Back to resultsA Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004)
Primary Purpose
Hematological Malignancies
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab/vibostolimab coformuation
Sponsored by
About this trial
This is an interventional treatment trial for Hematological Malignancies
Eligibility Criteria
Inclusion Criteria
- Have confirmed relapsed/refractory classic Hodgkins Lyphoma (cHL), Primary mediastinal B-cell lymphoma (PMBCL), Follicular Lymphoma (FL), Diffuse large B-cell lymphoma (DLBCL) or Non-Hodgkins Lymphoma (NHL), or multiple myeloma (MM).
For PMBCL, DLBCL, FL, and MM:
- Must be relapsed or refractory to CAR-T-cell therapy or unable to receive it.
For DLBCL and NHL:
- Must have exhausted or be ineligible for or intolerant to all treatments, which in the opinion of the investigator are standard of care for their disease.
For NHL:
- Participants with Mantle cell lymphoma (MCL) must have received prior Bruton's tyrosine kinase inhibitor therapy.
All participants:
- Have measurable disease.
- Have adequate organ function.
- Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before allocation.
- Must be able to provide newly obtained bone marrow biopsy or aspirate material for disease assessment.
- Female participants are eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of non child-bearing potential (WONCBP) OR Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle.
Exclusion Criteria
For DLBCL and NHL:
- Has lymphoplasmacytic lymphomas, Waldenstrom's macroglobulinemia, chronic lymphocytic leukemia (not associated with small lymphocytic lymphoma), Burkitt (-like) lymphoma, mature T cell and NK cell neoplasms, immunodeficiency associated lymphoproliferative neoplasms, or histiocytic and dendritic cell neoplasms.
For MM:
- Has oligo-secretory myeloma, plasma cell leukemia, smoldering multiple myeloma, or monoclonal gammopathy of undetermined significance.
- Has a history of primary amyloidosis, hyperviscosity or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
- Has known prior or current central nervous system (CNS) involvement.
For Epstein Barr virus (EBV) positive DLBCL:
- Associated with a solid organ transplant.
For all participants:
- A WOCBP who has a positive urine pregnancy test within 72 hours before study intervention allocation.
- Has clinically significant cardiovascular disease within 12 months from first dose of study intervention.
- Has a history of a second malignancy.
- Any PMBCL participants that require the use of urgent cytoreductive therapy.
- If the participant had major surgery, the participant must have recovered adequately from the procedure and/or any complications from the surgery before starting study intervention.
- Has received prior radiotherapy within 2 weeks of start of study intervention.
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.
- Has a known severe hypersensitivity to MK-7684A, vibostolimab or pembrolizumab and/or any of its excipients.
- Has a known history of Human Immunodeficiency Virus (HIV) infection.
- Has an active autoimmune disease that has required systemic treatment in past 2 years.
- Has an active infection requiring systemic therapy.
- Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
- Has present or progressive accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks before enrollment.
- Has dual active HBV infection (HBsAg (+) and /or detectable HBV DNA) and Hepatitis C (HCV) infection (anti-HCV Ab (+) and detectable HCV RNA) at study entry..
- Has had an allogenic hematopoietic stem cell/solid organ transplantation within the last 5 years.
Sites / Locations
- City of Hope Comprehensive Cancer Center-Hematology ( Site 0024)
- University of Colorado Anschutz Medical Campus-The Center for Cancer and Blood Disorders ( Site 0021
- University of Chicago Medical Center ( Site 0005)
- Henry Ford Hospital ( Site 0003)
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 0004)
- Rutgers Cancer Institute of New Jersey ( Site 0023)
- University of Texas MD Anderson Cancer Center ( Site 0014)
- Medical Oncology Associates, PS ( Site 0001)
- MEDICAL COLLEGE OF WISCONSIN ( Site 0016)
- Instituto do Câncer e Transplante de Curitiba ( Site 0611)
- Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0601)
- BC Cancer Vancouver ( Site 0034)
- Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0031)
- Jewish General Hospital ( Site 0032)
- McGill University Health Centre ( Site 0037)
- Instituto Nacional del Cancer ( Site 0626)
- FALP-UIDO ( Site 0623)
- Rigshospitalet-Hematology - CTU ( Site 0361)
- Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 0362)
- Gustave Roussy-DITEP ( Site 0301)
- centre hospitalier lyon sud-Service Hématologie ( Site 0300)
- Pitie Salpetriere University Hospital-Clinical haematology ( Site 0304)
- Universitätsklinikum Marburg ( Site 0333)
- Universitaetsklinikum Essen ( Site 0327)
- Universitaetsklinikum Koeln-Klinik I für Innere Medizin ( Site 0321)
- Klinikum Mutterhaus der Borromäerinnen-Innere Medizin I ( Site 0325)
- Universitätsklinikum Leipzig ( Site 0328)
- Universitaetsklinikum Hamburg-Eppendorf-II. medical clinic ( Site 0332)
- Pécsi Tudományegyetem Klinikai Központ-I.sz. Belgyógyászati Klinika Hematológia ( Site 0401)
- Országos Onkológiai Intézet-HEMATOLÓGIA ÉS LYMPHOMA OSZTÁLY KEMOTERÁPIA A ( Site 0405)
- Semmelweis University-Belgyógyászati és Hematológiai Klinika ( Site 0403)
- Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Haematologia) ( Site 0402)
- Soroka Medical Center-Hematology Department ( Site 0523)
- Rambam Health Care Campus ( Site 0526)
- Hadassah Medical Center ( Site 0522)
- Sheba Medical Center-Hemato Oncology ( Site 0524)
- Sourasky Medical Center ( Site 0525)
- Fondazione Policlinico Universitario Agostino Gemelli-ISTITUTO DI EMATOLOGIA ( Site 0383)
- Azienda Ospedaliera Spedali Civili di Brescia-Hemathology ( Site 0400)
- Ospedale San Raffaele-Unità Linfomi ( Site 0382)
- Policlinico S. Orsola- Malpighi-Istituto di Ematologia "L. e A. Seragnoli" ( Site 0381)
- Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku ( Site
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( S
- Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0424)
- Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0427)
- GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 0548)
- Almazov National Medical Research Centre-Intensive care unit No. 10 for oncohematological patients (
- Moscow City Clinical Hospital S.P. Botkin ( Site 0547)
- Russian Scientific Research Institute of Hematology and Blood Transfusion-Hematology ( Site 0542)
- Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 0442)
- Clinica Universidad de Navarra ( Site 0444)
- Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 0446)
- Hospital Universitario de Salamanca-Hematology ( Site 0441)
- Chang Gung Memorial Hospital at Kaohsiung ( Site 0263)
- Chang Gung Medical Foundation-Linkou Branch ( Site 0262)
- Ege University Medicine of Faculty ( Site 0565)
- Ankara University Hospital Cebeci ( Site 0561)
- Mega Medipol-Hematology ( Site 0567)
- Vehbi Koc Vakfi - Amerikan Hastanesi ( Site 0562)
- Dokuz Eylül Üniversitesi-Hematology ( Site 0563)
- Ondokuz Mayıs Universitesi ( Site 0564)
- Cherkasy Regional Oncology Dispensary ( Site 0593)
- National Cancer Institute ( Site 0585)
- Institute of Transfusion Medicine and Blood of the National Academy of Medical Sciences of Ukraine (
- National Research Center for Radiation Medicine of National Academy of Medical Sciences of Ukraine (
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pembrolizumab/vibostolimab coformulation
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of Participants with a Dose-Limiting Toxicity (DLT)
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)
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.
Number of Participants Who Discontinued Study Treatment Due to an AE
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.
Secondary Outcome Measures
Objective Response Rate (ORR)
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.
Duration of Response (DOR)
DOR is the time from response (R) to progression/death (P/D). The DOR will be presented.
Disease Control Rate (DCR)
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.
Lowest Plasma Concentration (Ctrough) of Vibostolimab
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.
Maximum Concentration (Cmax) of Vibostolimab
Cmax is the maximum concentration of the drug observed in plasma. Blood samples collected post dose will be used to determine Cmax of Vibostolimab.
Full Information
NCT ID
NCT05005442
First Posted
August 12, 2021
Last Updated
August 31, 2023
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT05005442
Brief Title
A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004)
Official Title
A Phase 2, Open-label Study to Evaluate the Safety and Efficacy of MK-7684A (MK-7684 [Vibostolimab] With MK-3475 [Pembrolizumab] Coformulation) in Participants With Relapsed or Refractory Hematological Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 28, 2021 (Actual)
Primary Completion Date
August 29, 2024 (Anticipated)
Study Completion Date
August 29, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematological Malignancies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pembrolizumab/vibostolimab coformulation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab/vibostolimab coformuation
Other Intervention Name(s)
MK7684A
Intervention Description
Pembrolizumab 200 mg + vibostolimab 200 mg/20 mL vial IV infusion Q3W up to approximately 2 years.
Primary Outcome Measure Information:
Title
Number of Participants with a Dose-Limiting Toxicity (DLT)
Description
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.
Time Frame
Up to approximately 6 weeks
Title
Number of Participants Who Experienced an Adverse Event (AE)
Description
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.
Time Frame
Up to approximately 27 months
Title
Number of Participants Who Discontinued Study Treatment Due to an AE
Description
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.
Time Frame
Up to approximately 24 months
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
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.
Time Frame
Up to approximately 24 months
Title
Duration of Response (DOR)
Description
DOR is the time from response (R) to progression/death (P/D). The DOR will be presented.
Time Frame
Up to approximately 24 months
Title
Disease Control Rate (DCR)
Description
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.
Time Frame
Up to approximately 24 months
Title
Lowest Plasma Concentration (Ctrough) of Vibostolimab
Description
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.
Time Frame
Predose at Cycles 1, 2, 4, 8, and every 12 weeks afterwards (up to ~2 years). Cycle = 3 weeks
Title
Maximum Concentration (Cmax) of Vibostolimab
Description
Cmax is the maximum concentration of the drug observed in plasma. Blood samples collected post dose will be used to determine Cmax of Vibostolimab.
Time Frame
Postdose: after end of infusion (up to ~10 minutes) at Cycles 1 and 8. Cycle = 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
- Have confirmed relapsed/refractory classic Hodgkins Lyphoma (cHL), Primary mediastinal B-cell lymphoma (PMBCL), Follicular Lymphoma (FL), Diffuse large B-cell lymphoma (DLBCL) or Non-Hodgkins Lymphoma (NHL), or multiple myeloma (MM).
For PMBCL, DLBCL, FL, and MM:
- Must be relapsed or refractory to CAR-T-cell therapy or unable to receive it.
For DLBCL and NHL:
- Must have exhausted or be ineligible for or intolerant to all treatments, which in the opinion of the investigator are standard of care for their disease.
For NHL:
- Participants with Mantle cell lymphoma (MCL) must have received prior Bruton's tyrosine kinase inhibitor therapy.
All participants:
Have measurable disease.
Have adequate organ function.
Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before allocation.
Must be able to provide newly obtained bone marrow biopsy or aspirate material for disease assessment.
Female participants are eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of non child-bearing potential (WONCBP) OR Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle.
Exclusion Criteria
For DLBCL and NHL:
- Has lymphoplasmacytic lymphomas, Waldenstrom's macroglobulinemia, chronic lymphocytic leukemia (not associated with small lymphocytic lymphoma), Burkitt (-like) lymphoma, mature T cell and NK cell neoplasms, immunodeficiency associated lymphoproliferative neoplasms, or histiocytic and dendritic cell neoplasms.
For MM:
Has oligo-secretory myeloma, plasma cell leukemia, smoldering multiple myeloma, or monoclonal gammopathy of undetermined significance.
Has a history of primary amyloidosis, hyperviscosity or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
Has known prior or current central nervous system (CNS) involvement.
For Epstein Barr virus (EBV) positive DLBCL:
- Associated with a solid organ transplant.
For all participants:
A WOCBP who has a positive urine pregnancy test within 72 hours before study intervention allocation.
Has clinically significant cardiovascular disease within 12 months from first dose of study intervention.
Has a history of a second malignancy.
Any PMBCL participants that require the use of urgent cytoreductive therapy.
If the participant had major surgery, the participant must have recovered adequately from the procedure and/or any complications from the surgery before starting study intervention.
Has received prior radiotherapy within 2 weeks of start of study intervention.
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.
Has a known severe hypersensitivity to MK-7684A, vibostolimab or pembrolizumab and/or any of its excipients.
Has a known history of Human Immunodeficiency Virus (HIV) infection.
Has an active autoimmune disease that has required systemic treatment in past 2 years.
Has an active infection requiring systemic therapy.
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
Has present or progressive accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks before enrollment.
Has dual active HBV infection (HBsAg (+) and /or detectable HBV DNA) and Hepatitis C (HCV) infection (anti-HCV Ab (+) and detectable HCV RNA) at study entry..
Has had an allogenic hematopoietic stem cell/solid organ transplantation within the last 5 years.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center-Hematology ( Site 0024)
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of Colorado Anschutz Medical Campus-The Center for Cancer and Blood Disorders ( Site 0021
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Chicago Medical Center ( Site 0005)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Henry Ford Hospital ( Site 0003)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0004)
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey ( Site 0023)
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center ( Site 0014)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Medical Oncology Associates, PS ( Site 0001)
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Facility Name
MEDICAL COLLEGE OF WISCONSIN ( Site 0016)
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Instituto do Câncer e Transplante de Curitiba ( Site 0611)
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80510130
Country
Brazil
Facility Name
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0601)
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59075-740
Country
Brazil
Facility Name
BC Cancer Vancouver ( Site 0034)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0031)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
m5g2m9
Country
Canada
Facility Name
Jewish General Hospital ( Site 0032)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
McGill University Health Centre ( Site 0037)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Instituto Nacional del Cancer ( Site 0626)
City
Chile
State/Province
Region M. De Santiago
ZIP/Postal Code
8380455
Country
Chile
Facility Name
FALP-UIDO ( Site 0623)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
6900941
Country
Chile
Facility Name
Rigshospitalet-Hematology - CTU ( Site 0361)
City
Copenhagen
State/Province
Hovedstaden
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 0362)
City
Aarhus
State/Province
Midtjylland
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Gustave Roussy-DITEP ( Site 0301)
City
Villejuif
State/Province
Paris
ZIP/Postal Code
94800
Country
France
Facility Name
centre hospitalier lyon sud-Service Hématologie ( Site 0300)
City
Pierre-Bénite
State/Province
Rhone
ZIP/Postal Code
69310
Country
France
Facility Name
Pitie Salpetriere University Hospital-Clinical haematology ( Site 0304)
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Universitätsklinikum Marburg ( Site 0333)
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35033
Country
Germany
Facility Name
Universitaetsklinikum Essen ( Site 0327)
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Universitaetsklinikum Koeln-Klinik I für Innere Medizin ( Site 0321)
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Klinikum Mutterhaus der Borromäerinnen-Innere Medizin I ( Site 0325)
City
Trier
State/Province
Rheinland-Pfalz
ZIP/Postal Code
54290
Country
Germany
Facility Name
Universitätsklinikum Leipzig ( Site 0328)
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitaetsklinikum Hamburg-Eppendorf-II. medical clinic ( Site 0332)
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Pécsi Tudományegyetem Klinikai Központ-I.sz. Belgyógyászati Klinika Hematológia ( Site 0401)
City
Pécs
State/Province
Baranya
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Országos Onkológiai Intézet-HEMATOLÓGIA ÉS LYMPHOMA OSZTÁLY KEMOTERÁPIA A ( Site 0405)
City
Budapest
State/Province
Pest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Semmelweis University-Belgyógyászati és Hematológiai Klinika ( Site 0403)
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Haematologia) ( Site 0402)
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Soroka Medical Center-Hematology Department ( Site 0523)
City
Be'er Sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Rambam Health Care Campus ( Site 0526)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Hadassah Medical Center ( Site 0522)
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Sheba Medical Center-Hemato Oncology ( Site 0524)
City
Ramat Gan
ZIP/Postal Code
5262100
Country
Israel
Facility Name
Sourasky Medical Center ( Site 0525)
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli-ISTITUTO DI EMATOLOGIA ( Site 0383)
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
Azienda Ospedaliera Spedali Civili di Brescia-Hemathology ( Site 0400)
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Ospedale San Raffaele-Unità Linfomi ( Site 0382)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
Policlinico S. Orsola- Malpighi-Istituto di Ematologia "L. e A. Seragnoli" ( Site 0381)
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku ( Site
City
Wrocaw
State/Province
Dolnoslaskie
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( S
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0424)
City
Gdańsk
State/Province
Pomorskie
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0427)
City
Gliwice
State/Province
Slaskie
ZIP/Postal Code
44-101
Country
Poland
Facility Name
GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 0548)
City
Ufa
State/Province
Baskortostan, Respublika
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
Almazov National Medical Research Centre-Intensive care unit No. 10 for oncohematological patients (
City
Saint Petersburg
State/Province
Leningradskaya Oblast
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Moscow City Clinical Hospital S.P. Botkin ( Site 0547)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Russian Scientific Research Institute of Hematology and Blood Transfusion-Hematology ( Site 0542)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
191024
Country
Russian Federation
Facility Name
Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 0442)
City
L'Hospitalet Del Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Clinica Universidad de Navarra ( Site 0444)
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 0446)
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario de Salamanca-Hematology ( Site 0441)
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Chang Gung Memorial Hospital at Kaohsiung ( Site 0263)
City
Kaohsiung Niao Sung Dist
State/Province
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Chang Gung Medical Foundation-Linkou Branch ( Site 0262)
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Ege University Medicine of Faculty ( Site 0565)
City
Bornova
State/Province
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Ankara University Hospital Cebeci ( Site 0561)
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Mega Medipol-Hematology ( Site 0567)
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Facility Name
Vehbi Koc Vakfi - Amerikan Hastanesi ( Site 0562)
City
Istanbul
ZIP/Postal Code
34365
Country
Turkey
Facility Name
Dokuz Eylül Üniversitesi-Hematology ( Site 0563)
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Ondokuz Mayıs Universitesi ( Site 0564)
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Facility Name
Cherkasy Regional Oncology Dispensary ( Site 0593)
City
Cherkassy
State/Province
Cherkaska Oblast
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
National Cancer Institute ( Site 0585)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
03022
Country
Ukraine
Facility Name
Institute of Transfusion Medicine and Blood of the National Academy of Medical Sciences of Ukraine (
City
Lviv
State/Province
Lvivska Oblast
ZIP/Postal Code
79044
Country
Ukraine
Facility Name
National Research Center for Radiation Medicine of National Academy of Medical Sciences of Ukraine (
City
Kyiv
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information
Learn more about this trial
A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004)
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