A Study of Zilovertamab Vedotin (MK-2140) as Monotherapy and in Combination in Participants With Aggressive and Indolent B-cell Malignancies (MK-2140-006)

NCT05458297 | Active Not Recruiting Phase 2 FDA Drug

• 6 other identifiers: 2140-006MK-2140-006jRCT20112300192022-501374-19-00U1111-1280-18492021-004450-36
• Study Type: interventional
• Target: 223
• Locations: 20 countries
• Sites: 108

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 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). As of Amendment 07, Cohort D is closed to enrollment of participants with CLL and enrollment of participants into Arm 2 (zilovertamab vedotin at Dose 2 on Days 1 \& 8 of each 3 Week Cycle (Q2/3W)).

Conditions

Chronic Lymphocytic Leukemia; Mantle Cell Lymphoma; Follicular Lymphoma; Richter Transformation Lymphoma

Outcome Measures

Primary Outcomes (6)

• Percentage of Participants with MCL (Cohort C), FL (Cohort D), and CLL with ≥1 Adverse Event (AE)

  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 (Cohort C), FL (Cohort D), and CLL who experienced an AE will be reported.

  Up to approximately 81 months

• Percentage of Participants with MCL (Cohort C), FL (Cohort D), and CLL who Discontinue from Study Therapy Due to AE

  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 (Cohort C), FL (Cohort D), and CLL who discontinued study treatment due to an AE will be reported.

  Up to approximately 81 months

• Percentage of Participants with MCL (Cohort C) who Experience a Dose-Limiting Toxicity (DLT)

  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 (Cohort C) as assessed by investigator will be reported.

  Up to approximately 81 months

• Objective Response Rate (ORR) per Lugano Response Criteria as Assessed by Blinded Independent Central Review (BICR) in Participants with MCL (Cohort A), RT, and FL (Cohorts D & E)

  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 in Participants with MCL (Cohort A), RT, and FL (Cohorts D \& E) will be reported.

  Up to approximately 81 months

• ORR per Lugano Response Criteria as Assessed by Investigator in Participants with MCL (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 in Participants with MCL (Cohort C) will be reported.

  Up to approximately 81 months

• ORR per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria as Assessed by Investigator in Participants with CLL

  ORR, defined as the percentage of participants who achieve a CR or PR per iwCLL criteria as assessed by investigator in participants with CLL will be reported.

  Up to approximately 81 months

Secondary Outcomes (5)

• Duration of Response (DOR) per Lugano Response Criteria as Assessed by BICR in Participants with MCL (Cohort A), RT, and FL (Cohorts D & E)

  Up to approximately 81 months

• DOR per Lugano Response Criteria as Assessed by Investigator in Participants with MCL (Cohort C)

  Up to approximately 81 months

• DOR per iwCLL Criteria as Assessed by Investigator in Participants with CLL

  Up to approximately 81 months

• Percentage of Participants with ≥1 AE in Participants with MCL (Cohort A), RT, and FL (Cohort E)

  Up to approximately 81 months

• Percentage of Participants Discontinuing from Study Therapy Due to AE in Participants with MCL (Cohort A), RT, and FL (Cohort E)

  Up to approximately 81 months

Study Arms (5)

Cohort A, Relapsed or Refractory MCL with 2 Prior Lines of Therapy

EXPERIMENTAL

Participants will receive zilovertamab vedotin intravenous (IV) infusion at Dose 1 every 3 weeks (Q3W) until disease progression or discontinuation.

Biological: Zilovertamab vedotin

Cohort B, Relapsed or Refractory RT with 1 Prior Line of Therapy

EXPERIMENTAL

Participants will receive zilovertamab vedotin IV infusion at Dose 1 every 3 weeks (Q3W) until disease progression or discontinuation.

Biological: Zilovertamab vedotin

Cohort C, Relapsed or Refractory MCL with 1 Prior Line of Therapy

EXPERIMENTAL

Participants will receive zilovertamab vedotin IV infusion at Dose 2 every 3 weeks (Q3W) combined with nemtabrutinib oral dose daily until disease progression or discontinuation.

Biological: Zilovertamab vedotin; Drug: Nemtabrutinib

Cohort D, Relapsed or Refractory FL and CLL with 2 Prior Lines of Therapy

EXPERIMENTAL

Participants will receive either zilovertamab vedotin IV infusion Dose 1 every 3 weeks (Q3W) until disease progression or discontinuation.

Biological: Zilovertamab vedotin

Cohort E, Relapsed or Refractory FL with 2 Prior Lines of Therapy

EXPERIMENTAL

Participants will receive either zilovertamab vedotin IV infuison Dose 1 every 3 weeks (Q3W) until disease progression or discontinuation.

Biological: Zilovertamab vedotin

Interventions

Zilovertamab vedotin BIOLOGICAL

IV infusion

Also known as: MK-2140

Cohort A, Relapsed or Refractory MCL with 2 Prior Lines of Therapy; Cohort B, Relapsed or Refractory RT with 1 Prior Line of Therapy; Cohort C, Relapsed or Refractory MCL with 1 Prior Line of Therapy; Cohort D, Relapsed or Refractory FL and CLL with 2 Prior Lines of Therapy; Cohort E, Relapsed or Refractory FL with 2 Prior Lines of Therapy

Nemtabrutinib DRUG

Oral tablet

Also known as: MK-1026

Cohort C, Relapsed or Refractory MCL with 1 Prior Line of Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For aggressive B-cell malignancies mantle cell lymphoma (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 follicular lymphoma (FL) and chronic lymphocytic leukemia (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 Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before cycle 1 day 1.

You may not qualify if:

• 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 not well controlled on antiretroviral therapy (ART)
• Active HBV or hepatitis C virus (HCV) infection.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (109)

Alaska Oncology and Hematology ( Site 0037)

Anchorage, Alaska, 99508, United States

Location

Banner MD Anderson Cancer Center ( Site 0040)

Gilbert, Arizona, 85234, United States

Location

Banner MD Anderson Cancer Center - University Medical Center Phoenix-Medical Oncology ( Site 0036)

Phoenix, Arizona, 85006, United States

Location

University of Colorado Anschutz Medical Campus-The Center for Cancer and Blood Disorders ( Site 0008)

Aurora, Colorado, 80045, United States

Location

Cancer Care Specialists of Illinois ( Site 0031)

Decatur, Illinois, 62526, United States

Location

University of Kansas Medical Center-Division of Hematologic Malignancies and Cellular Therapeutics ( Site 0038)

Fairway, Kansas, 66205, United States

Location

Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0007)

Saint Matthews, Kentucky, 40207, United States

Location

Greenebaum Comprehensive Cancer Center-Hematology & Multiple Myeloma ( Site 0010)

Baltimore, Maryland, 21201, United States

Location

Tufts Medical Center ( Site 0024)

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital ( Site 0018)

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute-Lymphoma ( Site 0026)

Boston, Massachusetts, 02215, United States

Location

University of Michigan ( Site 0009)

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Hospital ( Site 0035)

Detroit, Michigan, 48202, United States

Location

Icahn School of Medicine at Mount Sinai ( Site 0023)

New York, New York, 10029, United States

Location

Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0014)

Fargo, North Dakota, 58122, United States

Location

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0004)

Columbus, Ohio, 43210, United States

Location

Avera Cancer Institute- Research ( Site 0011)

Sioux Falls, South Dakota, 57105, United States

Location

Medical Oncology Associates, PS ( Site 0005)

Spokane, Washington, 99208, United States

Location

University of Wisconsin Hospitals and Clinics-Carbone Cancer Center ( Site 0030)

Madison, Wisconsin, 53792, United States

Location

Medical College of Wisconsin ( Site 0021)

Milwaukee, Wisconsin, 53226, United States

Location

Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 1807)

Natal, Rio Grande do Norte, 59075-740, Brazil

Location

Instituto Nacional de Câncer - INCA-Divisão de Pesquisa Clínica e Desenvolvimento Tecnológico HC1 ( Site 1809)

Rio de Janeiro, 20231-050, Brazil

Location

ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1808)

São Paulo, 01246-000, Brazil

Location

Hospital Paulistano-Americas Oncologia ( Site 1805)

São Paulo, 01321-001, Brazil

Location

BC Cancer Vancouver-Clinical Trials Unit ( Site 0201)

Vancouver, British Columbia, V5Z 4E6, Canada

Location

The Moncton Hospital-Oncology ( Site 0211)

Moncton, New Brunswick, E1C 6Z8, Canada

Location

QEII Health Sciences Centre - Victoria General Site ( Site 0213)

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

London Health Sciences Centre ( Site 0203)

London, Ontario, N6A 5W9, Canada

Location

Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0200)

Toronto, Ontario, M5G 2M9, Canada

Location

Jewish General Hospital ( Site 0202)

Montreal, Quebec, H3T 1E2, Canada

Location

Allan Blair Cancer Centre-Care Services ( Site 0208)

Regina, Saskatchewan, S4T 7T1, Canada

Location

IC La Serena Research ( Site 1909)

La Serena, Coquimbo Region, 1720430, Chile

Location

Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1907)

Santiago, Region M. de Santiago, 7500653, Chile

Location

Clínica Inmunocel ( Site 1910)

Santiago, Region M. de Santiago, 7580206, Chile

Location

Clínica Alemana de Santiago ( Site 1903)

Santiago, Region M. de Santiago, 7650568, Chile

Location

Beijing Cancer hospital ( Site 1200)

Beijing, Beijing Municipality, 100142, China

Location

Zhujiang Hospital ( Site 1207)

Guangzhou, Guangdong, 510280, China

Location

Southern Medical University Nanfang Hospital ( Site 1202)

Guangzhou, Guangdong, 510515, China

Location

Sun Yat-sen University Cancer Center ( Site 1201)

Guangzhou, Guangdong, 510700, China

Location

Henan Cancer Hospital-hematology department ( Site 1212)

Zhengzhou, Henan, 450003, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1210)

Wuhan, Hubei, 430023, China

Location

Tongji Hospital Tongji Medical,Science & Technology ( Site 1221)

Wuhan, Hubei, 430030, China

Location

The First Affiliated Hospital of Soochow University-hematology department ( Site 1218)

Suzhou, Jiangsu, 215006, China

Location

The Affiliated Hospital of Xuzhou Medical College ( Site 1223)

Xuzhou, Jiangsu, 221000, China

Location

The First Affiliated Hospital of Nanchang University ( Site 1204)

Nanchang, Jiangxi, 330006, China

Location

Jiangxi Provincial Cancer Hospital ( Site 1213)

Nanchang, Jiangxi, 330029, China

Location

Jilin Province Tumor Hospital-oncology department ( Site 1220)

Chuangchun, Jilin, 130012, China

Location

Fudan University Shanghai Cancer Center ( Site 1208)

Shanghai, Shanghai Municipality, 200032, China

Location

West China Hospital of Sichuan University-Head and Neck Oncology ( Site 1206)

Chengdu, Sichuan, 610041, China

Location

The First Affiliated Hospital, Zhejiang University ( Site 1211)

Hangzhou, Zhejiang, 310003, China

Location

Zhejiang Cancer Hospital ( Site 1214)

Hangzhou, Zhejiang, 310005, China

Location

Fakultní nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0300)

Brno, Brno-mesto, 625 00, Czechia

Location

Fakultni nemocnice Ostrava-Klinika Hematoonkologie ( Site 0301)

Ostrava, Moravskoslezský kraj, 708 52, Czechia

Location

Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0302)

Prague, 128 08, Czechia

Location

North Estonia Medical Centre Foundation ( Site 0401)

Tallinn, Harju, 13419, Estonia

Location

Universitaetsklinikum Ulm. ( Site 0502)

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Universitaetsklinikum Koeln ( Site 0506)

Cologne, North Rhine-Westphalia, 50937, Germany

Location

St. James's Hospital ( Site 0600)

Dublin, D08 E9P6, Ireland

Location

Emek Medical Center-Hematology Unit ( Site 0705)

Afula, 1834111, Israel

Location

Soroka Medical Center-Hematology Department ( Site 0707)

Beersheba, 8410101, Israel

Location

Rambam Health Care Campus-Hematology and Bone Marrow Transplantation ( Site 0706)

Haifa, 3109601, Israel

Location

Carmel Hospital ( Site 0709)

Haifa, 3436212, Israel

Location

Hadassah Medical Center ( Site 0701)

Jerusalem, 9112001, Israel

Location

Galilee Medical Center ( Site 0710)

Nahariya, 2210001, Israel

Location

Sheba Medical Center-Hemato Oncology ( Site 0700)

Ramat Gan, 5265601, Israel

Location

IRCCS - AOU di Bologna-SSD: Diagnosi e terapie dei linfomi e delle sindromi linfoproliferative cron ( Site 0800)

Bologna, Emilia-Romagna, 40138, Italy

Location

Humanitas-U.O di Oncologia medica ed Ematologia ( Site 0802)

Rozzano, Milano, 20089, Italy

Location

Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare -Azienda Ospedaliera Nazionale SS. Ant ( Site 0803)

Alessandria, 15121, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS -ISTITUTO DI EMATOLOGIA ( Site 0804)

Roma, 00168, Italy

Location

National Hospital Organization Nagoya Medical Center ( Site 1108)

Nagoya, Aichi-ken, 460-0001, Japan

Location

Hokkaido University Hospital ( Site 1104)

Sapporo, Hokkaido, 060-8648, Japan

Location

Tokai University Hospital ( Site 1100)

Isehara, Kanagawa, 259-1193, Japan

Location

Tohoku University Hospital ( Site 1106)

Sendai, Miyagi, 980-8574, Japan

Location

Kindai University Hospital ( Site 1102)

Sakai, Osaka, 590-0197, Japan

Location

National Cancer Center Hospital ( Site 1103)

Chuo-ku, Tokyo, 104-0045, Japan

Location

Cancer Institute Hospital of JFCR ( Site 1101)

Koto, Tokyo, 135-8550, Japan

Location

Kyushu University Hospital ( Site 1105)

Fukuoka, 812-8582, Japan

Location

Okayama University Hospital ( Site 1107)

Okayama, 700-8558, Japan

Location

Centro Medico Monte Carmelo ( Site 1702)

Arequipa, Ariqipa, 04001, Peru

Location

INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 1700)

Lima, 15038, Peru

Location

Pratia MCM Krakow ( Site 1001)

Krakow, Lesser Poland Voivodeship, 30-727, Poland

Location

Centrum Onkologii Ziemi Lubelskiej-Oddzial Hematologiczny ( Site 1006)

Lublin, Lublin Voivodeship, 20-090, Poland

Location

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( Site 1002)

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA w Olsztynie-Oddzial Kliniczny Hematologii ( Site 1007)

Olsztyn, Warmian-Masurian Voivodeship, 10-228, Poland

Location

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumat-Oddiał Hematologii Ogólnej ( Site 1008)

Lodz, Łódź Voivodeship, 93-513, Poland

Location

Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S ( Site 1010)

Kielce, Świętokrzyskie Voivodeship, 25-734, Poland

Location

Champalimaud Foundation ( Site 2002)

Lisbon, Lisbon District, 1400-038, Portugal

Location

Unidade Local de Saude de Braga - Hospital de Braga ( Site 2001)

Braga, 4710-243, Portugal

Location

Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 2000)

Porto, 4200-072, Portugal

Location

National Cancer Centre Singapore ( Site 1500)

Singapore, Central Singapore, 168583, Singapore

Location

Seoul National University Hospital ( Site 1300)

Seoul, 03080, South Korea

Location

Samsung Medical Center ( Site 1301)

Seoul, 06351, South Korea

Location

Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 4003)

L'Hospitalet Del Llobregat, Barcelona, 08908, Spain

Location

Hospital Universitari Vall d'Hebron ( Site 4004)

Barcelona, Catalonia, 08035, Spain

Location

MD Anderson Cancer Center ( Site 4006)

Madrid, Madrid, Comunidad de, 28033, Spain

Location

Clinica Universidad de Navarra ( Site 4005)

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca-Hematology ( Site 4001)

Salamanca, 37007, Spain

Location

Skånes Universitetssjukhus Lund ( Site 5000)

Lund, Skåne County, 22185, Sweden

Location

Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 5002)

Uppsala, Uppsala County, 751 85, Sweden

Location

Sahlgrenska Universitetssjukhuset ( Site 5003)

Gothenburg, Västra Götaland County, 413 45, Sweden

Location

Mega Medipol-Hematology ( Site 6009)

Stanbul, Istanbul, 34214, Turkey (Türkiye)

Location

Ege Universitesi Hastanesi ( Site 6002)

Bornova, İzmir, 35100, Turkey (Türkiye)

Location

Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 6001)

Ankara, 06100, Turkey (Türkiye)

Location

Trakya University ( Site 6005)

Edirne, 22030, Turkey (Türkiye)

Location

Ondokuz Mayıs Universitesi-Oncology department ( Site 6004)

Samsun, 55139, Turkey (Türkiye)

Location

The Royal Cornwall Hospital-Haematology ( Site 7006)

Truro, Cornwall, TR1 3LJ, United Kingdom

Location

University College London Hospital ( Site 7001)

London, London, City of, NW1 2PG, United Kingdom

Location

The Churchill Hospital ( Site 7002)

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

The Christie NHS Foundation Trust ( Site 7007)

Manchester, m20 4bx, United Kingdom

Location

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Mantle-Cell; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 14, 2022
• Study Start: July 21, 2022
• Primary Completion (Estimated): May 17, 2029
• Study Completion (Estimated): May 17, 2029
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

CA (7); IT (4); KR (2); DE (2); GB (4); SE (3); JP (9); PL (6); ES (5); CN (16); CZ (3); PT (3); PE (2); CL (4); SG (1); BR (4); US (20); TU (5); IL (7); IE (1)