Pembrolizumab Plus Lenvatinib for First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (1L nccRCC) (MK-3475-B61)

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

February 23, 2021

Primary Completion Date

January 27, 2025

Study Completion Date

October 25, 2025

Conditions
Renal Cell Carcinoma
Interventions
BIOLOGICAL

Pembrolizumab

Pembrolizumab 400 mg, every 6 weeks (Q6W) intravenous (IV) up to 18 infusions or up to progressive disease or discontinuation.

DRUG

Lenvatinib

Lenvatinib 20 mg, daily (QD), oral, until progressive disease or discontinuation.

Trial Locations (56)

1122

Országos Onkológiai Intézet-Urogenital Tumors Department and Clinical Pharmacology ( Site 0304), Budapest

2109

Macquarie University-MQ Health Clinical Trials Unit ( Site 0405), Macquarie Park

2298

Calvary Mater Newcastle ( Site 0403), Waratah

3168

Monash Health ( Site 0400), Clayton

3526

Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás C, Miskolc

4029

Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si, Brisbane

4032

Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 0300), Debrecen

5000

Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 0303), Szolnok

5037

Ashford Cancer Centre Research ( Site 0404), Kurralta Park

6150

Fiona Stanley Hospital ( Site 0402), Murdoch

10065

Memorial Sloan Kettering Cancer Center ( Site 0015), New York

14029

Chernihiv Medical Center of Modern Oncology ( Site 0509), Chernihiv

14076

Centre François Baclesse ( Site 1000), Caen

18009

Cherkasy Regional Oncology Dispensary ( Site 0504), Cherkassy

19111

Fox Chase Cancer Center ( Site 0011), Philadelphia

20007

Georgetown University Medical Center ( Site 0001), Washington D.C.

20133

Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0903), Milan

28034

Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 0200), Madrid

34070

Centre de Cancérologie du Grand Montpellier ( Site 1005), Montpellier

34098

Istanbul Universitesi Cerrahpasa ( Site 1104), Istanbul- Fatih

34722

Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 1103), Istanbul

35100

Ege University Medicine of Faculty ( Site 1102), Bornova

37134

Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma-Oncology Unit ( Site 0902), Verona

37232

Vanderbilt University Medical Center ( Site 0008), Nashville

46009

Fundación Instituto Valenciano de Oncología-Oncologico ( Site 0202), Valencia

49005

Dnepropetrovsk Regional Clinical Hospital Mechnikov-Department of urology ( Site 0508), Dnipro

53226

MEDICAL COLLEGE OF WISCONSIN ( Site 0006), Milwaukee

59102

St. Vincent Frontier Cancer Center ( Site 0004), Billings

61070

"CNPE Regional Center of Oncology-oncourology department ( Site 0502)", Kharkiv

67200

Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1007), Strasbourg

69310

centre hospitalier lyon sud ( Site 1003), Pierre-Bénite

89169

Comprehensive Cancer Centers of Nevada ( Site 0010), Las Vegas

94800

Gustave Roussy ( Site 1002), Villejuif

98109

Seattle Cancer Care Alliance ( Site 0014), Seattle

117485

Russian Scientific Center of Radiology-Russian Scientific Center of Radiology ( Site 0602), Moscow

188663

SHBI Leningrad Regional Clinical Oncology Dispensary-Clinical Trials Department ( Site 0607), Saint Petersburg

603074

Volga District Medical Center-Urology Department ( Site 0604), Nizhny Novgorod

603081

Nizhegorodsky Regional Oncology Dispensary, Branch #2-chemotherapy ( Site 0605), Nizhny Novgorod

V5Z 4E6

BC Cancer Vancouver-Clinical Trials Unit ( Site 1500), Vancouver

M4N 3M5

Sunnybrook Health Sciences Centre ( Site 1501), Toronto

M5G 2M9

Princess Margaret Cancer Centre ( Site 1504), Toronto

G1R 3S1

CHU de Quebec - Université Laval - Hotel Dieu de Quebec ( Site 1502), Québec

D24 NR0A

Tallaght University Hospital ( Site 1600), Dublin

00168

Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 0901), Rome

05100

Azienda Ospedaliera Santa Maria Terni-SC Oncologia ( Site 0900), Terni

60-569

Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu M-chemotherapy department ( Site 0800), Poznan

01-748

Luxmed Onkologia sp. z o. o. ( Site 0802), Warsaw

02-781

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (, Warsaw

03722

Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1302), Seoul

05505

Asan Medical Center-Department of Oncology ( Site 1300), Seoul

06351

Samsung Medical Center ( Site 1301), Seoul

08035

Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0201), Barcelona

06100

Ankara University Hospital Cebeci ( Site 1105), Ankara

06230

Hacettepe Universitesi-oncology hospital ( Site 1101), Ankara

CB2 0QQ

Cambridge University Hospital ( Site 1200), Cambridge

M20 4BX

The Christie ( Site 1205), Manchester

All Listed Sponsors
collaborator

Eisai Inc.

INDUSTRY

lead

Merck Sharp & Dohme LLC

INDUSTRY