Pembrolizumab/Vibostolimab Coformulation (MK-7684A) or Pembrolizumab/Vibostolimab Coformulation Plus Docetaxel Versus Docetaxel for Metastatic Non Small Cell Lung Cancer (NSCLC) With Progressive Disease After Platinum Doublet Chemotherapy and Immunotherapy (MK-7684A-002, KEYVIBE-002)

PHASE2CompletedINTERVENTIONAL
Enrollment

255

Participants

Timeline

Start Date

April 20, 2021

Primary Completion Date

January 26, 2023

Study Completion Date

October 17, 2024

Conditions
Metastatic Non Small Cell Lung Cancer
Interventions
BIOLOGICAL

Pembrolizumab/Vibostolimab coformulation

Pembrolizumab 200 mg + vibostolimab 200 mg/20 mL vial IV infusion Q3W up to approximately 2 years.

DRUG

Docetaxel

Docetaxel 75 mg\^m2 IV infusion Q3W until discontinuation due to progressive disease or unacceptable toxicity. Docetaxel will serve as part of an experimental treatment in Arm 1, and as an active comparator in Arm 3.

DRUG

Placebo

Normal saline IV infusion Q3W up to approximately 2 years

Trial Locations (95)

704

NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 2302), Tainan City

1090

UZ Brussel ( Site 0336), Brussels

1210

Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0204), Vienna

1932

AZ Nikolaas ( Site 0334), Sint-Niklaas

2100

Rigshospitalet ( Site 0702), Copenhagen

2605

Canberra Hospital ( Site 0104), Canberra

2800

AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0333), Mechelen

3500

Jessa Ziekenhuis-Pulmonology & Thoracic Oncology ( Site 0338), Hasselt

4020

Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0203), Linz

4215

Gold Coast University Hospital-Clinical Trials Service ( Site 0106), Southport

5000

Odense Universitetshospital ( Site 0700), Odense

5016

Hospital Privado Universitario de Córdoba ( Site 0001), Córdoba

6000

Grand Hôpital de Charleroi-Oncology & Hematology ( Site 0337), Charleroi

6150

Fiona Stanley Hospital-Medical Oncology ( Site 0102), Murdoch

6400

Sygehus Soenderjylland-Kraeftambulatoriet ( Site 0705), Sønderborg

6500

Ospedale Regionale Bellinzona e Valli ( Site 2203), Bellinzona

7600

Hospital Privado de Comunidad ( Site 0004), Mar del Plata

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0002), Mar del Plata

8036

Medizinische Universität Graz ( Site 0201), Graz

10002

National Taiwan University Hospital-Oncology ( Site 2304), Taipei

10043

Azienda Sanitaria Ospedaliera S Luigi Gonzaga-Oncologia Polmonare ( Site 1300), Orbassano

10330

Chulalongkorn University ( Site 2403), Bangkok

10449

Mackay Memorial Hospital-Chest Medicine ( Site 2305), Taipei

10461

Montefiore- Einstein Center for Cancer Care-Oncology ( Site 2509), The Bronx

10700

Faculty of Medicine Siriraj Hospital ( Site 2400), Bangkok

13620

Seoul National University Bundang Hospital ( Site 2003), Seongnam

14033

Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre ( Site 1006), Caen

14165

Helios Klinikum Emil von Behring Berlin-Zehlendorf ( Site 1106), Berlin

16247

The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 2005), Suwon

20132

Ospedale San Raffaele-Oncologia Medica ( Site 1305), Milan

20141

Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Toracica ( Site 1301), Milan

20520

Turku University Hospital-The Department of Pulmonary Medicine ( Site 0905), Turku

21201

University of Maryland ( Site 2528), Baltimore

25100

Hospital Tengku Ampuan Afzan ( Site 1500), Kuantan

28009

HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2101), Madrid

28644

Chungbuk National University Hospital-Internal medicine ( Site 2004), Cheongju-si

29607

St Francis Cancer Center-Research Office ( Site 2531), Greenville

31059

CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 1008), Toulouse

33000

Institut Bergonié - Centre Régional de Lutte Contre Le Cance-Medical Oncology ( Site 1009), Bordeaux

33081

CRO-IRCCS-medical oncology ( Site 1304), Aviano

33520

Tampereen yliopistollinen sairaala-Oncology ( Site 0906), Tampere

39401

Hattiesburg Clinic Hematology/Oncology ( Site 2511), Hattiesburg

40503

Baptist Health Lexington-Research ( Site 2502), Lexington

40705

Taichung Veterans General Hospital-Chest ( Site 2307), Taichung

41014

Hospital Universitario Virgen de Valme-Departamento de Oncologia ( Site 2103), Seville

45219

University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 2526), Cincinnati

46050

Beacon Hospital Sdn Bhd ( Site 1504), Petaling Jaya

50134

Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 1306), Florence

53127

Universitätsklinikum Bonn ( Site 1111), Bonn

59100

University Malaya Medical Centre ( Site 1501), Lembah Pantai

61615

Illinois Cancer Care ( Site 2534), Peoria

62660

Clinique Ambroise Paré ( Site 1007), Beuvry

63109

Mercy Research - David C. Pratt Cancer Center ( Site 2532), St Louis

65130

Vaasan Keskussairaala ( Site 0903), Vaasa

65199

Helios Dr. Horst Schmidt Kliniken ( Site 1108), Wiesbaden

65804

Mercy Research - Cancer and Hematology Center ( Site 2535), Springfield

67000

Nouvel Hôpital Civil (NHC) ( Site 1000), Strasbourg

72037

Centre Hospitalier du Mans ( Site 1002), Le Mans

80131

Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1308), Naples

81100

Hospital Sultan Ismail ( Site 1503), Johor Bahru

83301

Chang Gung Memorial Hospital at Kaohsiung ( Site 2303), Kaohsiung Niao Sung Dist

84000

Centre Hospitalier d'Avignon-Service d'Oncologie médicale et d'hématologie clinique ( Site 1004), Avignon

87509

Klinikverbund Allgaeu gGmbH ( Site 1109), Immenstadt im Allgäu

88212

Onkologie Ravensburg ( Site 1104), Ravensburg

90048

Cedars-Sinai Medical Center ( Site 2522), Los Angeles

90220

Oulun yliopistollinen sairaala ( Site 0902), Oulu

94800

Gustave Roussy ( Site 1005), Villejuif

111123

Moscow Clinical Research Center-Chemotherapy department ( Site 1910), Moscow

121205

Hadassah Medical-Oncology department ( Site 1912), Moscow

121359

Central Clinical Hospital of the Presidential Administrative Department ( Site 1902), Moscow

190020

Saint Petersburg State University-Clinic of advanced medical technologies n. a. Nicolay I. Pirogov (, Saint Petersburg

194291

GBUZ LOKB-Oncology department #1 ( Site 1905), Saint Petersburg

197758

N.N.Petrov Research Institute of Oncology-Department of Chemotherapy and Innovative Technologies ( S, Saint Petersburg

198255

Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 1911), Saint Petersburg

603081

Nizhegorodsky Regional Oncology Dispensary, Branch #2-chemotherapy ( Site 1909), Nizhny Novgorod

644013

Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary ( Site 1908), Omsk

3109601

Rambam Health Care Campus-Oncology ( Site 1203), Haifa

6423906

Sourasky Medical Center ( Site 1205), Tel Aviv

8410101

Soroka Medical Center ( Site 1202), Beersheba

9103102

Shaare Zedek Medical Center-Oncology ( Site 1206), Jerusalem

B1884BBF

Centro de Oncología e Investigación de Buenos Aires ( Site 0008), Berazategui

S2000KZE

Instituto de Oncología de Rosario ( Site 0003), Rosario

F5300COE

Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0005), La Rioja

91350-200

Hospital Nossa Senhora da Conceição ( Site 0403), Porto Alegre

01246-000

ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 0400), São Paulo

22250-905

Centro de Tratamento de Tumores Botafogo - CTTB-Pesquisa Clínica ( Site 0402), Rio de Janeiro

01321-000

Hospital Paulistano ( Site 0406), São Paulo

83800 Cedex 9

HIA Sainte Anne ( Site 1003), Toulon

00184

Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 1307), Rome

00168

Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1303), Roma

62-500

Przychodnia Lekarska KOMED ( Site 1704), Konin

02-781

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier, Warsaw

05505

Asan Medical Center-Oncology ( Site 2000), Songpagu

08036

HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit, Barcelona

08041

Hospital de la Santa Creu i Sant Pau-Oncología Médica ( Site 2102), Barcelona

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY