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NCT03833180 · ClinicalTrials.gov registry record · Phase 1
A Study of Zilovertamab Vedotin (MK-2140) (VLS-101) in Participants With Hematologic Malignancies (MK-2140-001)
A Phase 1 study of Chronic Lymphocytic Leukemia and Diffuse Large B Cell Lymphoma, sponsored by VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- Completed
- Registry status
- Phase 1
- Development phase
- 91
- Enrollment target
- 14
- Study locations
NCT03833180: Completed Phase 1 study of Chronic Lymphocytic Leukemia and Diffuse Large B Cell Lymphoma, sponsored by VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
NCT03833180 is a Phase 1 study of Chronic Lymphocytic Leukemia and Diffuse Large B Cell Lymphoma that has completed, run by VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). The registered enrollment target is 91 participants, below the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (50% lower). The trial reports 14 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03833180, a Phase 1 study of Chronic Lymphocytic Leukemia and Diffuse Large B Cell Lymphoma, has completed, sponsored by VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 91 participants
- Enrollment target
- 14
- Study locations
Study Summary
The purpose of this study is to evaluate the safety, pharmacokinetics, immunogenicity, and efficacy of zilovertamab vedotin given intravenously (IV) across a range of dose levels in participants with previously treated hematological cancers including acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML), Burkitt lymphoma (BL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), Richter transformation lymphoma (RTL), and T-cell non-Hodgkin lymphoma (NHL).
Primary Outcome
Participants will receive zilovertamab vedotin according to Schedule 1, 2, or 3. The MTD will be determined by the number of participants who experience a dose limiting toxicity (DLT). The MTD will be defined as the highest tested dose level at which ≥6 participants have been treated and which is associated with a Cycle 1 DLT in ≤17% of the participants.
Conditions Studied
Interventions
- DRUG Zilovertamab vedotin
Study Locations (14)
New York
- Northwell Health ( Site 0009) - New Hyde Park
- Weill Cornell Medical College ( Site 0005) - New York
- Memorial Sloan Kettering Cancer Center ( Site 0014) - New York
- University of Rochester ( Site 0008) - Rochester
- Memorial Sloan-Kettering Cancer Center ( Site 0019) - Uniondale
California
- City of Hope ( Site 0010) - Duarte
- University of California - San Diego ( Site 0003) - La Jolla
- UCLA Hematology & Oncology ( Site 0007) - Los Angeles
Texas
- MD Anderson Cancer Center ( Site 0001) - Houston
- MD Anderson Cancer Center ( Site 0011) - Houston
Nebraska
- University of Nebraska Medical Center ( Site 0006) - Omaha
Oregon
- Oregon Health & Science University ( Site 0004) - Portland
Virginia
- University of Virginia Cancer Center ( Site 0012) - Charlottesville
Washington
- Swedish Medical Center ( Site 0002) - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2019-03-14 |
| Est. Completion | 2023-12-18 |
| Phase | Phase 1 |
What the finished NCT03833180 record still lists
NCT03833180 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (50% lower).
The record links to 10 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Zilovertamab vedotin is the first listed.
NCT03833180 lists 14 locations in 7 states (New York, California, Texas).
Frequently Asked Questions
What is clinical trial NCT03833180 about?
NCT03833180 is a clinical study titled "A Study of Zilovertamab Vedotin (MK-2140) (VLS-101) in Participants With Hematologic Malignancies (MK-2140-001)". The purpose of this study is to evaluate the safety, pharmacokinetics, immunogenicity, and efficacy of zilovertamab vedotin given intravenously (IV) across a range of dose levels in participants with previously treated hematological cancers including acute lymphocytic leukemia (ALL), acute myeloid l...
What is the current status of trial NCT03833180?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 91 participants. The study started on 2019-03-14. Estimated completion is 2023-12-18.
What conditions does trial NCT03833180 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Diffuse Large B Cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma.
What interventions are being tested in trial NCT03833180?
The interventions under investigation include: Zilovertamab vedotin (DRUG).
Who is sponsoring clinical trial NCT03833180?
This trial is sponsored by VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03833180 being conducted?
This trial has 14 study locations across California, Nebraska, New York, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03833180's enrollment target sits among peer trials
91 68th of 187 higher than 120 of 187 other Chronic Lymphocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Lymphocytic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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