NCT05406401|Active Not RecruitingPhase 2FDA Drug

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Cyclophosphamide, Doxorubicin, and Prednisone Plus Rituximab or Rituximab Biosimilar (Truxima) (R-CHP) in Participants With Diffuse Large B-Cell Lymphoma (DLBCL) (MK-2140-007)

waveLINE-007

A Multicenter, Open-label, Phase 2 Dose Escalation and Confirmation, and Efficacy Expansion Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP in Participants With DLBCL (waveLINE)

Merck Sharp & Dohme LLC ClinicalTrials.gov

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5 other identifiers

2140-007MK-2140-0072022-501380-40U1111-1280-23482021-005861-41

Study Type

interventional

Target

Locations

7 countries

Sites

Timeline

RegisteredJun 2022

StartedJul 2022

CompletionApr 2029

Brief Summary

This study consists of a dose escalation/confirmation phase and an efficacy expansion phase. The dose escalation/confirmation phase is to determine the safety and tolerability and establish a preliminary recommended Phase 2 dose (RP2D) of zilovertamab vedotin when administered in combination with R-CHP in participants with DLBCL who have received no prior treatment for their disease. The efficacy expansion phase is to determine the efficacy of the RP2D of zilovertamab vedotin when administered in combination with R-CHP in participants with DLBCL who have received no prior treatment for their disease.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

37mo left

Started Jul 2022

Longer than P75 for phase_2

Geographic Reach

7 countries

22 active sites

Status

active not 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

6.8 years study duration

Study Progress56%

Jul 2022Apr 2029

First Submitted

Initial submission to the registry

June 1, 2022

Completed

5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2022

Completed

1 month until next milestone

Study Start

First participant enrolled

July 14, 2022

Completed

6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2029

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2029

Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

6.8 years

First QC Date

June 1, 2022

Last Update Submit

October 10, 2024

Conditions

Lymphoma, Large B-Cell, Diffuse (DLBCL)

Outcome Measures

Primary Outcomes (4)

Number of Participants Who Experienced Dose-limiting Toxicities (DLTs) in Cycle 1
DLTs will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 and are defined as any drug-related adverse event (AE) observed during the DLT evaluation period (e.g. Cycle 1) that results in a change to a given dose or a delay in initiating the next cycle. The number of participants with DLTs in Cycle 1 will be reported.
Cycle 1 (up to 21 days)
Number of Participants Who Experienced At Least One AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE will be reported.
Up to approximately 8 months
Number of Participants Who Discontinued Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 5.5 months
Complete Response Rate (CRR) per Lugano Response Criteria
CRR is defined as the percentage of participants who achieve a Complete Response (CR) per Lugano response criteria \[Cheson, B. D., et al 2014\] for malignant lymphoma as assessed by the investigator. Assessment includes anatomic imaging with computed tomography (CT) or magnetic resonance imaging (MRI), metabolic imaging with positron emission tomography (PET), and clinical findings including physical examination and bone marrow biopsy results. The percentage of participants with CRR will be reported.
Up to approximately 60 months

Secondary Outcomes (2)

Objective Response Rate (ORR) per Lugano Response Criteria
Up to approximately 60 months
Duration of Response (DOR) per Lugano Response Criteria
Up to approximately 60 months

Study Arms (2)

Zilovertamab Vedotin + R-CHP: Dose Escalation/Confirmation

EXPERIMENTAL

Participants in the dose escalation/confirmation phase receive a dose level of zilovertamab vedotin (from 1.5 mg/Kg up to 2.5 mg/Kg) plus 750 mg/m\^2 cyclophosphamide, 50 mg/m\^2 doxorubicin, and 375 mg/m\^2 rituximab or rituximab biosimilar (truxima) administered by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 8 cycles (up to approximately 5.5 months). Participants also receive 100 mg prednisone or prednisolone per day during Days 1-5 of each 21-day cycle for up to 8 cycles (up to approximately 5.5 months).

Biological: Zilovertamab VedotinDrug: CyclophosphamideDrug: DoxorubicinBiological: RituximabBiological: Rituximab BiosimilarDrug: PrednisoneDrug: Prednisolone

Zilovertamab Vedotin + R-CHP: Efficacy Expansion

EXPERIMENTAL

Participants in the efficacy expansion phase receive the RP2D of zilovertamab vedotin plus 750 mg/m\^2 cyclophosphamide, 50 mg/m\^2 doxorubicin, and 375 mg/m\^2 rituximab or rituximab biosimilar (truxima) administered by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 8 cycles (up to approximately 5.5 months). Participants also receive 100 mg prednisone or prednisolone per day during Days 1-5 of each 21-day cycle for up to 8 cycles (up to approximately 5.5 months).

Biological: Zilovertamab VedotinDrug: CyclophosphamideDrug: DoxorubicinBiological: RituximabBiological: Rituximab BiosimilarDrug: PrednisoneDrug: Prednisolone