Trial · NCT03833180
A Study of Zilovertamab Vedotin (MK-2140) (VLS-101) in Participants With Hematologic Malignancies (MK-2140-001)
NCT03833180, Phase 1, Completed, VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Zilovertamab Vedotin (MK-2140) (VLS-101) in Participants With Hematologic Malignancies (MK-2140-001). Trials, record NCT03833180. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03833180
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Zilovertamab Vedotin (MK-2140) (VLS-101) in Participants With Hematologic Malignancies (MK-2140-001)
- NCT number
- NCT03833180
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 91 participants, actual
- Lead sponsor
- VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Conditions
Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Diffuse Large B-cell Lymphoma, Richter Transformation Lymphoma, Burkitt Lymphoma, Lymphoplasmacytoid Lymphoma, T-cell Non-Hodgkin Lymphoma, Acute Lymphoid Leukemia, Acute Myeloid Leukemia, Waldenstrom Macroglobulinemia
- Interventions
- Zilovertamab vedotin
- First posted
- 2019-02-06
- Last updated
- 2024-01-12
Source ClinicalTrials.gov
Registered outcomes39
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose (MTD) of zilovertamab vedotin | Cycle 1 (Up to 21 Days) | 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. |
| Primary | Recommended Dosing Regimen (RDR) | Cycle 1 (Up to 21 Days) | Selection of the RDR will be based on consideration of short- and long-term safety information together with available pharmacokinetic, pharmacodynamic, and efficacy data. The RDR may be the MTD or may be a lower dose within the tolerable dose range. |
| Secondary | Average number of zilovertamab vedotin infusions administered | Up to 5 months | Zilovertamab vedotin drug administration will be assessed by prescribing records and the average number of zilovertamab vedotin infusions administered will be determined. |
| Secondary | Number of participants with a treatment-emergent adverse event (TEAE) | Up to approximately 3.5 years | An AE is any untoward medical occurrence in a participant administered a medicinal product; the event does not necessarily have a causal relationship with study drug administration or usage. Laboratory abnormalities, vital sign/oxygen saturation abnormalities, and adverse electrocardiogram (ECG) findings will also be recorded as AEs. A TEAE is defined as an AE that occurs or worsens in the period from the first dose of study drug administration to 30 days after the final dose of study drug administration. The number of participants with a TEAE will be reported for each arm. |
| Secondary | Number of participants with a DLT | Cycle 1 (Up to 21 Days) | A DLT is defined as a protocol pre-specified TEAE that occurs in Cycle 1 of zilovertamab vedotin therapy and is considered drug-related. Failure to recover to baseline by ≥21 days from the last dose of study drug in the current cycle due to a drug-related TEAE is also considered a DLT. The number of participants with a DLT will be reported for each arm. |
| Secondary | Number of participants with a serious adverse event (SAE) | Up to approximately 3.5 years | An SAE is defined as an untoward medical occurrence that results in any of the following outcomes: death, life-threatening situation, in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or other medically significant event. |
| Secondary | Number of participants with an adverse event of special interest (AESI) | Up to approximately 3.5 years | Prespecified AESIs for this study will include: Grade ≥3 infusion reactions, tumor lysis syndrome (TLS) of any grade, and Grade ≥3 peripheral neuropathy. The number of participants with an AESI will be reported for each arm. |
| Secondary | Number of participants that discontinue study treatment due to an AE | Up to approximately 3.5 years | An AE is any untoward medical occurrence in a participant administered a medicinal product; the event does not necessarily have a causal relationship with study drug administration or usage. The number of participants that discontinue study treatment due to an AE will be reported for each arm. |
| Secondary | Number of participants that use supportive care or concomitant medications | Up to approximately 3.5 years | The number of participants that use supportive care or concomitant medications will be reported for each arm. |
| Secondary | Plasma concentration of zilovertamab vedotin | Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion | Plasma concentration of zilovertamab vedotin will be reported for each arm. |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03833180
GET https://conductscience.org/api/trials/v1/NCT03833180/registered?page=2