Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003)

• ClinicalTrials.gov Identifier: NCT04728893
• Recruitment Status: Recruiting
• First Posted: January 28, 2021
• Last Update Posted: June 2, 2023
• Sponsor: Merck Sharp & Dohme LLC
• Information provided by (Responsible Party): Merck Sharp & Dohme LLC

Study Description

Brief Summary:

The purpose of this study is to evaluate the safety and efficacy of nemtabrutinib (formerly ARQ 531) in participants with hematologic malignancies of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Richter's transformation, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and Waldenström's macroglobulinemia (WM).

Condition or disease	Intervention/treatment	Phase
Hematologic Malignancies	Drug: Nemtabrutinib	Phase 2

Detailed Description:

This study will be performed in 2 parts: Dose Escalation and Confirmation (Part 1) and Cohort Expansion (Part 2). Following determination of a recommended phase 2 dose (RP2D) in Part 1, the study plans to proceed with Part 2 using 8 disease-specific expansion cohorts (Cohorts A to H).

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 450 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants With Hematologic Malignancies
• Actual Study Start Date: April 5, 2021
• Estimated Primary Completion Date: March 19, 2027
• Estimated Study Completion Date: March 19, 2027

Arms and Interventions

Arm	Intervention/treatment
Experimental: Nemtabrutinib; Participants receive nemtabrutinib orally once daily (QD) until progressive disease (PD) or discontinuation.	Drug: Nemtabrutinib; Nemtabrutinib tablets administered PO QD.; Other Names: ARQ 531; MK-1026

Outcome Measures

Primary Outcome Measures :

1. Part 1: Number of participants experiencing dose-limiting toxicities (DLTs) [ Time Frame: Up to ~56 days (Cycles 1-2, cycle = 28 days) ]
   DLTs will be defined as toxicities observed during the first 2 cycles (8 weeks) of Part 1 and include: Grade ≥3 nonhematologic toxicity (except Grade 3 nausea, vomiting, diarrhea, rash, fatigue, and uncontrolled hypertension which will not be considered a DLT unless lasting ≥72 hours despite optimal supportive care); Grade 4 hematologic toxicity lasting >7 days (except Grade 3 lymphocytosis, Grade 4 platelet count decreased of any duration, or Grade 3 platelet count decreased if associated with bleeding); any Grade 3 or Grade 4 nonhematologic laboratory abnormality if values result in drug-induced liver injury, or medical intervention is required, or the abnormality leads to hospitalization, or the abnormality persists for >1 week (with exceptions); missing >25% of nemtabrutinib doses as a result of drug-related adverse events (AEs) during the first 2 cycles (8 weeks); Grade 5 toxicity.
2. Part 1: Number of participants experiencing adverse events (AEs) [ Time Frame: Up to ~34 months ]
   An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants experiencing AEs will be reported for Part 1.
3. Part 1: Number of participants discontinuing study treatment due to AEs [ Time Frame: Up to ~34 months ]
   An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants discontinuing study treatment due to an AE will be reported for Part 1.
4. Part 2: Objective Response Rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria 2018 as assessed by independent central review (ICR) [ Time Frame: Up to ~78 months ]
   ORR per iwCLL 2018 criteria is defined as the percentage of participants achieving a complete response (CR), complete response with incomplete bone marrow recovery (CRi), nodular partial response (nPR), or partial response (PR). CR is defined as meeting the following criteria: no lymph nodes >1.5 cm, spleen size <13 cm, liver normal; no constitutional symptoms, normal lymphocyte count, platelets ≥100 x 10^9/L; hemoglobin ≥11 g/dL; and normocellular marrow (no CLL cells or B lymphoid nodules). CRi is defined as meeting CR criteria but with hypocellular bone marrow. nPR is defined as having features of CR but with lymphoid nodules in the marrow. PR is defined as ≥50% decrease in ≥2 of the following: lymph nodes, liver and/or spleen size, lymphocytes PLUS ≥1 of the following met: platelets ≥100 x 10^9/L or ≥50% increase from screening, hemoglobin >11 g/dL or ≥50% increase from screening, CLL cells or B lymphoid nodules in marrow.
5. Part 2: ORR per Lugano criteria 2014 as assessed by ICR [ Time Frame: Up to ~78 months ]
   ORR per Lugano criteria 2014 is defined as the percentage of participants achieving a CR or PR. CR defined as EITHER CR by imaging (computed tomography [CT]): all lymph nodes normal (none ≥15 mm) and normal liver and spleen OR complete metabolic response (CMR): score of 1, 2 or 3 on the 5-point scale assessing fluorodeoxyglucose (FDG) metabolic activity in lymphomatous lesions (ranging from 1=no uptake above background to 5=uptake markedly higher than liver) AND bone marrow (BM) normal by morphology. PR defined as EITHER PR by imaging (CT) with ≥50% decrease in the sum of the product of diameters [SPD] of target lesions, no worsening of nontarget lesions, no new lesions and ≥50% spleen abnormal portion OR Partial Metabolic Response (PMR) with score of 4 or 5 on the FDG 5-point scale (with no new lesions) and decreased overall uptake AND residual BM abnormalities; OR CR by imaging with residual BM abnormalities; OR PR by imaging without residual BM abnormalities.
6. Part 2: ORR per International Workshop on Waldenström's Macroglobulinemia (IWWM) criteria 2014 as assessed by ICR [ Time Frame: Up to ~78 months ]
   ORR per IWWM criteria 2014 is defined as the percentage of participants achieving a CR, very good partial response (VGPR), or PR. CR is defined as all lymph nodes are normal in size (none ≥15 mm), liver and spleen normal in size, serum immunoglobulin M (IgM) values in the normal range, disappearance of monoclonal protein by immunofixation (confirmation needed with a second immunofixation at any subsequent timepoint), and no histological evidence of BM involvement. VGPR is defined as ≥50% decrease from baseline in SPD of lymph nodes (if abnormal at baseline), ≥50% decrease from baseline in the abnormal portion of the spleen (if previously abnormal), and ≥90% decrease from baseline in serum IgM, or serum IgM values in normal range. PR is defined as ≥50% decrease from baseline in SPD of lymph nodes (if abnormal at baseline), ≥50% decrease from baseline in serum IgM, and ≥50% decrease from baseline in the abnormal portion of the spleen (if previously abnormal).

Secondary Outcome Measures :

1. Part 1: Area Under the Curve (AUC) of Nemtabrutinib [ Time Frame: At designated time points (up to ~57 days) ]
   Blood samples will be obtained at designated time points during Part 1 for the assessment of nemtabrutinib AUC (Day 1 of Cycles 1 and 2: Pre-dose, 2, 4, 6, 8, and 24 hours post-dose; Day 1 of Cycle 3: pre-dose and 2, 4, and 6 hours post-dose [up to ~57 days]). Each cycle is 28 days.
2. Part 1: Minimum Concentration (Cmin) of Nemtabrutinib [ Time Frame: At designated time points (up to ~57 days) ]
   Blood samples will be obtained at designated time points during Part 1 for the assessment of nemtabrutinib Cmin (Day 1 of Cycles 1 and 2: Pre-dose, 2, 4, 6, 8, and 24 hours post-dose; Day 1 of Cycle 3: pre-dose and 2, 4, and 6 hours post-dose [up to ~57 days]). Each cycle is 28 days.
3. Part 1: Maximum Concentration (Cmax) of Nemtabrutinib [ Time Frame: At designated time points (up to ~57 days) ]
   Blood samples will be obtained at designated time points during Part 1 for the assessment of nemtabrutinib Cmax (Day 1 of Cycles 1 and 2: Pre-dose, 2, 4, 6, 8, and 24 hours post-dose; Day 1 of Cycle 3: pre-dose and 2, 4, and 6 hours post-dose [up to ~57 days]). Each cycle is 28 days.
4. Part 1: ORR per iwCLL criteria 2018 as assessed by ICR [ Time Frame: Up to ~34 months ]
   ORR per iwCLL 2018 criteria is defined as the percentage of participants achieving a CR, CRi, nPR, or PR. CR is defined as meeting the following criteria: no lymph nodes >1.5 cm, spleen size <13 cm, liver normal; no constitutional symptoms, normal lymphocyte count, platelets ≥100 x 10^9/L; hemoglobin ≥11 g/dL; and normocellular marrow (no CLL cells or B lymphoid nodules). CRi is defined as meeting CR criteria but with hypocellular bone marrow. nPR is defined as having features of CR but with lymphoid nodules in the marrow. PR is defined as ≥50% decrease in ≥2 of the following: lymph nodes, liver and/or spleen size, lymphocytes PLUS ≥1 of the following met: platelets ≥100 x 10^9/L or ≥50% increase from screening, hemoglobin >11 g/dL or ≥50% increase from screening, CLL cells or B lymphoid nodules in marrow.
5. Part 1: Duration of Response (DOR) per iwCLL criteria 2018 as assessed by ICR [ Time Frame: Up to ~34 months ]
   For participants with CR, CRi, nPR, or PR per iwCLL 2018 criteria, DOR is defined as the time from the first documented evidence of objective response until PD or death due to any cause, whichever occurs first. CR is defined as meeting the following criteria: no lymph nodes >1.5 cm, spleen size <13 cm, liver normal; no constitutional symptoms, normal lymphocyte count, platelets ≥100 x 10^9/L; hemoglobin ≥11 g/dL; and normocellular marrow (no CLL cells or B lymphoid nodules). CRi is defined as meeting CR criteria but with hypocellular bone marrow. nPR is defined as having features of CR but with lymphoid nodules in the marrow. PR is defined as ≥50% decrease in ≥2 of the following: lymph nodes, liver and/or spleen size, lymphocytes PLUS ≥1 of the following met: platelets ≥100 x 10^9/L or ≥50% increase from screening, hemoglobin >11 g/dL or ≥50% increase from screening, CLL cells or B lymphoid nodules in marrow.
6. Part 2: Number of participants experiencing AEs [ Time Frame: Up to ~78 months ]
   An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants experiencing AEs will be reported for Part 2.
7. Part 2: Number of participants discontinuing study treatment due to AEs [ Time Frame: Up to ~78 months ]
   An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants discontinuing study treatment due to an AE will be reported for Part 2.
8. Part 2: AUC of Nemtabrutinib [ Time Frame: At designated time points (up to ~57 days) ]
   Blood samples will be obtained at designated time points during Part 2 for the assessment of nemtabrutinib AUC (Day 1 of Cycles 1, 2, and 3: Pre-dose, 2, 4, 6, hours post-dose [up to ~57 days]). Each cycle is 28 days.
9. Part 2: Cmin of Nemtabrutinib [ Time Frame: At designated time points (up to ~57 days) ]
   Blood samples will be obtained at designated time points during Part 2 for the assessment of nemtabrutinib Cmin (Day 1 of Cycles 1, 2, and 3: Pre-dose, 2, 4, 6, hours post-dose [up to ~57 days]). Each cycle is 28 days.
10. Part 2: Cmax of Nemtabrutinib [ Time Frame: At designated time points (up to ~57 days) ]
    Blood samples will be obtained at designated time points during Part 2 for the assessment of nemtabrutinib Cmax (Day 1 of Cycles 1, 2, and 3: Pre-dose, 2, 4, 6, hours post-dose [up to ~57 days]). Each cycle is 28 days.
11. Part 2: DOR per iwCLL criteria 2018 as assessed by ICR [ Time Frame: Up to ~78 months ]
    For participants with CR, CRi, nPR, or PR per iwCLL 2018 criteria, DOR is defined as the time from the first documented evidence of objective response until disease progression or death due to any cause, whichever occurs first. CR is defined as meeting the following criteria: no lymph nodes >1.5 cm, spleen size <13 cm, liver normal; no constitutional symptoms, normal lymphocyte count, platelets ≥100 x 10^9/L; hemoglobin ≥11 g/dL; and normocellular marrow (no CLL cells or B lymphoid nodules). CRi is defined as meeting CR criteria but with hypocellular bone marrow. nPR is defined as having features of CR but with lymphoid nodules in the marrow. PR is defined as ≥50% decrease in ≥2 of the following: lymph nodes, liver and/or spleen size, lymphocytes PLUS ≥1 of the following met: platelets ≥100 x 10^9/L or ≥50% increase from screening, hemoglobin >11 g/dL or ≥50% increase from screening, CLL cells or B lymphoid nodules in marrow.
12. Part 2: DOR per Lugano criteria 2014 as assessed by ICR [ Time Frame: Up to ~78 months ]
    For participants with CR or PR per Lugano criteria 2014, DOR is defined as the time from the first documented evidence of objective response until PD or death due to any cause, whichever occurs first. CR defined as EITHER CR by imaging (CT): all lymph nodes normal (none ≥15 mm) and normal liver and spleen OR CMR: score of 1, 2 or 3 on the 5-point scale assessing FDG metabolic activity in lymphomatous lesions (ranging from 1=no uptake above background to 5=uptake markedly higher than liver and/or new lesions) AND BM normal by morphology. PR defined as EITHER PR by imaging (CT) with ≥50% decrease in the SPD of target lesions, no worsening of nontarget lesions, no new lesions and ≥50% spleen abnormal portion OR PMR with score of 4 or 5 on the FDG 5-point scale (with no new lesions) and decreased overall uptake AND residual BM abnormalities; OR CR by imaging with residual BM abnormalities; OR PR by imaging without residual BM abnormalities.
13. Part 2: DOR per IWWM criteria 2014 as assessed by ICR [ Time Frame: Up to ~78 months ]
    For participants with CR, VGPR, or PR per IWWM criteria 2014, DOR defined as the time from first documented evidence of objective response until PD or death due to any cause, whichever occurs first. CR defined as all lymph nodes normal in size (none ≥15 mm), liver and spleen normal in size, serum IgM values in normal range, disappearance of monoclonal protein by immunofixation (confirmation needed with second immunofixation at any subsequent timepoint), and no histological evidence of BM involvement. VGPR defined as ≥50% decrease from baseline in SPD of lymph nodes (if abnormal at baseline), ≥50% decrease from baseline in abnormal portion of the spleen (if previously abnormal), and ≥90% decrease from baseline in serum IgM, or serum IgM values in normal range. PR is defined as ≥50% decrease from baseline in SPD of lymph nodes (if abnormal at baseline), ≥50% decrease from baseline in serum IgM, and ≥50% decrease from baseline in abnormal portion of the spleen (if previously abnormal).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days prior to allocation
• Has a life expectancy of at least 3 months, based on the investigator assessment
• Has the ability to swallow and retain oral medication
• 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
• Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
• Has adequate organ function
• Male participants agree to refrain from donating sperm and agree to either remain abstinent from heterosexual intercourse as their preferred and usual lifestyle OR agree to use contraception, during the intervention period and for 12 days after last dose of study intervention
• Female participants not pregnant or breastfeeding are eligible to participate if not a woman of childbearing potential (WOCBP), or if a WOCBP they either use a contraceptive method that is highly effective OR remain abstinent from heterosexual intercourse as their preferred and usual lifestyle during the intervention period and for at least 30 days after the last dose of study intervention
• Participants with HIV are eligible if they meet all of the following: the CD4 count is >350 cells/uL at screening, the HIV viral load is below the detectable level, are on a stable ART regimen for at least 4 weeks prior to study entry, and are compliant with their ART

Part 1 and Part 2 (Cohorts A to C)

• Has a confirmed diagnosis of CLL/SLL with

  • At least 2 lines of prior therapy (Part 1 only)
  • Part 2 Cohort A: CLL/SLL participants who are relapsed or refractory to prior therapy with a covalent, irreversible Bruton's tyrosine kinase inhibitor (BTKi), and a B-cell lymphoma 2 inhibitor (BCL2i). CLL participants must have received and failed, been intolerant to, or determined by their treating physician to be a poor phosphoinositide 3-kinase inhibitor (PI3Ki) candidate or ineligible for a PI3Ki per local guidelines
  • Part 2 Cohort B: CLL/SLL participants who are relapsed or refractory following at least 1 line of prior therapy and are BTKi treatment naive
  • Part 2 Cohort C: CLL/SLL participants with 17p deletion or tumor protein p53 (TP53) mutation who are relapsed or refractory following at least 1 line of prior therapy
  • Has active disease for CLL/SLL clearly documented to initiate therapy
  • Has evaluable core or excisional lymph node biopsy for biomarker analysis from an archival or newly obtained biopsy at Screening (optional for participants enrolling in Part 1)

Part 2 (Cohorts D to G)

• Has a confirmed diagnosis of and response to previous treatment of one of the following:

  • Participants with Richter's transformation who are relapsed or refractory following at least 1 line of prior therapy (Cohort D)
  • Participants with pathologically confirmed MCL, documented by either overexpression of cyclin D1 or t(11;14), who are relapsed or are refractory to chemoimmunotherapy and a covalent irreversible BTKi (Cohort E)
  • Participants with MZL (including splenic, nodal, and extra nodal MZL) who are relapsed or refractory to chemoimmunotherapy and a covalent irreversible BTKi (Cohort F)
  • Participants with FL who are relapsed or refractory to chemoimmunotherapy, immunomodulatory agents (i.e. lenalidomide plus rituximab) (Cohort G)
• Have measurable disease defined as at least 1 lesion that can be accurately measured in at least 2 dimensions with spiral CT scan
• Has a lymph node biopsy for biomarker analysis from an archival or newly obtained biopsy at Screening

Part 2 (Cohort H): confirmed diagnosis of WM; participants who are relapsed or refractory to standard therapies for WM including chemoimmunotherapy and a covalent irreversible BTKi

• Has active disease defined as 1 of the following: systemic symptoms, physical findings, laboratory abnormalities, coexisting disease
• Has measurable disease, satisfying any of the following: at least 1 lesion that can be accurately measured in at least 2 dimensions with spiral CT scan (minimum measurement must be >15 mm in the longest diameter or >10 mm in the short axis); IgM ≥450 mg/dL; or bone marrow infiltration of 10%
• Has fresh bone marrow aspirate or a lymph node biopsy for biomarker analysis at Screening or a lymph node biopsy from an archival

Exclusion Criteria:

• Has active HBV/HCV infection (Part 1 and Part 2)
• Has a history of malignancy ≤3 years before providing documented informed consent. Participants with basal cell carcinoma of skin, squamous cell carcinoma of skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potential curative therapy are not excluded. Participants with low-risk, early-stage prostate cancer (T1-T2a, Gleason score ≤6, and prostate-specific antigen <10 ng/mL) either treated with definitive intent or untreated in active surveillance with SD are not excluded
• Has active central nervous system (CNS) disease
• Has an active infection requiring systemic therapy
• Has received prior systemic anti-cancer therapy within 4 weeks prior to allocation
• Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention
• Has any clinically significant gastrointestinal abnormalities that might alter absorption
• History of severe bleeding disorders

Contacts and Locations

Contacts

Contact: Toll Free Number; 1-888-577-8839; Trialsites@merck.com

Locations

United States, Arkansas

Highlands Oncology Group ( Site 2728); Recruiting

Springdale, Arkansas, United States, 72762

Contact: Study Coordinator 479-872-8130

United States, California

Lundquist Institute for Biomedical Innovation at Harbor-UCLA-Hematology and Medical Oncology ( Site; Recruiting

Torrance, California, United States, 90502

Contact: Study Coordinator 424-201-3000

United States, Colorado

Colorado Blood Cancer Institute ( Site 2726); Recruiting

Denver, Colorado, United States, 80218

Contact: Study Coordinator 720-754-4800

United States, Minnesota

Mayo Clinic - Rochester ( Site 2706); Recruiting

Rochester, Minnesota, United States, 55905

Contact: Study Coordinator 507-284-2511

United States, New Jersey

John Theurer Cancer Center at Hackensack University Medical Center ( Site 2704); Recruiting

Hackensack, New Jersey, United States, 07601

Contact: Study Coordinator 551-996-3003

United States, North Dakota

Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 2708); Recruiting

Fargo, North Dakota, United States, 58102

Contact: Study Coordinator 701-234-7592

United States, Washington

Medical Oncology Associates (Summit Cancer Centers) ( Site 2710); Recruiting

Spokane, Washington, United States, 99208

Contact: Study Coordinator 509-462-2273

Argentina

Hospital Aleman ( Site 0102); Recruiting

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1118AAT

Contact: Study Coordinator +541148277000

Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0103); Recruiting

Buenos Aires, Caba, Argentina, C1431FWO

Contact: Study Coordinator +541152990247

FUNDALEU ( Site 0104); Recruiting

Caba, Argentina, C1114AAN

Contact: Study Coordinator 5411 48771046

Hospital Privado Universitario de Córdoba ( Site 0107); Recruiting

Cordoba, Argentina, X5016KEH

Contact: Study Coordinator +54-11-1569634187

Fundacion Centro Oncologico de Integración Regional-Medical Oncology ( Site 0110); Recruiting

Mendoza, Argentina, 5500

Contact: Study Coordinator +54261-4252575

Australia, New South Wales

Nepean Hospital-Nepean Cancer Care Centre ( Site 0204); Recruiting

Sydney, New South Wales, Australia, 2747

Contact: Study Coordinator +61247343500

Australia, Victoria

Box Hill Hospital ( Site 0203); Recruiting

Box Hill, Victoria, Australia, 3128

Contact: Study Coordinator +611300342255

Australia, Western Australia

Sir Charles Gairdner Hospital ( Site 0200); Recruiting

Nedlands, Western Australia, Australia, 6009

Contact: Study Coordinator +61864573333

Brazil

Hospital das Clinicas FMUSP-Pesquisa Clínica Hematologia ( Site 0303); Recruiting

São Paulo, Sao Paulo, Brazil, 05403-000

Contact: Study Coordinator 551145737543

Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0300); Recruiting

Rio de Janeiro, Brazil, 20231-050

Contact: Study Coordinator +552132076564

BP - A Beneficencia Portuguesa de São Paulo ( Site 0302); Recruiting

Sao Paulo, Brazil, 01321-001

Contact: Study Coordinator +551134744249

Hospital Paulistano - Amil Clinical Research ( Site 0311); Recruiting

Sao Paulo, Brazil, 01321-001

Contact: Study Coordinator +551130161340

Canada, Alberta

Tom Baker Cancer Centre ( Site 0401); Recruiting

Calgary, Alberta, Canada, T4N 4N2

Contact: Study Coordinator 4035213723

Canada, Ontario

The Ottawa Hospital ( Site 0404); Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contact: Study Coordinator 613 737-7700

Canada, Quebec

CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0403); Recruiting

Montreal, Quebec, Canada, H1T 2M4

Contact: Study Coordinator 5142523400

Jewish General Hospital ( Site 0400); Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contact: Study Coordinator 5143408222 x 24572

China, Anhui

Anhui Provincial Hospital ( Site 2808); Recruiting

Hefei, Anhui, China, 230071

Contact: Study Coordinator 13866173932

China, Guangxi

Guangxi Medical University - Liuzhou Renmin Hospital ( Site 2817); Recruiting

Liuzhou, Guangxi, China, 545006

Contact: Study Coordinator 13877299966

Guangxi Medical University Affiliated Tumor Hospital ( Site 2814); Recruiting

Nanning, Guangxi, China, 530021

Contact: Study Coordinator 13507711671

China, Henan

Henan Cancer Hospital-hematology department ( Site 2802); Recruiting

Zhengzhou, Henan, China, 450008

Contact: Study Coordinator 0371-65588007

China, Hubei

Wuhan Union Hospital ( Site 2816); Recruiting

Wuhan, Hubei, China, 430022

Contact: Study Coordinator +8618627091655

China, Hunan

The Second Xiangya Hospital of Central South University ( Site 2820); Recruiting

Changsha, Hunan, China, 410011

Contact: Study Coordinator +8613975806137

China, Jiangsu

The Affiliated Hospital of Xuzhou Medical College ( Site 2818); Recruiting

Xuzhou, Jiangsu, China, 221006

Contact: Study Coordinator 18168777317

China, Jiangxi

The First Affiliated Hospital of Nanchang University ( Site 2815); Recruiting

Nanchang, Jiangxi, China, 330006

Contact: Study Coordinator 13970038386

China, Jilin

The First Hospital of Jilin University-Hematology ( Site 2803); Recruiting

Changchun, Jilin, China, 130021

Contact: Study Coordinator 0431-88786014

China, Shanghai

Fudan University Shanghai Cancer Center ( Site 2801); Recruiting

Shanghai, Shanghai, China, 200032

Contact: Study Coordinator 18017312613

China, Sichuan

West China Hospital Sichuan University ( Site 2810); Recruiting

Cheng Du, Sichuan, China, 610041

Contact: Study Coordinator 18980601247

China, Tianjin

Institute of hematology&blood disease hospital-Hematology ( Site 2800); Recruiting

Tianjin, Tianjin, China, 300020

Contact: Study Coordinator +8615900265415

Czechia

Fakultní nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0600); Recruiting

Brno, Brno-mesto, Czechia, 62500

Contact: Study Coordinator +420532233642

Fakultni nemocnice Hradec Kralove ( Site 0601); Recruiting

Hradec Kralove, Czechia, 50005

Contact: Study Coordinator +420495832159

Denmark

Aalborg Universitetshospital ( Site 0703); Recruiting

Aalborg, Nordjylland, Denmark, 9000

Contact: Study Coordinator 004597660000

Sjaellands Universitetshospital Roskilde ( Site 0701); Recruiting

Roskilde, Sjaelland, Denmark, 4000

Contact: Study Coordinator +45 46 32 32 00

Odense University Hospital ( Site 0705); Recruiting

Odense C, Syddanmark, Denmark, 5000

Contact: Study Coordinator +45 66 11 33 33

France

Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 0810); Recruiting

Nice, Alpes-Maritimes, France, 06202

Contact: Study Coordinator +33 4 92 03 57 85

Institut Paoli-Calmettes ( Site 0803); Recruiting

Marseille, Bouches-du-Rhone, France, 13009

Contact: Study Coordinator +33491223537

Centre Hospitalier Lyon-Sud ( Site 0804); Recruiting

Pierre Benite, Rhone-Alpes, France, 69495

Contact: Study Coordinator +33478864348

Hopital Saint Louis ( Site 0805); Recruiting

Paris, France, 75010

Contact: Study Coordinator 33142499236

Germany

Universitaetsklinikum Ulm ( Site 0906); Recruiting

Ulm, Baden-Wurttemberg, Germany, 89081

Contact: Study Coordinator + 49 731 500 45901

St. Marien-Krankenhaus Siegen ( Site 0914); Recruiting

Siegen, Nordrhein-Westfalen, Germany, 57072

Contact: Study Coordinator 02712311302

Universitaetsklinikum Carl Gustav Carus ( Site 0902); Recruiting

Dresden, Sachsen, Germany, 01307

Contact: Study Coordinator 0049 351 458 5692

Hungary

Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar ( Site 1202); Recruiting

Pecs, Baranya, Hungary, 7624

Contact: Study Coordinator +3672536000

Debreceni Egyetem Klinikai Kozpont ( Site 1201); Recruiting

Debrecen, Hajdu-Bihar, Hungary, 4032

Contact: Study Coordinator +3652255

Szabolcs Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz ( Site 1206); Recruiting

Nyiregyhaza, Szabolcs-Szatmar-Bereg, Hungary, 4400

Contact: Study Coordinator +3642599700

Orszagos Onkologiai Intezet ( Site 1200); Recruiting

Budapest, Hungary, 1122

Contact: Study Coordinator +3612248600

Israel

Ha Emek Medical Center ( Site 1305); Recruiting

Afula, Israel, 1834111

Contact: Study Coordinator 972-46494052

Soroka Medical Center ( Site 1307); Recruiting

Beer-Sheva, Israel, 8410101

Contact: Study Coordinator +972544203424

Rambam Medical Center ( Site 1301); Recruiting

Haifa, Israel, 3109601

Contact: Study Coordinator +97247772547

Hadassah Ein Karem Jerusalem ( Site 1300); Recruiting

Jerusalem, Israel, 9112001

Contact: Study Coordinator +97226778180

Chaim Sheba Medical Center ( Site 1302); Recruiting

Ramat Gan, Israel, 5262001

Contact: Study Coordinator +972526669155

Kaplan Medical Center ( Site 1304); Recruiting

Rehovot, Israel, 7610001

Contact: Study Coordinator +97289441726

Sourasky Medical Center ( Site 1303); Recruiting

Tel Aviv, Israel, 6423906

Contact: Study Coordinator +97236973782

Italy

Istituto Tumori Giovanni Paolo II ( Site 1409); Recruiting

Bari, Italy, 70124

Contact: Study Coordinator +390805555905

A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 1400); Recruiting

Bologna, Italy, 40138

Contact: Study Coordinator +390516363680

ASST Spedali Civili di Brescia ( Site 1408); Recruiting

Brescia, Italy, 25123

Contact: Study Coordinator +39 0303996416

IRCCS Ospedale San Raffaele ( Site 1402); Recruiting

Milano, Italy, 20132

Contact: Study Coordinator 00390226434797

Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1403); Recruiting

Napoli, Italy, 80131

Contact: Study Coordinator +39 0815903 382

Fondazione IRCCS Policlinico San Matteo ( Site 1407); Recruiting

Pavia, Italy, 27100

Contact: Study Coordinator +39 0382503084

IRCCS - Arcispedale Santa Maria Nuova ( Site 1405); Recruiting

Reggio Emilia, Italy, 42123

Contact: Study Coordinator +39 0522295654

Policlinico Umberto I ( Site 1404); Recruiting

Roma, Italy, 00161

Contact: Study Coordinator +390649974752

Korea, Republic of

Severance Hospital Yonsei University Health System ( Site 2201); Recruiting

Seoul, Korea, Republic of, 03722

Contact: Study Coordinator +82222281972

Samsung Medical Center ( Site 2200); Recruiting

Seoul, Korea, Republic of, 06351

Contact: Study Coordinator +82234106548

Poland

Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku ( Site; Recruiting

Wroclaw, Dolnoslaskie, Poland, 50-367

Contact: Study Coordinator +48717842576

Pratia MCM Krakow ( Site 1601); Recruiting

Krakow, Malopolskie, Poland, 30-727

Contact: Study Coordinator 48 12 2954135

Szpital Wojewódzki w Opolu-Hematology Department ( Site 1607); Recruiting

Opole, Opolskie, Poland, 45-061

Contact: Study Coordinator 774433100

Szpitale Pomorskie Sp. z o.o. ( Site 1600); Recruiting

Gdynia, Pomorskie, Poland, 81-519

Contact: Study Coordinator 48587260102

Romania

Ovidius Clinical Hospital ( Site 1804); Recruiting

Ovidiu, Constanta, Romania, 905900

Contact: Study Coordinator 40241503485

Institutul Regional de Oncologie Iasi ( Site 1801); Recruiting

Iasi, Romania, 700483

Contact: Study Coordinator 40374278811

Spain

Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 2000); Recruiting

Hospitalet de Llobregat, Barcelona, Spain, 08908

Contact: Study Coordinator +34932607750

Hospital Universitari Vall d'Hebron ( Site 2001); Recruiting

Barcelona, Spain, 08035

Contact: Study Coordinator +34934893806

Hospital Universitario 12 de Octubre ( Site 2003); Recruiting

Madrid, Spain, 28041

Contact: Study Coordinator +34917792809

Hospital Universitario de Salamanca ( Site 2002); Recruiting

Salamanca, Spain, 37007

Contact: Study Coordinator +34 923 29 11 00 Ext. 55974

Switzerland

Inselspital Bern ( Site 2303); Recruiting

Bern, Berne, Switzerland, 3010

Contact: Study Coordinator +41316329023

Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 2302); Recruiting

Bellinzona, Ticino, Switzerland, 6500

Contact: Study Coordinator +41918118540

Turkey

Mega Medipol-Hematology ( Site 2406); Recruiting

Stanbul, Istanbul, Turkey, 34214

Contact: Study Coordinator 905437870708

Ankara Universitesi Tip Fakultesi Cebeci Hastanesi ( Site 2400); Recruiting

Ankara, Turkey, 06590

Contact: Study Coordinator +903125957099

VKV Amerikan Hastanesi ( Site 2403); Recruiting

Istanbul, Turkey, 34365

Contact: Study Coordinator +905322566160

Sisli Florence Nightingale Hastanesi ( Site 2407); Recruiting

Istanbul, Turkey, 34381

Contact: Study Coordinator +90 542 502 50 75

Dokuz Eylül Üniversitesi-Hematology ( Site 2402); Recruiting

Izmir, Turkey, 35340

Contact: Study Coordinator +905425151780

Ukraine

Kyiv City Clinical Hospital 9 ( Site 2502); Suspended

Kyiv, Ukraine, 04112

United Kingdom

Nottingham University Hospitals NHS Trust. City Hospital Campus ( Site 2601); Recruiting

Nottingham, England, United Kingdom, NG5 1PF

Contact: Study Coordinator +441159691169

GenesisCare - Windsor ( Site 2608); Recruiting

Windsor, England, United Kingdom, SL4 3HD

Contact: Study Coordinator +447989474250

GenesisCare - Oxford ( Site 2607); Recruiting

Oxford, Oxfordshire, United Kingdom, OX4 6LB

Contact: Study Coordinator +447989474250

The Royal Marsden NHS Foundation Trust. ( Site 2606); Recruiting

London, Surrey, United Kingdom, SM3 5PT

Contact: Study Coordinator 02089156773

The Christie NHS Foundation Trust ( Site 2602); Recruiting

Manchester, United Kingdom, M20 4BX

Contact: Study Coordinator 01619561217

Sponsors and Collaborators

Merck Sharp & Dohme LLC

Investigators

• Study Director: Medical Director; Merck Sharp & Dohme LLC

More Information

Additional Information:

Merck Oncology Clinical Trials Information 

• Responsible Party: Merck Sharp & Dohme LLC
• ClinicalTrials.gov Identifier: NCT04728893
• Other Study ID Numbers: 1026-003; MK-1026-003 ( Other Identifier: Merck ); 2020-002324-36 ( EudraCT Number )
• First Posted: January 28, 2021
• Last Update Posted: June 2, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
• URL: http://engagezone.msd.com/ds_documentation.php

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Hematologic Diseases