A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495)

PHASE2CompletedINTERVENTIONAL
Enrollment

245

Participants

Timeline

Start Date

October 1, 2018

Primary Completion Date

June 13, 2025

Study Completion Date

June 13, 2025

Conditions
Advanced Non-Small Cell Lung Cancer
Interventions
BIOLOGICAL

Pembrolizumab

200 mg pembrolizumab solution for intravenous (IV) infusion administered Q3W

BIOLOGICAL

Favezelimab

200 mg or 800 mg favezelimab solution for IV infusion administered Q3W

DRUG

Lenvatinib

20 mg lenvatinib capsules administered orally once daily

DRUG

Quavonlimab

Quavonlimab solution for IV infusion administered at the RP2D (dose and schedule based on study NCT03179436)

Trial Locations (81)

704

National Cheng Kung University Hospital ( Site 1202), Tainan City

1211

Hopitaux Universitaires de Geneve HUG ( Site 2106), Geneva

1939

Vaal Triangle Oncology Centre ( Site 2314), Vereeniging

2148

Blacktown Hospital Western Sydney Local Health District ( Site 0200), Blacktown

2193

Wits Clinical Research ( Site 2313), Parktown-Johannesburg

2196

Sandton Oncology Medical Group PTY LTD ( Site 2316), Sandton

4031

Universitaetsspital Basel ( Site 2104), Basel

4120

Gallipoli Medical Research Foundation ( Site 0202), Brisbane

4320

Umhlanga Oncolgy Center ( Site 2311), Umhlanga

6150

Fiona Stanley Hospital ( Site 0201), Murdoch

7000

Kantonsspital Graubuenden ( Site 2103), Chur

7570

Cape Town Oncology Trials Pty Ltd ( Site 2312), Kraaifontein

8091

Universitaetsspital Zuerich ( Site 2100), Zurich

9007

Kantonsspital St. Gallen ( Site 2102), Saint Gallen

10043

AOU San Luigi Gonzaga di Orbassano ( Site 0707), Orbassano

10048

National Taiwan University Hospital ( Site 1200), Taipei

10065

Memorial Sloan Kettering Cancer Center ( Site 0113), New York

Weill Cornell Medical College ( Site 0138), New York

11217

Taipei Veterans General Hospital ( Site 1204), Taipei

13620

Seoul National University Bundang Hospital ( Site 0803), Seongnam-si

15232

UPMC Cancer Center/Hillman Cancer Center ( Site 0104), Pittsburgh

19104

University of Pennsylvania ( Site 0132), Philadelphia

20089

Istituto Clinico Humanitas Research Hospital ( Site 0700), Rozzano

21201

University of Maryland ( Site 0136), Baltimore

22903

Emily Couric Clinical Cancer Center ( Site 0134), Charlottesville

28034

Hospital Universitario Ramon y Cajal ( Site 1101), Madrid

28041

Hospital Universitario 12 de Octubre ( Site 1102), Madrid

32224

Mayo Clinic Florida ( Site 0115), Jacksonville

37045

AULSS21 Regione Veneto Ospedale Mater Salutis - Legnago ( Site 0701), Legnago

45242

Oncology Hematology Care ( Site 8005), Cincinnati

47014

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 0702), Meldola

53100

Azienda Ospedaliera Universitaria Senese ( Site 0705), Siena

53792

University of Wisconsin- Madison Carbone Cancer Center ( Site 0130), Madison

55905

Mayo Clinic Rochester - St. Mary's Hospital ( Site 0117), Rochester

75702

Texas Oncology-Tyler ( Site 8003), Tyler

77024

Texas Oncology-Memorial City ( Site 8006), Houston

80131

Seconda Universita degli Studi di Napoli ( Site 0704), Napoli

83301

Kaohsiung Chang Gung Memorial Hospital ( Site 1203), Kaohsiung City

85284

Arizona Oncology Associates, PC- HAL ( Site 8001), Tempe

90404

UCLA Hematology/Oncology -Santa Monica ( Site 0108), Santa Monica

94143

University of California San Francisco ( Site 0111), San Francisco

95817

University of California Davis Comprehensive Cancer Center ( Site 0137), Sacramento

98158

Azienda Ospedaliera Papardo ( Site 0706), Messina

98684

Northwest Cancer Specialists, P.C. ( Site 8000), Vancouver

111123

The Loginov Moscow Clinical Scientific Center ( Site 1008), Moscow

115478

N.N. Blokhin NMRCO ( Site 1000), Moscow

119074

National University Hospital ( Site 1901), Singapore

169610

National Cancer Centre Singapore ( Site 1900), Singapore

194291

SBHI Leningrad Regional Clinical Hospital ( Site 1001), Saint Petersburg

198255

St Petersburg City Clinical Oncology Dispensary ( Site 1002), Saint Petersburg

420029

Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1005), Kazan'

450054

Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1003), Ufa

644013

Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site, Omsk

06520

Yale University School of Medicine ( Site 0100), New Haven

07601

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0112), Hackensack

K1H 8L6

The Ottawa Hospital ( Site 0306), Ottawa

M4N 3M5

Sunnybrook Health Science Centre ( Site 0304), Toronto

M5G 2M9

Princess Margaret Cancer Centre ( Site 0309), Toronto

G7H 5H6

CIUSSS du Saguenay-Lac-St-Jean ( Site 0305), Chicoutimi

H3T 1E2

Jewish General Hospital ( Site 0307), Montreal

H3T 1M5

CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0310), Montreal

000

Prince of Wales Hospital ( Site 1801), Hong Kong

Unknown

Queen Mary Hospital ( Site 1800), Hong Kong

D08 K0Y5

St James Hospital ( Site 2200), Dublin

V94 YVH0

Mid Western Cancer Centre ( Site 2201), Limerick

00168

Fondazione Policlinico Universitario A. Gemelli ( Site 0703), Roma

104-0045

National Cancer Center Hospital ( Site 2001), Tokyo

135-8550

The Cancer Institute Hospital of JFCR ( Site 2000), Tokyo

60-693

MED-POLONIA Sp. z o.o. ( Site 0907), Poznan

53-413

Dolnoslaskie Centrum Onkologii. ( Site 0993), Wroclaw

02-781

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

0181

MPOC ( Site 2310), Groenkloof Pretoria

0002

Univ. Pretoria and Steve Biko Academic Hospitals ( Site 2315), Pretoria

05505

Asan Medical Center ( Site 0801), Songpa-gu

03080

Seoul National University Hospital ( Site 0800), Seoul

03722

Severance Hospital Yonsei University Health System ( Site 0802), Seoul

06351

Samsung Medical Center ( Site 0805), Seoul

08035

Hospital General Universitari Vall d Hebron ( Site 1100), Barcelona

CB2 0QQ

Cambridge University Hospitals NHS Trust ( Site 1306), Cambridge

NW1 2PG

University College London Hospital NHS Foundation Trust ( Site 1308), London

PL6 8DH

Derriford Hospital ( Site 1301), Plymouth

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03516981 - A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495) | Biotech Hunter | Biotech Hunter