Comparing 6 approaches for DLBCL
Official 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)
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)
- Phase 2
- 6 groups
- One site, in Toronto
- Recruiting
Interventions (6)
- Biological therapy
Zilovertamab vedotin
Intravenous (IV) Infusion 1.5 mg/kg, 1.75 mg/kg, 2.0 mg/kg, 2.25 mg/kg, 2.5 mg/kg
- Biological therapy
Rituximab
IV Infusion 375 mg/m\^2
- Medication
Gemcitabine
IV Infusion 1000 mg/m\^2
- Medication
Oxaliplatin
IV Infusion 100 mg/m\^2
- Medication
Bendamustine
IV Infusion 90 mg/m\^2
- Medication
Granulocyte Colony-Stimulating Factor (G-CSF)
Prophylactic G-CSF will be administered at each cycle of zilovertamab vedotin as per the institutional guidelines.
Canadian Sites (1)
1 listed, none recruiting
- Completed
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0200)
Toronto, Ontario
Eligibility Criteria
See who this study is looking for31 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 within 7 days prior to study treatment initiation.
- +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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →.
- +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 armsArmOne of the groups in a study, each receiving something different.Read more →:
- +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 protocolProtocolThe detailed plan a study must follow.Read more → 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
- −Has contraindication to any of the study intervention components including but not limited to prior anaphylactic reaction.
- −Has a known history of human immunodeficiency virus (HIV) infection.
- −Has a known active Hepatitis C virus infection.
- −Not applicable with protocolProtocolThe detailed plan a study must follow.Read more → 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 received prior systemic anticancer therapy, including investigational agents within 4 weeks prior to the first dose of study intervention.
- −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 psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
- −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.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more →/3 — a combined study that runs the middle stage and the large comparison stage together.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 6 groups in this study.
Groups A and B receive one or more of: Zilovertamab vedotin, Rituximab, Gemcitabine, Oxaliplatin and Granulocyte Colony-Stimulating Factor (G-CSF).
Registry label: A: ZV + R-GemOx (Part 1) · B: ZV + R-GemOx (Part 2)
Group C, the comparison group, receives one or more of: Rituximab, Gemcitabine and Oxaliplatin.
Registry label: C: R-GemOx (active control for Part 2)
Groups D and F receive one or more of: Zilovertamab vedotin, Rituximab, Bendamustine and Granulocyte Colony-Stimulating Factor (G-CSF).
Registry label: D: ZV + BR (Part 2) · F: ZV + BR (Part 1)
Group E, the comparison group, receives Bendamustine and Rituximab.
Registry label: E: Bendamustine Rituximab (BR)
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 290 people.
The study is currently expected to finish around September 2027.
The main measurement is taken over: Up to ~6 weeks.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Number of participants who experienced dose-limiting toxicities (DLTs) in Part 1 — measured over Up to ~6 weeks.
Number of participants who experienced an adverse eventAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AE) — measured over Up to ~68 months.
Number of participants who discontinued study treatment due to an AE — measured over Up to ~68 months.
Overall survival (OS) — measured over Up to ~35 months.
The study lists 1 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05139017 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Zilovertamab vedotinBiological
Intravenous (IV) Infusion 1.5 mg/kg, 1.75 mg/kg, 2.0 mg/kg, 2.25 mg/kg, 2.5 mg/kg
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About RituximabBiological
IV Infusion 375 mg/m\^2
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About GemcitabineDrug
IV Infusion 1000 mg/m\^2
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About OxaliplatinDrug
IV Infusion 100 mg/m\^2
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About BendamustineDrug
IV Infusion 90 mg/m\^2
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Granulocyte Colony-Stimulating Factor (G-CSF)Drug
Prophylactic G-CSF will be administered at each cycle of zilovertamab vedotin as per the institutional guidelines.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to ~6 weeks.
The study as a whole is currently expected to finish around 2027-09-24.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 290 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 4 locations, including: Toronto, Ontario, Canada; Grand Rapids, Michigan, United States; Billings, Montana, United States; Valhalla, New York, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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. 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.
Other Sites (3)
Corewell Health ( Site 0162)
Grand Rapids, Michigan, United States
St. Vincent Frontier Cancer Center-Research ( Site 0108)
Billings, Montana, United States
New York Medical College ( Site 0113)
Valhalla, New York, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.