Back to resultsA Study of Zilovertamab Vedotin (MK-2140) as Monotherapy and in Combination in Participants With Aggressive and Indolent B-cell Malignancies (MK-2140-006)
Primary Purpose
Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma, Follicular Lymphoma
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Zilovertamab vedotin
Nemtabrutinib
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Lymphocytic Leukemia
Eligibility Criteria
The main inclusion criteria include, but are not limited to the following:
Inclusion Criteria:
- For aggressive B-cell malignancies MCL and RTL: Has histologically confirmed biopsy according to the 2016 World Health Organization (WHO) classification of neoplasms of the hematopoietic and lymphoid tissues and has relapsed or refractory disease.
- For indolent B-cell malignancies FL and CLL: Has histologically confirmed biopsy and has relapsed or refractory disease after at least 2 prior systemic therapies and no other available therapy.
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization/allocation.
- Have an ECOG performance status of 0 to 2 assessed within 7 days before cycle 1 day 1.
Exclusion Criteria:
- Has received solid organ transplant at any time.
- Has clinically significant (ie, active) cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina (<6 months prior to enrollment), congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication.
- Has pericardial effusion or clinically significant pleural effusion.
- Has ongoing Grade >1 peripheral neuropathy.
- Has a demyelinating form of Charcot-Marie-Tooth disease.
- Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
- Participants with FL who have transformed to a more aggressive type of lymphoma.
- Has received prior systemic anticancer therapy, including investigational agents, within 5 half-lives or 4 weeks (if prior therapy was a monoclonal antibodies) or 2 weeks (small molecules like kinase inhibitors) 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.
- 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.
- Active HBV or hepatitis C virus (HCV) infection.
- For MCL, has any clinically significant gastrointestinal abnormalities that might alter absorption.
Sites / Locations
- Alaska Oncology and Hematology ( Site 0037)Recruiting
- Banner MD Anderson Cancer Center - University Medical Center Phoenix-Medical Oncology ( Site 0036)Recruiting
- University of Colorado Anschutz Medical Campus-The Center for Cancer and Blood Disorders ( Site 0008Recruiting
- Cancer Care Specialists of Illinois ( Site 0031)Recruiting
- Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0007)Recruiting
- Greenebaum Comprehensive Cancer Center-Hematology & Multiple Myeloma ( Site 0010)Recruiting
- Tufts Medical Center ( Site 0024)Recruiting
- Massachusetts General Hospital ( Site 0018)Recruiting
- Dana-Farber Cancer Institute-Lymphoma ( Site 0026)Recruiting
- University of Michigan ( Site 0009)Recruiting
- Icahn School of Medicine at Mount Sinai ( Site 0023)Recruiting
- Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0014)Recruiting
- The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive CRecruiting
- Avera Cancer Institute- Research ( Site 0011)Recruiting
- Medical Oncology Associates, PS ( Site 0005)Recruiting
- University of Wisconsin Hospitals and Clinics-Carbone Cancer Center ( Site 0030)Recruiting
- MEDICAL COLLEGE OF WISCONSIN ( Site 0021)Recruiting
- Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 1807)Recruiting
- ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1808)Recruiting
- Hospital Paulistano-Americas Oncologia ( Site 1805)Recruiting
- BC Cancer Vancouver-Clinical Trials Unit ( Site 0201)Recruiting
- The Moncton Hospital-Oncology ( Site 0211)Recruiting
- QEII Health Sciences Centre - Victoria General Site ( Site 0213)Recruiting
- Lawson Health Research Institute - London Health Sciences Ce-London Regional Cancer Program ( Site 0Recruiting
- Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0200)Recruiting
- Jewish General Hospital ( Site 0202)Recruiting
- IC La Serena Research ( Site 1909)Recruiting
- Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1907)Recruiting
- Clínica Alemana de Santiago ( Site 1903)Recruiting
- Beijing Cancer hospital ( Site 1200)Recruiting
- Sun Yat-sen University Cancer Center ( Site 1201)Recruiting
- Zhujiang Hospital ( Site 1207)Recruiting
- Southern Medical University Nanfang Hospital ( Site 1202)Recruiting
- Henan Cancer Hospital-hematology department ( Site 1212)Recruiting
- Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1210)Recruiting
- Tongji Hospital Tongji Medical,Science & Technology ( Site 1221)Recruiting
- The First Affiliated Hospital of Soochow University-hematology department ( Site 1218)Recruiting
- The Affiliated Hospital of Xuzhou Medical College ( Site 1223)Recruiting
- The First Affiliated Hospital of Nanchang University ( Site 1204)Recruiting
- Jiangxi Provincial Cancer Hospital ( Site 1213)Recruiting
- Jilin Province Tumor Hospital-oncology department ( Site 1220)Recruiting
- Fudan University Shanghai Cancer Center ( Site 1208)Recruiting
- West China Hospital of Sichuan University-Head and Neck Oncology ( Site 1206)Recruiting
- The First Affiliated Hospital, Zhejiang University ( Site 1211)Recruiting
- Zhejiang Cancer Hospital ( Site 1214)Recruiting
- Fakultní nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0300)Recruiting
- Fakultni nemocnice Ostrava-Klinika Hematoonkologie ( Site 0301)Recruiting
- Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0302)Recruiting
- North Estonia Medical Centre Foundation ( Site 0401)Recruiting
- Universitaetsklinikum Ulm ( Site 0502)Recruiting
- Universitaetsklinikum Koeln ( Site 0506)Recruiting
- St. James's Hospital ( Site 0600)Recruiting
- Emek Medical Center-Hematology Unit ( Site 0705)Recruiting
- Soroka Medical Center-Hematology Department ( Site 0707)Recruiting
- Rambam Health Care Campus-Hematology and Bone Marrow Transplantation ( Site 0706)Recruiting
- Hadassah Medical Center ( Site 0701)Recruiting
- Sheba Medical Center-Hemato Oncology ( Site 0700)Recruiting
- IRCCS - AOU di Bologna-SSD: Diagnosi e terapie dei linfomi e delle sindromi linfoproliferative cronRecruiting
- Humanitas-U.O di Oncologia medica ed Ematologia ( Site 0802)Recruiting
- Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare -Azienda Ospedaliera Nazionale SS. AntRecruiting
- National Hospital Organization Nagoya Medical Center ( Site 1108)Recruiting
- Hokkaido University Hospital ( Site 1104)Recruiting
- Tokai University Hospital- Isehara Campus ( Site 1100)Recruiting
- Tohoku University Hospital ( Site 1106)Recruiting
- Kindai University Hospital- Osakasayama Campus ( Site 1102)Recruiting
- National Cancer Center Hospital ( Site 1103)Recruiting
- Japanese Foundation for Cancer Research ( Site 1101)Recruiting
- Okayama University Hospital ( Site 1107)Recruiting
- Seoul National University Hospital ( Site 1300)Recruiting
- Samsung Medical Center ( Site 1301)Recruiting
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumat-Oddiał Hematologii Ogólnej ( Site 1008)Recruiting
- Centrum Onkologii Ziemi Lubelskiej-Oddzial Hematologiczny ( Site 1006)Recruiting
- Pratia MCM Krakow ( Site 1001)Recruiting
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( SRecruiting
- Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA w Olsztynie-Oddzial Kliniczny Hematologii ( SitRecruiting
- Champalimaud Foundation ( Site 2002)Recruiting
- 2CA BRAGA ( Site 2001)Recruiting
- Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 2000)Recruiting
- National Cancer Centre Singapore ( Site 1500)Recruiting
- Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 4003)Recruiting
- Hospital Universitari Vall d'Hebron ( Site 4004)Recruiting
- Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca-Hematology ( SRecruiting
- Skånes Universitetssjukhus Lund ( Site 5000)Recruiting
- Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 5002)Recruiting
- Mega Medipol-Hematology ( Site 6009)Recruiting
- Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 6001)Recruiting
- Trakya University ( Site 6005)Recruiting
- Ege Universitesi Hastanesi ( Site 6002)Recruiting
- Ondokuz Mayıs Universitesi-Oncology department ( Site 6004)Recruiting
- The Royal Cornwall Hospital-Haematology ( Site 7006)Recruiting
- The Churchill Hospital ( Site 7002)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort A
Cohort B
Cohort C
Cohort D
Cohort E
Cohort F
Arm Description
Participants will receive zilovertamab vedotin 2.5 mg/kg every 3 weeks (Q3W) until disease progression or discontinuation.
Participants will receive zilovertamab vedotin 2.5 mg/kg every 3 weeks (Q3W) until disease progression or discontinuation.
Participants will receive zilovertamab vedotin every 3 weeks (Q3W) combined with nemtabrutinib daily until disease progression or discontinuation.
Participants will receive either zilovertamab vedotin 2.5 mg/kg every 3 weeks (Q3W) or 2.0 mg/kg with infusions on Days 1 and 8 of each 3 week cycle (Q2/3W) until disease progression or discontinuation.
Participants will receive either zilovertamab vedotin 2.5 mg/kg every 3 weeks (Q3W) or 2.0 mg/kg with infusions on Days 1 and 8 of each 3 week cycle (Q2/3W) until disease progression or discontinuation.
Participants will receive either zilovertamab vedotin 2.5 mg/kg every 3 weeks (Q3W) or 2.0 mg/kg with infusions on Days 1 and 8 of each 3 week cycle (Q2/3W) until disease progression or discontinuation.
Outcomes
Primary Outcome Measures
Percentage of Participants with ≥1 Adverse Event (AE) [cohort C and D]
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with MCL, FL, and CLL who experienced an AE will be reported.
Percentage of Participants Discontinuing from Study Therapy Due to AE (cohort C and D)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with MCL, FL, and CLL who discontinued study treatment due to an AE will be reported.
Percentage of Participants with Dose-Limiting Toxicity (DLT) [cohort C]
The Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 will be used to grade the severity of AEs. DLTs for participants with MCL as assessed by investigator will be reported.
Objective Response Rate (ORR) per Lugano Response Criteria as Assessed by Blinded Independent Central Review (BICR) [cohorts A, B, E and FL participants in D]
ORR, defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) per Lugano Response Criteria as assessed by BICR will be reported.
ORR per Lugano Response Criteria as Assessed by Investigator (cohort C)
ORR, defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) per Lugano Response Criteria as assessed by investigator will be reported.
ORR per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria as Assessed by Investigator
ORR, defined as the percentage of participants who achieve a CR or PR per iwCLL criteria as assessed by investigator will be reported.
Secondary Outcome Measures
Duration of Response (DOR) per Lugano Response Criteria as Assessed by BICR (cohorts A, B, D (FL), and E)
DOR, defined as the time from the first documented evidence of CR or PR per Lugano Response Criteria as assessed by BICR, until disease progression or death due to any cause, whichever occurs first, will be reported.
DOR per Lugano Response Criteria as Assessed by Investigator (cohort C)
DOR, defined as the time from the first documented evidence of CR or PR per Lugano Response Criteria as assessed by investigator, until disease progression or death due to any cause, whichever occurs first, will be reported.
DOR per iwCLL Criteria as Assessed by Investigator (cohorts D [CLL] and F)
DOR, defined as the time from the first documented evidence of CR or PR per iwCLL criteria as assessed by investigator, until disease progression or death due to any cause, whichever occurs first, will be reported.
Percentage of Participants with ≥1 AE (cohorts A, B, E, and F)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with MCL, RTL, FL, and CLL who experienced an AE will be reported.
Percentage of Participants Discontinuing from Study Therapy Due to AE (cohorts A, B, E, and F)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with MCL, RTL, FL, and CLL who discontinued study treatment due to an AE will be reported.
Full Information
NCT ID
NCT05458297
First Posted
July 11, 2022
Last Updated
October 18, 2023
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT05458297
Brief Title
A Study of Zilovertamab Vedotin (MK-2140) as Monotherapy and in Combination in Participants With Aggressive and Indolent B-cell Malignancies (MK-2140-006)
Official Title
A Multicenter, Open-label, Phase 2 Basket Study to Evaluate the Safety and Efficacy of MK-2140 as a Monotherapy and in Combination in Participants With Aggressive and Indolent B-cell Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2022 (Actual)
Primary Completion Date
March 13, 2027 (Anticipated)
Study Completion Date
April 26, 2027 (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 assess the safety and tolerability of zilovertamab vedotin as monotherapy and in combination in participants with select B-cell lymphomas including mantle cell lymphoma (MCL), Richter's transformation lymphoma (RTL), follicular lymphoma (FL), and chronic lymphocytic leukemia (CLL). This study will also evaluate zilovertamab vedotin as monotherapy and in combination with respect to objective response rate.
Cohort A: Participants with relapsed or refractory MCL relapsed or refractory disease after at least 2 prior systemic therapies including a Bruton's tyrosine kinase inhibition/inhibitor (BTKi), and post therapy chimeric antigen receptor T (CAR-T) cell therapy or ineligible for CAR-T cell therapy
Cohort B: Participants with relapsed or refractory RT disease after at least 1 prior systemic therapy
Cohort C: Participants with relapsed or refractory MCL relapsed or refractory disease after at least 1 prior systemic therapy and no prior exposure to a non-covalent BTKi
Cohort D: Participants with relapsed or refractory FL and CLL relapsed or refractory disease after at least 2 prior systemic therapies and have no other available therapy
Cohort E: Participants with relapsed or refractory FL after at least 2 prior systemic therapies and have no other available therapy
Cohort F: Participants with relapsed or refractory CLL after at least 2 prior systemic therapies and have no other available therapy
The primary study hypothesis is that zilovertamab vedotin monotherapy has an increased Objective Response Rate (ORR) per Lugano Response Criteria as assessed by blinded independent central review (BICR).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma, Follicular Lymphoma, Richter Transformation Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
275 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort A
Arm Type
Experimental
Arm Description
Participants will receive zilovertamab vedotin 2.5 mg/kg every 3 weeks (Q3W) until disease progression or discontinuation.
Arm Title
Cohort B
Arm Type
Experimental
Arm Description
Participants will receive zilovertamab vedotin 2.5 mg/kg every 3 weeks (Q3W) until disease progression or discontinuation.
Arm Title
Cohort C
Arm Type
Experimental
Arm Description
Participants will receive zilovertamab vedotin every 3 weeks (Q3W) combined with nemtabrutinib daily until disease progression or discontinuation.
Arm Title
Cohort D
Arm Type
Experimental
Arm Description
Participants will receive either zilovertamab vedotin 2.5 mg/kg every 3 weeks (Q3W) or 2.0 mg/kg with infusions on Days 1 and 8 of each 3 week cycle (Q2/3W) until disease progression or discontinuation.
Arm Title
Cohort E
Arm Type
Experimental
Arm Description
Participants will receive either zilovertamab vedotin 2.5 mg/kg every 3 weeks (Q3W) or 2.0 mg/kg with infusions on Days 1 and 8 of each 3 week cycle (Q2/3W) until disease progression or discontinuation.
Arm Title
Cohort F
Arm Type
Experimental
Arm Description
Participants will receive either zilovertamab vedotin 2.5 mg/kg every 3 weeks (Q3W) or 2.0 mg/kg with infusions on Days 1 and 8 of each 3 week cycle (Q2/3W) until disease progression or discontinuation.
Intervention Type
Biological
Intervention Name(s)
Zilovertamab vedotin
Other Intervention Name(s)
MK-2140
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Nemtabrutinib
Other Intervention Name(s)
MK-1026
Intervention Description
65 mg once daily (QD) orally
Primary Outcome Measure Information:
Title
Percentage of Participants with ≥1 Adverse Event (AE) [cohort C and D]
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with MCL, FL, and CLL who experienced an AE will be reported.
Time Frame
Up to approximately 57 months
Title
Percentage of Participants Discontinuing from Study Therapy Due to AE (cohort C and D)
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with MCL, FL, and CLL who discontinued study treatment due to an AE will be reported.
Time Frame
Up to approximately 57 months
Title
Percentage of Participants with Dose-Limiting Toxicity (DLT) [cohort C]
Description
The Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 will be used to grade the severity of AEs. DLTs for participants with MCL as assessed by investigator will be reported.
Time Frame
Up to approximately 57 months
Title
Objective Response Rate (ORR) per Lugano Response Criteria as Assessed by Blinded Independent Central Review (BICR) [cohorts A, B, E and FL participants in D]
Description
ORR, defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) per Lugano Response Criteria as assessed by BICR will be reported.
Time Frame
Up to approximately 57 months
Title
ORR per Lugano Response Criteria as Assessed by Investigator (cohort C)
Description
ORR, defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) per Lugano Response Criteria as assessed by investigator will be reported.
Time Frame
Up to approximately 57 months
Title
ORR per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria as Assessed by Investigator
Description
ORR, defined as the percentage of participants who achieve a CR or PR per iwCLL criteria as assessed by investigator will be reported.
Time Frame
Up to approximately 57 months
Secondary Outcome Measure Information:
Title
Duration of Response (DOR) per Lugano Response Criteria as Assessed by BICR (cohorts A, B, D (FL), and E)
Description
DOR, defined as the time from the first documented evidence of CR or PR per Lugano Response Criteria as assessed by BICR, until disease progression or death due to any cause, whichever occurs first, will be reported.
Time Frame
Up to approximately 57 months
Title
DOR per Lugano Response Criteria as Assessed by Investigator (cohort C)
Description
DOR, defined as the time from the first documented evidence of CR or PR per Lugano Response Criteria as assessed by investigator, until disease progression or death due to any cause, whichever occurs first, will be reported.
Time Frame
Up to approximately 57 months
Title
DOR per iwCLL Criteria as Assessed by Investigator (cohorts D [CLL] and F)
Description
DOR, defined as the time from the first documented evidence of CR or PR per iwCLL criteria as assessed by investigator, until disease progression or death due to any cause, whichever occurs first, will be reported.
Time Frame
Up to approximately 57 months
Title
Percentage of Participants with ≥1 AE (cohorts A, B, E, and F)
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with MCL, RTL, FL, and CLL who experienced an AE will be reported.
Time Frame
Up to approximately 57 months
Title
Percentage of Participants Discontinuing from Study Therapy Due to AE (cohorts A, B, E, and F)
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with MCL, RTL, FL, and CLL who discontinued study treatment due to an AE will be reported.
Time Frame
Up to approximately 57 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
The main inclusion criteria include, but are not limited to the following:
Inclusion Criteria:
For aggressive B-cell malignancies MCL: Has histologically confirmed biopsy according to the 2016 World Health Organization (WHO) classification of neoplasms of the hematopoietic and lymphoid tissues and has relapsed or refractory disease after at least 2 prior systemic therapies including a Bruton's tyrosine kinase inhibition/inhibitor(s) (BTKi), and is post chimeric antigen receptor T (CAR-T) cell therapy or is ineligible for CAR-T cell therapy.
For aggressive B-cell malignancies MCL Cohort C: Has histologically confirmed biopsy according to the 2016 World Health Organization (WHO) classification of neoplasms of the hematopoietic and lymphoid tissues and has relapsed or refractory disease after at least 1 prior systemic therapy and has no prior exposure to a non-covalent BTKi.
For aggressive B-cell malignancies Richter transformation lymphoma (RTL): Has histologically confirmed biopsy according to the 2016 World Health Organization (WHO) classification of neoplasms of the hematopoietic and lymphoid tissues and has relapsed or refractory disease.
For indolent B-cell malignancies FL and CLL: Has histologically confirmed biopsy and has relapsed or refractory disease after at least 2 prior systemic therapies and no other available therapy.
Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization/allocation.
Have an ECOG performance status of 0 to 2 assessed within 7 days before cycle 1 day 1.
Exclusion Criteria:
Has received solid organ transplant at any time.
Has clinically significant (ie, active) cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina (<6 months prior to enrollment), congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication.
Has pericardial effusion or clinically significant pleural effusion.
Has ongoing Grade >1 peripheral neuropathy.
Has a demyelinating form of Charcot-Marie-Tooth disease.
Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
Participants with FL who have transformed to a more aggressive type of lymphoma.
Has received prior systemic anticancer therapy within 5 half-lives or 4 weeks (if prior therapy was a monoclonal antibodies) or 2 weeks (if prior therapy was small molecules like kinase inhibitors) 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.
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.
Active HBV or hepatitis C virus (HCV) infection.
For Cohort C only: has any clinically significant gastrointestinal abnormalities that might alter absorption.
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
Alaska Oncology and Hematology ( Site 0037)
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
907-257-9851
Facility Name
Banner MD Anderson Cancer Center - University Medical Center Phoenix-Medical Oncology ( Site 0036)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
602-521-3700
Facility Name
University of Colorado Anschutz Medical Campus-The Center for Cancer and Blood Disorders ( Site 0008
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
206-963-7643
Facility Name
Cancer Care Specialists of Illinois ( Site 0031)
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
217-690-7045
Facility Name
Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0007)
City
Saint Matthews
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
502-899-3366
Facility Name
Greenebaum Comprehensive Cancer Center-Hematology & Multiple Myeloma ( Site 0010)
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
Tufts Medical Center ( Site 0024)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
646-591-1770
Facility Name
Massachusetts General Hospital ( Site 0018)
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
Dana-Farber Cancer Institute-Lymphoma ( Site 0026)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
617-632-6844
Facility Name
University of Michigan ( Site 0009)
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
908-337-8293
Facility Name
Icahn School of Medicine at Mount Sinai ( Site 0023)
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
347-263-1843
Facility Name
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0014)
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
701-234-2000
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
614-371-7022
Facility Name
Avera Cancer Institute- Research ( Site 0011)
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
267-844-7119
Facility Name
Medical Oncology Associates, PS ( Site 0005)
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
509-462-2273
Facility Name
University of Wisconsin Hospitals and Clinics-Carbone Cancer Center ( Site 0030)
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
608-262-9317
Facility Name
MEDICAL COLLEGE OF WISCONSIN ( Site 0021)
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
501-218-3305
Facility Name
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 1807)
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59075-740
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
84 999278442
Facility Name
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1808)
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5511 4573-7631
Facility Name
Hospital Paulistano-Americas Oncologia ( Site 1805)
City
Sao Paulo
ZIP/Postal Code
01321-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+551130161075
Facility Name
BC Cancer Vancouver-Clinical Trials Unit ( Site 0201)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
6048776000672017
Facility Name
The Moncton Hospital-Oncology ( Site 0211)
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5068702404
Facility Name
QEII Health Sciences Centre - Victoria General Site ( Site 0213)
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
9024737006
Facility Name
Lawson Health Research Institute - London Health Sciences Ce-London Regional Cancer Program ( Site 0
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
519685850075017
Facility Name
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0200)
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
41694645012821
Facility Name
Jewish General Hospital ( Site 0202)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
514340822224572
Facility Name
IC La Serena Research ( Site 1909)
City
La Serena
State/Province
Coquimbo
ZIP/Postal Code
1720430
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56993718661
Facility Name
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1907)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7500653
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
569 9789 0202
Facility Name
Clínica Alemana de Santiago ( Site 1903)
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
56992794676
Facility Name
Beijing Cancer hospital ( Site 1200)
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
+8601088196118
Facility Name
Sun Yat-sen University Cancer Center ( Site 1201)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13798101121
Facility Name
Zhujiang Hospital ( Site 1207)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510280
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13430200803
Facility Name
Southern Medical University Nanfang Hospital ( Site 1202)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
020-61641888
Facility Name
Henan Cancer Hospital-hematology department ( Site 1212)
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0371-65588007
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1210)
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
15871725926
Facility Name
Tongji Hospital Tongji Medical,Science & Technology ( Site 1221)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86 131 3569 1993
Facility Name
The First Affiliated Hospital of Soochow University-hematology department ( Site 1218)
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13616219570
Facility Name
The Affiliated Hospital of Xuzhou Medical College ( Site 1223)
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13813282842
Facility Name
The First Affiliated Hospital of Nanchang University ( Site 1204)
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13970038386
Facility Name
Jiangxi Provincial Cancer Hospital ( Site 1213)
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13607045741
Facility Name
Jilin Province Tumor Hospital-oncology department ( Site 1220)
City
Changchun
State/Province
Jilin
ZIP/Postal Code
132000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13843126796
Facility Name
Fudan University Shanghai Cancer Center ( Site 1208)
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
18017312613
Facility Name
West China Hospital of Sichuan University-Head and Neck Oncology ( Site 1206)
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
+8618980601027
Facility Name
The First Affiliated Hospital, Zhejiang University ( Site 1211)
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
13857190311
Facility Name
Zhejiang Cancer Hospital ( Site 1214)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
8613857182590
Facility Name
Fakultní nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0300)
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
420532233642
Facility Name
Fakultni nemocnice Ostrava-Klinika Hematoonkologie ( Site 0301)
City
Ostrava
State/Province
Moravskoslezsky Kraj
ZIP/Postal Code
708 52
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
420597372091
Facility Name
Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0302)
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
+420 224 962 527
Facility Name
North Estonia Medical Centre Foundation ( Site 0401)
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
Universitaetsklinikum Ulm ( Site 0502)
City
Ulm
State/Province
Baden-Wurttemberg
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+49731/5000
Facility Name
Universitaetsklinikum Koeln ( Site 0506)
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
004922147897046
Facility Name
St. James's Hospital ( Site 0600)
City
Dublin
ZIP/Postal Code
D08 E9P6
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33 (01) 410 3754
Facility Name
Emek Medical Center-Hematology Unit ( Site 0705)
City
Afula
ZIP/Postal Code
1834111
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+972 4 6495437
Facility Name
Soroka Medical Center-Hematology Department ( Site 0707)
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
97286403827
Facility Name
Rambam Health Care Campus-Hematology and Bone Marrow Transplantation ( Site 0706)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+972502061259
Facility Name
Hadassah Medical Center ( Site 0701)
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
97226778180
Facility Name
Sheba Medical Center-Hemato Oncology ( Site 0700)
City
Ramat Gan
ZIP/Postal Code
5262100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+972526667154
Facility Name
IRCCS - AOU di Bologna-SSD: Diagnosi e terapie dei linfomi e delle sindromi linfoproliferative cron
City
Bologna
State/Province
Emilia-Romagna
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
Humanitas-U.O di Oncologia medica ed Ematologia ( Site 0802)
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
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare -Azienda Ospedaliera Nazionale SS. Ant
City
Alessandria
ZIP/Postal Code
15121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390131206262
Facility Name
National Hospital Organization Nagoya Medical Center ( Site 1108)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-52-951-1111
Facility Name
Hokkaido University Hospital ( Site 1104)
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-11-716-1161
Facility Name
Tokai University Hospital- Isehara Campus ( Site 1100)
City
Isehara
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-463-93-1121
Facility Name
Tohoku University Hospital ( Site 1106)
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-22-717-7000
Facility Name
Kindai University Hospital- Osakasayama Campus ( Site 1102)
City
Osaka-sayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-72-366-0221
Facility Name
National Cancer Center Hospital ( Site 1103)
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-3-3542-2511
Facility Name
Japanese Foundation for Cancer Research ( Site 1101)
City
Koto
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-3-3520-0111
Facility Name
Okayama University Hospital ( Site 1107)
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-86-223-7151
Facility Name
Seoul National University Hospital ( Site 1300)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82220721672
Facility Name
Samsung Medical Center ( Site 1301)
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
+82221487390
Facility Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumat-Oddiał Hematologii Ogólnej ( Site 1008)
City
Łódź
State/Province
Lodzkie
ZIP/Postal Code
93-513
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48426895191
Facility Name
Centrum Onkologii Ziemi Lubelskiej-Oddzial Hematologiczny ( Site 1006)
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-090
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48 81 454 1221
Facility Name
Pratia MCM Krakow ( Site 1001)
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-727
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48602338290
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
+48225462223
Facility Name
Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA w Olsztynie-Oddzial Kliniczny Hematologii ( Sit
City
Olsztyn
State/Province
Warminsko-mazurskie
ZIP/Postal Code
10-228
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+485398757
Facility Name
Champalimaud Foundation ( Site 2002)
City
Lisbon
State/Province
Lisboa
ZIP/Postal Code
1400-038
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351210480200
Facility Name
2CA BRAGA ( Site 2001)
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351253027249
Facility Name
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 2000)
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351 22 508 4000
Facility Name
National Cancer Centre Singapore ( Site 1500)
City
Singapore
State/Province
Central Singapore
ZIP/Postal Code
168583
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6564368000
Facility Name
Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 4003)
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
0034932607750
Facility Name
Hospital Universitari Vall d'Hebron ( Site 4004)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0034932746000
Facility Name
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca-Hematology ( S
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34923291100 ext 56606
Facility Name
Skånes Universitetssjukhus Lund ( Site 5000)
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
0046 (0)46177520
Facility Name
Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 5002)
City
Uppsala
State/Province
Uppsala Lan
ZIP/Postal Code
751 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0046 (0)186110000
Facility Name
Mega Medipol-Hematology ( Site 6009)
City
Stanbul
State/Province
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
Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 6001)
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0 312 595 74 82
Facility Name
Trakya University ( Site 6005)
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905335544797
Facility Name
Ege Universitesi Hastanesi ( Site 6002)
City
İzmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+90 232 343 43 43
Facility Name
Ondokuz Mayıs Universitesi-Oncology department ( Site 6004)
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
The Royal Cornwall Hospital-Haematology ( Site 7006)
City
Truro
State/Province
Cornwall
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+44 (0) 1872 250000
Facility Name
The Churchill Hospital ( Site 7002)
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+44 (0)1865 617331
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 Zilovertamab Vedotin (MK-2140) as Monotherapy and in Combination in Participants With Aggressive and Indolent B-cell Malignancies (MK-2140-006)
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