Recruiting NCT06890884

A Clinical Study of Zilovertamab Vedotin (MK-2140) Plus Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Polatuzumab Vedotin Plus R-CHP in People With Diffuse Large B-cell Lymphoma (DLBCL) (MK-2140-011/waveLINE-011)

Phase II Interventional Lymphoma, Large B-Cell, Diffuse

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Zilovertamab vedotin, Rituximab, Cyclophosphamide, Doxorubicin.
Who it may be relevant to: Registry conditions: Lymphoma, Large B-Cell, Diffuse. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Belgium, Germany, Ireland, Israel +4
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Zilovertamab Vedotin (MK-2140) Plus R-CHP Versus Polatuzumab Vedotin Plus R-CHP in Treatment-naïve Participants With GCB Subtype of Diffuse Large B-cell Lymphoma (DLBCL)

Overview

Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing. The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP.

Interventions

Biological Zilovertamab vedotin
IV infusion
Biological Rituximab
IV infusion
Drug Cyclophosphamide
IV infusion
Drug Doxorubicin
IV infusion
Biological Rituximab Biosimilar
IV infusion
Drug Prednisone
Oral administration or IV infusion
Drug Prednisolone
Oral administration or IV infusion
Biological Polatuzumab vedotin
IV infusion
Drug Rescue Medication
Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medication is Granulocyte Colony-Stimulating Factor (G-CSF).

Primary outcome measures

Complete Response Rate (CRR) at End of Treatment (EOT) per Lugano Response Criteria [Time frame: Up to approximately 31 months]

Secondary outcome measures (10)

Progression-free Survival (PFS) per Lugano Response Criteria [Time frame: Up to approximately 51 months]
Overall Survival (OS) [Time frame: Up to approximately 87 months]
Event-free Survival (EFS) per Lugano Response Criteria [Time frame: Up to approximately 51 months]
Duration of CR [Time frame: Up to approximately 51 months]
Number of participants who experience one or more adverse events (AEs) [Time frame: Up to approximately 9 months]
Number of participants who discontinue study intervention due to an AE [Time frame: Up to approximately 6 months]
Change From Baseline in Health-Related Quality Of Life (HRQoL) on Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Trial Outcome Index (TOI) [Time frame: Baseline and up to Week 25]
Change From Baseline in HRQoL on FACT-Lym Total Score [Time frame: Baseline and up to Week 25]
Change From Baseline in HRQoL on FACT-Lym Physical Well-being (PWB) (Items General Physical [GP]1 through GP7) [Time frame: Baseline and up to Week 25]
Change From Baseline in HRQoL on Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) Neurotoxicity Subscale Score [Time frame: Baseline and up to Week 25]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment

Study locations

United States · 73 centers

Infirmary Cancer Care ( Site 0157) — Mobile
Ironwood Cancer & Research Centers ( Site 0204) — Chandler
Palo Verde Cancer Specialists ( Site 0105) — Glendale
City of Hope - Phoenix ( Site 0202) — Goodyear
Genesis Cancer and Blood Institute ( Site 0193) — Hot Springs
Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Si — Burbank
City of Hope Comprehensive Cancer Center ( Site 0191) — Duarte
Bass Medical Group ( Site 0123) — Walnut Creek
… and 65 more centers

Germany · 16 centers

Klinikum Stuttgart. Klinik fur Hamatologie. Onkologie. Palliativmedizin und Stammzelltrans — Stuttgart
… and 15 more centers

United Kingdom · 12 centers