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-naive Participants with GCB Subtype of Diffuse Large B Cell Lymphoma (DLBCL).

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515526-89-00

Acronym

MK-2140-011

Enrollment

240

Registered

2025-05-08

Start date

2025-05-16

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Large B-Cell Lymphoma (DLBCL)

Brief summary

Complete Response Rate (CRR) at End of Treatment (EOT) per Lugano Response Criteria

Detailed description

Progression-free Survival (PFS) per Lugano Response Criteria, Overall Survival (OS), Event-free Survival (EFS) per Lugano Response Criteria, Duration of CR, Number of Participants Who Experienced At Least One Adverse Event (AE), Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE), Change From Baseline in Health-Related Quality Of Life (HRQoL) on Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Trial Outcome Index (TOI), Change From Baseline in HRQoL on FACT-Lym Total Score, Change From Baseline in HRQoL on FACT-Lym Physical Well-being (PWB), Items General Physical (GP)1 through GP7, Change From Baseline in HRQoL on Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) Neurotoxicity Subscale Score

Interventions

DRUGCYCLOPHOSPHAMIDE

DRUGPREDNISONE

DRUG-

DRUGZilovertamab vedotin

DRUGDOXORUBICIN

DRUGPOLATUZUMAB VEDOTIN

DRUGRITUXIMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Complete Response Rate (CRR) at End of Treatment (EOT) per Lugano Response Criteria	—

Secondary

Measure	Time frame
Progression-free Survival (PFS) per Lugano Response Criteria, Overall Survival (OS), Event-free Survival (EFS) per Lugano Response Criteria, Duration of CR, Number of Participants Who Experienced At Least One Adverse Event (AE), Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE), Change From Baseline in Health-Related Quality Of Life (HRQoL) on Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Trial Outcome Index (TOI), Change From Baseline in HRQoL on FACT-Lym Total Score, Change From Baseline in HRQoL on FACT-Lym Physical Well-being (PWB), Items General Physical (GP)1 through GP7, Change From Baseline in HRQoL on Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) Neurotoxicity Subscale Score	—

Measure

Time frame

—

Countries

Belgium, Germany, Ireland, Italy, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026