Clinical trial • Phase II • Oncology

ZILOVERTAMAB VEDOTIN for Diffuse large B-cell lymphoma

Phase II trial of ZILOVERTAMAB VEDOTIN for Diffuse large B-cell lymphoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Diffuse large B-cell lymphoma
Trial Stage
Phase II
Drug Modality
ADC|Monoclonal antibody|Small molecule|Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
20-01-2025
First CTIS Authorization Date
08-05-2025

Trial design

Randomised, open-label, zilovertamab vedotin (mk-2140) plus r-chp versus polatuzumab vedotin plus r-chp; r-chp = rituximab + cyclophosphamide + doxorubicin + prednisone. doses and schedules not specified in the provided data.-controlled Phase II trial in Belgium, Germany, Ireland and others.

Randomised
Yes
Open Label
Yes
Comparator
Zilovertamab vedotin (MK-2140) plus R-CHP versus Polatuzumab vedotin plus R-CHP; R-CHP = Rituximab + Cyclophosphamide + Doxorubicin + Prednisone. Doses and schedules not specified in the provided data.
Target Sample Size
354

Eligibility

Recruits 354 No vulnerable population selected (isVulnerablePopulationSelected: false). Informed consent documents (country-specific ICFs) are provided for adult participants (documents listed for Belgium, Germany, Ireland, Italy, Poland). No assent/consent process for minors or other vulnerable groups is indicated in the available data..

Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected: false). Informed consent documents (country-specific ICFs) are provided for adult participants (documents listed for Belgium, Germany, Ireland, Italy, Poland). No assent/consent process for minors or other vulnerable groups is indicated in the available data.

Inclusion criteria

  • {"criterion_text":"- Has histologically confirmed diagnosis of germinal center B-cell (GCB) subtype of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, according to the World Health Organization (WHO) classification of neoplasms of the hematopoietic and lymphoid tissues\n- Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale\n- Has received no prior treatment for their DLBCL\n- Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)\n- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load prior to randomization\n- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening"}

Exclusion criteria

  • {"criterion_text":"- Has a history of transformation of indolent disease to DLBCL\n- Known additional malignancy that is progressing or has required active treatment within the past 2 years\n- Known active central nervous system (CNS) lymphoma\n- Has active autoimmune disease that has required systemic treatment in the past 2 years\n- Has active infection requiring systemic therapy\n- Has active HBV (defined as HBsAg positive and detectable HBV deoxyribonucleic acid (DNA)) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection\n- Has history of stem cell/solid organ transplant\n- Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma\n- Has Ann Arbor Stage I DLBCL\n- Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication\n- Has clinically significant pericardial or pleural effusion\n- Has ongoing Grade >1 peripheral neuropathy\n- Has a demyelinating form of Charcot-Marie-Tooth disease\n- HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease\n- Has ongoing corticosteroid therapy"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Complete Response Rate (CRR) at End of Treatment (EOT) per Lugano Response Criteria","definition_or_measurement_approach":"Per Lugano response criteria as assessed by Blinded Independent Central Review (BICR)."}

Secondary endpoints

  • {"endpoint_text":"- Progression-free Survival (PFS) per Lugano Response Criteria","definition_or_measurement_approach":"Per Lugano response criteria as assessed by BICR."}
  • {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":"All-cause mortality measured from randomization to death."}
  • {"endpoint_text":"- Event-free Survival (EFS) per Lugano Response Criteria","definition_or_measurement_approach":"Per Lugano response criteria as assessed by BICR."}
  • {"endpoint_text":"- Duration of CR","definition_or_measurement_approach":"Time from first documented complete response to relapse/progression or death."}
  • {"endpoint_text":"- Number of Participants Who Experienced At Least One Adverse Event (AE)","definition_or_measurement_approach":"Count and incidence of participants with ≥1 AE (safety monitoring)."}
  • {"endpoint_text":"- Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)","definition_or_measurement_approach":"Count of participants discontinuing treatment because of AEs."}
  • {"endpoint_text":"- Change From Baseline in Health-Related Quality Of Life (HRQoL) on Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Trial Outcome Index (TOI)","definition_or_measurement_approach":"Change from baseline on FACT-Lym TOI questionnaire scores."}
  • {"endpoint_text":"- Change From Baseline in HRQoL on FACT-Lym Total Score","definition_or_measurement_approach":"Change from baseline on FACT-Lym total score."}
  • {"endpoint_text":"- Change From Baseline in HRQoL on FACT-Lym Physical Well-being (PWB), Items General Physical (GP)1 through GP7","definition_or_measurement_approach":"Change from baseline on FACT-Lym PWB subscale (GP1–GP7 items)."}
  • {"endpoint_text":"- Change From Baseline in HRQoL on Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) Neurotoxicity Subscale Score","definition_or_measurement_approach":"Change from baseline on FACT/GOG-NTX neurotoxicity subscale score."}

Recruitment

Planned Sample Size
354
Recruitment Window Months
67
Consent Approach
Written informed consent is required from each participant prior to study procedures. Country-specific subject information and informed consent forms are provided (documents listed for Belgium, Germany, Ireland, Italy, Poland). No assent or minor consent procedures are indicated in the available data.

Geography

Total Number Of Sites
50
Total Number Of Participants
240

Belgium

Earliest CTIS Part Ii Submission Date
09-04-2025
Latest Decision Or Authorization Date
08-05-2025
Processing Time Days
29
Number Of Sites
6
Number Of Participants
38

Sites

Site Name
UZ Leuven
Department Name
Hematology
Contact Person Name
Vibeke Vergote
Contact Person Email
vibeke.vergote@uzleuven.be
Site Name
Emmaues
Department Name
Hematology
Contact Person Name
Toine Mercier
Contact Person Email
toine.mercier@emmaus.be
Site Name
Pole Hospitalier Jolimont
Department Name
Hematology
Contact Person Name
Marie-Christine Ngirabacu
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Hematology
Contact Person Name
Sarah Bailly
Site Name
Algemeen Ziekenhuis Delta
Department Name
Hematology
Contact Person Name
Caressa Meert
Contact Person Email
caressa.meert@azdelta.be
Site Name
Vitaz
Department Name
Hematology
Contact Person Name
Vanessa Van Hende
Contact Person Email
Vanessa.VanHende@vitaz.be

Germany

Earliest CTIS Part Ii Submission Date
24-04-2025
Latest Decision Or Authorization Date
09-05-2025
Processing Time Days
15
Number Of Sites
25
Number Of Participants
116

Sites

Site Name
Helios Universitaetsklinikum Wuppertal
Department Name
Onkologisches Zentrum
Contact Person Name
Silke Schostock
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Medizinische Klinik, Innere Medizin II
Contact Person Name
Stefan Wirths
Site Name
Klinikum Chemnitz gGmbH
Department Name
Klinik für Innere Medizin III
Contact Person Name
Mathias Hänel
Contact Person Email
m.haenel@skc.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Hämatologie und Onkologie
Contact Person Name
Niklas Gebauer
Contact Person Email
Niklas.Gebauer@uksh.de
Site Name
Klinikum Region Hannover GmbH
Department Name
Klinik für Hämatologie, Onkologie und Immunologie
Contact Person Name
Martin Müller
Contact Person Email
martin.mueller@krh.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Medizinische Klinik 5 – Hämatologie und Internistische Onkologie
Contact Person Name
Fabian Müller
Contact Person Email
fabian.mueller@uk-erlangen.de
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Zentrum Innere Medizin (ZIM)
Contact Person Name
Max Topp
Contact Person Email
Topp_M@ukw.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Zentrum für Leukämie, Lymphom, Myelom
Contact Person Name
Andreas Viardot
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Hämatologie und Stammzelltransplantation
Contact Person Name
Bastian von Tresckow
Site Name
University Hospital Cologne AöR
Department Name
Innere Medizin I
Contact Person Name
Peter Borchmann
Contact Person Email
studien-innere1@uk-koeln.de
Site Name
Klinikum Kassel GmbH
Department Name
Klinik für Hämatologie, Onkologie und Immunologie
Contact Person Name
Daniela Dörfel
Contact Person Email
daniela.doerfel@gnh.net
Site Name
Otto Von Guericke Universitaet Magdeburg
Department Name
Universitätsklinik für Hämatologie, Onkologie und Zelltherapie
Contact Person Name
Vanja Zeremski
Contact Person Email
hem-onk@med.ovgu.de
Site Name
Universitaet Muenster
Department Name
Medizinische Klinik A - Onkologie , Hämatologie und Pneumologie
Contact Person Name
EVgenii Shumilov
Contact Person Email
evgenii.shumilov@ukmuenster.de
Site Name
Philipps-Universitaet Marburg
Department Name
Klinik für Innere Medizin, Schwerpunkt Hämatologie, Onkologie und Immunologie
Contact Person Name
Jörg Hoffmann
Site Name
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Department Name
Hämostaseologie und Stammzelltransplantation
Contact Person Name
Kudret Kama
Contact Person Email
k.kama@klinikum-stuttgart.de
Site Name
Vivantes Netzwerk fuer Gesundheit GmbH
Department Name
Klinik für Innere Medizin – Hämatologie und Onkologie und Palliativmedizin
Contact Person Name
Christian Scholz
Contact Person Email
onkostudien.kau@vivantes.de
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Klinik für Hämatologie, Onkologie,
Contact Person Name
Mareike Christina Tometten
Contact Person Email
mtometten@ukaachen.de
Site Name
Heinrich-Braun-Klinikum Zwickau gGmbH
Department Name
Klinik für Innere Medizin III (Hämatologie, Onkologie und Palliativmedizin)
Contact Person Name
Sara Hilber
Contact Person Email
sara.hilber@hbk-zwickau.de
Site Name
Johanniter GmbH
Department Name
Hämatologie, Internistische Onkologie
Contact Person Name
Yon-Dschhun Ko
Site Name
LMU Klinikum Muenchen AöR
Department Name
Medizinische Klinik und Poliklinik III des LMU Klinikums
Contact Person Name
Christian Schmidt
Site Name
Centrum für Hämatologie und Onkologie Bethanien
Department Name
Centrum für Hämatologie und Onkologie Bethanien
Contact Person Name
Christian Schmitt
Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik für Innere Medizin II Abteilung Hämatologie und Internistische Onkologie
Contact Person Name
Ulf Schnetzke
Contact Person Email
Ulf.Schnetzke@med.uni-jena.de
Site Name
Universitaetsmedizin Goettingen
Department Name
Klinik für Hämatologie und Onkologie
Contact Person Name
Gerald Wulf
Site Name
Diakonie Klinikum Dietrich Bonhoeffer GmbH
Department Name
Klinik für Innere Medizin 5 (Hämatologie, Onkologie, Immunologie)
Contact Person Name
Philipp Hemmati
Contact Person Email
OZ-Stb@dbknb.de
Site Name
Gemeinschaftsklinikum Mittelrhein gGmbH
Department Name
Innere Medizin - Hämatologie/Onkologie, Palliativmedizin
Contact Person Name
Jens Chemnitz
Contact Person Email
Jens-Marcus.Chemnitz@gk.de

Ireland

Earliest CTIS Part Ii Submission Date
23-04-2025
Latest Decision Or Authorization Date
09-05-2025
Processing Time Days
16
Number Of Sites
3
Number Of Participants
17

Sites

Site Name
Mater Misericordiae University Hospital
Department Name
Haematology
Contact Person Name
Anne Fortune
Contact Person Email
lscahill@mater.ie
Site Name
St Vincent's University Hospital
Department Name
Haematology
Contact Person Name
Liam Smyth
Contact Person Email
liamsmyth@svhg.ie
Site Name
University Hospital Limerick
Department Name
Haematology
Contact Person Name
Ruth Clifford
Contact Person Email
Ruth.clifford1@hse.ie

Italy

Earliest CTIS Part Ii Submission Date
27-03-2025
Latest Decision Or Authorization Date
09-05-2025
Processing Time Days
43
Number Of Sites
8
Number Of Participants
36

Sites

Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
SC Ematologia, Dipartimento Oncologico e Tecnologie Avanzate
Contact Person Name
Stefano Luminari
Contact Person Email
stefano.luminari@ausl.re.it
Site Name
Universita' Degli Studi Di Napoli Federico II
Department Name
U.O.C. Ematologia e Trapianti di Midollo
Contact Person Name
Fabrizio Pane
Contact Person Email
fabrizio.pane@unina.it
Site Name
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Department Name
U.O.C. di Oncoematologia
Contact Person Name
Caterina Patti
Contact Person Email
k.patti@villasofia.it
Site Name
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
Department Name
SCDU Ematologia
Contact Person Name
Marco Ladetto
Contact Person Email
marco.ladetto@ospedale.al.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Ematologia
Contact Person Name
Armando Santoro
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Divisione di Oncoematologia
Contact Person Name
Enrico Derenzini
Contact Person Email
enrico.derenzini@ieo.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
S.C. Oncologia Medica
Contact Person Name
Gerardo Musuraca
Contact Person Email
gerardo.musuraca@irst.emr.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l. (duplicate entry under sites)
Department Name
S.C. Oncologia Medica
Contact Person Name
Gerardo Musuraca
Contact Person Email
gerardo.musuraca@irst.emr.it

Poland

Earliest CTIS Part Ii Submission Date
24-04-2025
Latest Decision Or Authorization Date
13-05-2025
Processing Time Days
19
Number Of Sites
8
Number Of Participants
33

Sites

Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Hematologii i Transplantologii
Contact Person Name
Agata Szymanska
Contact Person Email
klhem@gumed.edu.pl
Site Name
Pratia S.A.
Department Name
Pratia MCM Kraków
Contact Person Name
Wojciech Jurczak
Contact Person Email
biuro.mcm@pratia.com
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworów Układu Chłonnego
Contact Person Name
Ewa Paszkiewicz-Kozik
Site Name
Szpital Specjalistyczny Im. Jedrzeja Sniadeckiego W Nowym Saczu SPZOZ
Department Name
Oddział Hematologiczny
Contact Person Name
Szymon Fornagiel
Contact Person Email
ho@szpitalnowysacz.pl
Site Name
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Department Name
Klinika Hematologii i Transplantacji Szpiku
Contact Person Name
Pawel Steckiewcz
Site Name
Pratia Hematologia Sp. z o.o.
Department Name
Pratia Onkologia Katowice
Contact Person Name
Sebastian Grosicki
Site Name
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego
Department Name
Oddzial Hematologii
Contact Person Name
Aleksandra Butrym
Contact Person Email
onkocwbk@zdrowie.walbrzych.pl
Site Name
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego (duplicate site listing)
Department Name
Oddzial Hematologii
Contact Person Name
Aleksandra Butrym
Contact Person Email
onkocwbk@zdrowie.walbrzych.pl

Sponsor

Primary sponsor

Full Name
Merck Sharp & Dohme LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
PPD Global Central Labs
Responsibilities
Laboratory services (sponsorDuties code: 4)
Name
Almac Clinical Technologies LLC
Responsibilities
Clinical supply/technology services (sponsorDuties code: 3)
Name
Almac Clinical Services LLC
Responsibilities
Clinical services (sponsorDuties code: 4)
Name
PPD Laboratories
Responsibilities
Laboratory services (sponsorDuties code: 4)
Name
Bioclinica Inc.
Responsibilities
Imaging – collection and reconciliation of scans
Name
Parexel International Corp.
Responsibilities
Medical information and EUB Call center
Name
Signant Health Global LLC
Responsibilities
Electronic Patient Reported Outcomes (ePRO)
Name
Infinity Biologix LLC
Responsibilities
Laboratory/biological sample services (sponsorDuties code: 4)

Third parties

  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"sponsorDuties codes: [\"3\"]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Infinity Biologix LLC","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"Electronic Patient Reported Outcomes (ePRO) (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Laboratories","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Imaging – collection and reconciliation of scans (sponsorDuties code: 15)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"Medical information (Physician Consulting) and EUB Call center (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Zilovertamab vedotin
Active Substance
ZILOVERTAMAB VEDOTIN
Modality
ADC
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
Investigational (clinical trial product)
Investigational Product Name
Polatuzumab vedotin
Active Substance
POLATUZUMAB VEDOTIN
Modality
ADC
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Investigational Product Name
Rituximab
Active Substance
RITUXIMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Investigational Product Name
Cyclophosphamide
Active Substance
CYCLOPHOSPHAMIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Investigational Product Name
Doxorubicin (hydrochloride)
Active Substance
DOXORUBICIN HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Investigational Product Name
Prednisone (prednisolone listed)
Active Substance
PREDNISOLONE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Investigational Product Name
Colony stimulating factors (auxiliary)
Active Substance
-
Modality
Peptide/protein/enzyme
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Combination Treatment
Yes

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