Trial · NCT03010176
Study of Ulevostinag (MK-1454) Alone or in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors or Lymphomas (MK-1454-001)
NCT03010176, Phase 1, Completed, Merck Sharp & Dohme LLC; results first posted 2024-02-26
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study of Ulevostinag (MK-1454) Alone or in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors or Lymphomas (MK-1454-001). Trials, record NCT03010176. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03010176
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Ulevostinag (MK-1454) Alone or in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors or Lymphomas (MK-1454-001)
- NCT number
- NCT03010176
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 156 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Solid Tumors, Lymphoma
- Interventions
- Ulevostinag, Pembrolizumab
- First posted
- 2017-01-04
- Last updated
- 2025-10-29
- Other registries' IDs
- eudract:2016-003160-40
- Results first posted
- 2024-02-26
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Percentage of Participants Who Experienced a Dose-limiting Toxicity (DLT) Per Common Terminology Criteria for Adverse Events, Version 4.0 (CTCAE 4.0) | Cycle 1 (21-day cycle) | DLTs were assessed during the first cycle (21 days) \& are defined as: Grade (Gr) 4 nonhematologic toxicity; Gr 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia, Gr 4 thrombocytopenia, Gr 3 thrombocytopenia (if associated with clinically significant bleeding); nonhematologic adverse event (AE) ≥ Gr 3 (with exceptions); Gr 3 or 4 nonhematologic lab abnormality (if medical intervention is required, leads to hospitalization, or persists for \>1 week); Gr 3 or 4 febrile neutropenia; drug-related toxicity that causes treatment discontinuation or dose delay \>7 days between consecutive doses during Cycle 1; drug-related toxicity that causes a \>2 week delay in Cycle 2 initiation; elevated aspartate aminotransferase or alanine aminotransferase lab value that is ≥3× upper limit of normal (ULN) \& an elevated total bilirubin value ≥2× ULN \& an alkaline phosphatase value \<2× ULN, in which no alternative reasons can be found; ≥Gr 2 immune-mediated uveitis; or Gr 5 toxicity. |
| Primary | Parts 1 and 2: Number of Participants Who Experienced One or More Adverse Events (AEs) | Up to approximately 2 years | AEs are defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study treatment, is also an AE. |
| Primary | Parts 1 and 2: Number of Participants Who Discontinued Study Drug Due to an AE | Up to approximately 2 years | AEs are defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study treatment, is also an AE. |
| Secondary | Parts 1 and 2: Ulevostinag Area Under the Plasma Drug Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24) | Cycle 1 Day 1: Predose, at end of IT injection (up to 15 minutes) and 0.5, 1, 1.5, 4, 6, 12, and 24 hours postdose. Each cycle was 21 days. | The AUC0-24 is a measure of the amount of drug in the blood over time for 0 hours to 24 hours. The AUC0-24 of ulevostinag administered via IT injection as monotherapy and the AUC0-24 of ulevostinag administered via IT injection as combination therapy with pembrolizumab IV infusion were evaluated. |
| Secondary | Parts 1 and 2: Ulevostinag Minimum Plasma Concentration (Cmin) | Cycle 1 Day 1: Predose, at end of IT injection (up to 15 minutes) and 0.5, 1, 1.5, 4, 6, 12, and 24 hours postdose; Cycle 2 Day 1: Predose, at end of IT injection (up to 15 minutes) and 0.5, 1, 1.5, 4, and 6 hours postdose. Each cycle was 21 days. | Cmin is a measure of the minimum amount of drug in the plasma after the dose is given. The Cmin of ulevostinag administered via IT injection as monotherapy and the Cmin of ulevostinag administered via IT injection as combination therapy with pembrolizumab IV infusion were evaluated. |
| Secondary | Parts 1 and 2: Ulevostinag Maximum Plasma Concentration (Cmax) | Cycle 1 Day 1: Predose, at end of IT injection (up to 15 minutes) and 0.5, 1, 1.5, 4, 6, 12, and 24 hours postdose; Cycle 2 Day 1: Predose, at end of IT injection (up to 15 minutes) and 0.5, 1, 1.5, 4, and 6 hours postdose. Each cycle was 21 days. | Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. The Cmax of ulevostinag administered via IT injection as monotherapy and the Cmax of ulevostinag administered via IT injection as combination therapy with pembrolizumab IV infusion were evaluated. |
| Secondary | Parts 1 and 2: Pembrolizumab Minimum Plasma Concentration (Cmin) | Predose on Day 1 of Cycles 1, 2, and 4, and every 4 cycles thereafter up to Cycle 35 (up to 2 years). Each cycle was 21 days. | Cmin is a measure of the minimum amount of drug in the plasma after the dose is given. The Cmin of pembrolizumab IV infusion in combination with MK-1454 administered via IT injection was evaluated. |
| Secondary | Parts 1 and 2: Objective Response Rate (ORR) As Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to approximately 2 years | ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. The ORR of ulevostinag at the preliminary RP2D in combination with pembrolizumab will be assessed by RECIST 1.1 modified to follow a maximum of 10 target lesions with a maximum of 5 target lesions per organ. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Percentage of Participants Who Experienced a Dose-limiting Toxicity (DLT) Per Common Terminology Criteria for Adverse Events, Version 4.0 (CTCAE 4.0) | Cycle 1 (21-day cycle) | All participants who received at least 1 dose of study treatment and were either observed for safety for 21 days after the first dose of treatment or experienced a DLT prior to 21 days after the first dose of treatment | Percentage of participants | NUMBER |
| PRIMARY | Parts 1 and 2: Number of Participants Who Experienced One or More Adverse Events (AEs) | Up to approximately 2 years | All participants who received at least 1 dose of study treatment | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Parts 1 and 2: Number of Participants Who Discontinued Study Drug Due to an AE | Up to approximately 2 years | All participants who received at least 1 dose of study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Parts 1 and 2: Ulevostinag Area Under the Plasma Drug Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24) | Cycle 1 Day 1: Predose, at end of IT injection (up to 15 minutes) and 0.5, 1, 1.5, 4, 6, 12, and 24 hours postdose. Each cycle was 21 days. | All participants who complied with the protocol sufficiently to ensure that the data they generated were likely to exhibit the effects of treatment, according to the underlying scientific model | nM*hr | MEDIAN |
| SECONDARY | Parts 1 and 2: Ulevostinag Minimum Plasma Concentration (Cmin) | Cycle 1 Day 1: Predose, at end of IT injection (up to 15 minutes) and 0.5, 1, 1.5, 4, 6, 12, and 24 hours postdose; Cycle 2 Day 1: Predose, at end of IT injection (up to 15 minutes) and 0.5, 1, 1.5, 4, and 6 hours postdose. Each cycle was 21 days. | All participants who complied with the protocol sufficiently to ensure that the data they generated were likely to exhibit the effects of treatment, according to the underlying scientific model | ng/mL | MEDIAN |
| SECONDARY | Parts 1 and 2: Ulevostinag Maximum Plasma Concentration (Cmax) | Cycle 1 Day 1: Predose, at end of IT injection (up to 15 minutes) and 0.5, 1, 1.5, 4, 6, 12, and 24 hours postdose; Cycle 2 Day 1: Predose, at end of IT injection (up to 15 minutes) and 0.5, 1, 1.5, 4, and 6 hours postdose. Each cycle was 21 days. | All participants who complied with the protocol sufficiently to ensure that the data they generated were likely to exhibit the effects of treatment, according to the underlying scientific model | nM | MEDIAN |
| SECONDARY | Parts 1 and 2: Pembrolizumab Minimum Plasma Concentration (Cmin) | Predose on Day 1 of Cycles 1, 2, and 4, and every 4 cycles thereafter up to Cycle 35 (up to 2 years). Each cycle was 21 days. | All participants who complied with the protocol sufficiently to ensure that the data they generated were likely to exhibit the effects of treatment, according to the underlying scientific model | ng/mL | MEDIAN |
| SECONDARY | Parts 1 and 2: Objective Response Rate (ORR) As Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to approximately 2 years | All participants with a baseline scan that demonstrated measurable disease by investigator assessment, and who received a dose of study medicine | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group37
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1: Percentage of Participants Who Experienced a Dose-limiting Toxicity (DLT) Per Common Terminology Criteria for Adverse Events, Version 4.0 (CTCAE 4.0) | Part 1 Arm 1: Ulevostinag (Cut/Subcut Lesions) | 15.1 | 80% Confidence Interval 6.6 to 21.8 | Percentage of participants | |
| Part 1: Percentage of Participants Who Experienced a Dose-limiting Toxicity (DLT) Per Common Terminology Criteria for Adverse Events, Version 4.0 (CTCAE 4.0) | Part 1 Arm 2: Ulevostinag+Pembro (Cut/Subcut Lesions) | 10.4 | 80% Confidence Interval 5.3 to 14.5 | Percentage of participants | |
| Part 1: Percentage of Participants Who Experienced a Dose-limiting Toxicity (DLT) Per Common Terminology Criteria for Adverse Events, Version 4.0 (CTCAE 4.0) | Part 1 Arm 3: Ulevostinag+Pembro (Visceral Lesions) | 0 | 80% Confidence Interval 0.0 to 6.0 | Percentage of participants | |
| Parts 1 and 2: Number of Participants Who Experienced One or More Adverse Events (AEs) | Part 1 Arm 1: Ulevostinag (Cut/Subcut Lesions) | 32 | Participants | ||
| Parts 1 and 2: Number of Participants Who Experienced One or More Adverse Events (AEs) | Part 1 Arm 2: Ulevostinag+Pembro (Cut/Subcut Lesions) | 66 | Participants | ||
| Parts 1 and 2: Number of Participants Who Experienced One or More Adverse Events (AEs) | Part 1 Arm 3: Ulevostinag+Pembro (Visceral Lesions) | 26 | Participants | ||
| Parts 1 and 2: Number of Participants Who Experienced One or More Adverse Events (AEs) | Part 2 Cohort A: HNSCC Anti-PD-1/PD-L1 Refractory | 21 | Participants | ||
| Parts 1 and 2: Number of Participants Who Experienced One or More Adverse Events (AEs) | Part 2 Cohort B: Anti-PD-1/PD-L1 TrT-Naïve or Refractory TNBC | 25 | Participants | ||
| Parts 1 and 2: Number of Participants Who Discontinued Study Drug Due to an AE | Part 1 Arm 1: Ulevostinag (Cut/Subcut Lesions) | 3 | Participants | ||
| Parts 1 and 2: Number of Participants Who Discontinued Study Drug Due to an AE | Part 1 Arm 2: Ulevostinag+Pembro (Cut/Subcut Lesions) | 7 | Participants |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part 1 Arm 1: Ulevostinag (Cut/Subcut Lesions) | 32 | |
| Overall Study | STARTED | Part 1 Arm 2: Ulevostinag+Pembro (Cut/Subcut Lesions) | 52 | |
| Overall Study | STARTED | Part 1 Arm 3: Ulevostinag+Pembro (Visceral Lesions) | 26 | |
| Overall Study | STARTED | Part 2 Cohort A: HNSCC Anti-PD-1/PD-L1 Refractory | 21 | |
| Overall Study | STARTED | Part 2 Cohort B: Anti-PD-1/PD-L1 TrT-Naïve or Refractory TNBC | 25 | |
| Overall Study | STARTED | Part 2 Cohort C: Anti-PD-1/PD-L1 TrT-Naïve Solid Tumors-Liver | 0 | |
| Overall Study | Treated | Part 1 Arm 1: Ulevostinag (Cut/Subcut Lesions) | 32 | |
| Overall Study | Treated | Part 1 Arm 2: Ulevostinag+Pembro (Cut/Subcut Lesions) | 52 | |
| Overall Study | Treated | Part 1 Arm 3: Ulevostinag+Pembro (Visceral Lesions) | 26 | |
| Overall Study | Treated | Part 2 Cohort A: HNSCC Anti-PD-1/PD-L1 Refractory | 21 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events845
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 | Anaemia | Blood and lymphatic system disorders | Part 1 Arm 1: Ulevostinag (Cut/Subcut Lesions) | 14 | 32 | 17 |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 Arm 2: Ulevostinag+Pembro (Cut/Subcut Lesions) | 27 | 66 | 42 |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 Arm 3: Ulevostinag+Pembro (Visceral Lesions) | 6 | 26 | 11 |
| other | Anaemia | Blood and lymphatic system disorders | Part 2 Cohort A: HNSCC Anti-PD-1/PD-L1 Refractory | 11 | 21 | 14 |
| other | Anaemia | Blood and lymphatic system disorders | Part 2 Cohort B: Anti-PD-1/PD-L1 TrT-Naïve or Refractory TNBC | 7 | 25 | 9 |
| other | Leukocytosis | Blood and lymphatic system disorders | Part 1 Arm 1: Ulevostinag (Cut/Subcut Lesions) | 2 | 32 | 2 |
| other | Leukocytosis | Blood and lymphatic system disorders | Part 1 Arm 2: Ulevostinag+Pembro (Cut/Subcut Lesions) | 1 | 66 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Part 1 Arm 3: Ulevostinag+Pembro (Visceral Lesions) | 1 | 26 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Part 2 Cohort A: HNSCC Anti-PD-1/PD-L1 Refractory | 0 | 21 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Part 2 Cohort B: Anti-PD-1/PD-L1 TrT-Naïve or Refractory TNBC | 0 | 25 | 0 |
1 to 10 of 845Source ClinicalTrials.gov
See all 845 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1 Arm 1: Ulevostinag (Cut/Subcut Lesions) | 21 | 32 |
| Total, all-cause mortality | Part 1 Arm 2: Ulevostinag+Pembro (Cut/Subcut Lesions) | 45 | 66 |
| Total, all-cause mortality | Part 1 Arm 3: Ulevostinag+Pembro (Visceral Lesions) | 19 | 26 |
| Total, all-cause mortality | Part 2 Cohort A: HNSCC Anti-PD-1/PD-L1 Refractory | 19 | 21 |
| Total, all-cause mortality | Part 2 Cohort B: Anti-PD-1/PD-L1 TrT-Naïve or Refractory TNBC | 15 | 25 |
| Total, other adverse events | Part 1 Arm 1: Ulevostinag (Cut/Subcut Lesions) | 32 | 32 |
| Total, other adverse events | Part 1 Arm 2: Ulevostinag+Pembro (Cut/Subcut Lesions) | 65 | 66 |
| Total, other adverse events | Part 1 Arm 3: Ulevostinag+Pembro (Visceral Lesions) | 26 | 26 |
| Total, other adverse events | Part 2 Cohort A: HNSCC Anti-PD-1/PD-L1 Refractory | 21 | 21 |
| Total, other adverse events | Part 2 Cohort B: Anti-PD-1/PD-L1 TrT-Naïve or Refractory TNBC | 25 | 25 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
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/NCT03010176
GET https://conductscience.org/api/trials/v1/NCT03010176/results?page=2