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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)

NCT05406401 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-10-15

No results posted yet for this study

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.

Conditions

  • Lymphoma, Large B-Cell, Diffuse (DLBCL)

Interventions

BIOLOGICAL

Zilovertamab Vedotin

IV infusion

DRUG

Cyclophosphamide

IV infusion

DRUG

Doxorubicin

IV infusion

BIOLOGICAL

Rituximab

IV infusion

BIOLOGICAL

Rituximab Biosimilar

IV infusion

DRUG

Prednisone

IV or oral administration (per local guidelines)

DRUG

Prednisolone

IV or oral administration (per local guidelines)

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-14
Primary Completion
2029-04-26
Completion
2029-04-26
FDA Drug
Yes

Countries

  • Canada
  • Israel
  • Italy
  • Poland
  • South Korea
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05406401 on ClinicalTrials.gov