A Clinical Trial of MK-1045 With Zilovertamab Vedotin in Participants With Diffuse Large B-cell Lymphoma (MK-1045-010)
NCT07917754, Phase 2, Phase 3, Not yet recruiting, Merck Sharp & Dohme LLC
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Clinical Trial of MK-1045 With Zilovertamab Vedotin in Participants With Diffuse Large B-cell Lymphoma (MK-1045-010) | ClinicalTrials.gov |
| NCT number | NCT07917754 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2, Phase 3 | ClinicalTrials.gov |
| Enrollment | 470 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Merck Sharp & Dohme LLC | ClinicalTrials.gov |
| Conditions | Lymphoma, Large B-Cell, Diffuse, Diffuse Large B-Cell Lymphoma | ClinicalTrials.gov |
| Interventions | MK-1045, Zilovertamab vedotin, Rituximab, Rituximab biosimilar, Polatuzumab vedotin, Bendamustine, Lenalidomide, Tafasitamab, Rescue Medication - Biological, Rescue Medications - Drug, Granulocyte-colony stimulating factor (G-CSF) | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Part 1A: Number of Participants Who Experience Dose Limiting Toxicity (DLT) | Up to approximately 42 days | The following events, if considered drug related by the Investigator, will be considered a DLT: Grade (Gr) 5 toxicity; Gr 4 nonhematologic toxicity; Gr 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Gr 4 thrombocytopenia of any duration; Gr 3 thrombocytopenia associated with any Gr2 or higher bleeding; Nonhematologic AEs ≥Gr 3 with exceptions; Gr 3 or Gr 4 non-hematologic laboratory values if requires medical intervention, leads to hospitalization, or persists for \>72 hours; Gr 3 of 4 febrile neutropenia; Treatment-related toxicities that lead to discontinuation of study treatment or results in receiving incomplete planned doses of study treatment during DLT evaluation window (up to approximately 42 days). | ClinicalTrials.gov |
| Primary | Part 1A and 1B: Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 53 months | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. | ClinicalTrials.gov |
| Primary | Part 1A and 1B: Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 11 months | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. | ClinicalTrials.gov |
| Primary | Part 1B: Objective Response Rate (ORR) | Up to approximately 53 months | ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 50% decrease in the sum of diameters of target lesions) per Lugano response criteria. The percentage of participants who experience CR or PR as assessed by physician investigator will be presented. | ClinicalTrials.gov |
| Primary | Part 2: Progression Free Survival (PFS) | Up to approximately 53 months | PFS is defined as the time from randomization to the first documented disease progression per Lugano response criteria by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurs first. | ClinicalTrials.gov |
| Secondary | Part 1A: ORR | Up to approximately 53 months | ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 50% decrease in the sum of diameters of target lesions) per Lugano response criteria. The percentage of participants who experience CR or PR as assessed by physician investigator will be presented. | ClinicalTrials.gov |
| Secondary | Part 1A and 1B: Duration of Response (DOR) | Up to approximately 53 months | For participants who demonstrate a CR or PR per Lugano response criteria as assessed by physician investigator. DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. | ClinicalTrials.gov |
| Secondary | Part 1A and 1B: Complete Response Rate (CRR) | Up to approximately 53 months | For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) per Lugano response criteria. CR rate is defined as the percentage of participants who experience a CR. The CR rate as assessed by physician investigator will be presented. | ClinicalTrials.gov |
| Secondary | Part 1A and 1B: Area Under the Time Concentration Curve (AUC) of MK-1045 | Predose and at designated time points post-dose (up to approximately 11 months) | Blood samples will be collected at designated timepoints to estimate the AUC of MK-1045. | ClinicalTrials.gov |
| Secondary | Part 1A and 1B: Maximum Concentration (Cmax) of MK-1045 | Predose and at designated time points post-dose (up to approximately 11 months) | Blood samples will be collected at designated timepoints to estimate the Cmax of MK-1045. | ClinicalTrials.gov |
| Secondary | Part 1A and 1B: Minimum Concentration Just Before the Next Dose (Ctrough) of MK-1045 | Predose and at designated time points post-dose (up to approximately 11 months) | Blood samples will be collected at designated timepoints to estimate the Ctrough of MK-1045. | ClinicalTrials.gov |
| Secondary | Part 2: Overall Survival (OS) | Up to approximately 53 months | OS is defined as the time from randomization to death due to any cause. | ClinicalTrials.gov |
| Secondary | Part 2: ORR | Up to approximately 53 months | ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 50% decrease in the sum of diameters of target lesions) per Lugano response criteria. The percentage of participants who experience CR or PR as assessed by BICR will be presented. | ClinicalTrials.gov |
| Secondary | Part 2: Number of Participants Who Experience an AE | Up to approximately 53 months | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. | ClinicalTrials.gov |
| Secondary | Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 11 months | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. | ClinicalTrials.gov |
| Secondary | Part 2: CRR | Up to approximately 53 months | For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) per Lugano response criteria. CR rate is defined as the percentage of participants who experience a CR. The CR rate as assessed by BICR will be presented. | ClinicalTrials.gov |
| Secondary | Part 2: DOR | Up to approximately 53 months | For participants who demonstrate a CR or PR per Lugano response criteria as assessed by BICR. DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. | ClinicalTrials.gov |
| Secondary | Part 2: Minimal Residual Disease (MRD) Negativity Rate | Predose and at designated time points post-dose (up to approximately 11 months) | MRD is defined as the percentage of participants reaching MRD negativity by ctDNA clearance at predefined timepoints. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
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 | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)