A Study of Zilovertamab Vedotin (MK-2140) as Monotherapy and in Combination in Participants With Aggressive and Indolent B-cell Malignancies (MK-2140-006)
Public ClinicalTrials.gov record NCT05458297. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05458297
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 189 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 21, 2022 (Actual)
- Primary completion
- May 17, 2029 (Estimated)
- Completion
- May 17, 2029 (Estimated)
- Last update posted
- Aug 21, 2026
2022 – 2029
United States locations
- U.S. sites
- 20
- U.S. states
- 15
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alaska Oncology and Hematology ( Site 0037) | Anchorage | Alaska | 99508 | — |
| Banner MD Anderson Cancer Center ( Site 0040) | Gilbert | Arizona | 85234 | — |
| Banner MD Anderson Cancer Center - University Medical Center Phoenix-Medical Oncology ( Site 0036) | Phoenix | Arizona | 85006 | — |
| University of Colorado Anschutz Medical Campus-The Center for Cancer and Blood Disorders ( Site 0008) | Aurora | Colorado | 80045 | — |
| Cancer Care Specialists of Illinois ( Site 0031) | Decatur | Illinois | 62526 | — |
| University of Kansas Medical Center-Division of Hematologic Malignancies and Cellular Therapeutics ( Site 0038) | Fairway | Kansas | 66205 | — |
| Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0007) | Saint Matthews | Kentucky | 40207 | — |
| Greenebaum Comprehensive Cancer Center-Hematology & Multiple Myeloma ( Site 0010) | Baltimore | Maryland | 21201 | — |
| Tufts Medical Center ( Site 0024) | Boston | Massachusetts | 02111 | — |
| Massachusetts General Hospital ( Site 0018) | Boston | Massachusetts | 02114 | — |
| Dana-Farber Cancer Institute-Lymphoma ( Site 0026) | Boston | Massachusetts | 02215 | — |
| University of Michigan ( Site 0009) | Ann Arbor | Michigan | 48109 | — |
| Henry Ford Hospital ( Site 0035) | Detroit | Michigan | 48202 | — |
| Icahn School of Medicine at Mount Sinai ( Site 0023) | New York | New York | 10029 | — |
| Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0014) | Fargo | North Dakota | 58102 | — |
| The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0004) | Columbus | Ohio | 43210 | — |
| Avera Cancer Institute- Research ( Site 0011) | Sioux Falls | South Dakota | 57105 | — |
| Medical Oncology Associates, PS ( Site 0005) | Spokane | Washington | 99208 | — |
| University of Wisconsin Hospitals and Clinics-Carbone Cancer Center ( Site 0030) | Madison | Wisconsin | 53792 | — |
| Medical College of Wisconsin ( Site 0021) | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 89 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05458297, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 21, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05458297 live on ClinicalTrials.gov.