A Research Study, where the participant and healthcare providers are aware of the treatment being given, to evaluate safety and effectiveness of medication MK-2140 in patients with Diffuse Large B Cell Lymphoma who failed prior therapies.
EU CTIS ID: 2022-501243-33-00
What this study is testing
To evaluate zilovertamab vedotin with respect to objective response rate per Lugano Response Criteria as assessed by Blinded Independent Central Review (BICR)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Has relapsed or refractory (rr) diffuse large B-cell lymphoma diffused large B-cell lymphoma (DLBCL); has progressed after at least 2 lines of prior therapy; and has progressed after auto- stem cell transplant (SCT) or are auto-SCT ineligible. Must have received prior multiagent regimen that includes an alkylating agent. anthracycline, and anti-CD20 (cluster of differentiation 20) monoclonal antibody.
- Has histologically confirmed diagnosis of DLBCL.
- Has radiographically measurable DLBCL per the Lugano Response Criteria
- Should either be post- chimeric antigen receptor T cell therapy (CAR-T) failure or ineligible for CAR-T (for any reason)
- Life expectancy of at least 3 months
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before time of enrollment
You likely can't join if
- Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL)
- 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 28 days of start of study intervention. Participants must have recovered from all radiation-related toxicities
- Has ongoing corticosteroid therapy (exceeding 30 mg daily of prednisone equivalent)
- 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
See the full eligibility criteria
- Has relapsed or refractory (rr) diffuse large B-cell lymphoma diffused large B-cell lymphoma (DLBCL); has progressed after at least 2 lines of prior therapy; and has progressed after auto- stem cell transplant (SCT) or are auto-SCT ineligible. Must have received prior multiagent regimen that includes an alkylating agent. anthracycline, and anti-CD20 (cluster of differentiation 20) monoclonal antibody.
- Has histologically confirmed diagnosis of DLBCL.
- Has radiographically measurable DLBCL per the Lugano Response Criteria
- Should either be post- chimeric antigen receptor T cell therapy (CAR-T) failure or ineligible for CAR-T (for any reason)
- Life expectancy of at least 3 months
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before time of enrollment
- Has adequate organ function
- Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL)
- 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 28 days of start of study intervention. Participants must have recovered from all radiation-related toxicities
- Has ongoing corticosteroid therapy (exceeding 30 mg daily of prednisone equivalent)
- 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
- Has an active infection requiring systemic therapy
- Has a known history of human immunodeficiency virus (HIV) infection
- Has a known history of hepatitis B or known active hepatitis C virus (HCV)
- Has undergone solid organ transplant at any time
- Has a history of any clinically significant cardiovascular conditions within 6 months of screening or serious cardiac arrhythmia requiring medication
- Has known history of liver cirrhosis
- Has pericardial effusion or clinically significant 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
- Transformed DLBCL from indolent lymphoma
- In participants with prior allo-SCT, acute graft versus host disease (GVHD) or ongoing evidence of chronic GVHD
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- Chile
- China
- United States
- Canada
- Korea, Republic of
- Thailand
- Turkey
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; Chile; China; United States; Canada; Korea, Republic of and 2 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 EU CTIS; the study team decides eligibility.