About this trial
The purpose of this Phase 2/3, randomized, multisite, open-label, dose confirmation, and expansion study is to evaluate the safety, and efficacy of zilovertamab vedotin (ZV) in combination with standard of care options for the treatment of rrDLBCL.
This study will be divided into 2 parts: Dose Confirmation (Part 1) and Efficacy Expansion (Part 2) and will enroll participants who are at least 18 years of age with rrDLBCL. The hypotheses are: ZV in combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx) is superior to R-GemOx with respect to progression-free survival (PFS) per Lugano response criteria by blinded independent review committee (BICR); and that ZV in combination with bendamustine rituximab (BR) is superior to BR with respect to PFS per Lugano response criteria by BICR.
In Part 1, Dose Confirmation will be determined by modified toxicity probability interval (mTPI) design, where participants will be assigned to two treatment groups, cohort: A (zilovertamab vedotin in combinatio with R-GemOx) in parallel with cohort B (zilovertamab vedotin in combination with BR). Part 2 will be an Efficacy Expansion (cohorts A & B) where all participants in each cohort will be assigned to 2 treatment groups for the duration of the study.
With protocol amendment 4 (effective: 04-April-2024), enrollment in Cohort B (study arms Bendamustine Rituximab [BR] and ZV + BR) is discontinued. No efficacy outcome analysis and hypothesis testing will be conducted for Cohort B.
Patient Profile
Inclusion Criteria:
- Has a histologically confirmed diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL).
- Has radiographically measurable DLBCL per the Lugano response criteria, as assessed locally by the investigator.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days prior to study treatment initiation.
- Has adequate organ function.
- Is able to provide new or archival tumor tissue sample not previously irradiated.
Zilovertamab vedotin plus R-GemOx, or R-GemOx study arms:
- Has relapsed or refractory DLBCL and is ineligible for or have failed autologous stem-cell transplant (ASCT) and have failed at least 1 line of prior therapy.
- Has post-chimeric antigen receptor T (post-CAR-T) cell therapy failure or is ineligible for CAR-T cell therapy.
Not applicable with protocol amendment 4: Zilovertamab vedotin plus Bendamustine Rituximab (BR), and Bendamustine Rituximab study arms:
- Has relapsed or refractory DLBCL and is ineligible for or have failed ASCT and have failed at least 2 lines of prior therapy.
- Has post-CAR-T therapy failure or is ineligible for CAR-T cell therapy.
Where’s this trial being run?
St James’s Hospital
Can I join this study / trial?
The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.
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QuestionsSummary Data
| Name: | MK-2140-003 |
|---|---|
| Number: | MK2140-003 |
| Full Title: | A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003) |
| Principal Investigator: | Dr Carmel Waldron |
|---|---|
| Type: | Industry Sponsored |
| Sponsor: | MSD |
| Recruitment Started: |
Global: 14-Jan-2022 Ireland: |
| Global Recruitment Target: | 275 |
|---|---|
| Ireland Recruitment Target: | 3 |