Treatment for relapsed or refractory diffuse large B-cell lymphoma using zilovertamab vedotin

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of zilovertamab vedotin (ZV) in combination with standard care treatments for patients with relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL). The study is divided into two parts: a dose confirmation phase and an efficacy expansion phase. Participants will receive either ZV with rituximab, gemcitabine, and oxaliplatin or ZV with bendamustine and rituximab, with the aim of improving progression-free survival compared to standard treatments. The trial will enroll adults aged 18 and older who meet specific eligibility criteria.

Why it matters

Who can join: the full rules

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.

Exclusion Criteria:

* Not applicable with protocol amendment 4: Has history of transformation of indolent disease to DLBCL
* Has received solid organ transplant at any time.
* Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL).
* Has clinically significant (ie, active) cardiovascular disease or serious cardiac arrhythmia requiring medication.
* Has ongoing graft-versus-host disease (GVHD) of any grade, or is receiving treatment for their GVHD.
* Has clinically significant pericardial or pleural effusion.
* Has ongoing Grade \>1 peripheral neuropathy.
* 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 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.
* 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.

Where it's running

• Palo Verde Hematology/ Oncology Center, Ltd. ( Site 0175)
  Glendale, Arizona, United States Recruiting
• Bass Medical Group ( Site 0166)
  Walnut Creek, California, United States Recruiting
• Boca Raton Regional Hospital- Lynn Cancer Institute ( Site 0163)
  Boca Raton, Florida, United States Recruiting
• Clermont Oncology Center ( Site 0174)
  Clermont, Florida, United States Recruiting
• BRP-Hialeah Hospital ( Site 0182)
  Hialeah, Florida, United States Recruiting
• Illinois Cancer Specialists ( Site 8000)
  Niles, Illinois, United States Recruiting

+85 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Predicting response to first-line DLBCL treatment using ctDNA and PET/CT

  This project will test whether combining a blood ctDNA test with PET/CT scans after two treatment cycles can predict treatment response in people newly diagnosed with DLBCL who are starting standard first-line therapy.

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• Treatment for elderly patients with DLBCL who can't tolerate chemotherapy

  This study is testing a new combination treatment for older patients with diffuse large B-cell lymphoma who can't handle traditional chemotherapy to see if it can help them.

  Recruiting Phase 2 First Affiliated Hospital of Ningbo University · Ningbo, Zhejiang · NCT06758037

• Evaluating a new treatment combination for untreated diffuse large B-cell lymphoma

  This study is testing a new treatment that combines zilovertamab vedotin with standard chemotherapy to see if it helps people with untreated diffuse large B-cell lymphoma live longer without their cancer getting worse.

  Recruiting at 264 sites Phase 3 Merck Sharp & Dohme LLC · Mobile, Alabama and 287 other locations · NCT06717347

• Treatment for relapsed or refractory B-cell lymphoma using SynKIR-310

  This study is testing a new treatment called SynKIR-310 to see if it can help adults with relapsed or refractory B-cell lymphoma feel better.

  Recruiting at 5 sites Phase 1 Verismo Therapeutics · Denver, Colorado and 4 other locations · NCT06544265

• Zilovertamab Vedotin for Pediatric and Young Adult Cancer Patients

  This study is testing a new drug called zilovertamab vedotin to see if it can help kids and young adults with certain types of cancer that haven't responded to other treatments.

  Recruiting at 70 sites Phase 1/2 Merck Sharp & Dohme LLC · Los Angeles, California and 70 other locations · NCT06395103

• Comparing two treatments for elderly patients with diffuse large B-cell lymphoma

  This study is testing whether a new treatment for elderly patients with diffuse large B-cell lymphoma works better than the standard treatment.

  Recruiting at 52 sites Phase 3 Nordic Lymphoma Group · Albury and 68 other locations · NCT04332822

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.