A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004)
- Conditions
- Hematological Malignancies
- Interventions
- Biological: Pembrolizumab/vibostolimab coformuation
- Registration Number
- NCT05005442
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of the study is to determine the safety and tolerability of pembrolizumab/vibostolimab (MK-7684A) in hematological malignancies. This study will also evaluate the overall response rate (ORR), the duration of response (DOR), and disease control rate (DCR) following administration of pembrolizumab/vibostolimab. In addition, this study will characterize pharmacokinetic (PK) profile of vibostolimab (MK-7684).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 191
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pembrolizumab/vibostolimab coformulation Pembrolizumab/vibostolimab coformuation Participants will receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
- Primary Outcome Measures
Name Time Method Number of Participants Who Discontinued Study Treatment Due to an AE Up to approximately 24 months An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The number of participants discontinued from the study treatment due to an AE will be reported.
Number of Participants with a Dose-Limiting Toxicity (DLT) Up to approximately 6 weeks A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0). Number of participants who experience a DLT per CTCAE 5.0 will be reported.
Number of Participants Who Experienced an Adverse Event (AE) Up to approximately 27 months An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The number of participants who experience an AE will be reported.
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) Up to approximately 24 months ORR is defined as the percentage of participants who have a response as defined by the specific disease criteria of the hematological malignancy. The percentage of participants who experience a response will be presented.
Maximum Concentration (Cmax) of Vibostolimab Postdose: after end of infusion (up to ~10 minutes) at Cycles 1 and 8. Cycle = 3 weeks Cmax is the maximum concentration of the drug observed in plasma. Blood samples collected post dose will be used to determine Cmax of Vibostolimab.
Lowest Plasma Concentration (Ctrough) of Vibostolimab Predose at Cycles 1, 2, 4, 8, and every 12 weeks afterwards (up to ~2 years). Cycle = 3 weeks Ctrough is the lowest concentration reached by a drug before the next dose is administered. Blood samples collected predose will be used to determine Ctrough of Vibostolimab.
Disease Control Rate (DCR) Up to approximately 24 months DCR is defined as the percentage of participants who have a Complete Response (CR), a Partial Response (PR), or Stable Disease (SD). The percentage of participants who experience a CR, a PR, or SD will be presented.
Duration of Response (DOR) Up to approximately 24 months DOR is the time from response (R) to progression/death (P/D). The DOR will be presented.
Trial Locations
- Locations (65)
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0601)
🇧🇷Natal, Rio Grande Do Norte, Brazil
University of Colorado Anschutz Medical Campus-The Center for Cancer and Blood Disorders ( Site 0021
🇺🇸Aurora, Colorado, United States
Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 0362)
🇩🇰Aarhus, Midtjylland, Denmark
Universitaetsklinikum Essen ( Site 0327)
🇩🇪Essen, Nordrhein-Westfalen, Germany
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0004)
🇺🇸Hackensack, New Jersey, United States
Instituto do Câncer e Transplante de Curitiba ( Site 0611)
🇧🇷Curitiba, Parana, Brazil
Instituto Nacional del Cancer ( Site 0626)
🇨🇱Chile, Region M. De Santiago, Chile
BC Cancer Vancouver ( Site 0034)
🇨🇦Vancouver, British Columbia, Canada
Policlinico S. Orsola- Malpighi-Istituto di Ematologia "L. e A. Seragnoli" ( Site 0381)
🇮🇹Bologna, Italy
GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 0548)
🇷🇺Ufa, Baskortostan, Respublika, Russian Federation
Almazov National Medical Research Centre-Intensive care unit No. 10 for oncohematological patients (
🇷🇺Saint Petersburg, Leningradskaya Oblast, Russian Federation
Pitie Salpetriere University Hospital-Clinical haematology ( Site 0304)
🇫🇷Paris, France
Universitätsklinikum Leipzig ( Site 0328)
🇩🇪Leipzig, Sachsen, Germany
Országos Onkológiai Intézet-HEMATOLÓGIA ÉS LYMPHOMA OSZTÁLY KEMOTERÁPIA A ( Site 0405)
🇭🇺Budapest, Pest, Hungary
centre hospitalier lyon sud-Service Hématologie ( Site 0300)
🇫🇷Pierre-Bénite, Rhone, France
Rambam Health Care Campus ( Site 0526)
🇮🇱Haifa, Israel
Ospedale San Raffaele-Unità Linfomi ( Site 0382)
🇮🇹Milano, Lombardia, Italy
Russian Scientific Research Institute of Hematology and Blood Transfusion-Hematology ( Site 0542)
🇷🇺Saint Petersburg, Sankt-Peterburg, Russian Federation
National Cancer Institute ( Site 0585)
🇺🇦Kyiv, Kyivska Oblast, Ukraine
Universitaetsklinikum Hamburg-Eppendorf-II. medical clinic ( Site 0332)
🇩🇪Hamburg, Germany
Klinikum Mutterhaus der Borromäerinnen-Innere Medizin I ( Site 0325)
🇩🇪Trier, Rheinland-Pfalz, Germany
Sheba Medical Center-Hemato Oncology ( Site 0524)
🇮🇱Ramat Gan, Israel
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0427)
🇵🇱Gliwice, Slaskie, Poland
Ankara University Hospital Cebeci ( Site 0561)
🇹🇷Ankara, Turkey
Pécsi Tudományegyetem Klinikai Központ-I.sz. Belgyógyászati Klinika Hematológia ( Site 0401)
🇭🇺Pécs, Baranya, Hungary
Semmelweis University-Belgyógyászati és Hematológiai Klinika ( Site 0403)
🇭🇺Budapest, Hungary
Hadassah Medical Center ( Site 0522)
🇮🇱Jerusalem, Israel
Sourasky Medical Center ( Site 0525)
🇮🇱Tel Aviv, Israel
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( S
🇵🇱Warszawa, Mazowieckie, Poland
Moscow City Clinical Hospital S.P. Botkin ( Site 0547)
🇷🇺Moscow, Moskva, Russian Federation
Dokuz Eylül Üniversitesi-Hematology ( Site 0563)
🇹🇷Izmir, Turkey
Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku ( Site
🇵🇱Wrocaw, Dolnoslaskie, Poland
MEDICAL COLLEGE OF WISCONSIN ( Site 0016)
🇺🇸Milwaukee, Wisconsin, United States
Ege University Medicine of Faculty ( Site 0565)
🇹🇷Bornova, Izmir, Turkey
University of Chicago Medical Center ( Site 0005)
🇺🇸Chicago, Illinois, United States
City of Hope Comprehensive Cancer Center-Hematology ( Site 0024)
🇺🇸Duarte, California, United States
Henry Ford Hospital ( Site 0003)
🇺🇸Detroit, Michigan, United States
Rutgers Cancer Institute of New Jersey ( Site 0023)
🇺🇸New Brunswick, New Jersey, United States
University of Texas MD Anderson Cancer Center ( Site 0014)
🇺🇸Houston, Texas, United States
Medical Oncology Associates, PS ( Site 0001)
🇺🇸Spokane, Washington, United States
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0031)
🇨🇦Toronto, Ontario, Canada
Jewish General Hospital ( Site 0032)
🇨🇦Montreal, Quebec, Canada
McGill University Health Centre ( Site 0037)
🇨🇦Montréal, Quebec, Canada
FALP-UIDO ( Site 0623)
🇨🇱Santiago, Region M. De Santiago, Chile
Rigshospitalet-Hematology - CTU ( Site 0361)
🇩🇰Copenhagen, Hovedstaden, Denmark
Gustave Roussy-DITEP ( Site 0301)
🇫🇷Villejuif, Paris, France
Universitätsklinikum Marburg ( Site 0333)
🇩🇪Marburg, Hessen, Germany
Universitaetsklinikum Koeln-Klinik I für Innere Medizin ( Site 0321)
🇩🇪Köln, Nordrhein-Westfalen, Germany
Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Haematologia) ( Site 0402)
🇭🇺Debrecen, Hungary
Soroka Medical Center-Hematology Department ( Site 0523)
🇮🇱Be'er Sheva, Israel
Fondazione Policlinico Universitario Agostino Gemelli-ISTITUTO DI EMATOLOGIA ( Site 0383)
🇮🇹Roma, Lazio, Italy
Azienda Ospedaliera Spedali Civili di Brescia-Hemathology ( Site 0400)
🇮🇹Brescia, Lombardia, Italy
Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0424)
🇵🇱Gdańsk, Pomorskie, Poland
Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 0442)
🇪🇸L'Hospitalet Del Llobregat, Barcelona, Spain
Hospital Universitario de Salamanca-Hematology ( Site 0441)
🇪🇸Salamanca, Spain
Clinica Universidad de Navarra ( Site 0444)
🇪🇸Pamplona, Navarra, Spain
Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 0446)
🇪🇸Madrid, Spain
Chang Gung Memorial Hospital at Kaohsiung ( Site 0263)
🇨🇳Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 0262)
🇨🇳Taoyuan, Taiwan
Vehbi Koc Vakfi - Amerikan Hastanesi ( Site 0562)
🇹🇷Istanbul, Turkey
Mega Medipol-Hematology ( Site 0567)
🇹🇷Istanbul, Turkey
Cherkasy Regional Oncology Dispensary ( Site 0593)
🇺🇦Cherkassy, Cherkaska Oblast, Ukraine
Ondokuz Mayıs Universitesi ( Site 0564)
🇹🇷Samsun, Turkey
National Research Center for Radiation Medicine of National Academy of Medical Sciences of Ukraine (
🇺🇦Kyiv, Ukraine
Institute of Transfusion Medicine and Blood of the National Academy of Medical Sciences of Ukraine (
🇺🇦Lviv, Lvivska Oblast, Ukraine