Trial · NCT03396445

Study of Boserolimab (MK-5890) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)

NCT03396445, Phase 1, Completed, Merck Sharp & Dohme LLC; results first posted 2025-11-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Boserolimab (MK-5890) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001). Trials, record NCT03396445. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03396445

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Boserolimab (MK-5890) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)
NCT number: NCT03396445
Status: Completed
Phases: Phase 1
Enrollment: 182 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Pharmacokinetics, Solid Tumor, Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms
Interventions: Boserolimab, Pembrolizumab, Pemetrexed, Carboplatin, Nab-paclitaxel
First posted: 2018-01-11
Last updated: 2025-11-05
Other registries' IDs: eudract:2017-004550-41
Results first posted: 2025-11-05

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT)	Up to 21 days in Cycle 1	DLTs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. A DLT was defined as any of the following events: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Grade 4 thrombocytopenia; Grade 3 thrombocytopenia requiring a platelet transfusion; Nonhematologic adverse event (AE) Grade ≥3, with exceptions; Grade 3 or 4 nonhematologic laboratory abnormality; Prolonged delay (\>2 weeks) in initiating Cycle 2 due to treatment-related toxicity; Treatment-related toxicity resulting in study drug discontinuation during the DLT evaluation period; Missing \>25% of any study drug during the DLT evaluation period due to a treatment-related AE; or Grade 5 toxicity. The number of participants who experienced one or more DLTs is reported.
Primary	Number of Participants With One or More AEs	Up to approximately 78 months	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced one or more AEs is reported.
Primary	Number of Participants Who Discontinued Study Treatment Due to an AE	Up to 23 months	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study treatment due to an AE is reported.
Secondary	Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) of Boserolimab	Predose Day 1 Cycle 1 and at designated timepoints up to Day 1 Cycle 2	AUC0-last was defined as the area under the concentration versus time curve for boserolimab from 0 to the time of the last quantifiable concentration in serum. Samples were taken predose and at specified times postdose to determine the AUC0-last of boserolimab. PK collection time frames include: Arms 1, 2 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 5, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 1a, 2a, 2b, 3 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 2c and 4 (Cycle = 6 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15, 22 of Cycle 1, and predose on Day 1 of Cycle 2.
Secondary	Area Under the Concentration-Time Curve From Time 0 to 3 Weeks (AUC0-3w) of Boserolimab	Predose Day 1 Cycle 1 and at designated timepoints up to Day 1 Cycle 2	AUC0-3w was defined as the area under the concentration versus time curve for boserolimab from 0 to 3 weeks in serum. Samples were taken predose and at specified times postdose to determine the AUC0-3w of boserolimab. PK collection time frames include: Arms 1, 2 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 5, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 1a, 2a, 2b, 3 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 2c and 4 (Cycle = 6 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15, 22 of Cycle 1.
Secondary	Area Under the Concentration-Time Curve From Time 0 to 6 Weeks (AUC0-6w) of Boserolimab	Arms 2c and 4 (Cycle = 6 weeks): Predose, at start & end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15, 22 of Cycle 1, and predose on Day 1 Cycle 2	AUC0-6w was defined as the area under the concentration versus time curve for boserolimab from 0 to 6 weeks in serum. Samples were taken predose and at specified times postdose to determine the AUC0-6w of boserolimab. As pre-specified in the protocol, different arms had different sampling schedules and cycle lengths and therefore AUC0-6w was not analyzed for all Arms; AUC0-6w was only analyzed for Arms 2c and 4 which had 6-week cycles.
Secondary	Minimum Concentration (Cmin) of Boserolimab	Predose Day 1 Cycle 1 and at designated timepoints up to Day 1 Cycle 2	Cmin of boserolimab was defined as the minimum concentration of boserolimab observed in serum. Samples were taken predose and at specified times postdose to determine the Cmin of boserolimab. PK collection time frames include: Arms 1, 2 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 5, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 1a, 2a, 2b, 3 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 2c and 4 (Cycle = 6 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15, 22 of Cycle 1, and predose on Day 1 of Cycle 2.
Secondary	Maximum Concentration (Cmax) of Boserolimab	Predose Day 1 Cycle 1 and at designated timepoints up to Day 1 Cycle 2	Cmax of boserolimab was defined as the maximum concentration of boserolimab observed in serum. Samples were taken predose and at specified times postdose to determine the Cmax of boserolimab. PK collection time frames include: Arms 1, 2 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 5, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 1a, 2a, 2b, 3 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 2c and 4 (Cycle = 6 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15, 22 of Cycle 1, and predose on Day 1 of Cycle 2.
Secondary	Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	Up to approximately 78 months	ORR was defined as the percentage of participants who had 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) as assessed using RECIST 1.1. As pre-specified in the protocol, ORR was analyzed for participants treated with boserolimab when used as monotherapy in Arm 1a, in combination with pembrolizumab in Switch-over Arm 1a and Arms 2a, 2b, and 2c, or in combination with pembrolizumab + nab-paclitaxel in Arm 4. Per protocol, ORR was not analyzed in Arms 1, 2, or 3. The percentage of participants who experienced a CR or PR, as assessed by the investigator, is reported.
Secondary	Arm 3: Number of Participants Who Experienced a DLT	Up to 21 days in Cycle 1	DLTs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. A DLT was defined as any of the following events: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Grade 4 thrombocytopenia; Grade 3 thrombocytopenia requiring a platelet transfusion; Nonhematologic adverse event (AE) Grade ≥3, with exceptions; Grade 3 or 4 nonhematologic laboratory abnormality; Prolonged delay (\>2 weeks) in initiating Cycle 2 due to treatment-related toxicity; Treatment-related toxicity resulting in study drug discontinuation during the DLT evaluation period; Missing \>25% of any study drug during the DLT evaluation period due to a treatment-related AE; or Grade 5 toxicity. The number of participants who experienced one or more DLTs in Arm 3 is reported

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
SECONDARY	Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) of Boserolimab	Predose Day 1 Cycle 1 and at designated timepoints up to Day 1 Cycle 2	All participants who complied with the protocol sufficiently to ensure that the data was likely to exhibit the effects of treatment, according to the underlying scientific model, and who had available AUC0-last data from ≥1 study treatment. As pre-specified in the protocol, PK outcomes were not analyzed separately for the Switch-over Arms.	day*μg/mL	GEOMETRIC_MEAN
PRIMARY	Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT)	Up to 21 days in Cycle 1	All participants in Arms 1, 1a, 2, 2a, 2b, 2c, and Switch-over Arms who received ≥1 dose of study treatment and who were observed for DLTs for up to 21 days following the first dose of study treatment in Cycle 1. As pre-specified in the protocol, DLTs were analyzed separately for the Switch-over Arms.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With One or More AEs	Up to approximately 78 months	All participants in Arms 1, 1a, 2, 2a, 2b, 2c, and Switch-over Arms who received ≥1 dose of study treatment. As pre-specified in the protocol, safety data were analyzed separately for the Switch-over Arms.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants Who Discontinued Study Treatment Due to an AE	Up to 23 months	All participants in Arms 1, 1a, 2, 2a, 2b, 2c, and Switch-over Arms who received ≥1 dose of study treatment. As pre-specified in the protocol, safety data were analyzed separately for the Switch-over Arms.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Area Under the Concentration-Time Curve From Time 0 to 3 Weeks (AUC0-3w) of Boserolimab	Predose Day 1 Cycle 1 and at designated timepoints up to Day 1 Cycle 2	All participants who complied with the protocol sufficiently to ensure that the data was likely to exhibit the effects of treatment, according to the underlying scientific model, and who had available AUC0-3w data from ≥1 study treatment. As pre-specified in the protocol, PK outcomes were not analyzed separately for the Switch-over Arms.	day*μg/mL	GEOMETRIC_MEAN
SECONDARY	Area Under the Concentration-Time Curve From Time 0 to 6 Weeks (AUC0-6w) of Boserolimab	Arms 2c and 4 (Cycle = 6 weeks): Predose, at start & end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15, 22 of Cycle 1, and predose on Day 1 Cycle 2	All participants in Arms 2c and 4 who complied with the protocol sufficiently to ensure that the data was likely to exhibit the effects of treatment, according to the underlying scientific model, and who had available AUC0-6w data from ≥1 study treatment. As pre-specified in the protocol, PK outcomes were not analyzed separately for the Switch-over Arms.	day*μg/mL	GEOMETRIC_MEAN
SECONDARY	Minimum Concentration (Cmin) of Boserolimab	Predose Day 1 Cycle 1 and at designated timepoints up to Day 1 Cycle 2	All participants who complied with the protocol sufficiently to ensure that the data was likely to exhibit the effects of treatment, according to the underlying scientific model, and who had available Cmin data from ≥1 study treatment. As pre-specified in the protocol, PK outcomes were not analyzed separately for the Switch-over Arms.	μg/mL	MEAN
SECONDARY	Maximum Concentration (Cmax) of Boserolimab	Predose Day 1 Cycle 1 and at designated timepoints up to Day 1 Cycle 2	All participants who complied with the protocol sufficiently to ensure that the data was likely to exhibit the effects of treatment, according to the underlying scientific model, and who had available Cmax data from ≥1 study treatment. As pre-specified in the protocol, PK outcomes were not analyzed separately for the Switch-over Arms.	μg/mL	GEOMETRIC_MEAN
SECONDARY	Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	Up to approximately 78 months	All participants in Arm 1a, 2a, 2b, 2c, 4, and Switch-over Arm 1a with a baseline scan who demonstrated measurable disease by investigator assessment, and who were administered at least 1 dose of study treatment.	Percentage of Participants	NUMBER
SECONDARY	Arm 3: Number of Participants Who Experienced a DLT	Up to 21 days in Cycle 1	All participants in Arm 3 who received ≥1 dose of study treatment and who were observed for DLTs for up to 21 days following the first dose of study treatment in Cycle 1.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group154

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) of Boserolimab	Arm 1 Boserolimab 2 mg Q3W	0.761	Geometric Coefficient of Variation 179	day*μg/mL
Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) of Boserolimab	Arm 1 Boserolimab 7 mg Q3W	7.61	Geometric Coefficient of Variation NA	day*μg/mL
Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) of Boserolimab	Arm 1 Boserolimab 20 mg Q3W	44.4	Geometric Coefficient of Variation 28.6	day*μg/mL
Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) of Boserolimab	Arm 1 Boserolimab 70 mg Q3W	150	Geometric Coefficient of Variation 14.2	day*μg/mL
Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) of Boserolimab	Arm 1 Boserolimab 200 mg Q3W	469	Geometric Coefficient of Variation 42.9	day*μg/mL
Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) of Boserolimab	Arm 1 Boserolimab 700 mg Q3W	918	Geometric Coefficient of Variation 21.4	day*μg/mL
Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) of Boserolimab	Arm 1a Boserolimab 30 mg Q3W (Endometrial)	44.4	Geometric Coefficient of Variation 51.7	day*μg/mL
Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) of Boserolimab	Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W	0.816	Geometric Coefficient of Variation 20.8	day*μg/mL
Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) of Boserolimab	Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W	3.9	Geometric Coefficient of Variation 117	day*μg/mL
Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) of Boserolimab	Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W	26.1	Geometric Coefficient of Variation 38.5	day*μg/mL

1 to 10 of 154Source ClinicalTrials.gov

See all 154 results by group

Participant flow208

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment Period	STARTED	Arm 1 Boserolimab 2 mg Q3W	3
Treatment Period	STARTED	Arm 1 Boserolimab 7 mg Q3W	3
Treatment Period	STARTED	Arm 1 Boserolimab 20 mg Q3W	6
Treatment Period	STARTED	Arm 1 Boserolimab 70 mg Q3W	3
Treatment Period	STARTED	Arm 1 Boserolimab 200 mg Q3W	9
Treatment Period	STARTED	Arm 1 Boserolimab 700 mg Q3W	2
Treatment Period	STARTED	Arm 1a Boserolimab 30 mg Q3W (Endometrial)	14
Treatment Period	STARTED	Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W	3
Treatment Period	STARTED	Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W	3
Treatment Period	STARTED	Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W	4

1 to 10 of 208Source ClinicalTrials.gov

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Adverse events8,840

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	Arm 1 Boserolimab 2 mg Q3W	0	3	0
other	Anaemia	Blood and lymphatic system disorders	Arm 1 Boserolimab 7 mg Q3W	0	3	0
other	Anaemia	Blood and lymphatic system disorders	Arm 1 Boserolimab 20 mg Q3W	0	6	0
other	Anaemia	Blood and lymphatic system disorders	Arm 1 Boserolimab 70 mg Q3W	0	3	0
other	Anaemia	Blood and lymphatic system disorders	Arm 1 Boserolimab 200 mg Q3W	0	8	0
other	Anaemia	Blood and lymphatic system disorders	Arm 1 Boserolimab 700 mg Q3W	0	2	0
other	Anaemia	Blood and lymphatic system disorders	Arm 1a Boserolimab 30 mg Q3W (Endometrial)	2	14	2
other	Anaemia	Blood and lymphatic system disorders	Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W	0	3	0
other	Anaemia	Blood and lymphatic system disorders	Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W	0	3	0
other	Anaemia	Blood and lymphatic system disorders	Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W	1	3	2

1 to 10 of 8,840Source ClinicalTrials.gov

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Adverse event totals78

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm 1 Boserolimab 2 mg Q3W	2	3
Total, all-cause mortality	Arm 1 Boserolimab 7 mg Q3W	2	3
Total, all-cause mortality	Arm 1 Boserolimab 20 mg Q3W	1	6
Total, all-cause mortality	Arm 1 Boserolimab 70 mg Q3W	1	3
Total, all-cause mortality	Arm 1 Boserolimab 200 mg Q3W	3	9
Total, all-cause mortality	Arm 1 Boserolimab 700 mg Q3W	2	2
Total, all-cause mortality	Arm 1a Boserolimab 30 mg Q3W (Endometrial)	5	14
Total, all-cause mortality	Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W	3	3
Total, all-cause mortality	Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W	3	3
Total, all-cause mortality	Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W	4	4

1 to 10 of 78Source ClinicalTrials.gov

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Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Arm 3 Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W + Pemetrexed + Carboplatin (NSCLC) vs Arm 4 Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W + Nab-paclitaxel (TNBC): Arm 3 and 4: Number of Participants Who Discontinued Study Treatment Due to an AE	Trial comparisons
Arm 3 Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W + Pemetrexed + Carboplatin (NSCLC) vs Arm 4 Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W + Nab-paclitaxel (TNBC): Arm 3 and 4: Number of Participants With One or More AEs	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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