MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)

PHASE2CompletedINTERVENTIONAL
Enrollment

613

Participants

Timeline

Start Date

September 16, 2021

Primary Completion Date

August 5, 2025

Study Completion Date

August 5, 2025

Conditions
Uterine Cervical NeoplasmsEndometrial NeoplasmsSquamous Cell Carcinoma of Head and NeckGallbladder NeoplasmsCholangiocarcinomaEsophageal NeoplasmsTriple Negative Breast NeoplasmsHepatocellular CarcinomaUrinary Bladder NeoplasmsOvarian NeoplasmsStomach Neoplasms
Interventions
BIOLOGICAL

Pembrolizumab/Vibostolimab Co-Formulation

Pembrolizumab 200 mg plus vibostolimab 200 mg administered via IV infusion Q3W

BIOLOGICAL

Pembrolizumab

Pembrolizumab 200 mg administered via IV infusion Q3W.

DRUG

Lenvatinib

Lenvatinib 20 mg, 12 mg, or 8 mg (dependent on cancer type and body weight) administered via oral capsule QD

DRUG

5-Fluorouracil

5-FU 800 mg/m\^2/day administered via continuous IV infusion on each of days 1 to 5 Q3W for up to 35 cycles

DRUG

Cisplatin

Cisplatin administered via IV infusion

DRUG

Paclitaxel

Paclitaxel administered via IV infusion at investigator's choice of dose

DRUG

Gemcitabine

Gemcitabine administered via IV infusion on Day 1 and Day 8 of each 3-week cycle, until PD or unacceptable toxicity

DRUG

Carboplatin

Carboplatin administered via IV infusion at investigator's choice of dose and frequency

DRUG

Docetaxel

For participants who cannot receive paclitaxel due to hypersensitivity or adverse event (AE), docetaxel administered via IV infusion Q3W, Day 1 of each cycle for up to 5 cycles

DRUG

Bevacizumab

Bevacizumab (or biosimilars such as MVASI®, Zirabev®, Aybintio®, ALYMSYS®, Abevmy®, Onbevezy®, Vegzelma®) administered via IV infusion Q3W; Day 1 of each 3-week cycle for up to 15 cycles

DRUG

Capecitabine

Capecitabine administered via oral tablet twice daily on Days 1 to 14 of each cycle (Q3W) for up to 35 cycles

DRUG

Oxaliplatin

Oxaliplatin administered via IV infusion Q3W up to 35 cycles

Trial Locations (73)

333

Chang Gung Medical Foundation-Linkou Branch ( Site 1304), Taoyuan District

704

NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 1302), Tainan City

10002

National Taiwan University Hospital-Oncology ( Site 1301), Taipei

10065

Memorial Sloan Kettering Cancer Center ( Site 1002), New York

10449

Mackay Memorial Hospital ( Site 1305), Taipei

10604

Memorial Sloan Kettering - Westchester ( Site 1020), Harrison

11553

Memorial Sloan Kettering - Nassau ( Site 1026), Uniondale

11725

Memorial Sloan Kettering- Commack ( Site 1021), Commack

12203

Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 1171), Berlin

20089

Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1138), Rozzano

20132

Ospedale San Raffaele-Oncologia Medica ( Site 1135), Milan

20141

Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative (, Milan

21079

Centre Georges François Leclerc ( Site 1155), Dijon

22030

Trakya University-Medical Oncology ( Site 1207), Edirne

28027

Clinica Universidad de Navarra-Medical Oncology ( Site 1118), Madrid

28034

Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1111), Madrid

28223

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1117), Pozuelo de Alarcón

34098

Istanbul Universitesi Cerrahpasa ( Site 1203), Istanbul- Fatih

34298

Institut Regional du Cancer Montpellier ( Site 1157), Montpellier

34303

Acibadem Universitesi Atakent Hastanesi ( Site 1208), Istanbul

34722

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1204), Istanbul

40225

Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 1172), Düsseldorf

41013

HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1114), Seville

48201

Karmanos Cancer Institute ( Site 1007), Detroit

57104

Sanford Cancer Center-Gynecologic Oncology ( Site 1015), Sioux Falls

69120

Universitaetsklinikum Heidelberg-Nationales Centrum für Tumorerkrankungen ( Site 1180), Heidelberg

72076

Universitaetsklinikum Tuebingen-Department of Internal Medicine VIII - Medical Oncology, ECTU, Pne, Tübingen

74146

Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1024), Tulsa

75248

Institut Curie ( Site 1152), Paris

77030

Houston Methodist Hospital ( Site 1017), Houston

80131

Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Sperimentazioni Cliniche ( Site 1134), Napoli

81337

Klinikum der Universität München Großhadern ( Site 1176), München

84000

Sainte Catherine Institut du Cancer Avignon Provence-Oncologie médicale ( Site 1156), Avignon

91010

City of Hope Comprehensive Cancer Center ( Site 1001), Duarte

94800

Gustave Roussy-medicine departement ( Site 1153), Villejuif

99508

Alaska Womens Cancer Care ( Site 1016), Anchorage

111511

Instituto Nacional de Cancerología-Clinical Oncology ( Site 1425), Bogotá

661001

Oncologos del Occidente ( Site 1424), Pereira

681017

Fundación Cardiovascular de Colombia ( Site 1423), Piedecuesta

3109601

Rambam Health Care Campus-Oncology ( Site 1141), Haifa

4800827

James Lind Centro de Investigacion del Cancer ( Site 1404), Temuco

5265601

Sheba Medical Center-ONCOLOGY ( Site 1144), Ramat Gan

6423906

Sourasky Medical Center-Oncology ( Site 1143), Tel Aviv

7500921

FALP-UIDO ( Site 1401), Santiago

7510032

Oncovida ( Site 1405), Santiago

8420383

Bradfordhill-Clinical Area ( Site 1402), Santiago

9112001

Hadassah Medical Center-Oncology ( Site 1142), Jerusalem

92868-3201

University of California, Irvine (UCI) Health - UC Irvine Me-Chao Family Comprehensive Cancer Cente, Orange

07920

Memorial Sloan Kettering - Basking Ridge ( Site 1023), Basking Ridge

07748

Memorial Sloan Kettering - Monmouth ( Site 1022), Middletown

07645

Memorial Sloan Kettering - Bergen ( Site 1025), Montvale

K7L 2V7

Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1051), Kingston

M5G 2M9

Princess Margaret Cancer Centre ( Site 1056), Toronto

050030

Fundacion Colombiana de Cancerología Clinica Vida ( Site 1422), Medellín

080020

Clinica de la Costa S.A.S. ( Site 1421), Barranquilla

69373 Cedex 08

CENTRE LEON BERARD-Medical oncology ( Site 1151), Lyon

00168

Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 1136), Rome

464-8681

Aichi Cancer Center Hospital ( Site 1324), Nagoya

277-8577

National Cancer Center Hospital East ( Site 1321), Kashiwa

541-8567

Osaka International Cancer Institute ( Site 1323), Osaka

104-0045

National Cancer Center Hospital ( Site 1322), Tokyo

1066CX

Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 1121), Amsterdam

3015 GD

Erasmus Medisch Centrum-Medical Oncology ( Site 1122), Rotterdam

02-781

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 1101, Warsaw

80-952

Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 1103), Gdansk

75-581

Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1104), Koszalin

03080

Seoul National University Hospital-Internal Medicine ( Site 1312), Seoul

03722

Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1311), Seoul

05505

Asan Medical Center ( Site 1313), Seoul

08907

Instituto Catalan de Oncologia - Hospital Duran i Reynals-Medical Oncology ( Site 1113), Hospitalet

01250

Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1201), Adana

06230

Hacettepe Universitesi-oncology hospital ( Site 1209), Ankara

06800

Ankara City Hospital-Medical Oncology ( Site 1202), Ankara

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT05007106 - MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005) | Biotech Hunter | Biotech Hunter