Back to resultsA Study to Evaluate Zilovertamab Vedotin (MK-2140) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (MK-2140-004)
Primary Purpose
Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MK-2140 (zilovertamab vedotin)
MK-2140 (zilovertamab vedotin)
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Has relapsed or refractory (rr) DLBCL; has progressed after at least 2 lines of prior therapy; and has progressed after auto- stem cell transplant (SCT) or are auto-SCT ineligible. Must have received prior multiagent regimen that includes an alkylating agent. anthracycline, and anti-CD20 (cluster of differentiation 20) monoclonal antibody.
- Has histologically confirmed diagnosis of DLBCL.
- Has radiographically measurable DLBCL per the Lugano Response Criteria.
- Should either be post- chimeric antigen receptor T cell therapy (CAR-T) failure or ineligible for CAR-T (for any reason).
- Life expectancy of at least 3 months.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before time of enrollment.
- Has adequate organ function.
Exclusion Criteria:
- Has received a diagnosis of Primary mediastinal B-cell lymphoma (PMBCL).
- Has undergone solid organ transplant at any time.
- Has a history of any clinically significant cardiovascular conditions within 6 months of screening or serious cardiac arrhythmia requiring medication.
- Has known history of liver cirrhosis.
- Has pericardial effusion or clinically significant pleural effusion.
- Has ongoing Grade >1 peripheral neuropathy.
- Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
- Transformed DLBCL from indolent lymphoma.
- In participants with prior allo-SCT, acute graft versus host disease (GVHD) or ongoing evidence of chronic GVHD.
- Has received prior systemic anticancer therapy, including investigational agents within 4 weeks prior to the first dose of study intervention.
- Has received prior radiotherapy within 28 days of start of study intervention. Participants.
must have recovered from all radiation-related toxicities.
- Has ongoing corticosteroid therapy (exceeding 30 mg daily of prednisone equivalent).
- 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 known active central nervous system (CNS) lymphoma involvement or active CNS involvement by lymphoma.
- Has an active infection requiring systemic therapy.
- Has a known history of human immunodeficiency virus (HIV) infection.
- Has a known history of hepatitis B or known active hepatitis C virus (HCV).
Sites / Locations
- St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0229)Recruiting
- Innovative Clinical Research Institute ( Site 0202)
- Georgetown University Medical Center ( Site 0204)
- Northside Hospital ( Site 0206)Recruiting
- University of Chicago Medical Center ( Site 0207)Recruiting
- Franciscan St. Francis Health ( Site 0225)Recruiting
- University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 0211)Recruiting
- Massachusetts General Hospital-Cancer Center Protocol Office ( Site 0203)Recruiting
- University of Michigan ( Site 0200)Recruiting
- Karmanos Cancer Institute ( Site 0216)Recruiting
- Saint Louis University Cancer Center ( Site 0209)Recruiting
- Atlantic Health System Morristown Medical Center ( Site 0213)Recruiting
- New York Medical College ( Site 0215)Recruiting
- University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0217)Recruiting
- University Hospitals Cleveland Medical Center ( Site 0222)Recruiting
- The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive CRecruiting
- AHN West Penn Hospital ( Site 0212)Recruiting
- Avera Cancer Institute- Research ( Site 0233)Recruiting
- MEDICAL COLLEGE OF WISCONSIN ( Site 0234)Recruiting
- Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0100)Recruiting
- James Lind Centro de Investigación del Cáncer ( Site 2705)Recruiting
- Clínica Alemana de Santiago ( Site 2704)Recruiting
- Beijing Cancer hospital ( Site 2900)Recruiting
- SUN YAT-SEN UNIVERSITY CANCER CENTRE-Internal Medicine ( Site 2907)Recruiting
- Henan Cancer Hospital-hematology department ( Site 2903)
- Wuhan Union Hospital ( Site 2906)Recruiting
- Hunan Cancer Hospital ( Site 2905)Recruiting
- The First Hospital of Jilin University-Hematology ( Site 2910)Recruiting
- Fudan University Shanghai Cancer Center ( Site 2908)Recruiting
- Shanghai East Hospital ( Site 2902)Recruiting
- West China Hospital of Sichuan University-Head and Neck Oncology ( Site 2911)Recruiting
- Tianjin Medical University Cancer Institute and Hospital-lymphoma ( Site 2901)Recruiting
- The First Affiliated Hospital, Zhejiang University-Bone marrow transplant centre ( Site 2912)Recruiting
- Fakultní nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0800)Recruiting
- Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0801)Recruiting
- North Estonia Medical Centre Foundation ( Site 0900)Recruiting
- Centre Hospitalier de la Côte Basque ( Site 1002)Recruiting
- Pitie Salpetriere University Hospital-Clinical haematology ( Site 1000)Recruiting
- Evangelismos General Hospital of Athens ( Site 1214)Recruiting
- General Hospital of Athens "Laiko"-Hematology Department ( Site 1213)Recruiting
- Soroka Medical Center-Hematology Department ( Site 1403)Recruiting
- Shaare Zedek Medical Center ( Site 1404)Recruiting
- Hadassah Medical Center ( Site 1402)Recruiting
- Sourasky Medical Center ( Site 1400)Recruiting
- Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa di Ematologia ( Site 1501)Recruiting
- Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1503)Recruiting
- IRCCS - AOU di Bologna-Istituto di Ematologia "L. e A. Seragnoli" ( Site 1500)Recruiting
- Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1502)Recruiting
- Severance Hospital, Yonsei University Health System-Medical oncology ( Site 0601)Recruiting
- Samsung Medical Center ( Site 0600)Recruiting
- Haukeland Universitetssjukehus ( Site 1601)Recruiting
- Oslo universitetssykehus, Radiumhospitalet ( Site 1600)Recruiting
- Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku ( SiteRecruiting
- Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie-Oncology Department ( Site 1707)Recruiting
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( SRecruiting
- Szpitale Pomorskie Sp. z o. o.-Hematology and Bone Marrow Transplantation Department ( Site 1702)Recruiting
- Pratia Onkologia ( Site 1701)Recruiting
- Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 2002)Recruiting
- Hospital Universitari Vall d'Hebron ( Site 2005)Recruiting
- Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 2000)Recruiting
- Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca ( Site 2003)Recruiting
- Skånes Universitetssjukhus Lund ( Site 2100)Recruiting
- Karolinska Universitetssjukhuset Solna ( Site 2102)Recruiting
- Maharaj Nakorn Chiang Mai Hospital ( Site 0702)Recruiting
- Faculty of Medicine Siriraj Hospital ( Site 0701)Recruiting
- Ankara University Hospital Cebeci-hematology ( Site 2300)Recruiting
- Hacettepe Universitesi-Department of Hematology ( Site 2302)Recruiting
- Mega Medipol-Hematology ( Site 2308)Recruiting
- Dokuz Eylül Üniversitesi-Hematology ( Site 2304)Recruiting
- Ondokuz Mayıs Universitesi ( Site 2306)Recruiting
- Karadeniz Teknik Universitesi Tip Fakultesi-Hematology ( Site 2307)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm A
Arm B
Arm Description
Participants will receive treatment with zilovertamab vedotin 2.5 mg/kg via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks (Q3W)) until documented disease progression or any other discontinuation criterion is met.
Participants will receive treatment with zilovertamab vedotin 2.25 mg/kg via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks (Q3W)) until documented disease progression or any other discontinuation criterion is met.
Outcomes
Primary Outcome Measures
Objective Response Rate (ORR) per Lugano Response Criteria
ORR is percentage of participants with complete response (CR) or partial response (PR). ORR by cohort, relapsed or refractory (rr) DLBCL as assessed by BICR according to Lugano Response Criteria 2014 in participants treated with zilovertamab vedotin Q3W. CR is the complete radiologic response. PR is a partial response, >=50% decrease in sum of the product of the perpendicular diameters for multiple lesions for up to 6 target measurable nodes and extranodal sites.
Secondary Outcome Measures
Duration of Response (DOR) per Lugano Response Criteria
Duration of Response (DOR) is time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Number of Participants Who Experience an Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented.
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be presented.
Full Information
NCT ID
NCT05144841
First Posted
November 22, 2021
Last Updated
October 18, 2023
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT05144841
Brief Title
A Study to Evaluate Zilovertamab Vedotin (MK-2140) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (MK-2140-004)
Official Title
A Phase 2 Open-label Clinical Study to Evaluate the Efficacy and Safety of Zilovertamab Vedotin (MK-2140) in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (waveLINE-004)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 8, 2022 (Actual)
Primary Completion Date
June 10, 2025 (Anticipated)
Study Completion Date
June 10, 2025 (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 this study is to evaluate zilovertamab vedotin with respect to objective response rate and duration of response per Lugano Response Criteria as assessed by blinded independent central review (BICR). Safety and tolerability will also be evaluated in this Phase 2, single arm, interventional study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory Diffuse Large B-Cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
Participants will receive treatment with zilovertamab vedotin 2.5 mg/kg via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks (Q3W)) until documented disease progression or any other discontinuation criterion is met.
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Participants will receive treatment with zilovertamab vedotin 2.25 mg/kg via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks (Q3W)) until documented disease progression or any other discontinuation criterion is met.
Intervention Type
Biological
Intervention Name(s)
MK-2140 (zilovertamab vedotin)
Intervention Description
IV infusion of 2.5 mg/kg
Intervention Type
Biological
Intervention Name(s)
MK-2140 (zilovertamab vedotin)
Intervention Description
IV infusion of 2.25 mg/kg
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) per Lugano Response Criteria
Description
ORR is percentage of participants with complete response (CR) or partial response (PR). ORR by cohort, relapsed or refractory (rr) DLBCL as assessed by BICR according to Lugano Response Criteria 2014 in participants treated with zilovertamab vedotin Q3W. CR is the complete radiologic response. PR is a partial response, >=50% decrease in sum of the product of the perpendicular diameters for multiple lesions for up to 6 target measurable nodes and extranodal sites.
Time Frame
Up to approximately 50 months
Secondary Outcome Measure Information:
Title
Duration of Response (DOR) per Lugano Response Criteria
Description
Duration of Response (DOR) is time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Time Frame
Up to approximately 50 months
Title
Number of Participants Who Experience an Adverse Event (AE)
Description
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented.
Time Frame
Up to approximately 50 months
Title
Number of Participants Who Discontinue Study Treatment Due to an AE
Description
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be presented.
Time Frame
Up to approximately 50 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has relapsed or refractory (rr) DLBCL; has progressed after at least 2 lines of prior therapy; and has progressed after auto- stem cell transplant (SCT) or are auto-SCT ineligible. Must have received prior multiagent regimen that includes an alkylating agent. anthracycline, and anti-CD20 (cluster of differentiation 20) monoclonal antibody.
Has histologically confirmed diagnosis of DLBCL.
Has radiographically measurable DLBCL per the Lugano Response Criteria.
Should either be post- chimeric antigen receptor T cell therapy (CAR-T) failure or ineligible for CAR-T (for any reason).
Life expectancy of at least 3 months.
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before time of enrollment.
Has adequate organ function.
Exclusion Criteria:
Has received a diagnosis of Primary mediastinal B-cell lymphoma (PMBCL).
Has undergone solid organ transplant at any time.
Has a history of any clinically significant cardiovascular conditions within 6 months of screening or serious cardiac arrhythmia requiring medication.
Has known history of liver cirrhosis.
Has pericardial effusion or clinically significant pleural effusion.
Has ongoing Grade >1 peripheral neuropathy.
Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
Transformed DLBCL from indolent lymphoma.
In participants with prior allo-SCT, acute graft versus host disease (GVHD) or ongoing evidence of chronic GVHD.
Has received prior systemic anticancer therapy, including investigational agents within 4 weeks prior to the first dose of study intervention.
Has received prior radiotherapy within 28 days of start of study intervention. Participants.
must have recovered from all radiation-related toxicities.
Has ongoing corticosteroid therapy (exceeding 30 mg daily of prednisone equivalent).
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 known active central nervous system (CNS) lymphoma involvement or active CNS involvement by lymphoma.
Has an active infection requiring systemic therapy.
Has a known history of human immunodeficiency virus (HIV) infection.
Has a known history of hepatitis B or known active hepatitis C virus (HCV).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
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
St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0229)
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
714-734-6220
Facility Name
Innovative Clinical Research Institute ( Site 0202)
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Individual Site Status
Completed
Facility Name
Georgetown University Medical Center ( Site 0204)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Completed
Facility Name
Northside Hospital ( Site 0206)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
404-255-1930
Facility Name
University of Chicago Medical Center ( Site 0207)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
773-702-5550
Facility Name
Franciscan St. Francis Health ( Site 0225)
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
317-528-5500
Facility Name
University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 0211)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
410-328-3689
Facility Name
Massachusetts General Hospital-Cancer Center Protocol Office ( Site 0203)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
617-571-3037
Facility Name
University of Michigan ( Site 0200)
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
800-865-1125
Facility Name
Karmanos Cancer Institute ( Site 0216)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
800-526-6266
Facility Name
Saint Louis University Cancer Center ( Site 0209)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
314-496-7035
Facility Name
Atlantic Health System Morristown Medical Center ( Site 0213)
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
973-971-7960
Facility Name
New York Medical College ( Site 0215)
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
914-594-2150
Facility Name
University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0217)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
513-584-7698
Facility Name
University Hospitals Cleveland Medical Center ( Site 0222)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
216-983-4753
Facility Name
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
614-366-6386
Facility Name
AHN West Penn Hospital ( Site 0212)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
412-578-4484
Facility Name
Avera Cancer Institute- Research ( Site 0233)
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
605-322-3035
Facility Name
MEDICAL COLLEGE OF WISCONSIN ( Site 0234)
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
414-805-3000
Facility Name
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0100)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
4165817823
Facility Name
James Lind Centro de Investigación del Cáncer ( Site 2705)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4800827
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56452982404
Facility Name
Clínica Alemana de Santiago ( Site 2704)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8320325
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+562221011111
Facility Name
Beijing Cancer hospital ( Site 2900)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
010-88196023
Facility Name
SUN YAT-SEN UNIVERSITY CANCER CENTRE-Internal Medicine ( Site 2907)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13798101121
Facility Name
Henan Cancer Hospital-hematology department ( Site 2903)
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Wuhan Union Hospital ( Site 2906)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
02765655802
Facility Name
Hunan Cancer Hospital ( Site 2905)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0731-89762510
Facility Name
The First Hospital of Jilin University-Hematology ( Site 2910)
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86 13039046656
Facility Name
Fudan University Shanghai Cancer Center ( Site 2908)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
021-64175590
Facility Name
Shanghai East Hospital ( Site 2902)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
02138804518
Facility Name
West China Hospital of Sichuan University-Head and Neck Oncology ( Site 2911)
City
Cheng Du
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
028-85422114
Facility Name
Tianjin Medical University Cancer Institute and Hospital-lymphoma ( Site 2901)
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
022-23340123-6416
Facility Name
The First Affiliated Hospital, Zhejiang University-Bone marrow transplant centre ( Site 2912)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
15179171432
Facility Name
Fakultní nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0800)
City
Brno
State/Province
Brno-mesto
ZIP/Postal Code
625 00
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+420 532 23 1111
Facility Name
Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0801)
City
Praha 2
ZIP/Postal Code
12808
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+420 224 961 111
Facility Name
North Estonia Medical Centre Foundation ( Site 0900)
City
Tallinn
State/Province
Harjumaa
ZIP/Postal Code
13419
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3726172177
Facility Name
Centre Hospitalier de la Côte Basque ( Site 1002)
City
Bayonne
State/Province
Aquitaine
ZIP/Postal Code
64109
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33559443845
Facility Name
Pitie Salpetriere University Hospital-Clinical haematology ( Site 1000)
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33142162330
Facility Name
Evangelismos General Hospital of Athens ( Site 1214)
City
Athens
State/Province
Attiki
ZIP/Postal Code
106 76
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+302107201721
Facility Name
General Hospital of Athens "Laiko"-Hematology Department ( Site 1213)
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+302132061702
Facility Name
Soroka Medical Center-Hematology Department ( Site 1403)
City
Be'er Sheva
ZIP/Postal Code
8410101
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
97286403780
Facility Name
Shaare Zedek Medical Center ( Site 1404)
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
97225646488
Facility Name
Hadassah Medical Center ( Site 1402)
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
97226776687
Facility Name
Sourasky Medical Center ( Site 1400)
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
97236973782
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa di Ematologia ( Site 1501)
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390223902950
Facility Name
Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1503)
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390282244080
Facility Name
IRCCS - AOU di Bologna-Istituto di Ematologia "L. e A. Seragnoli" ( Site 1500)
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390516363680
Facility Name
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1502)
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
390815903382
Facility Name
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 0601)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
8221487390
Facility Name
Samsung Medical Center ( Site 0600)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
82234106548
Facility Name
Haukeland Universitetssjukehus ( Site 1601)
City
Bergen
State/Province
Hordaland
ZIP/Postal Code
5021
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4755972010
Facility Name
Oslo universitetssykehus, Radiumhospitalet ( Site 1600)
City
Oslo
ZIP/Postal Code
0379
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4722934000
Facility Name
Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku ( Site
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
50-367
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48717842576
Facility Name
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie-Oncology Department ( Site 1707)
City
Kraków
State/Province
Malopolskie
ZIP/Postal Code
31-826
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
004812646 82 51
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48225462366
Facility Name
Szpitale Pomorskie Sp. z o. o.-Hematology and Bone Marrow Transplantation Department ( Site 1702)
City
Gdynia
State/Province
Pomorskie
ZIP/Postal Code
81-519
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48587260187
Facility Name
Pratia Onkologia ( Site 1701)
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-519
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48323499751
Facility Name
Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 2002)
City
L'Hospitalet Del Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
93 260 77 50
Facility Name
Hospital Universitari Vall d'Hebron ( Site 2005)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
34932746000X4975
Facility Name
Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 2000)
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34 91 550 48 00 Ext 3750
Facility Name
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca ( Site 2003)
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34 923 291100, ext-55384
Facility Name
Skånes Universitetssjukhus Lund ( Site 2100)
City
Lund
State/Province
Skane Lan
ZIP/Postal Code
22185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4646171000
Facility Name
Karolinska Universitetssjukhuset Solna ( Site 2102)
City
Solna
State/Province
Stockholms Lan
ZIP/Postal Code
171 64
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+46851770000
Facility Name
Maharaj Nakorn Chiang Mai Hospital ( Site 0702)
City
Muang
State/Province
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+66826949794
Facility Name
Faculty of Medicine Siriraj Hospital ( Site 0701)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+66840114290
Facility Name
Ankara University Hospital Cebeci-hematology ( Site 2300)
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+90 505 502 50 50
Facility Name
Hacettepe Universitesi-Department of Hematology ( Site 2302)
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905394826000
Facility Name
Mega Medipol-Hematology ( Site 2308)
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905437870708
Facility Name
Dokuz Eylül Üniversitesi-Hematology ( Site 2304)
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905425151780
Facility Name
Ondokuz Mayıs Universitesi ( Site 2306)
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905324412859
Facility Name
Karadeniz Teknik Universitesi Tip Fakultesi-Hematology ( Site 2307)
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905323446368
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
http://merckoncologyclinicaltrials.com
Description
Merck Oncology Clinical Trials Information
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=2140-004&kw=2140-004
Description
Plain Language Summary
Learn more about this trial
A Study to Evaluate Zilovertamab Vedotin (MK-2140) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (MK-2140-004)
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