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 (waveLINE-006)

Status: Recruiting
Location: See all (106) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 2
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)).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alaska
Alaska Oncology and Hematology ( Site 0037)
RECRUITING
Anchorage
Arizona
Banner MD Anderson Cancer Center ( Site 0040)
RECRUITING
Gilbert
Banner MD Anderson Cancer Center - University Medical Center Phoenix-Medical Oncology ( Site 0036)
RECRUITING
Phoenix
Colorado
University of Colorado Anschutz Medical Campus-The Center for Cancer and Blood Disorders ( Site 0008)
RECRUITING
Aurora
Illinois
Cancer Care Specialists of Illinois ( Site 0031)
COMPLETED
Decatur
Kansas
University of Kansas Medical Center-Division of Hematologic Malignancies and Cellular Therapeutics ( Site 0038)
COMPLETED
Fairway
Kentucky
Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0007)
RECRUITING
Saint Matthews
Massachusetts
Dana-Farber Cancer Institute-Lymphoma ( Site 0026)
RECRUITING
Boston
Massachusetts General Hospital ( Site 0018)
RECRUITING
Boston
Tufts Medical Center ( Site 0024)
RECRUITING
Boston
Maryland
Greenebaum Comprehensive Cancer Center-Hematology & Multiple Myeloma ( Site 0010)
RECRUITING
Baltimore
Michigan
University of Michigan ( Site 0009)
RECRUITING
Ann Arbor
Henry Ford Hospital ( Site 0035)
RECRUITING
Detroit
North Dakota
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0014)
COMPLETED
Fargo
New York
Icahn School of Medicine at Mount Sinai ( Site 0023)
COMPLETED
New York
Ohio
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0004)
RECRUITING
Columbus
South Dakota
Avera Cancer Institute- Research ( Site 0011)
RECRUITING
Sioux Falls
Washington
Medical Oncology Associates, PS ( Site 0005)
RECRUITING
Spokane
Wisconsin
University of Wisconsin Hospitals and Clinics-Carbone Cancer Center ( Site 0030)
RECRUITING
Madison
MEDICAL COLLEGE OF WISCONSIN ( Site 0021)
COMPLETED
Milwaukee
Other Locations
Brazil
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 1807)
RECRUITING
Natal
Instituto Nacional de Câncer - INCA-Divisão de Pesquisa Clínica e Desenvolvimento Tecnológico HC1 ( Site 1809)
RECRUITING
Rio De Janeiro
Hospital Paulistano-Americas Oncologia ( Site 1805)
RECRUITING
São Paulo
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1808)
RECRUITING
São Paulo
Canada
QEII Health Sciences Centre - Victoria General Site ( Site 0213)
RECRUITING
Halifax
Lawson Health Research Institute - London Health Sciences Ce-London Regional Cancer Program ( Site 0203)
RECRUITING
London
The Moncton Hospital-Oncology ( Site 0211)
RECRUITING
Moncton
Jewish General Hospital ( Site 0202)
RECRUITING
Montreal
Allan Blair Cancer Centre-Care Services ( Site 0208)
COMPLETED
Regina
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0200)
RECRUITING
Toronto
BC Cancer Vancouver-Clinical Trials Unit ( Site 0201)
RECRUITING
Vancouver
Chile
IC La Serena Research ( Site 1909)
RECRUITING
La Serena
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1907)
RECRUITING
Santiago
Clínica Alemana de Santiago ( Site 1903)
RECRUITING
Santiago
Clínica Inmunocel ( Site 1910)
RECRUITING
Santiago
China
Beijing Cancer hospital ( Site 1200)
RECRUITING
Beijing
West China Hospital of Sichuan University-Head and Neck Oncology ( Site 1206)
COMPLETED
Chengdu
Jilin Province Tumor Hospital-oncology department ( Site 1220)
COMPLETED
Chuangchun
Southern Medical University Nanfang Hospital ( Site 1202)
RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center ( Site 1201)
RECRUITING
Guangzhou
Zhujiang Hospital ( Site 1207)
RECRUITING
Guangzhou
The First Affiliated Hospital, Zhejiang University ( Site 1211)
RECRUITING
Hangzhou
Zhejiang Cancer Hospital ( Site 1214)
COMPLETED
Hangzhou
Jiangxi Provincial Cancer Hospital ( Site 1213)
RECRUITING
Nanchang
The First Affiliated Hospital of Nanchang University ( Site 1204)
RECRUITING
Nanchang
Fudan University Shanghai Cancer Center ( Site 1208)
RECRUITING
Shanghai
The First Affiliated Hospital of Soochow University-hematology department ( Site 1218)
COMPLETED
Suzhou
Tongji Hospital Tongji Medical,Science & Technology ( Site 1221)
COMPLETED
Wuhan
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1210)
COMPLETED
Wuhan
The Affiliated Hospital of Xuzhou Medical College ( Site 1223)
RECRUITING
Xuzhou
Henan Cancer Hospital-hematology department ( Site 1212)
RECRUITING
Zhengzhou
Estonia
North Estonia Medical Centre Foundation ( Site 0401)
COMPLETED
Tallinn
Germany
Universitaetsklinikum Koeln ( Site 0506)
RECRUITING
Cologne
Universitaetsklinikum Ulm. ( Site 0502)
RECRUITING
Ulm
Ireland
St. James's Hospital ( Site 0600)
RECRUITING
Dublin
Israel
Emek Medical Center-Hematology Unit ( Site 0705)
COMPLETED
Afula
Soroka Medical Center-Hematology Department ( Site 0707)
RECRUITING
Beersheba
Carmel Hospital ( Site 0709)
RECRUITING
Haifa
Rambam Health Care Campus-Hematology and Bone Marrow Transplantation ( Site 0706)
COMPLETED
Haifa
Hadassah Medical Center ( Site 0701)
RECRUITING
Jerusalem
Galilee Medical Center ( Site 0710)
COMPLETED
Nahariya
Sheba Medical Center-Hemato Oncology ( Site 0700)
RECRUITING
Ramat Gan
Italy
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare -Azienda Ospedaliera Nazionale SS. Ant ( Site 0803)
COMPLETED
Alessandria
IRCCS - AOU di Bologna-SSD: Diagnosi e terapie dei linfomi e delle sindromi linfoproliferative cron ( Site 0800)
RECRUITING
Bologna
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -ISTITUTO DI EMATOLOGIA ( Site 0804)
RECRUITING
Roma
Humanitas-U.O di Oncologia medica ed Ematologia ( Site 0802)
RECRUITING
Rozzano
Japan
National Cancer Center Hospital ( Site 1103)
RECRUITING
Chuo-ku
Kyushu University Hospital ( Site 1105)
RECRUITING
Fukuoka
Tokai University Hospital ( Site 1100)
RECRUITING
Isehara
Cancer Institute Hospital of JFCR ( Site 1101)
RECRUITING
Koto
National Hospital Organization Nagoya Medical Center ( Site 1108)
RECRUITING
Nagoya
Okayama University Hospital ( Site 1107)
RECRUITING
Okayama
Hokkaido University Hospital ( Site 1104)
RECRUITING
Sapporo
Kindai University Hospital ( Site 1102)
RECRUITING
Sayama
Tohoku University Hospital ( Site 1106)
RECRUITING
Sendai
Peru
Centro Medico Monte Carmelo ( Site 1702)
RECRUITING
Arequipa
INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 1700)
RECRUITING
Lima
Poland
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S ( Site 1010)
RECRUITING
Kielce
Pratia MCM Krakow ( Site 1001)
RECRUITING
Krakow
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumat-Oddiał Hematologii Ogólnej ( Site 1008)
COMPLETED
Lodz
Centrum Onkologii Ziemi Lubelskiej-Oddzial Hematologiczny ( Site 1006)
RECRUITING
Lublin
Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA w Olsztynie-Oddzial Kliniczny Hematologii ( Site 1007)
RECRUITING
Olsztyn
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( Site 1002)
RECRUITING
Warsaw
Portugal
Unidade Local de Saude de Braga - Hospital de Braga ( Site 2001)
RECRUITING
Braga
Champalimaud Foundation ( Site 2002)
RECRUITING
Lisbon
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 2000)
RECRUITING
Porto
Republic of Korea
Samsung Medical Center ( Site 1301)
RECRUITING
Seoul
Seoul National University Hospital ( Site 1300)
RECRUITING
Seoul
Singapore
National Cancer Centre Singapore ( Site 1500)
RECRUITING
Singapore
Spain
Hospital Universitari Vall d'Hebron ( Site 4004)
RECRUITING
Barcelona
Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 4003)
COMPLETED
L'hospitalet Del Llobregat
MD Anderson Cancer Center ( Site 4006)
RECRUITING
Madrid
Clinica Universidad de Navarra ( Site 4005)
RECRUITING
Pamplona
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca-Hematology ( Site 4001)
RECRUITING
Salamanca
Sweden
Sahlgrenska Universitetssjukhuset ( Site 5003)
RECRUITING
Gothenburg
Skånes Universitetssjukhus Lund ( Site 5000)
RECRUITING
Lund
Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 5002)
RECRUITING
Uppsala
Turkey
Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 6001)
RECRUITING
Ankara
Trakya University ( Site 6005)
RECRUITING
Edirne
Ege Universitesi Hastanesi ( Site 6002)
RECRUITING
Izmir
Ondokuz Mayıs Universitesi-Oncology department ( Site 6004)
RECRUITING
Samsun
Mega Medipol-Hematology ( Site 6009)
RECRUITING
Stanbul
United Kingdom
University College London Hospital ( Site 7001)
RECRUITING
London
The Christie NHS Foundation Trust ( Site 7007)
RECRUITING
Manchester
The Churchill Hospital ( Site 7002)
RECRUITING
Oxford
The Royal Cornwall Hospital-Haematology ( Site 7006)
RECRUITING
Truro
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2022-07-21
Estimated Completion Date: 2029-05-17
Participants
Target number of participants: 223
Treatments
Experimental: Cohort A, Relapsed or Refractory MCL with 2 Prior Lines of Therapy
Participants will receive zilovertamab vedotin intravenous (IV) infusion at Dose 1 every 3 weeks (Q3W) until disease progression or discontinuation.
Experimental: Cohort B, Relapsed or Refractory RT with 1 Prior Line of Therapy
Participants will receive zilovertamab vedotin IV infusion at Dose 1 every 3 weeks (Q3W) until disease progression or discontinuation.
Experimental: Cohort C, Relapsed or Refractory MCL with 1 Prior Line of Therapy
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.
Experimental: Cohort D, Relapsed or Refractory FL and CLL with 2 Prior Lines of Therapy
Participants will receive either zilovertamab vedotin IV infusion Dose 1 every 3 weeks (Q3W) until disease progression or discontinuation.
Experimental: Cohort E, Relapsed or Refractory FL with 2 Prior Lines of Therapy
Participants will receive either zilovertamab vedotin IV infuison Dose 1 every 3 weeks (Q3W) until disease progression or discontinuation.
Sponsors
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov