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Taking people in TürkiyePhase 2/3

Tests zilovertamab vedotin with standard treatment in relapsed large B-cell lymphoma

Tests zilovertamab vedotin with standard medicines in adults with returning large B-cell lymphoma.

Key facts

Who runs it
Merck Sharp & Dohme LLC
Where
Ankara, Bornova, Istanbul, Izmir, Samsun, and Yenimahalle, TürkiyeSee the 6 sitesAlso in 25 other countries, 124 sites
Trial code
Registry 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)
Status
Recruiting
Phase
Phase 2/3
People taking part
290 people, planned
Started
14 Jan 2022
Expected to end
24 Sept 2027
Type of study
Interventional, 6 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Zilovertamab vedotin
  • Rituximab
  • Gemcitabine
  • Oxaliplatin
  • Bendamustine
  • Granulocyte Colony-Stimulating Factor (G-CSF)
Record updated
3 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with diffuse large B-cell lymphoma (DLBCL) that came back or did not respond to earlier treatment. It tests zilovertamab vedotin added to standard treatment.

Age
18 years or older.
Sex
All sexes can join.
Disease stage
DLBCL confirmed by tissue tests and measurable on scans. It must have come back or not responded. People must have failed or be unable to have autologous stem-cell transplant, and have failed at least 1 earlier line of therapy. They must have failed CAR-T cell therapy or be unable to have it. ECOG performance status 0 to 2.
Earlier treatment
At least 1 earlier line of therapy that failed. Not ineligible if earlier stem-cell transplant or CAR-T therapy failed. No other cancer treatment or study drug in the 4 weeks before the first dose.
Biomarker or test result
A tumor tissue sample not previously irradiated (new or archived) must be available.

Main reasons for not taking part

  • Solid organ transplant at any time
  • Primary mediastinal B-cell lymphoma
  • Known HIV infection or active hepatitis C
  • Active lymphoma in the brain or spinal cord area (CNS)
  • Active infection needing systemic treatment

The registry criteria, word for word

Show all 29 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Has received solid organ transplant at any time
  • Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL)
  • Has ongoing graft-versus-host disease (GVHD) of any grade, or is receiving treatment for their GVHD
  • Has contraindication to any of the study intervention components including but not limited to prior anaphylactic reaction
  • Has received prior systemic anticancer therapy, including investigational agents within 4 weeks prior to the first dose of study intervention
  • Has received prior radiotherapy within 4 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis
  • Has ongoing corticosteroid therapy
  • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
  • Has known active central nervous system (CNS) lymphoma involvement or active CNS involvement by lymphoma. Participants with prior CNS involvement are eligible if their CNS disease is in radiographic, cytological (for cerebrospinal fluid disease), and clinical remission
  • Not applicable with protocol amendment 4: Has history of transformation of indolent disease to DLBCL
  • Has clinically significant (ie, active) cardiovascular disease or serious cardiac arrhythmia requiring medication
  • Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
  • Has a demyelinating form of Charcot-Marie-Tooth disease
  • Has an active infection requiring systemic therapy
  • Has a known history of human immunodeficiency virus (HIV) infection
  • Has a known active Hepatitis C virus infection
  • Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
  • Has clinically significant pericardial or pleural effusion
  • Has ongoing Grade >1 peripheral neuropathy

Where in Türkiye

Also in 25 other countries, 124 sites

  • Ankara University Hospital Cebeci-hematology (Site 1901)Ankara, TürkiyeContact: Study CoordinatorTaking people
  • Ege University Medicine of Faculty (Site 1902)Bornova, TürkiyeContact: Study CoordinatorTaking people
  • Mega Medipol-Hematology (Site 1909)Istanbul, TürkiyeContact: Study CoordinatorTaking people
  • Dokuz Eylül Üniversitesi-Hematology (Site 1905)Izmir, TürkiyeContact: Study CoordinatorTaking people
  • Ondokuz Mayıs Universitesi (Site 1907)Samsun, TürkiyeContact: Toll Free NumberNo longer taking part
  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi (Site 1912)Yenimahalle, TürkiyeContact: Study CoordinatorTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 6 groups in the trial

  • ZV + R-GemOx (Part 1)Treatment being tested

    Participants in this arm will receive doses of ZV (from 1.5 mg/Kg up to 2.5 mg/Kg) plus Rituximab 375 mg/m\^2, Gemcitabine 1000 mg/m\^2 and Oxaliplatin 100 mg/m\^2 (R-GemOx) given intravenously on Day 1 of repeated 21-day cycles. Treatment will continue for up to 6 cycles.

    Treatment: Zilovertamab vedotin, Rituximab, Gemcitabine, Oxaliplatin, and Granulocyte Colony-Stimulating Factor (G-CSF)

  • ZV + R-GemOx (Part 2)Treatment being tested

    Using the recommended Phase 2 dose (RP2D) dose of ZV plus R-GemOx from Part 1, participants will receive ZV plus R-GemOx given intravenously on Day 1 of repeated 21-day cycles. Treatment will continue for up to 6 cycles or until progressive disease or discontinuation.

    Treatment: Zilovertamab vedotin, Rituximab, Gemcitabine, Oxaliplatin, and Granulocyte Colony-Stimulating Factor (G-CSF)

  • R-GemOx (active control for Part 2)Existing treatment, for comparison

    Participants will receive R-GemOx given intravenously on Day 1 of repeated 21-day cycles. Treatment will continue for up to 6 cycles or until progressive disease or discontinuation.

    Treatment: Rituximab, Gemcitabine, and Oxaliplatin

  • ZV + BR (Part 2)Treatment being tested

    Using RP2D from Part 1, participants will receive ZV plus Rituximab 375 mg/m\^2, given intravenously on Day 1 and Bendamustine 90 mg/m\^2 given intravenously on Day 1 and 2, of repeated 21-day cycles. Treatment will continue for up to 6 cycles or until progressive disease or discontinuation.

    Treatment: Zilovertamab vedotin, Rituximab, Bendamustine, and Granulocyte Colony-Stimulating Factor (G-CSF)

  • Bendamustine Rituximab (BR)Existing treatment, for comparison

    Participants will receive Rituximab 375 mg/m\^2, given intravenously on Day 1 Bendamustine 90 mg/m\^2 given intravenously on Day 1 and 2 of repeated 21-day cycles. Treatment will continue for up to 6 cycles or until progressive disease or discontinuation.

    Treatment: Rituximab and Bendamustine

  • ZV + BR (Part 1)Treatment being tested

    Participants in this arm will receive doses of ZV (from 1.5 mg/Kg up to 2.5 mg/Kg) plus Rituximab 375 mg/m\^2, Bendamustine 90 mg/m\^2 (BR) given intravenously on Day 1 and 2 of repeated 21-day cycles. Treatment will continue for up to 6 cycles.

    Treatment: Zilovertamab vedotin, Rituximab, Bendamustine, and Granulocyte Colony-Stimulating Factor (G-CSF)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 2/3 Multicenter, Open-label, Randomized, Active-Control Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (waveLINE-003)
Plain-language title
Tests zilovertamab vedotin with standard treatment in relapsed large B-cell lymphomaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
3 November 2026