Chronic Lymphocytic Leukemia Clinical Trial
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
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).
| Status | Recruiting |
| Enrollment | 275 |
| Est. completion date | April 26, 2027 |
| Est. primary completion date | March 13, 2027 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 1807) | Natal | Rio Grande Do Norte |
| Brazil | Instituto Nacional de Câncer - INCA-Divisão de Pesquisa Clínica e Desenvolvimento Tecnológico HC1 ( | Rio de Janeiro | |
| Brazil | Hospital Paulistano-Americas Oncologia ( Site 1805) | Sao Paulo | |
| Brazil | ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1808) | São Paulo | Sao Paulo |
| Canada | QEII Health Sciences Centre - Victoria General Site ( Site 0213) | Halifax | Nova Scotia |
| Canada | Lawson Health Research Institute - London Health Sciences Ce-London Regional Cancer Program ( Site 0 | London | Ontario |
| Canada | The Moncton Hospital-Oncology ( Site 0211) | Moncton | New Brunswick |
| Canada | Jewish General Hospital ( Site 0202) | Montreal | Quebec |
| Canada | Allan Blair Cancer Centre-Care Services ( Site 0208) | Regina | Saskatchewan |
| Canada | Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0200) | Toronto | Ontario |
| Canada | BC Cancer Vancouver-Clinical Trials Unit ( Site 0201) | Vancouver | British Columbia |
| Chile | IC La Serena Research ( Site 1909) | La Serena | Coquimbo |
| Chile | Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1907) | Santiago | Region M. De Santiago |
| Chile | Clínica Alemana de Santiago ( Site 1903) | Santiago | Region M. De Santiago |
| Chile | Clínica Inmunocel ( Site 1910) | Santiago | Region M. De Santiago |
| China | Beijing Cancer hospital ( Site 1200) | Beijing | Beijing |
| China | Jilin Province Tumor Hospital-oncology department ( Site 1220) | Changchun | Jilin |
| China | West China Hospital of Sichuan University-Head and Neck Oncology ( Site 1206) | Cheng Du | Sichuan |
| China | Southern Medical University Nanfang Hospital ( Site 1202) | Guangzhou | Guangdong |
| China | Sun Yat-sen University Cancer Center ( Site 1201) | Guangzhou | Guangdong |
| China | Zhujiang Hospital ( Site 1207) | Guangzhou | Guangdong |
| China | The First Affiliated Hospital, Zhejiang University ( Site 1211) | Hangzhou | Zhejiang |
| China | Zhejiang Cancer Hospital ( Site 1214) | Hangzhou | Zhejiang |
| China | Jiangxi Provincial Cancer Hospital ( Site 1213) | Nanchang | Jiangxi |
| China | The First Affiliated Hospital of Nanchang University ( Site 1204) | Nanchang | Jiangxi |
| China | Fudan University Shanghai Cancer Center ( Site 1208) | Shanghai | Shanghai |
| China | The First Affiliated Hospital of Soochow University-hematology department ( Site 1218) | Suzhou | Jiangsu |
| China | Tongji Hospital Tongji Medical,Science & Technology ( Site 1221) | Wuhan | Hubei |
| China | Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1210) | Wuhan | Hubei |
| China | The Affiliated Hospital of Xuzhou Medical College ( Site 1223) | Xuzhou | Jiangsu |
| China | Henan Cancer Hospital-hematology department ( Site 1212) | Zhengzhou | Henan |
| Czechia | Fakultní nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0300) | Brno | Brno-mesto |
| Czechia | Fakultni nemocnice Ostrava-Klinika Hematoonkologie ( Site 0301) | Ostrava | Moravskoslezsky Kraj |
| Czechia | Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0302) | Praha 2 | |
| Estonia | North Estonia Medical Centre Foundation ( Site 0401) | Tallinn | Harjumaa |
| Germany | Universitaetsklinikum Koeln ( Site 0506) | Köln | Nordrhein-Westfalen |
| Germany | Universitaetsklinikum Ulm ( Site 0502) | Ulm | Baden-Wurttemberg |
| Ireland | St. James's Hospital ( Site 0600) | Dublin | |
| Israel | Emek Medical Center-Hematology Unit ( Site 0705) | Afula | |
| Israel | Soroka Medical Center-Hematology Department ( Site 0707) | Be'er Sheva | |
| Israel | Carmel Hospital ( Site 0709) | Haifa | |
| Israel | Rambam Health Care Campus-Hematology and Bone Marrow Transplantation ( Site 0706) | Haifa | |
| Israel | Hadassah Medical Center ( Site 0701) | Jerusalem | |
| Israel | Sheba Medical Center-Hemato Oncology ( Site 0700) | Ramat Gan | |
| Italy | Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare -Azienda Ospedaliera Nazionale SS. Ant | Alessandria | |
| Italy | IRCCS - AOU di Bologna-SSD: Diagnosi e terapie dei linfomi e delle sindromi linfoproliferative cron | Bologna | Emilia-Romagna |
| Italy | Fondazione Policlinico Universitario Agostino Gemelli IRCCS -ISTITUTO DI EMATOLOGIA ( Site 0804) | Roma | Lazio |
| Italy | Humanitas-U.O di Oncologia medica ed Ematologia ( Site 0802) | Rozzano | Milano |
| Japan | National Cancer Center Hospital ( Site 1103) | Chuo-ku | Tokyo |
| Japan | Kyushu University Hospital ( Site 1105) | Fukuoka | |
| Japan | Tokai University Hospital- Isehara Campus ( Site 1100) | Isehara | Kanagawa |
| Japan | Japanese Foundation for Cancer Research ( Site 1101) | Koto | Tokyo |
| Japan | National Hospital Organization Nagoya Medical Center ( Site 1108) | Nagoya | Aichi |
| Japan | Okayama University Hospital ( Site 1107) | Okayama | |
| Japan | Kindai University Hospital- Osakasayama Campus ( Site 1102) | Osaka-sayama | Osaka |
| Japan | Hokkaido University Hospital ( Site 1104) | Sapporo | Hokkaido |
| Japan | Tohoku University Hospital ( Site 1106) | Sendai-shi | Miyagi |
| Korea, Republic of | Samsung Medical Center ( Site 1301) | Seoul | |
| Korea, Republic of | Seoul National University Hospital ( Site 1300) | Seoul | |
| Peru | Centro Medico Monte Carmelo ( Site 1702) | Arequipa | Ariqipa |
| Peru | INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 1700) | Lima | |
| Poland | Pratia MCM Krakow ( Site 1001) | Krakow | Malopolskie |
| Poland | Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumat-Oddial Hematologii Ogólnej ( Site 1008) | Lódz | Lodzkie |
| Poland | Centrum Onkologii Ziemi Lubelskiej-Oddzial Hematologiczny ( Site 1006) | Lublin | Lubelskie |
| Poland | Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA w Olsztynie-Oddzial Kliniczny Hematologii ( Sit | Olsztyn | Warminsko-mazurskie |
| Poland | Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Ukladu Chlonnego ( S | Warszawa | Mazowieckie |
| Portugal | 2CA BRAGA ( Site 2001) | Braga | |
| Portugal | Champalimaud Foundation ( Site 2002) | Lisbon | Lisboa |
| Portugal | Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 2000) | Porto | |
| Singapore | National Cancer Centre Singapore ( Site 1500) | Singapore | Central Singapore |
| Spain | Hospital Universitari Vall d'Hebron ( Site 4004) | Barcelona | Cataluna |
| Spain | Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 4003) | L'Hospitalet Del Llobregat | Barcelona |
| Spain | Clinica Universidad de Navarra ( Site 4005) | Pamplona | Navarra |
| Spain | Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca-Hematology ( S | Salamanca | |
| Sweden | Sahlgrenska Universitetssjukhuset ( Site 5003) | Gothenburg | Vastra Gotalands Lan |
| Sweden | Skånes Universitetssjukhus Lund ( Site 5000) | Lund | Skane Lan |
| Sweden | Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 5002) | Uppsala | Uppsala Lan |
| Turkey | Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 6001) | Ankara | |
| Turkey | Trakya University ( Site 6005) | Edirne | |
| Turkey | Ege Universitesi Hastanesi ( Site 6002) | Izmir | |
| Turkey | Ondokuz Mayis Universitesi-Oncology department ( Site 6004) | Samsun | |
| Turkey | Mega Medipol-Hematology ( Site 6009) | Stanbul | Istanbul |
| United Kingdom | University College London Hospital ( Site 7001) | London | England |
| United Kingdom | The Christie NHS Foundation Trust ( Site 7007) | Manchester | |
| United Kingdom | The Churchill Hospital ( Site 7002) | Oxford | Oxfordshire |
| United Kingdom | The Royal Cornwall Hospital-Haematology ( Site 7006) | Truro | Cornwall |
| United States | Alaska Oncology and Hematology ( Site 0037) | Anchorage | Alaska |
| United States | University of Michigan ( Site 0009) | Ann Arbor | Michigan |
| United States | University of Colorado Anschutz Medical Campus-The Center for Cancer and Blood Disorders ( Site 0008 | Aurora | Colorado |
| United States | Greenebaum Comprehensive Cancer Center-Hematology & Multiple Myeloma ( Site 0010) | Baltimore | Maryland |
| United States | Dana-Farber Cancer Institute-Lymphoma ( Site 0026) | Boston | Massachusetts |
| United States | Massachusetts General Hospital ( Site 0018) | Boston | Massachusetts |
| United States | Tufts Medical Center ( Site 0024) | Boston | Massachusetts |
| United States | The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C | Columbus | Ohio |
| United States | Cancer Care Specialists of Illinois ( Site 0031) | Decatur | Illinois |
| United States | Henry Ford Hospital ( Site 0035) | Detroit | Michigan |
| United States | University of Kansas Medical Center-Division of Hematologic Malignancies and Cellular Therapeutics ( | Fairway | Kansas |
| United States | Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0014) | Fargo | North Dakota |
| United States | University of Wisconsin Hospitals and Clinics-Carbone Cancer Center ( Site 0030) | Madison | Wisconsin |
| United States | MEDICAL COLLEGE OF WISCONSIN ( Site 0021) | Milwaukee | Wisconsin |
| United States | Icahn School of Medicine at Mount Sinai ( Site 0023) | New York | New York |
| United States | Banner MD Anderson Cancer Center - University Medical Center Phoenix-Medical Oncology ( Site 0036) | Phoenix | Arizona |
| United States | Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0007) | Saint Matthews | Kentucky |
| United States | Avera Cancer Institute- Research ( Site 0011) | Sioux Falls | South Dakota |
| United States | Medical Oncology Associates, PS ( Site 0005) | Spokane | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States, Brazil, Canada, Chile, China, Czechia, Estonia, Germany, Ireland, Israel, Italy, Japan, Korea, Republic of, Peru, Poland, Portugal, Singapore, Spain, Sweden, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Up to approximately 57 months | |
| Primary | 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. | Up to approximately 57 months | |
| Primary | 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. | Up to approximately 57 months | |
| Primary | 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. | Up to approximately 57 months | |
| Primary | 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. | Up to approximately 57 months | |
| Primary | 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. | Up to approximately 57 months | |
| Secondary | 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. | Up to approximately 57 months | |
| Secondary | 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. | Up to approximately 57 months | |
| Secondary | 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. | Up to approximately 57 months | |
| Secondary | 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. | Up to approximately 57 months | |
| Secondary | 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. | Up to approximately 57 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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