BridgeMD
New treatment option 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)
ClinicalTrials.gov ID: NCT05139017
What this study is testing
What is Zilovertamab vedotin?
Zilovertamab vedotin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for dlbcl.
Also referred to as MK-2140, VLS-101.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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:
You likely can't join if
- 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.
See the full eligibility 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Glendale, Arizona, United States
- Beverly Hills, California, United States
- Walnut Creek, California, United States
- Whittier, California, United States
- Boca Raton, Florida, United States
- Clermont, Florida, United States
- Hialeah, Florida, United States
- Niles, Illinois, United States
- Edgewood, Kentucky, United States
- Lexington, Kentucky, United States
- Louisville, Kentucky, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Worcester, Massachusetts, United States
- Grand Rapids, Michigan, United States
- Billings, Montana, United States
- Grand Island, Nebraska, United States
- Omaha, Nebraska, United States
- Las Vegas, Nevada, United States
- Morristown, New Jersey, United States
+ 99 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glendale, Arizona, United States; Beverly Hills, California, United States; Walnut Creek, California, United States; Whittier, California, United States; Boca Raton, Florida, United States; Clermont, Florida, United States and 113 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.