Clinical trial NCT05007106: MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: 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
Keywords: Programmed Cell Death-1 (PD1, PD-1)
Programmed Death-Ligand 1 (PDL1, PD-L1)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2021-08-16
Enrollment: 613
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants with locally recurrent unresectable or metastatic cervical cancer whose tumors express programmed cell death 1 ligand 1 (PD-LI) and have a combined positive score (CPS) ≥1 will be randomly assigned to treatment with either pembrolizumab/vibostolimab co-formulation or pembrolizumab only. The other study intervention arms will be assigned to participants depending on the selected cancer type.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* One of the following histologically or cytologically confirmed, advanced (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.

Primary outcomes:
measure: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)
timeFrame: Up to approximately 2 years
measure: Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR
timeFrame: Up to approximately 2 years
measure: ORR per RECIST 1.1 as Assessed by Investigator in Participants with Selected Solid Tumors
timeFrame: Up to approximately 2 years
measure: PFS per RECIST 1.1 as Assessed by Investigator at 9 months
timeFrame: 9 months
measure: PFS per RECIST 1.1 as Assessed by Investigator at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 5.5 years
measure: PFS per RECIST 1.1 as Assessed by Investigator
timeFrame: Up to approximately 2 years
measure: Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
timeFrame: Up to approximately 2 years
measure: DOR per RECIST 1.1 as Assessed by Investigator
timeFrame: Up to approximately 2 years
measure: ORR per RECIST 1.1 as Assessed by Investigator
timeFrame: Up to approximately 2 years
measure: PFS per RECIST 1.1 as Assessed by Investigator in Participants with Cervical Cancer
timeFrame: Up to approximately 2 years
measure: Change from Baseline in Global Health Status/Quality of Life Score (European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 [EORTC QLQ-C30] Items 29 and 30)
timeFrame: Baseline and up to approximately 2 years
measure: Change from Baseline in Physical Functioning Score (EORTC QLQ-C30 Items 1-5)
timeFrame: Baseline and up to approximately 2 years
measure: Number of Participants Who Experienced One or More Adverse Events (AEs)
timeFrame: Up to approximately 2 years
measure: Number of Participants Who Discontinued Study Intervention Due to an AE
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Womens Cancer Care ( Site 1016)
state: Alaska
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center ( Site 1001)
state: California
city: Orange
country: United States
facility: University of California, Irvine (UCI) Health - UC Irvine Me-Chao Family Comprehensive Cancer Cente
state: California
city: Detroit
country: United States
facility: Karmanos Cancer Institute ( Site 1007)
state: Michigan
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering - Basking Ridge ( Site 1023)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering - Monmouth ( Site 1022)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering - Bergen ( Site 1025)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering- Commack ( Site 1021)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering - Westchester ( Site 1020)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center ( Site 1002)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering - Nassau ( Site 1026)
state: New York
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1024)
state: Oklahoma
city: Sioux Falls
country: United States
facility: Sanford Cancer Center-Gynecologic Oncology ( Site 1015)
state: South Dakota
city: Houston
country: United States
facility: Houston Methodist Hospital ( Site 1017)
state: Texas
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1051)
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre ( Site 1056)
state: Ontario
city: Temuco
country: Chile
facility: James Lind Centro de Investigacion del Cancer ( Site 1404)
state: Araucania
city: Santiago
country: Chile
facility: FALP-UIDO ( Site 1401)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Oncovida ( Site 1405)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Bradfordhill-Clinical Area ( Site 1402)
state: Region M. De Santiago
city: Medellin
country: Colombia
facility: Fundacion Colombiana de Cancerología Clinica Vida ( Site 1422)
state: Antioquia
city: Barranquilla
country: Colombia
facility: Clinica de la Costa S.A.S. ( Site 1421)
state: Atlantico
city: Bogotá
country: Colombia
facility: Instituto Nacional de Cancerología-Clinical Oncology ( Site 1425)
state: Cundinamarca
city: Pereira
country: Colombia
facility: Oncologos del Occidente ( Site 1424)
state: Risaralda
city: Piedecuesta
country: Colombia
facility: Fundación Cardiovascular de Colombia ( Site 1423)
state: Santander
city: Dijon
country: France
facility: Centre Georges François Leclerc ( Site 1155)
state: Cote-d Or
city: Montpellier
country: France
facility: Institut Regional du Cancer Montpellier ( Site 1157)
state: Herault
city: Villejuif
country: France
facility: Gustave Roussy-medicine departement ( Site 1153)
state: Paris
city: Lyon
country: France
facility: CENTRE LEON BERARD-Medical oncology ( Site 1151)
state: Rhone-Alpes
city: Avignon
country: France
facility: Sainte Catherine Institut du Cancer Avignon Provence-Oncologie médicale ( Site 1156)
state: Vaucluse
city: Paris
country: France
facility: Institut Curie ( Site 1152)
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg-Nationales Centrum für Tumorerkrankungen ( Site 1180)
state: Baden-Wurttemberg
city: Tübingen
country: Germany
facility: Universitaetsklinikum Tuebingen-Department of Internal Medicine VIII - Medical Oncology, ECTU, Pne
state: Baden-Wurttemberg
city: München
country: Germany
facility: Klinikum der Universität München Großhadern ( Site 1176)
state: Bayern
city: Düsseldorf
country: Germany
facility: Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 1172)
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 1171)
city: Haifa
country: Israel
facility: Rambam Health Care Campus-Oncology ( Site 1141)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center-Oncology ( Site 1142)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center-ONCOLOGY ( Site 1144)
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center-Oncology ( Site 1143)
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 1136)
state: Lazio
city: Milano
country: Italy
facility: Ospedale San Raffaele-Oncologia Medica ( Site 1135)
state: Lombardia
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1138)
state: Milano
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative (
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Sperimentazioni Cliniche ( Site 1134)
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital ( Site 1324)
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 1321)
state: Chiba
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 1323)
city: Tokyo
country: Japan
facility: National Cancer Center Hospital ( Site 1322)
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital-Internal Medicine ( Site 1312)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1311)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 1313)
city: Amsterdam
country: Netherlands
facility: Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 1121)
state: Noord-Holland
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum-Medical Oncology ( Site 1122)
state: Zuid-Holland
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 1101
state: Mazowieckie
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 1103)
state: Pomorskie
city: Koszalin
country: Poland
facility: Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1104)
state: Zachodniopomorskie
city: Hospitalet
country: Spain
facility: Instituto Catalan de Oncologia - Hospital Duran i Reynals-Medical Oncology ( Site 1113)
state: Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1111)
state: Madrid, Comunidad De
city: Pozuelo de Alarcon
country: Spain
facility: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1117)
state: Madrid
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra-Medical Oncology ( Site 1118)
city: Sevilla
country: Spain
facility: HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1114)
city: Tainan
country: Taiwan
facility: NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 1302)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital-Oncology ( Site 1301)
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital ( Site 1305)
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch ( Site 1304)
city: Istanbul- Fatih
country: Turkey
facility: Istanbul Universitesi Cerrahpasa ( Site 1203)
state: Istanbul
city: Adana
country: Turkey
facility: Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1201)
city: Ankara
country: Turkey
facility: Hacettepe Universitesi-oncology hospital ( Site 1209)
city: Ankara
country: Turkey
facility: Ankara City Hospital-Medical Oncology ( Site 1202)
city: Edirne
country: Turkey
facility: Trakya University-Medical Oncology ( Site 1207)
city: Istanbul
country: Turkey
facility: Acibadem Universitesi Atakent Hastanesi ( Site 1208)
city: Istanbul
country: Turkey
facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1204)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: