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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)
EU CTIS ID: 2022-502646-27-00
What this study is testing
1. To evaluate the safety and tolerability and to establish a RP2D of zilovertamab vedotin when used in combination with R-GemOx or BR. 2. To compare zilovertamab vedotin in combination with R-GemOx to R-GemOx with respect to OS in part 2 of the study. 3. To compare zilovertamab vedotin in combination with R-GemOx to R-GemOx with respect to PFS per Lugano response criteria by BICR in part 2 of the study. 4. Not Applicable: To compare zilovertamab vedotin in combination with BR to BR with respect to PFS per Lugano response criteria by BICR in part 2 of the study.
- Phase II and Phase III (Integrated)
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 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.
You likely can't join if
- Not Applicable: Has history of transformation of indolent disease to DLBCL.
- 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.
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: 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.
- Not Applicable: Has history of transformation of indolent disease to DLBCL.
- 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 received solid organ transplant at any time.
- 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 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 effusion 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.
The study team makes the final eligibility decision.
Where it's taking place
- Colombia
- Peru
- Israel
- New Zealand
- Thailand
- United Kingdom
- Chile
- Korea, Republic of
- Mexico
- United States
- Brazil
- Argentina
- Turkey
- Ukraine
- Australia
- Guatemala
- Hong Kong
- Canada
- China
- Costa Rica
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Colombia; Peru; Israel; New Zealand; Thailand; United Kingdom and 14 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.