site 0411)

City

Moscow

State/Province

Moskva

ZIP/Postal Code

125367

Country

Russian Federation

Facility Name

Murmansk Regional Oncology Dispensary ( Site 0420)

City

Murmansk

State/Province

Murmanskaya Oblast

ZIP/Postal Code

183057

Country

Russian Federation

Facility Name

Volga District Medical Center Federal Medical and Biological Agency ( Site 0413)

City

Nizhny Novgorod

State/Province

Nizhegorodskaya Oblast

ZIP/Postal Code

603074

Country

Russian Federation

Facility Name

Omsk Clinical Oncology Dispensary ( Site 0418)

City

Omsk

State/Province

Omskaya Oblast

ZIP/Postal Code

644013

Country

Russian Federation

Facility Name

Clinical Hospital Saint Luka ( Site 0421)

City

Saint-Petersburg

State/Province

Sankt-Peterburg

ZIP/Postal Code

194044

Country

Russian Federation

Facility Name

Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 0414)

City

Yaroslavl

State/Province

Yaroslavskaya Oblast

ZIP/Postal Code

150054

Country

Russian Federation

Facility Name

Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 0351)

City

Badalona

State/Province

Barcelona

ZIP/Postal Code

08916

Country

Spain

Facility Name

ICO L Hospitalet ( Site 0361)

City

Hospitalet de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08908

Country

Spain

Facility Name

Xarxa Assistencial Universitaria Manresa ( Site 0354)

City

Manresa

State/Province

Barcelona

ZIP/Postal Code

08243

Country

Spain

Facility Name

Hospital Teresa Herrera - Chuac ( Site 0357)

City

A Coruna

State/Province

La Coruna

ZIP/Postal Code

15006

Country

Spain

Facility Name

Hospital Universitario HM Sanchinarro ( Site 0356)

City

Madrid

State/Province

Madrid, Comunidad De

ZIP/Postal Code

28050

Country

Spain

Facility Name

Hospital Infanta Cristina ( Site 0355)

City

Badajoz

ZIP/Postal Code

06080

Country

Spain

Facility Name

Hospital General Universitari Vall d Hebron ( Site 0358)

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Hospital La Princesa ( Site 0862)

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Hospital Universitario Gregorio Maranon ( Site 0352)

City

Madrid

ZIP/Postal Code

28009

Country

Spain

Facility Name

Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 0216)

City

Kaoshiung

State/Province

Kaohsiung

ZIP/Postal Code

807

Country

Taiwan

Facility Name

Kaohsiung Chang Gung Memorial Hospital ( Site 0217)

City

Kaohsiung

ZIP/Postal Code

83301

Country

Taiwan

Facility Name

China Medical University Hospital ( Site 0213)

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

Taichung Veterans General Hospital ( Site 0214)

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Facility Name

National Cheng Kung University Hospital ( Site 0215)

City

Tainan

ZIP/Postal Code

70403

Country

Taiwan

Facility Name

National Taiwan University Hospital ( Site 0211)

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

Taipei Veterans General Hospital ( Site 0212)

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Facility Name

Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi ( Site 0457)

City

Adana

ZIP/Postal Code

01330

Country

Turkey

Facility Name

Ankara Sehir Hastanesi ( Site 0455)

City

Ankara

ZIP/Postal Code

06800

Country

Turkey

Facility Name

Antalya Memorial Hospital Department of Medical Oncology ( Site 0461)

City

Antalya

ZIP/Postal Code

07020

Country

Turkey

Facility Name

Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0454)

City

Istanbul

ZIP/Postal Code

34098

Country

Turkey

Facility Name

Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0459)

City

Istanbul

ZIP/Postal Code

34722

Country

Turkey

Facility Name

Ege Universitesi Tulay Aktas Onkoloji Hastanesi ( Site 0462)

City

İzmir

ZIP/Postal Code

35100

Country

Turkey

Facility Name

Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0456)

City

Konya

ZIP/Postal Code

42080

Country

Turkey

Facility Name

Sakarya Universitesi Tip Fakultesi Arastirma Hastanesi ( Site 0460)

City

Sakarya

ZIP/Postal Code

54290

Country

Turkey

Facility Name

Weston Park Hospital ( Site 0387)

City

Sheffield

State/Province

Derbyshire

ZIP/Postal Code

S10 2SJ

Country

United Kingdom

Facility Name

Queens Hospital-Purple Zone ( Site 0377)

City

Romford

State/Province

Essex

ZIP/Postal Code

RM7 0AG

Country

United Kingdom

Facility Name

Lister Hospital ( Site 0376)

City

Stevenage

State/Province

Hertfordshire

ZIP/Postal Code

SG1 4AB

Country

United Kingdom

Facility Name

Kent and Canterbury Hospital ( Site 0390)

City

Canterbury

State/Province

Kent

ZIP/Postal Code

CT1 3NG

Country

United Kingdom

Facility Name

Royal Preston Hospital ( Site 0379)

City

Preston

State/Province

Lancashire

ZIP/Postal Code

PR2 9HT

Country

United Kingdom

Facility Name

Saint Bartholomew s Hospital - London ( Site 0386)

City

London

State/Province

London, City Of

ZIP/Postal Code

EC1A 7BE

Country

United Kingdom

Facility Name

University College London Hospital NHS Foundation Trust ( Site 0380)

City

London

State/Province

London, City Of

ZIP/Postal Code

NW1 2PG

Country

United Kingdom

Facility Name

Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 0378)

City

London

State/Province

London, City Of

ZIP/Postal Code

W6 8RF

Country

United Kingdom

Facility Name

Nottingham University Hospital NHS Trust ( Site 0383)

City

Nottingham

ZIP/Postal Code

NG5 1PB

Country

United Kingdom

Facility Name

Derriford Hospital ( Site 0388)

City

Plymouth

ZIP/Postal Code

PL6 8DH

Country

United Kingdom

Facility Name

Royal Stoke University Hospital Univ. Hosps of North Midlands NHST ( Site 0392)

City

Stoke-on-Trent

ZIP/Postal Code

ST4 6QG

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

IPD Sharing URL

http://engagezone.msd.com/ds_documentation.php

Citations:

PubMed Identifier

33300372

Citation

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.

Results Reference

derived

Links:

URL

http://merckoncologyclinicaltrials.com

Description

Merck Oncology Clinical Trial Information

Learn more about this trial

We'll reach out to this number within 24 hrs