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

A Multicenter, Open-label, Phase 2 Basket Study of MK-7684A, a Co-formation of Vibostolimab (MK-7684) With Pembrolizumab (MK-3475), With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors

INTRODUCTION

  • Org Study ID: 7684A-005
  • Secondary ID: MK-7684A-005, jRCT2031210335, KEYVIBE-005, 2021-001700-15
  • NTC ID: NCT05007106
  • Sponsor: Merck Sharp & Dohme LLC

BRIEF 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.

  • Overall Status
    Recruiting
  • Start Date
    September 16, 2021
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)

Primary Outcome 1 - Timeframe: Up to approximately 2 years

Primary Outcome 2 - Measure: Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR

Primary Outcome 2 - Timeframe: Up to approximately 2 years

Primary Outcome 3 - Measure: ORR per RECIST 1.1 as Assessed by Investigator

Primary Outcome 3 - Timeframe: Up to approximately 2 years

Primary Outcome 4 - Measure: PFS per RECIST 1.1 as Assessed by Investigator at 9 months

Primary Outcome 4 - Timeframe: 9 months

Primary Outcome 5 - Measure: PFS per RECIST 1.1 as Assessed by Investigator at 12 months

Primary Outcome 5 - Timeframe: 12 months

CONDITION

  • Uterine Cervical Neoplasms
  • Endometrial Neoplasms
  • Squamous Cell Carcinoma of Head and Neck
  • Gallbladder Neoplasms
  • Cholangiocarcinoma
  • Esophageal Neoplasms
  • Triple Negative Breast Neoplasms
  • Hepatocellular Carcinoma
  • Urinary Bladder Neoplasms
  • Ovarian Neoplasms
  • Stomach Neoplasms

ELIGIBILITY

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Medical Director

Role: Study Director

Affiliation: Merck Sharp & Dohme LLC

Overall Contact

Name: Medical Director

Phone: 1-888-577-8839

Email: Trialsites@merck.com

LOCATION

Facility Status Contact
Facility: Alaska Womens Cancer Care ( Site 1016)
Anchorage, Alaska 99508
United States
Status: Recruiting Contact: Contact
Study Coordinator
111-111-1111
Facility: City of Hope Comprehensive Cancer Center ( Site 1001)
Duarte, California 91010
United States
Status: Recruiting Contact: Contact
Study Coordinator
888-88-8888
Facility: University of California, Irvine (UCI) Health - UC Irvine Me-Chao Family Comprehensive Cancer Cente
Orange, California 92868
United States
Status: Recruiting Contact: Contact
Study Coordinator
111-111-1111
Facility: Karmanos Cancer Institute ( Site 1007)
Detroit, Michigan 48201
United States
Status: Recruiting Contact: Contact
Study Coordinator
111-111-1111
Facility: Memorial Sloan Kettering - Monmouth ( Site 1022)
Middletown, New Jersey 07748
United States
Status: Recruiting Contact: Contact
Study Coordinator
888-88-8888
Facility: Memorial Sloan Kettering- Commack ( Site 1021)
Commack, New York 11725
United States
Status: Recruiting Contact: Contact
Study Coordinator
888-88-8888
Facility: Memorial Sloan Kettering - Westchester ( Site 1020)
Harrison, New York 10604
United States
Status: Recruiting Contact: Contact
Study Coordinator
888-88-8888
Facility: Memorial Sloan Kettering Cancer Center ( Site 1002)
New York, New York 10065
United States
Status: Recruiting Contact: Contact
Study Coordinator
888-88-8888
Facility: Sanford Cancer Center-Gynecologic Oncology ( Site 1015)
Sioux Falls, South Dakota 57104
United States
Status: Recruiting Contact: Contact
Study Coordinator
111-111-1111
Facility: Houston Methodist Hospital ( Site 1017)
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
Study Coordinator
111-111-1111
Facility: Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 1056)
Toronto, Ontario M5G 2M9
Canada
Status: Recruiting Contact: Contact
Study Coordinator
416-946-4575
Facility: James Lind Centro de Investigación del Cáncer ( Site 1404)
Temuco, Araucania 4780000
Chile
Status: Recruiting Contact: Contact
Study Coordinator
+56961064692
Facility: FALP-UIDO ( Site 1401)
Santiago, Region M. De Santiago 6900941
Chile
Status: Recruiting Contact: Contact
Study Coordinator
+56939263055
Facility: Oncovida ( Site 1405)
Santiago, Region M. De Santiago 7510032
Chile
Status: Recruiting Contact: Contact
Study Coordinator
+56961064692
Facility: Bradfordhill-Clinical Area ( Site 1402)
Santiago, Region M. De Santiago 8420383
Chile
Status: Recruiting Contact: Contact
Study Coordinator
+56961064692
Facility: Clínica Vida Fundación - Sede Poblado ( Site 1422)
Medellin, Antioquia 050030
Colombia
Status: Recruiting Contact: Contact
Study Coordinator
+573126867004
Facility: Clinica de la Costa LTDA ( Site 1421)
Barranquilla, Atlantico 080020
Colombia
Status: Recruiting Contact: Contact
Study Coordinator
+575 3369999
Facility: Oncologos del Occidente ( Site 1424)
Pereira, Risaralda 660001
Colombia
Status: Recruiting Contact: Contact
Study Coordinator
+57 6 3310712 Ext. 417
Facility: Fundación Cardiovascular de Colombia ( Site 1423)
Floridablanca, Santander 681004
Colombia
Status: Recruiting Contact: Contact
Study Coordinator
573215433439
Facility: Centre Georges François Leclerc ( Site 1155)
Dijon, Cote-d Or 21079
France
Status: Recruiting Contact: Contact
Study Coordinator
03 45 34 80 68
Facility: Institut Régional du Cancer Montpellier ( Site 1157)
Montpellier, Herault 34298
France
Status: Recruiting Contact: Contact
Study Coordinator
33467612304
Facility: Gustave Roussy-medicine departement ( Site 1153)
Villejuif, Paris 94800
France
Status: Recruiting Contact: Contact
Study Coordinator
33142114571
Facility: CENTRE LEON BERARD-Medical oncology ( Site 1151)
Lyon, Rhone-Alpes 69008
France
Status: Recruiting Contact: Contact
Study Coordinator
33478782935
Facility: Sainte Catherine Institut du Cancer Avignon Provence-Oncologie médicale ( Site 1156)
Avignon, Vaucluse 84918
France
Status: Recruiting Contact: Contact
Study Coordinator
33490276397
Facility: Institut Curie ( Site 1152)
Paris, Baden-Wurttemberg 75005
France
Status: Recruiting Contact: Contact
Study Coordinator
33144324086
Facility: Universitaetsklinikum Heidelberg-Nationales Centrum für Tumorerkrankungen ( Site 1180)
Heidelberg, Baden-Wurttemberg 69120
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+4962215636051
Facility: Universitaetsklinikum Tuebingen-Department of Internal Medicine VIII - Medical Oncology, ECTU, Pne
Tübingen, Nordrhein-Westfalen 72076
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+4970712982795
Facility: Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 1172)
Düsseldorf, Lombardia 40225
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+492118117820
Facility: Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 1171)
Berlin, Chiba 12203
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+49 30 84450
Facility: Rambam Health Care Campus-Oncology ( Site 1141)
Haifa, Noord-Holland 3109601
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+ 972 4 7776724
Facility: Hadassah Medical Center-Oncology ( Site 1142)
Jerusalem, Zuid-Holland 9112001
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+ 972 2 6776760
Facility: Sheba Medical Center-ONCOLOGY ( Site 1144)
Ramat Gan, Mazowieckie 5265601
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+ 972 3 5302243
Facility: Sourasky Medical Center-Oncology ( Site 1143)
Tel Aviv, Pomorskie 6423906
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+ 972 3 6973082
Facility: Ospedale San Raffaele-Oncologia Medica ( Site 1135)
Milano, Zachodniopomorskie 20132
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+390226436523
Facility: Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative (
Milano, Barcelona 20141
Italy
Status: Recruiting Contact: Contact
Study Coordinator
390257490439
Facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Sperimentazioni Cliniche ( Site 1134)
Napoli, Madrid, Comunidad De 80131
Italy
Status: Recruiting Contact: Contact
Study Coordinator
00393331891929
Facility: National Cancer Center Hospital East ( Site 1321)
Kashiwa, Madrid 277-8577
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-4-7133-1111
Facility: National Cancer Center Hospital ( Site 1322)
Tokyo, 104-0045
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-3-3542-2511
Facility: Seoul National University Hospital-Internal Medicine ( Site 1312)
Seoul, 03080
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+82-2-2072-0850
Facility: Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1311)
Seoul, 03722
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+82-2-2228-8132
Facility: Asan Medical Center ( Site 1313)
Seoul, 05505
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+82-2-3010-0491
Facility: Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) ( Site 1121)
Amsterdam, 1066CX
Netherlands
Status: Recruiting Contact: Contact
Study Coordinator
+31205122446
Facility: Erasmus Medisch Centrum-Medical Oncology ( Site 1122)
Rotterdam, 3015 GD
Netherlands
Status: Recruiting Contact: Contact
Study Coordinator
+31107034897
Facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 1101
Warszawa, 02-781
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+48 22 546 33 81
Facility: Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 1103)
Gdańsk, 80-952
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+48 695 802 353
Facility: Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1104)
Koszalin, 75-581
Poland
Status: Recruiting Contact: Contact
Study Coordinator
48502204953
Facility: Instituto Catalan de Oncologia - Hospital Duran i Reynals-Medical Oncology ( Site 1113)
Hospitalet, 08907
Spain
Status: Recruiting Contact: Contact
Study Coordinator
932607294
Facility: Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1111)
Madrid, 28034
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+34 913368263
Facility: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1117)
Pozuelo de Alarcon, 28223
Spain
Status: Recruiting Contact: Contact
Study Coordinator
34914521987
Facility: HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1114)
Sevilla, 41013
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+34955013068
Facility: NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 1302)
Tainan, 704
Taiwan
Status: Recruiting Contact: Contact
Study Coordinator
+886-6-2353535
Facility: National Taiwan University Hospital-Oncology ( Site 1301)
Taipei, 10002
Taiwan
Status: Recruiting Contact: Contact
Study Coordinator
886-2-23123456
Facility: Mackay Memorial Hospital ( Site 1305)
Taipei, 10449
Taiwan
Status: Recruiting Contact: Contact
Study Coordinator
+886 2 2543 3535
Facility: Chang Gung Medical Foundation-Linkou Branch ( Site 1304)
Taoyuan, 333
Taiwan
Status: Recruiting Contact: Contact
Study Coordinator
886-3-3281200
Facility: Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1201)
Adana, 01250
Turkey
Status: Recruiting Contact: Contact
Study Coordinator
+903223444445
Facility: Hacettepe Universitesi-oncology hospital ( Site 1209)
Ankara, 06230
Turkey
Status: Recruiting Contact: Contact
Study Coordinator
90 312 305 29 29
Facility: Ankara City Hospital-Medical Oncology ( Site 1202)
Ankara, 06800
Turkey
Status: Recruiting Contact: Contact
Study Coordinator
0903125526000
Facility: Trakya University-Medical Oncology ( Site 1207)
Edirne, 22030
Turkey
Status: Recruiting Contact: Contact
Study Coordinator
90 284 235 76 41
Facility: Acibadem Universitesi Atakent Hastanesi ( Site 1208)
Istanbul, 34303
Turkey
Status: Recruiting Contact: Contact
Study Coordinator
+905324634021
Facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1204)
Istanbul, 34722
Turkey
Status: Recruiting Contact: Contact
Study Coordinator
90 216 606 52 00