NCT06890884|RecruitingPhase 2DMCFDA Drug

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)

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)

Merck Sharp & Dohme LLC ClinicalTrials.gov

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6 other identifiers

2140-0112024-515526-89-00U1111-1309-2852MK-2140-011waveLINE-011jRCT2021250001

Study Type

interventional

Target

594

Locations

9 countries

Sites

121

Timeline

RegisteredMar 2025

StartedApr 2025

CompletionDec 2032

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

594

participants targeted

Target at P75+ for phase_2

Timeline

81mo left

Started Apr 2025

Longer than P75 for phase_2

Geographic Reach

9 countries

121 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.7 years study duration

Study Progress14%

Apr 2025Dec 2032

First Submitted

Initial submission to the registry

March 20, 2025

Completed

4 days until next milestone

First Posted

Study publicly available on registry

March 24, 2025

Completed

18 days until next milestone

Study Start

First participant enrolled

April 11, 2025

Completed

2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2027

Expected

5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2032

Last Updated

May 5, 2026

Status Verified

May 1, 2026

Enrollment Period

2.7 years

First QC Date

March 20, 2025

Last Update Submit

May 1, 2026

Conditions

Lymphoma, Large B-Cell, Diffuse

Outcome Measures

Primary Outcomes (1)

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 (10)

Progression-free Survival (PFS) per Lugano Response Criteria
Up to approximately 51 months
Overall Survival (OS)
Up to approximately 87 months
Event-free Survival (EFS) per Lugano Response Criteria
Up to approximately 51 months
Duration of CR
Up to approximately 51 months
Number of participants who experience one or more adverse events (AEs)
Up to approximately 9 months
+5 more secondary outcomes

Study Arms (2)

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 vedotinBiological: RituximabDrug: CyclophosphamideDrug: DoxorubicinBiological: Rituximab BiosimilarDrug: PrednisoneDrug: PrednisoloneDrug: 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: RituximabDrug: CyclophosphamideDrug: DoxorubicinBiological: Rituximab BiosimilarDrug: PrednisoneDrug: PrednisoloneBiological: Polatuzumab vedotinDrug: Rescue Medication

Interventions

Zilovertamab vedotinBIOLOGICAL

IV infusion

Also known as: MK-2140, VLS-101

Zilovertamab vedotin + Rituximab + Cyclophosphamide, Doxorubicin, Prednisone (R-CHP)

RituximabBIOLOGICAL

IV infusion

Also known as: RITUXAN®