A Clinical Study of Zilovertamab Vedotin (MK-2140) Plus R... | NCT06890884

NCT06890884

ID	Type	Description
2024-515526-89-00	Registry Identifier	EU CT
U1111-1309-2852	Registry Identifier	UTN
MK-2140-011	Other Identifier	MSD
waveLINE-011	Other Identifier	MSD
jRCT2021250001	Registry Identifier	Japan Registry of Clinical Trials (jRCT)

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Zilovertamab vedotin + Rituximab + Cyclophosphamide, Doxorubicin, Prednisone (R-CHP)	Experimental	Participants will receive a dose of zilovertamab vedotin (1.75 mg/kg) plus 750 mg/m^2 cyclophosphamide, 50 mg/m^2 doxorubicin, and 375 mg/m^2 rituximab or rituximab biosimilar administered by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 6 cycles (up to approximately 4 months) plus 2 additional cycles of rituximab or biosimilar for participants with high risk DLBCL. Participants will also receive 100 mg prednisone or prednisolone via oral tablet per day during Days 1-5 of each 3-week cycle for up to 6 cycles (up to approximately 4 months).	Biological: Zilovertamab vedotin Biological: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Biological: Rituximab Biosimilar Drug: Prednisone Drug: Prednisolone Drug: Rescue Medication
Polatuzumab vedotin + R-CHP	Active Comparator	Participants will receive a dose of polatuzumab vedotin (1.8 mg/kg) plus 750 mg/m^2 cyclophosphamide, 50 mg/m^2 doxorubicin, and 375 mg/m^2 rituximab or rituximab biosimilar administered by IV infusion on Day 1 of each 3-week cycle for up to 6 cycles (up to approximately 4 months) plus 2 additional cycles of rituximab or biosimilar for participants with high risk DLBCL. Participants will also receive 100 mg prednisone or prednisolone via oral tablet per day during Days 1-5 of each 3-week cycle for up to 6 cycles (up to approximately 4 months).	Biological: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Biological: Rituximab Biosimilar Drug: Prednisone Drug: Prednisolone Biological: Polatuzumab vedotin Drug: Rescue Medication

Name	Type	Description	Arm Group Labels	Other Names
Zilovertamab vedotin	Biological	IV infusion	Zilovertamab vedotin + Rituximab + Cyclophosphamide, Doxorubicin, Prednisone (R-CHP)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complete Response Rate (CRR) at End of Treatment (EOT) per Lugano Response Criteria	CRR at EOT is defined as the percentage of participants who experience complete response (CR) per Lugano response criteria as assessed by blinded independent central review (BICR) at end of treatment. CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. Participants with missing data or who discontinue treatment or study prior to reaching EOT will be considered non-responders and included in the total number of participants.	Up to approximately 31 months

Secondary Outcomes

Measure	Description	Time Frame
Progression-free Survival (PFS) per Lugano Response Criteria	PFS is defined as the time from randomization to the first documented disease progression per Lugano response criteria by BICR or death due to any cause, whichever occurs first.	Up to approximately 51 months
Overall Survival (OS)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

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.
Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale.
Has received no prior treatment for their DLBCL.
Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART).
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.
Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

Has a history of transformation of indolent disease to DLBCL.
Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma.
Has Ann Arbor Stage I DLBCL.
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.
Has clinically significant pericardial or pleural effusion.
Has ongoing Grade >1 peripheral neuropathy.
Has a demyelinating form of Charcot-Marie-Tooth disease.
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
Has ongoing corticosteroid therapy.
Known additional malignancy that is progressing or has required active treatment within the past 2 years.
Known active central nervous system (CNS) lymphoma.
Has active autoimmune disease that has required systemic treatment in the past 2 years.
Has active infection requiring systemic therapy.
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.
Has history of stem cell/solid organ transplant.

Name	Role	Phone	Extension	Email
Toll Free Number	Contact	1-888-577-8839		Trialsites@msd.com

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Infirmary Cancer Care ( Site 0157)	Recruiting	Mobile	Alabama	36607	United States

Label	URL
Merck Clinical Trials Information	View source
Plain Language Summary	View source

Ancestor Terms

ID	Term
D058846	Antibodies, Monoclonal, Murine-Derived
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D009930	Organic Chemicals
D063088	Phosphoramides
D009943	Organophosphorus Compounds
D003630	Daunorubicin
D018943	Anthracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D011083	Polycyclic Compounds
D000617	Aminoglycosides
D006027	Glycosides
D002241	Carbohydrates
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011246	Pregnadienetriols

ID	Term
D016393	Lymphoma, B-Cell
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

ID	Term
D000069283	Rituximab
D003520	Cyclophosphamide
D004317	Doxorubicin
D011241	Prednisone
D011239	Prednisolone
C000600736	polatuzumab vedotin