A Study of Zilovertamab Vedotin (MK-2140) as Monotherapy and in Combination in Participants With Aggressive and Indolent B-cell Malignancies (MK-2140-006) (NCT05458297)
A Multicenter, Open-label, Phase 2 Basket Study to Evaluate the Safety and Efficacy of MK-2140 as a Monotherapy and in Combination in Participants With Aggressive and Indolent B-cell Malignancies (waveLINE-006)
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to assess the safety and tolerability of zilovertamab vedotin as monotherapy and in combination in participants with select B-cell lymphomas including mantle cell lymphoma (MCL), Richter's transformation lymphoma (RTL), follicular lymphoma (FL), and chronic lymphocytic leukemia (CLL). This study will also evaluate zilovertamab vedotin as monotherapy and in combination with respect to objective response rate. * Cohort A: Participants with relapsed or refractory MCL relapsed or refractory disease after at least 2 prior systemic therapies including a Bruton's tyrosine kinase inhibition/inhibitor (BTKi), and post therapy chimeric antigen receptor T (CAR-T) cell therapy or ineligible for CAR-T cell therapy * Cohort B: Participants with relapsed or refractory RT disease after at least 1 prior systemic therapy * Cohort C: Participants with relapsed or refractory MCL relapsed or refractory disease after at least 1 prior systemic therapy and no prior exposure to a non-covalent BTKi * Cohort D: Participants with relapsed or refractory FL and CLL relapsed or refractory disease after at least 2 prior systemic therapies and have no other available therapy * Cohort E: Participants with relapsed or refractory FL after at least 2 prior systemic therapies and have no other available therapy The primary study hypothesis is that zilovertamab vedotin monotherapy has an increased Objective Response Rate (ORR) per Lugano Response Criteria as assessed by blinded independent central review (BICR). As of Amendment 07, Cohort D is closed to enrollment of participants with CLL and enrollment of participants into Arm 2 (zilovertamab vedotin at Dose 2 on Days 1 \& 8 of each 3 Week Cycle (Q2/3W)). As of Amendment 09, no additional participants with RT will be enrolled in Cohort B; however, those currently enrolled will continue with study intervention treatment (if applicable) until a protocol specified discontinuation criterion is met. Cohort E will be closed, as no participants with FL have been treated in this cohort.
Who can join: Review the eligibility criteria below.
Location: Alaska Oncology and Hematology ( Site 0037) — Anchorage, Alaska
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (109 Sites)
Showing the first 25 of 109 sites.
- Alaska Oncology and Hematology ( Site 0037) — Anchorage, Alaska
- Banner MD Anderson Cancer Center ( Site 0040) — Gilbert, Arizona
- Banner MD Anderson Cancer Center - University Medical Center Phoenix-Medical Oncology ( Site 0036) — Phoenix, Arizona
- University of Colorado Anschutz Medical Campus-The Center for Cancer and Blood Disorders ( Site 0008) — Aurora, Colorado
- Cancer Care Specialists of Illinois ( Site 0031) — Decatur, Illinois
- University of Kansas Medical Center-Division of Hematologic Malignancies and Cellular Therapeutics ( Site 0038) — Fairway, Kansas
- Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0007) — Saint Matthews, Kentucky
- Greenebaum Comprehensive Cancer Center-Hematology & Multiple Myeloma ( Site 0010) — Baltimore, Maryland
- Tufts Medical Center ( Site 0024) — Boston, Massachusetts
- Massachusetts General Hospital ( Site 0018) — Boston, Massachusetts
- Dana-Farber Cancer Institute-Lymphoma ( Site 0026) — Boston, Massachusetts
- University of Michigan ( Site 0009) — Ann Arbor, Michigan
- Henry Ford Hospital ( Site 0035) — Detroit, Michigan
- Icahn School of Medicine at Mount Sinai ( Site 0023) — New York, New York
- Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0014) — Fargo, North Dakota
- The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0004) — Columbus, Ohio
- Avera Cancer Institute- Research ( Site 0011) — Sioux Falls, South Dakota
- Medical Oncology Associates, PS ( Site 0005) — Spokane, Washington
- University of Wisconsin Hospitals and Clinics-Carbone Cancer Center ( Site 0030) — Madison, Wisconsin
- Medical College of Wisconsin ( Site 0021) — Milwaukee, Wisconsin
- Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 1807) — Natal, Rio Grande do Norte
- Instituto Nacional de Câncer - INCA-Divisão de Pesquisa Clínica e Desenvolvimento Tecnológico HC1 ( Site 1809) — Rio de Janeiro,
- ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1808) — São Paulo,
- Hospital Paulistano-Americas Oncologia ( Site 1805) — São Paulo,
- BC Cancer Vancouver-Clinical Trials Unit ( Site 0201) — Vancouver, British Columbia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.