Breast Cancer Clinical Trial

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

Summary

The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of pembrolizumab/vibostolimab co-formulation (MK-7684A) with or without other anticancer therapies in participants with selected advanced solid tumors. The primary hypothesis is that pembrolizumab/vibostolimab co-formulation is superior to pembrolizumab alone in terms of objective response rate or progression-free survival in participants with cervical cancer.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

One of the following histologically or cytologically confirmed, advanced (locally recurrent unresectable or metastatic) solid tumors:

Squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
Endometrial cancer
Head and neck squamous cell carcinoma (HNSCC)
Unresectable biliary adenocarcinoma (gallbladder or biliary tree [intrahepatic or extrahepatic] cholangiocarcinoma)
Adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the gastroesophageal junction (GEJ).
Triple-negative breast cancer (TNBC)
Hepatocellular carcinoma (HCC)
Urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra
Ovarian cancer
Gastric cancer
Measurable disease per RECIST v1.1 as assessed by BICR or local site investigator.
Adequately controlled blood pressure (BP) with or without antihypertensive medications.
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).
Male participants must agree to follow contraceptive guidance.
Female participants are not pregnant or breastfeeding, not a woman of child-bearing potential (WOCBP) or is a WOCBP and agrees to follow contraceptive guidance.
Adequate organ function.

Exclusion Criteria:

History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.
Prior therapy with anti-programmed cell-death (PD-1), anti-PD-L1, anti-PD-L2, or anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT) agent.
Prior systemic anticancer therapy including investigational agents within 4 weeks before randomization/allocation.
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study medication.
Active autoimmune disease that has required systemic treatment in past 2 years.
Active infection requiring systemic therapy.
Concurrent active hepatitis B and hepatitis C virus infection.
History of allogenic tissue/solid organ transplant.
Previous treatment with lenvatinib (for participants who will receive lenvatinib in their assigned treatment arm).
Has clinically significant cardiovascular disease within 12 months from first dose of study intervention.

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

610

Study ID:

NCT05007106

Recruitment Status:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 64 Locations for this study

See Locations Near You

Alaska Womens Cancer Care ( Site 1016)
Anchorage Alaska, 99508, United States More Info
Study Coordinator
Contact
907-562-4673
City of Hope Comprehensive Cancer Center ( Site 1001)
Duarte California, 91010, United States More Info
Study Coordinator
Contact
626-471-9200
University of California, Irvine (UCI) Health - UC Irvine Me-Chao Family Comprehensive Cancer Cente
Orange California, 92868, United States More Info
Study Coordinator
Contact
714-456-8020
Karmanos Cancer Institute ( Site 1007)
Detroit Michigan, 48201, United States More Info
Study Coordinator
Contact
734-330-6512
Memorial Sloan Kettering - Monmouth ( Site 1022)
Middletown New Jersey, 07748, United States More Info
Study Coordinator
Contact
626-679-5955
Memorial Sloan Kettering- Commack ( Site 1021)
Commack New York, 11725, United States More Info
Study Coordinator
Contact
626-679-5955
Memorial Sloan Kettering - Westchester ( Site 1020)
Harrison New York, 10604, United States More Info
Study Coordinator
Contact
626-679-5955
Memorial Sloan Kettering Cancer Center ( Site 1002)
New York New York, 10065, United States More Info
Study Coordinator
Contact
626-679-5955
Sanford Cancer Center-Gynecologic Oncology ( Site 1015)
Sioux Falls South Dakota, 57104, United States More Info
Study Coordinator
Contact
605-376-4905
Houston Methodist Hospital ( Site 1017)
Houston Texas, 77030, United States More Info
Study Coordinator
Contact
713-441-6616
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1051)
Kingston Ontario, K7L 2, Canada More Info
Study Coordinator
Contact
613-549-6666 Ext 6641
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 1056)
Toronto Ontario, M5G 2, Canada More Info
Study Coordinator
Contact
416-946-4575
James Lind Centro de Investigación del Cáncer ( Site 1404)
Temuco Araucania, 48008, Chile More Info
Study Coordinator
Contact
+56961064692
FALP-UIDO ( Site 1401)
Santiago Region M. De Santiago, 69009, Chile More Info
Study Coordinator
Contact
+56939263055
Oncovida ( Site 1405)
Santiago Region M. De Santiago, 75100, Chile More Info
Study Coordinator
Contact
+56961064692
Bradfordhill-Clinical Area ( Site 1402)
Santiago Region M. De Santiago, 84203, Chile More Info
Study Coordinator
Contact
+56961064692
Clínica Vida Fundación - Sede Poblado ( Site 1422)
Medellin Antioquia, 05003, Colombia More Info
Study Coordinator
Contact
+573126867004
Clinica de la Costa S.A.S. ( Site 1421)
Barranquilla Atlantico, 08002, Colombia More Info
Study Coordinator
Contact
+575 3369999
Instituto Nacional de Cancerología-Clinical Oncology ( Site 1425)
Bogotá Cundinamarca, 11151, Colombia More Info
Study Coordinator
Contact
573125199934
Oncologos del Occidente ( Site 1424)
Pereira Risaralda, 66000, Colombia More Info
Study Coordinator
Contact
+57 6 3310712 Ext. 417
Fundación Cardiovascular de Colombia ( Site 1423)
Piedecuesta Santander, 68101, Colombia More Info
Study Coordinator
Contact
573215433439
Centre Georges François Leclerc ( Site 1155)
Dijon Cote-d Or, 21079, France More Info
Study Coordinator
Contact
03 45 34 80 68
Institut Régional du Cancer Montpellier ( Site 1157)
Montpellier Herault, 34298, France More Info
Study Coordinator
Contact
33467612304
Gustave Roussy-medicine departement ( Site 1153)
Villejuif Paris, 94800, France More Info
Study Coordinator
Contact
33142114571
CENTRE LEON BERARD-Medical oncology ( Site 1151)
Lyon Rhone-Alpes, 69008, France More Info
Study Coordinator
Contact
33478782935
Sainte Catherine Institut du Cancer Avignon Provence-Oncologie médicale ( Site 1156)
Avignon Vaucluse, 84918, France More Info
Study Coordinator
Contact
33490276397
Institut Curie ( Site 1152)
Paris , 75005, France More Info
Study Coordinator
Contact
33144324086
Universitaetsklinikum Heidelberg-Nationales Centrum für Tumorerkrankungen ( Site 1180)
Heidelberg Baden-Wurttemberg, 69120, Germany More Info
Study Coordinator
Contact
+4962215636051
Universitaetsklinikum Tuebingen-Department of Internal Medicine VIII - Medical Oncology, ECTU, Pne
Tübingen Baden-Wurttemberg, 72076, Germany More Info
Study Coordinator
Contact
+4970712982795
Klinikum der Universität München Großhadern ( Site 1176)
München Bayern, 81377, Germany More Info
Study Coordinator
Contact
+4989 4400 75250
Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 1172)
Düsseldorf Nordrhein-Westfalen, 40225, Germany More Info
Study Coordinator
Contact
+492118117820
Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 1171)
Berlin , 12203, Germany More Info
Study Coordinator
Contact
+49 30 84450
Rambam Health Care Campus-Oncology ( Site 1141)
Haifa , 31096, Israel More Info
Study Coordinator
Contact
+ 972 4 7776724
Hadassah Medical Center-Oncology ( Site 1142)
Jerusalem , 91120, Israel More Info
Study Coordinator
Contact
+ 972 2 6776760
Sheba Medical Center-ONCOLOGY ( Site 1144)
Ramat Gan , 52621, Israel More Info
Study Coordinator
Contact
+ 972 3 5302243
Sourasky Medical Center-Oncology ( Site 1143)
Tel Aviv , 64239, Israel More Info
Study Coordinator
Contact
+ 972 3 6973082
Ospedale San Raffaele-Oncologia Medica ( Site 1135)
Milano Lombardia, 20132, Italy More Info
Study Coordinator
Contact
+390226436523
Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative (
Milano , 20141, Italy More Info
Study Coordinator
Contact
390257490439
Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Sperimentazioni Cliniche ( Site 1134)
Napoli , 80131, Italy More Info
Study Coordinator
Contact
00393331891929
National Cancer Center Hospital East ( Site 1321)
Kashiwa Chiba, 277-8, Japan More Info
Study Coordinator
Contact
+81-4-7133-1111
Osaka International Cancer Institute ( Site 1323)
Osaka , 541-8, Japan More Info
Study Coordinator
Contact
+81-6-6945-1181
National Cancer Center Hospital ( Site 1322)
Tokyo , 104-0, Japan More Info
Study Coordinator
Contact
+81-3-3542-2511
Seoul National University Hospital-Internal Medicine ( Site 1312)
Seoul , 03080, Korea, Republic of More Info
Study Coordinator
Contact
+82-2-2072-0850
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1311)
Seoul , 03722, Korea, Republic of More Info
Study Coordinator
Contact
+82-2-2228-8132
Asan Medical Center ( Site 1313)
Seoul , 05505, Korea, Republic of More Info
Study Coordinator
Contact
+82-2-3010-0491
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) ( Site 1121)
Amsterdam Noord-Holland, 1066 , Netherlands More Info
Study Coordinator
Contact
+31205122446
Erasmus Medisch Centrum-Medical Oncology ( Site 1122)
Rotterdam Zuid-Holland, 3015 , Netherlands More Info
Study Coordinator
Contact
+31107034897
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 1101
Warszawa Mazowieckie, 02-78, Poland More Info
Study Coordinator
Contact
+48 22 546 33 81
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 1103)
Gdańsk Pomorskie, 80-95, Poland More Info
Study Coordinator
Contact
+48 695 802 353
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1104)
Koszalin Zachodniopomorskie, 75-58, Poland More Info
Study Coordinator
Contact
48502204953
Instituto Catalan de Oncologia - Hospital Duran i Reynals-Medical Oncology ( Site 1113)
Hospitalet Barcelona, 08907, Spain More Info
Study Coordinator
Contact
932607294
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1111)
Madrid Madrid, Comunidad De, 28034, Spain More Info
Study Coordinator
Contact
+34 913368263
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1117)
Pozuelo de Alarcon Madrid, 28223, Spain More Info
Study Coordinator
Contact
34914521987
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1114)
Sevilla , 41013, Spain More Info
Study Coordinator
Contact
+34955013068
NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 1302)
Tainan , 704, Taiwan More Info
Study Coordinator
Contact
+886-6-2353535
National Taiwan University Hospital-Oncology ( Site 1301)
Taipei , 10002, Taiwan More Info
Study Coordinator
Contact
886-2-23123456
Mackay Memorial Hospital ( Site 1305)
Taipei , , Taiwan More Info
Study Coordinator
Contact
+886 2 2543 3535
Chang Gung Medical Foundation-Linkou Branch ( Site 1304)
Taoyuan , 333, Taiwan More Info
Study Coordinator
Contact
886-3-3281200
Istanbul Universitesi Cerrahpasa ( Site 1203)
Istanbul- Fatih Istanbul, 34098, Turkey More Info
Study Coordinator
Contact
+90 2124400000
Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1201)
Adana , 01250, Turkey More Info
Study Coordinator
Contact
+903223444445
Hacettepe Universitesi-oncology hospital ( Site 1209)
Ankara , 06230, Turkey More Info
Study Coordinator
Contact
90 312 305 29 29
Ankara City Hospital-Medical Oncology ( Site 1202)
Ankara , 06800, Turkey More Info
Study Coordinator
Contact
0903125526000
Trakya University-Medical Oncology ( Site 1207)
Edirne , 22030, Turkey More Info
Study Coordinator
Contact
90 284 235 76 41
Acibadem Universitesi Atakent Hastanesi ( Site 1208)
Istanbul , 34303, Turkey More Info
Study Coordinator
Contact
+905324634021
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1204)
Istanbul , 34722, Turkey More Info
Study Coordinator
Contact
90 216 606 52 00

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

610

Study ID:

NCT05007106

Recruitment Status:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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