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

Primary Purpose

Hematologic Malignancies, Waldenstroms Macroglobulinaemia, Non-Hodgkins Lymphoma

Status

Recruiting

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Nemtabrutinib

About this trial

This is an interventional treatment trial for Hematologic Malignancies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Highlands Oncology Group ( Site 2728)Recruiting
Lundquist Institute for Biomedical Innovation at Harbor-UCLA-Hematology and Medical Oncology ( SiteRecruiting
Colorado Blood Cancer Institute ( Site 2726)Recruiting
The University of Louisville, James Graham Brown Cancer Center ( Site 2729)Recruiting
Mayo Clinic - Rochester ( Site 2706)Recruiting
John Theurer Cancer Center at Hackensack University Medical Center ( Site 2704)Recruiting
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 2708)Recruiting
Medical Oncology Associates (Summit Cancer Centers) ( Site 2710)Recruiting
Hospital Aleman ( Site 0102)Recruiting
Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0103)Recruiting
FUNDALEU ( Site 0104)Recruiting
Hospital Privado Universitario de Córdoba ( Site 0107)Recruiting
Fundacion Centro Oncologico de Integración Regional-Medical Oncology ( Site 0110)Recruiting
Nepean Hospital-Nepean Cancer Care Centre ( Site 0204)Recruiting
Box Hill Hospital ( Site 0203)Recruiting
Sir Charles Gairdner Hospital ( Site 0200)Recruiting
Hospital das Clinicas FMUSP-Pesquisa Clínica Hematologia ( Site 0303)Recruiting
Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0300)Recruiting
BP - A Beneficencia Portuguesa de São Paulo ( Site 0302)
Hospital Paulistano - Amil Clinical Research ( Site 0311)Recruiting
Tom Baker Cancer Centre ( Site 0401)Recruiting
The Ottawa Hospital ( Site 0404)Recruiting
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0406)Recruiting
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0403)Recruiting
Jewish General Hospital ( Site 0400)Recruiting
Anhui Provincial Hospital ( Site 2808)Recruiting
2nd Affiliated Hospital Chongqing Medical Universi-Hematology ( Site 2825)Recruiting
Sun Yat-sen University Cancer Center-Internal Medicine ( Site 2824)Recruiting
Guangxi Medical University - Liuzhou Renmin Hospital ( Site 2817)Recruiting
Guangxi Medical University Affiliated Tumor Hospital ( Site 2814)Recruiting
Henan Cancer Hospital-hematology department ( Site 2802)Recruiting
Wuhan Union Hospital ( Site 2816)Recruiting
The Second Xiangya Hospital of Central South University ( Site 2820)Recruiting
The Affiliated Hospital of Xuzhou Medical College ( Site 2818)Recruiting
The First Affiliated Hospital of Nanchang University ( Site 2815)Recruiting
The First Hospital of Jilin University-Hematology ( Site 2803)Recruiting
Fudan University Shanghai Cancer Center ( Site 2801)Recruiting
Huashan Hospital, Fudan University ( Site 2821)Recruiting
West China Hospital Sichuan University ( Site 2810)Recruiting
Institute of hematology&blood disease hospital-Hematology ( Site 2800)Recruiting
The First Affiliated Hospital, Zhejiang University ( Site 2826)Recruiting
Fakultní nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0600)Recruiting
Fakultni nemocnice Hradec Kralove ( Site 0601)Recruiting
Aarhus University Hospital ( Site 0702)Recruiting
Aalborg Universitetshospital ( Site 0703)Recruiting
Sjaellands Universitetshospital Roskilde ( Site 0701)Recruiting
Odense University Hospital ( Site 0705)Recruiting
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 0810)Recruiting
Institut Paoli-Calmettes ( Site 0803)Recruiting
Centre Hospitalier Lyon-Sud ( Site 0804)Recruiting
Centre Hospitalier de Versailles ( Site 0809)Recruiting
Hopital Saint Louis ( Site 0805)Recruiting
Universitaetsklinikum Ulm ( Site 0906)Recruiting
Universitaetsklinikum Koeln ( Site 0901)Recruiting
St. Marien-Krankenhaus Siegen ( Site 0914)
Universitaetsklinikum Carl Gustav Carus ( Site 0902)Recruiting
Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar ( Site 1202)Recruiting
Debreceni Egyetem Klinikai Kozpont ( Site 1201)Recruiting
Szabolcs Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz ( Site 1206)Recruiting
Orszagos Onkologiai Intezet ( Site 1200)Recruiting
Beaumont Hospital ( Site 2900)Recruiting
University Hospital Limerick ( Site 2903)Recruiting
Ha Emek Medical Center ( Site 1305)Recruiting
Soroka Medical Center ( Site 1307)Recruiting
Rambam Medical Center ( Site 1301)Recruiting
Hadassah Ein Karem Jerusalem ( Site 1300)Recruiting
Chaim Sheba Medical Center ( Site 1302)Recruiting
Kaplan Medical Center ( Site 1304)Recruiting
Sourasky Medical Center ( Site 1303)Recruiting
Istituto Tumori Giovanni Paolo II ( Site 1409)Recruiting
A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 1400)Recruiting
ASST Spedali Civili di Brescia ( Site 1408)Recruiting
IRCCS Ospedale San Raffaele ( Site 1402)Recruiting
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1403)Recruiting
Fondazione IRCCS Policlinico San Matteo ( Site 1407)Recruiting
IRCCS - Arcispedale Santa Maria Nuova ( Site 1405)Recruiting
Policlinico Umberto I ( Site 1404)Recruiting
Severance Hospital Yonsei University Health System ( Site 2201)Recruiting
Samsung Medical Center ( Site 2200)Recruiting
Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku ( SiteRecruiting
Pratia MCM Krakow ( Site 1601)Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( SiteRecruiting
Szpital Wojewódzki w Opolu-Hematology Department ( Site 1607)
Szpitale Pomorskie Sp. z o.o. ( Site 1600)Recruiting
Ovidius Clinical Hospital ( Site 1804)Recruiting
Institutul Regional de Oncologie Iasi ( Site 1801)Recruiting
Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 2000)Recruiting
Hospital Universitari Vall d'Hebron ( Site 2001)Recruiting
Hospital Universitario 12 de Octubre ( Site 2003)Recruiting
Hospital Universitario de Salamanca ( Site 2002)Recruiting
Inselspital Bern ( Site 2303)Recruiting
Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 2302)Recruiting
Mega Medipol-Hematology ( Site 2406)Recruiting
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi ( Site 2400)Recruiting
VKV Amerikan Hastanesi ( Site 2403)Recruiting
Sisli Florence Nightingale Hastanesi ( Site 2407)Recruiting
Dokuz Eylül Üniversitesi-Hematology ( Site 2402)Recruiting
Kyiv City Clinical Hospital 9 ( Site 2502)
Bristol Haematology and Oncology Centre ( Site 2610)Recruiting
Nottingham University Hospitals NHS Trust. City Hospital Campus ( Site 2601)Recruiting
GenesisCare - Windsor ( Site 2608)Recruiting
Sarah Cannon Research Institute UK ( Site 2612)Recruiting
GenesisCare - Oxford ( Site 2607)Recruiting
GenesisCare - Cambridge ( Site 2611)Recruiting
The Royal Marsden NHS Foundation Trust. ( Site 2606)Recruiting
The Christie NHS Foundation Trust ( Site 2602)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nemtabrutinib

Arm Description

Participants receive nemtabrutinib orally once daily (QD) until progressive disease (PD) or discontinuation.

Outcomes

Primary Outcome Measures

Part 1: Number of participants experiencing dose-limiting toxicities (DLTs)

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.

Part 1: Number of participants experiencing adverse events (AEs)

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.

Part 1: Number of participants discontinuing study treatment due to AEs

Part 2: Objective Response Rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria 2018 as assessed by independent central review (ICR)

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.

Part 2: ORR per Lugano criteria 2014 as assessed by ICR

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.

Part 2: ORR per International Workshop on Waldenström's Macroglobulinemia (IWWM) criteria 2014 as assessed by ICR

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

Part 1: Area Under the Curve (AUC) of Nemtabrutinib

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.

Part 1: Minimum Concentration (Cmin) of Nemtabrutinib

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.

Part 1: Maximum Concentration (Cmax) of Nemtabrutinib

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.

Part 1: ORR per iwCLL criteria 2018 as assessed by ICR

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.

Part 1: Duration of Response (DOR) per iwCLL criteria 2018 as assessed by ICR

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.

Part 2: Number of participants experiencing AEs

Part 2: Number of participants discontinuing study treatment due to AEs

Part 2: AUC of Nemtabrutinib

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.

Part 2: Cmin of Nemtabrutinib

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.

Part 2: Cmax of Nemtabrutinib

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.

Part 2: DOR per iwCLL criteria 2018 as assessed by ICR

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.

Part 2: DOR per Lugano criteria 2014 as assessed by ICR

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.

Part 2: DOR per IWWM criteria 2014 as assessed by ICR

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).

Full Information

NCT ID

NCT04728893

First Posted

January 25, 2021

Last Updated

October 13, 2023

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT04728893

Brief Title

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

Official Title

A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants With Hematologic Malignancies

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 5, 2021 (Actual)

Primary Completion Date

March 19, 2027 (Anticipated)

Study Completion Date

March 19, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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).

Detailed Description

This study will be performed in 2 parts: Dose Escalation and Confirmation (Part 1) and Cohort Expansion (Part 2). Following determination of the 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hematologic Malignancies, Waldenstroms Macroglobulinaemia, Non-Hodgkins Lymphoma, Chronic Lymphocytic Leukaemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Nemtabrutinib

Arm Type

Experimental

Arm Description

Participants receive nemtabrutinib orally once daily (QD) until progressive disease (PD) or discontinuation.

Intervention Type

Drug

Intervention Name(s)

Nemtabrutinib

Other Intervention Name(s)

ARQ 531, MK-1026

Intervention Description

Nemtabrutinib tablets administered PO QD.

Primary Outcome Measure Information:

Title

Part 1: Number of participants experiencing dose-limiting toxicities (DLTs)

Description

Time Frame

Up to ~56 days (Cycles 1-2, cycle = 28 days)

Title

Part 1: Number of participants experiencing adverse events (AEs)

Description

Time Frame

Up to ~34 months

Title

Part 1: Number of participants discontinuing study treatment due to AEs

Description

Time Frame

Up to ~34 months

Title

Part 2: Objective Response Rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria 2018 as assessed by independent central review (ICR)

Description

Time Frame

Up to ~78 months

Title

Part 2: ORR per Lugano criteria 2014 as assessed by ICR

Description

Time Frame

Up to ~78 months

Title

Part 2: ORR per International Workshop on Waldenström's Macroglobulinemia (IWWM) criteria 2014 as assessed by ICR

Description

Time Frame

Up to ~78 months

Secondary Outcome Measure Information:

Title

Part 1: Area Under the Curve (AUC) of Nemtabrutinib

Description

Time Frame

At designated time points (up to ~57 days)

Title

Part 1: Minimum Concentration (Cmin) of Nemtabrutinib

Description

Time Frame

At designated time points (up to ~57 days)

Title

Part 1: Maximum Concentration (Cmax) of Nemtabrutinib

Description

Time Frame

At designated time points (up to ~57 days)

Title

Part 1: ORR per iwCLL criteria 2018 as assessed by ICR

Description

Time Frame

Up to ~34 months

Title

Part 1: Duration of Response (DOR) per iwCLL criteria 2018 as assessed by ICR

Description

Time Frame

Up to ~34 months

Title

Part 2: Number of participants experiencing AEs

Description

Time Frame

Up to ~78 months

Title

Part 2: Number of participants discontinuing study treatment due to AEs

Description

Time Frame

Up to ~78 months

Title

Part 2: AUC of Nemtabrutinib

Description

Time Frame

At designated time points (up to ~57 days)

Title

Part 2: Cmin of Nemtabrutinib

Description

Time Frame

At designated time points (up to ~57 days)

Title

Part 2: Cmax of Nemtabrutinib

Description

Time Frame

At designated time points (up to ~57 days)

Title

Part 2: DOR per iwCLL criteria 2018 as assessed by ICR

Description

Time Frame

Up to ~78 months

Title

Part 2: DOR per Lugano criteria 2014 as assessed by ICR

Description

Time Frame

Up to ~78 months

Title

Part 2: DOR per IWWM criteria 2014 as assessed by ICR

Description

Time Frame

Up to ~78 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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 penile-vaginal intercourse as their preferred and usual lifestyle OR agree to use contraception, during the intervention period and for at least the time required to eliminate the study intervention after last dose of study intervention Female participants assigned female sex at birth who are not pregnant or breastfeeding are eligible to participate if not a participant of childbearing potential (POCBP), or if a POCBP they either use a contraceptive method that is highly effective OR remain abstinent from penile-vaginal 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 or bone marrow aspirate 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 or bone marrow aspirate (Cohort D) 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Toll Free Number

Phone

1-888-577-8839

Trialsites@merck.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

Facility Information:

Facility Name

Highlands Oncology Group ( Site 2728)

City

Springdale

State/Province

Arkansas

ZIP/Postal Code

72762

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

479-872-8130

Facility Name

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

City

Torrance

State/Province

California

ZIP/Postal Code

90502

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

424-201-3000

Facility Name

Colorado Blood Cancer Institute ( Site 2726)

City

Denver

State/Province

Colorado

ZIP/Postal Code

80218

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

720-754-4800

Facility Name

The University of Louisville, James Graham Brown Cancer Center ( Site 2729)

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

502-562-4543

Facility Name

Mayo Clinic - Rochester ( Site 2706)

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

507-284-2511

Facility Name

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

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

551-996-3003

Facility Name

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

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58122

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

701-234-7592

Facility Name

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

City

Spokane

State/Province

Washington

ZIP/Postal Code

99208

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

509-462-2273

Facility Name

Hospital Aleman ( Site 0102)

City

Ciudad Autonoma de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1118AAT

Country

Argentina

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+541148277000

Facility Name

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

City

Buenos Aires

State/Province

Caba

ZIP/Postal Code

C1431FWO

Country

Argentina

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+541152990247

Facility Name

FUNDALEU ( Site 0104)

City

Caba

ZIP/Postal Code

C1114AAN

Country

Argentina

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

5411 48771046

Facility Name

Hospital Privado Universitario de Córdoba ( Site 0107)

City

Cordoba

ZIP/Postal Code

X5016KEH

Country

Argentina

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+541569634187

Facility Name

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

City

Mendoza

ZIP/Postal Code

5500

Country

Argentina

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+54261-4252575

Facility Name

Nepean Hospital-Nepean Cancer Care Centre ( Site 0204)

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

2747

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+61247343500

Facility Name

Box Hill Hospital ( Site 0203)

City

Box Hill

State/Province

Victoria

ZIP/Postal Code

3128

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+611300342255

Facility Name

Sir Charles Gairdner Hospital ( Site 0200)

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+61864573333

Facility Name

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

City

São Paulo

State/Province

Sao Paulo

ZIP/Postal Code

05403-000

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

551145737543

Facility Name

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

City

Rio de Janeiro

ZIP/Postal Code

20231-050

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+552132076564

Facility Name

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

City

Sao Paulo

ZIP/Postal Code

01321-001

Country

Brazil

Individual Site Status

Active, not recruiting

Facility Name

Hospital Paulistano - Amil Clinical Research ( Site 0311)

City

Sao Paulo

ZIP/Postal Code

01321-001

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+551130161340

Facility Name

Tom Baker Cancer Centre ( Site 0401)

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

4035213723

Facility Name

The Ottawa Hospital ( Site 0404)

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

613 737-7700

Facility Name

Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0406)

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

416-946-2827

Facility Name

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

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 2M4

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

5142523400

Facility Name

Jewish General Hospital ( Site 0400)

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

5143408222 x 24572

Facility Name

Anhui Provincial Hospital ( Site 2808)

City

Hefei

State/Province

Anhui

ZIP/Postal Code

230071

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

13866173932

Facility Name

2nd Affiliated Hospital Chongqing Medical Universi-Hematology ( Site 2825)

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400042

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+8613508331213

Facility Name

Sun Yat-sen University Cancer Center-Internal Medicine ( Site 2824)

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

(+86)13719189172

Facility Name

Guangxi Medical University - Liuzhou Renmin Hospital ( Site 2817)

City

Liuzhou

State/Province

Guangxi

ZIP/Postal Code

545006

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

13877299966

Facility Name

Guangxi Medical University Affiliated Tumor Hospital ( Site 2814)

City

Nanning

State/Province

Guangxi

ZIP/Postal Code

530021

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

13507711671

Facility Name

Henan Cancer Hospital-hematology department ( Site 2802)

City

Zhengzhou

State/Province

Henan

ZIP/Postal Code

450008

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

0371-65588007

Facility Name

Wuhan Union Hospital ( Site 2816)

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430022

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+8618627091655

Facility Name

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

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410011

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+8613975806137

Facility Name

The Affiliated Hospital of Xuzhou Medical College ( Site 2818)

City

Xuzhou

State/Province

Jiangsu

ZIP/Postal Code

221006

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

18168777317

Facility Name

The First Affiliated Hospital of Nanchang University ( Site 2815)

City

Nanchang

State/Province

Jiangxi

ZIP/Postal Code

330006

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

13970038386

Facility Name

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

City

Changchun

State/Province

Jilin

ZIP/Postal Code

130021

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

0431-88786014

Facility Name

Fudan University Shanghai Cancer Center ( Site 2801)

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

18017312613

Facility Name

Huashan Hospital, Fudan University ( Site 2821)

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200040

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

8613621778391

Facility Name

West China Hospital Sichuan University ( Site 2810)

City

Cheng Du

State/Province

Sichuan

ZIP/Postal Code

610041

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

18980601247

Facility Name

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

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300020

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+8615900265415

Facility Name

The First Affiliated Hospital, Zhejiang University ( Site 2826)

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310002

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

057187236114

Facility Name

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

City

Brno

State/Province

Brno-mesto

ZIP/Postal Code

625 00

Country

Czechia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+420532233642

Facility Name

Fakultni nemocnice Hradec Kralove ( Site 0601)

City

Hradec Kralove

ZIP/Postal Code

50005

Country

Czechia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+420495832159

Facility Name

Aarhus University Hospital ( Site 0702)

City

Aarhus N

State/Province

Midtjylland

ZIP/Postal Code

8200

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

004578450000

Facility Name

Aalborg Universitetshospital ( Site 0703)

City

Aalborg

State/Province

Nordjylland

ZIP/Postal Code

9000

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

004597660000

Facility Name

Sjaellands Universitetshospital Roskilde ( Site 0701)

City

Roskilde

State/Province

Sjaelland

ZIP/Postal Code

4000

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+45 46 32 32 00

Facility Name

Odense University Hospital ( Site 0705)

City

Odense C

State/Province

Syddanmark

ZIP/Postal Code

5000

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+45 66 11 33 33

Facility Name

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

City

Nice

State/Province

Alpes-Maritimes

ZIP/Postal Code

06202

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+33 4 92 03 57 85

Facility Name

Institut Paoli-Calmettes ( Site 0803)

City

Marseille

State/Province

Bouches-du-Rhone

ZIP/Postal Code

13009

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+33491223537

Facility Name

Centre Hospitalier Lyon-Sud ( Site 0804)

City

Pierre Benite

State/Province

Rhone-Alpes

ZIP/Postal Code

69495

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+33478864348

Facility Name

Centre Hospitalier de Versailles ( Site 0809)

City

Le Chesnay

State/Province

Yvelines

ZIP/Postal Code

78150

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+33139638511

Facility Name

Hopital Saint Louis ( Site 0805)

City

Paris

ZIP/Postal Code

75010

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

33142499236

Facility Name

Universitaetsklinikum Ulm ( Site 0906)

City

Ulm

State/Province

Baden-Wurttemberg

ZIP/Postal Code

89081

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+ 49 731 500 45901

Facility Name

Universitaetsklinikum Koeln ( Site 0901)

City

Koeln

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

50937

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+4922147897046

Facility Name

St. Marien-Krankenhaus Siegen ( Site 0914)

City

Siegen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

57072

Country

Germany

Individual Site Status

Completed

Facility Name

Universitaetsklinikum Carl Gustav Carus ( Site 0902)

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01307

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

0049 351 458 5692

Facility Name

Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar ( Site 1202)

City

Pecs

State/Province

Baranya

ZIP/Postal Code

7624

Country

Hungary

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+3672536000

Facility Name

Debreceni Egyetem Klinikai Kozpont ( Site 1201)

City

Debrecen

State/Province

Hajdu-Bihar

ZIP/Postal Code

4032

Country

Hungary

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+3652255

Facility Name

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

City

Nyiregyhaza

State/Province

Szabolcs-Szatmar-Bereg

ZIP/Postal Code

4400

Country

Hungary

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+3642599700

Facility Name

Orszagos Onkologiai Intezet ( Site 1200)

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+3612248600

Facility Name

Beaumont Hospital ( Site 2900)

City

Dublin

ZIP/Postal Code

D09V2N0

Country

Ireland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+35318092010

Facility Name

University Hospital Limerick ( Site 2903)

City

Limerick

ZIP/Postal Code

V94 F858

Country

Ireland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+35361588320

Facility Name

Ha Emek Medical Center ( Site 1305)

City

Afula

ZIP/Postal Code

1834111

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

972-46494052

Facility Name

Soroka Medical Center ( Site 1307)

City

Beer-Sheva

ZIP/Postal Code

8410101

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+972544203424

Facility Name

Rambam Medical Center ( Site 1301)

City

Haifa

ZIP/Postal Code

3109601

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+97247772547

Facility Name

Hadassah Ein Karem Jerusalem ( Site 1300)

City

Jerusalem

ZIP/Postal Code

9112001

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+97226778180

Facility Name

Chaim Sheba Medical Center ( Site 1302)

City

Ramat Gan

ZIP/Postal Code

5262001

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+972526669155

Facility Name

Kaplan Medical Center ( Site 1304)

City

Rehovot

ZIP/Postal Code

7610001

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+97289441726

Facility Name

Sourasky Medical Center ( Site 1303)

City

Tel Aviv

ZIP/Postal Code

6423906

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+97236973782

Facility Name

Istituto Tumori Giovanni Paolo II ( Site 1409)

City

Bari

ZIP/Postal Code

70124

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+390805555905

Facility Name

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

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+390516363680

Facility Name

ASST Spedali Civili di Brescia ( Site 1408)

City

Brescia

ZIP/Postal Code

25123

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+39 0303996416

Facility Name

IRCCS Ospedale San Raffaele ( Site 1402)

City

Milano

ZIP/Postal Code

20132

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

00390226434797

Facility Name

Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1403)

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+39 0815903 382

Facility Name

Fondazione IRCCS Policlinico San Matteo ( Site 1407)

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+39 0382503084

Facility Name

IRCCS - Arcispedale Santa Maria Nuova ( Site 1405)

City

Reggio Emilia

ZIP/Postal Code

42123

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+39 0522295654

Facility Name

Policlinico Umberto I ( Site 1404)

City

Roma

ZIP/Postal Code

00161

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+390649974752

Facility Name

Severance Hospital Yonsei University Health System ( Site 2201)

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+82222281972

Facility Name

Samsung Medical Center ( Site 2200)

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+82234106548

Facility Name

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

City

Wroclaw

State/Province

Dolnoslaskie

ZIP/Postal Code

50-367

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+48717842576

Facility Name

Pratia MCM Krakow ( Site 1601)

City

Krakow

State/Province

Malopolskie

ZIP/Postal Code

30-727

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

48 12 2954135

Facility Name

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site

City

Warszawa

State/Province

Mazowieckie

ZIP/Postal Code

02-781

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

48225462366

Facility Name

Szpital Wojewódzki w Opolu-Hematology Department ( Site 1607)

City

Opole

State/Province

Opolskie

ZIP/Postal Code

45-061

Country

Poland

Individual Site Status

Completed

Facility Name

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

City

Gdynia

State/Province

Pomorskie

ZIP/Postal Code

81-519

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

48587260102

Facility Name

Ovidius Clinical Hospital ( Site 1804)

City

Ovidiu

State/Province

Constanta

ZIP/Postal Code

905900

Country

Romania

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

40241503485

Facility Name

Institutul Regional de Oncologie Iasi ( Site 1801)

City

Iasi

ZIP/Postal Code

700483

Country

Romania

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

40374278811

Facility Name

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

City

Hospitalet de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08908

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+34932607750

Facility Name

Hospital Universitari Vall d'Hebron ( Site 2001)

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+34934893806

Facility Name

Hospital Universitario 12 de Octubre ( Site 2003)

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+34917792809

Facility Name

Hospital Universitario de Salamanca ( Site 2002)

City

Salamanca

ZIP/Postal Code

37007

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+34 923 29 11 00 Ext. 55974

Facility Name

Inselspital Bern ( Site 2303)

City

Bern

State/Province

Berne

ZIP/Postal Code

3010

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+41316329023

Facility Name

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

City

Bellinzona

State/Province

Ticino

ZIP/Postal Code

6500

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+41918118540

Facility Name

Mega Medipol-Hematology ( Site 2406)

City

Stanbul

State/Province

Istanbul

ZIP/Postal Code

34214

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

905437870708

Facility Name

Ankara Universitesi Tip Fakultesi Cebeci Hastanesi ( Site 2400)

City

Ankara

ZIP/Postal Code

06590

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+903125957099

Facility Name

VKV Amerikan Hastanesi ( Site 2403)

City

Istanbul

ZIP/Postal Code

34365

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+905322566160

Facility Name

Sisli Florence Nightingale Hastanesi ( Site 2407)

City

Istanbul

ZIP/Postal Code

34381

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+90 542 502 50 75

Facility Name

Dokuz Eylül Üniversitesi-Hematology ( Site 2402)

City

Izmir

ZIP/Postal Code

35340

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+905425151780

Facility Name

Kyiv City Clinical Hospital 9 ( Site 2502)

City

Kyiv

ZIP/Postal Code

04112

Country

Ukraine

Individual Site Status

Suspended

Facility Name

Bristol Haematology and Oncology Centre ( Site 2610)

City

Bristol

State/Province

Bristol, City Of

ZIP/Postal Code

BS2 8ED

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+441173421121

Facility Name

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

City

Nottingham

State/Province

England

ZIP/Postal Code

NG5 1PF

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+441159691169

Facility Name

GenesisCare - Windsor ( Site 2608)

City

Windsor

State/Province

England

ZIP/Postal Code

SL4 3HD

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+447989474250

Facility Name

Sarah Cannon Research Institute UK ( Site 2612)

City

London

State/Province

London, City Of

ZIP/Postal Code

W1G 6AD

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+44 (0) 207 725 6822

Facility Name

GenesisCare - Oxford ( Site 2607)

City

Oxford

State/Province

Oxfordshire

ZIP/Postal Code

OX4 6LB

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+447989474250

Facility Name

GenesisCare - Cambridge ( Site 2611)

City

Newmarket

State/Province

Suffolk

ZIP/Postal Code

CB8 7XN

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

01223 607910

Facility Name

The Royal Marsden NHS Foundation Trust. ( Site 2606)

City

London

State/Province

Surrey

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

02089156773

Facility Name

The Christie NHS Foundation Trust ( Site 2602)

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

01619561217

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

IPD Sharing URL

http://engagezone.msd.com/ds_documentation.php

Links:

URL

https://www.merckclinicaltrials.com/

Description

Merck Clinical Trials Information

Learn more about this trial

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

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