Trial · NCT04504916
A Study of Zilovertamab Vedotin (MK-2140/VLS-101) in Participants With Solid Tumors (MK-2140-002)
NCT04504916, Phase 2, Terminated, VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); results first posted 2024-08-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Zilovertamab Vedotin (MK-2140/VLS-101) in Participants With Solid Tumors (MK-2140-002). Trials, record NCT04504916. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04504916
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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 Solid Tumors (MK-2140-002)
- NCT number
- NCT04504916
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 102 participants, actual
- Lead sponsor
- VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Conditions
Triple-negative Breast Cancer, Non-squamous Non-small-cell Lung Cancer, NSCLC, Estrogen-receptor-positive Breast Cancer, Progesterone-receptor-positive Breast Cancer, Estrogen-receptor-negative Breast Cancer, ER-negative Breast Cancer, Progesterone-receptor Negative Breast Cancer, PR-negative Breast Cancer, HER2-negative Breast Cancer, ER-positive Breast Cancer, PR-positive Breast Cancer, Platinum-resistant Ovarian Cancer, Gastric Cancer, Pancreatic Cancer
- Interventions
- Zilovertamab vedotin
- First posted
- 2020-08-07
- Last updated
- 2025-11-10
- Results first posted
- 2024-08-15
- Limitations and caveats
- Study terminated due to business reasons
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR)- Blinded Independent Central Review (BICR) | Up to ~18 months | The percentage of participants who achieved a Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: a ≥30% decrease in the sum of diameters \[SOD\] of target lesions) using per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 by BICR was reported. |
| Secondary | ORR- Investigator Assessed | Up to ~18 months | The percentage of participants who achieved a CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters \[SOD\] of target lesions) per RECIST, Version 1.1 by investigator was reported. |
| Secondary | Time to Response (TTR)- BICR | Up to ~30 months | TTR, defined as the time from the start of study treatment to the first documentation of objective tumor response per RECIST, Version 1.1 by BICR was reported. |
| Secondary | Duration of Response (DOR)- BICR | Up to ~30 months | DOR, defined as the interval from the first documentation of objective tumor response to the earlier of the first documentation of disease progression or death from any cause per RECIST, Version 1.1 by BICR was reported. |
| Secondary | Progression-free Survival (PFS)- BICR | Up to ~30 months | PFS, defined as the interval from the start of study treatment to the earlier of the first documentation of disease progression or death from any cause per RECIST, Version 1.1 by BICR was reported. |
| Secondary | Time to Treatment Failure (TTF)- BICR | Up to ~30 months | TTF, defined as the time from the start of study treatment to the earliest of the first documentation of disease progression, the permanent cessation of study drug due to an AE, or death from any cause per RECIST, Version 1.1 by BICR was reported. |
| Secondary | Overall Survival (OS) | Up to ~30 months | OS, defined as the interval from the start of study treatment to death from any cause will be reported. |
| Secondary | Number of Participants Who Experienced an Adverse Event (AE) | Up to ~30 months | An AE was any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE. The number of participants who experienced an AE was reported. |
| Secondary | Number of Participants Who Discontinued Study Treatment Due to an AE | Up to ~11 months | An AE was any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE. The number of participants who discontinued study treatment due to an AE was reported. |
| Secondary | Maximum Plasma Concentration (Cmax) of Zilovertamab Vedotin-Q1/3W Dosing Schedule | Day 1 [(predose; end of infusion (EOI); and 2 and 4 hours after EOI)], Day 8 (168 hr), Day 15 (336 hr), and Cycle 2 Day 1 (predose); each cycle=21 days | Cmax of zilovertamab vedotin determined by blood samples collected pre-dose and at designated timepoints post-dose were reported. Per protocol the Zilovertamab vedotin Q2/3W Dosing Group was not included in this analysis. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR)- Blinded Independent Central Review (BICR) | Up to ~18 months | Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug | Percentage of Participants | NUMBER |
| SECONDARY | ORR- Investigator Assessed | Up to ~18 months | FAS which included all participants who received ≥1 dose of study drug | Percentage of Participants | NUMBER |
| SECONDARY | Time to Response (TTR)- BICR | Up to ~30 months | Responding Analysis Set which included data from participants in the FAS who had measurable disease, who could be evaluated for tumor response with both baseline and on-study tumor evaluations, and who achieved an objective response. | Months | MEAN |
| SECONDARY | Duration of Response (DOR)- BICR | Up to ~30 months | Responding Analysis Set which included data from participants in the FAS who had measurable disease, who could be evaluated for tumor response with both baseline and on-study tumor evaluations, and who achieved an objective response. | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS)- BICR | Up to ~30 months | FAS which included all participants who received ≥1 dose of study drug | Months | MEDIAN |
| SECONDARY | Time to Treatment Failure (TTF)- BICR | Up to ~30 months | FAS which included all participants who received ≥1 dose of study drug | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to ~30 months | FAS which included all participants who received ≥1 dose of study drug | Months | MEDIAN |
| SECONDARY | Number of Participants Who Experienced an Adverse Event (AE) | Up to ~30 months | FAS which included all participants who received ≥1 dose of study drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Discontinued Study Treatment Due to an AE | Up to ~11 months | FAS which included all participants who received ≥1 dose of study drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maximum Plasma Concentration (Cmax) of Zilovertamab Vedotin-Q1/3W Dosing Schedule | Day 1 [(predose; end of infusion (EOI); and 2 and 4 hours after EOI)], Day 8 (168 hr), Day 15 (336 hr), and Cycle 2 Day 1 (predose); each cycle=21 days | Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest. | μg/mL | GEOMETRIC_MEAN |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR)- Blinded Independent Central Review (BICR) | Zilovertamab Vedotin Q1/3W | 1.4 | 95% Confidence Interval 0.0 to 7.7 | Percentage of Participants | |
| Objective Response Rate (ORR)- Blinded Independent Central Review (BICR) | Zilovertamab Vedotin Q2/3W | 0.0 | 95% Confidence Interval NA to NA | Percentage of Participants | |
| ORR- Investigator Assessed | Zilovertamab Vedotin Q1/3W | 1.4 | 95% Confidence Interval 0.0 to 7.7 | Percentage of Participants | |
| ORR- Investigator Assessed | Zilovertamab Vedotin Q2/3W | 0.0 | 95% Confidence Interval NA to NA | Percentage of Participants | |
| Time to Response (TTR)- BICR | Zilovertamab Vedotin Q1/3W | 1.9 | Standard Deviation NA | Months | |
| Duration of Response (DOR)- BICR | Zilovertamab Vedotin Q1/3W | 1 | 95% Confidence Interval NA to NA | Months | |
| Progression-free Survival (PFS)- BICR | Zilovertamab Vedotin Q1/3W | 2.3 | 95% Confidence Interval 2.0 to 4.1 | Months | |
| Progression-free Survival (PFS)- BICR | Zilovertamab Vedotin Q2/3W | 1.9 | 95% Confidence Interval 1.7 to 2.1 | Months | |
| Time to Treatment Failure (TTF)- BICR | Zilovertamab Vedotin Q1/3W | 2.2 | 95% Confidence Interval 1.9 to 4.1 | Months | |
| Time to Treatment Failure (TTF)- BICR | Zilovertamab Vedotin Q2/3W | 1.9 | 95% Confidence Interval 1.7 to 2.1 | Months |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Zilovertamab Vedotin Q1/3W | 70 | |
| Overall Study | STARTED | Zilovertamab Vedotin Q2/3W | 32 | |
| Overall Study | COMPLETED | Zilovertamab Vedotin Q1/3W | 0 | |
| Overall Study | COMPLETED | Zilovertamab Vedotin Q2/3W | 0 | |
| Overall Study | NOT COMPLETED | Zilovertamab Vedotin Q1/3W | 70 | |
| Overall Study | NOT COMPLETED | Zilovertamab Vedotin Q2/3W | 32 |
Source ClinicalTrials.gov
Adverse events238
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Eosinophilia | Blood and lymphatic system disorders | Zilovertamab Vedotin Q1/3W | 0 | 70 | 0 |
| other | Eosinophilia | Blood and lymphatic system disorders | Zilovertamab Vedotin Q2/3W | 2 | 32 | 4 |
| other | Sinus tachycardia | Cardiac disorders | Zilovertamab Vedotin Q1/3W | 1 | 70 | 1 |
| other | Sinus tachycardia | Cardiac disorders | Zilovertamab Vedotin Q2/3W | 2 | 32 | 3 |
| other | Abdominal distension | Gastrointestinal disorders | Zilovertamab Vedotin Q1/3W | 3 | 70 | 4 |
| other | Abdominal distension | Gastrointestinal disorders | Zilovertamab Vedotin Q2/3W | 4 | 32 | 4 |
| other | Abdominal pain | Gastrointestinal disorders | Zilovertamab Vedotin Q1/3W | 13 | 70 | 22 |
| other | Abdominal pain | Gastrointestinal disorders | Zilovertamab Vedotin Q2/3W | 4 | 32 | 5 |
| other | Constipation | Gastrointestinal disorders | Zilovertamab Vedotin Q1/3W | 15 | 70 | 16 |
| other | Constipation | Gastrointestinal disorders | Zilovertamab Vedotin Q2/3W | 6 | 32 | 7 |
1 to 10 of 238Source ClinicalTrials.gov
See all 238 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Zilovertamab Vedotin Q1/3W | 54 | 70 |
| Total, all-cause mortality | Zilovertamab Vedotin Q2/3W | 18 | 32 |
| Total, other adverse events | Zilovertamab Vedotin Q1/3W | 66 | 70 |
| Total, other adverse events | Zilovertamab Vedotin Q2/3W | 30 | 32 |
| Total, serious adverse events | Zilovertamab Vedotin Q1/3W | 29 | 70 |
| Total, serious adverse events | Zilovertamab Vedotin Q2/3W | 16 | 32 |
Source ClinicalTrials.gov
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Zilovertamab Vedotin Q1/3W vs Zilovertamab Vedotin Q2/3W: Number of Participants Who Experienced an Adverse Event (AE) | Trial comparisons |
| Zilovertamab Vedotin Q1/3W vs Zilovertamab Vedotin Q2/3W: Number of Participants Who Discontinued Study Treatment Due to an AE | Trial comparisons |
| Zilovertamab Vedotin Q1/3W vs Zilovertamab Vedotin Q2/3W: deaths from any cause | Trial comparisons |
| Zilovertamab Vedotin Q1/3W vs Zilovertamab Vedotin Q2/3W: serious adverse events | Trial comparisons |
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/NCT04504916
GET https://conductscience.org/api/trials/v1/NCT04504916/registered?page=2