18 and older, any sex, with Solid Tumors. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants Experiencing Dose Limiting ToxicitiesPrimary· Cycle 1 (3-week Cycle) (Up to 3 weeks)
A dose limiting toxicity (DLT) is defined as any hematologic or non-hematologic toxicity ≥Grade 3 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. The occurrence of any of the designated toxicities during Cycle 1 (3-week cycle) were considered a DLT, if assessed by the investigator to be possibly, probably, or definitely related to study treatment administration. The number of participants experiencing DLTs was assessed.
Group
Value
95% CI
MK-8353 50 mg + Selumetinib 25 mg
0
MK-8353 100 mg + Selumetinib 50 mg
1
MK-8353 150 mg + Selumetinib 75 mg
7
Number of Participants Experiencing Adverse EventsPrimary· ~90 days after last treatment dose (up to ~45 weeks)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants experiencing AEs was assessed.
Group
Value
95% CI
MK-8353 50 mg + Selumetinib 25 mg
3
MK-8353 100 mg + Selumetinib 50 mg
12
MK-8353 150 mg + Selumetinib 75 mg
15
Number of Participants Discontinuing Study Treatment Due to AEsPrimary· Up to ~33 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants discontinuing study treatment due to AEs was assessed.
Group
Value
95% CI
MK-8353 50 mg + Selumetinib 25 mg
0
MK-8353 100 mg + Selumetinib 50 mg
3
MK-8353 150 mg + Selumetinib 75 mg
1
Area Under the Plasma Concentration-Time Curve for MK-8353 From Time 0 to 12 HoursSecondary· Study Days 1 and 4 of Cycle 1 (3-week cycle) at pre-dose and at 1, 2, 4, 6 hours, and between 8 and 12 hours post-dose
Blood samples were collected to determine the area under the curve from time 0 to 12 hours (AUC0-12). AUC is a measure of the amount of drug in the blood over time.
MK-8353, Cycle 1, Day 1
Group
Value
95% CI
MK-8353 50 mg + Selumetinib 25 mg
14.3
± 62.7
MK-8353 100 mg + Selumetinib 50 mg
9.66
± 50.7
MK-8353 150 mg + Selumetinib 75 mg
13.7
± 32.8
MK-8353, Cycle 1, Day 4
Group
Value
95% CI
MK-8353 50 mg + Selumetinib 25 mg
16.7
± 365.7
MK-8353 100 mg + Selumetinib 50 mg
19.0
± 36.9
MK-8353 150 mg + Selumetinib 75 mg
20.9
± 60.6
AUC0-12 for SelumetinibSecondary· Study Days 1 and 4 of Cycle 1 (3-week cycle) at pre-dose and at 1, 2, 4, 6 hours, and between 8 and 12 hours post-dose
Blood samples were collected to determine the AUC0-12. AUC is a measure of the amount of drug in the blood over time.
Selumetinib, Cycle 1, Day 1
Group
Value
95% CI
MK-8353 50 mg + Selumetinib 25 mg
2.99
± 27.2
MK-8353 100 mg + Selumetinib 50 mg
5.20
± 63.2
MK-8353 150 mg + Selumetinib 75 mg
10.9
± 49.1
Selumetinib, Cycle 1, Day 4
Group
Value
95% CI
MK-8353 50 mg + Selumetinib 25 mg
3.80
± 24.6
MK-8353 100 mg + Selumetinib 50 mg
6.28
± 75.3
MK-8353 150 mg + Selumetinib 75 mg
12.7
± 31.5
Minimum Observed Plasma Concentration for MK-8353Secondary· Study Days 1 and 4 of Cycles 1 and 2 (3-week cycles). For Cycle 1, pre-dose and at 1, 2, 4, 6 hours, and between 8 and 12 hours post-dose; and for Cycle 2 pre-dose, and at 1 and 4 hours post-dose
Blood samples were collected to determine the minimum observed plasma concentration (Cmin) which is the minimum amount of drug in the plasma after the dose is given. In cases where Cmin values were below the limit of quantification (BLOQ), arithmetic mean (percent coefficient of variation \[%CV\]) was reported instead of geometric mean (percent geometric coefficient of variation \[%GCV\]), since geometric mean (%GCV) was not calculable. In cases where all Cmin values were BLOQ, mean was not calculable and indicated as "NA."
MK-8353, Cycle 1, Day 1
Group
Value
95% CI
MK-8353 50 mg + Selumetinib 25 mg
NA
± NA
MK-8353 100 mg + Selumetinib 50 mg
NA
± NA
MK-8353 150 mg + Selumetinib 75 mg
NA
± NA
MK-8353, Cycle 1 Day 4
Group
Value
95% CI
MK-8353 50 mg + Selumetinib 25 mg
0.695
± 222.6
MK-8353 100 mg + Selumetinib 50 mg
1.10
± 50.6
MK-8353 150 mg + Selumetinib 75 mg
1.47
± 455.5
MK-8353, Cycle 2 Day 1
Group
Value
95% CI
MK-8353 50 mg + Selumetinib 25 mg
0.0361
± 173.2
MK-8353 100 mg + Selumetinib 50 mg
0.0313
± 191.0
MK-8353 150 mg + Selumetinib 75 mg
0.0166
± 189.7
MK-8353, Cycle 2 Day 4
Group
Value
95% CI
MK-8353 50 mg + Selumetinib 25 mg
0.598
± 172.6
MK-8353 100 mg + Selumetinib 50 mg
0.995
± 90.7
MK-8353 150 mg + Selumetinib 75 mg
1.47
± 84.8
Cmin for SelumetinibSecondary· Study Days 1 and 4 of Cycles 1 and 2 (3-week cycles). For Cycle 1, pre-dose and at 1, 2, 4, 6 hours, and between 8 and 12 hours post-dose; and for Cycle 2 pre-dose, and at 1 and 4 hours post-dose
Blood samples were collected to determine the Cmin which is the minimum amount of drug in the plasma after the dose is given. In cases where Cmin values were BLOQ, arithmetic mean (%CV) was reported instead of geometric mean (%GCV), since geometric mean (%GCV) was not calculable. In cases where all Cmin values were BLOQ, mean was not calculable and indicated as "NA."
Selumetinib, Cycle 1, Day 1
Group
Value
95% CI
MK-8353 50 mg + Selumetinib 25 mg
NA
± NA
MK-8353 100 mg + Selumetinib 50 mg
NA
± NA
MK-8353 150 mg + Selumetinib 75 mg
NA
± NA
Selumetinib, Cycle 1, Day 4
Group
Value
95% CI
MK-8353 50 mg + Selumetinib 25 mg
0.101
± 35.1
MK-8353 100 mg + Selumetinib 50 mg
0.265
± 38.9
MK-8353 150 mg + Selumetinib 75 mg
0.456
± 160.1
Selumetinib, Cycle 2, Day 1
Group
Value
95% CI
MK-8353 50 mg + Selumetinib 25 mg
NA
± NA
MK-8353 100 mg + Selumetinib 50 mg
0.00202
± 232.9
MK-8353 150 mg + Selumetinib 75 mg
0.00124
± 215.7
Selumetinib, Cycle 2, Day 4
Group
Value
95% CI
MK-8353 50 mg + Selumetinib 25 mg
0.127
± 74.6
MK-8353 100 mg + Selumetinib 50 mg
0.174
± 80.3
MK-8353 150 mg + Selumetinib 75 mg
0.257
± 47.5
Maximum Observed Plasma Concentration for MK-8353Secondary· Study Days 1 and 4 of Cycle 1 (3-week cycle) at pre-dose and at 1, 2, 4, 6 hours, and between 8 and 12 hours post-dose
Blood samples were collected to determine the maximum observed plasma concentration (Cmax) which is the measure of the maximum amount of drug in the plasma after the dose is given.
MK-8353, Cycle 1, Day 1
Group
Value
95% CI
MK-8353 50 mg + Selumetinib 25 mg
1.24
± 138.4
MK-8353 100 mg + Selumetinib 50 mg
1.65
± 60.9
MK-8353 150 mg + Selumetinib 75 mg
2.95
± 62.3
MK-8353, Cycle 1, Day 4
Group
Value
95% CI
MK-8353 50 mg + Selumetinib 25 mg
1.87
± 149.4
MK-8353 100 mg + Selumetinib 50 mg
2.53
± 51.5
MK-8353 150 mg + Selumetinib 75 mg
3.61
± 80.9
Cmax for SelumetinibSecondary· Study Days 1 and 4 of Cycle 1 (3-week cycle) at pre-dose and at 1, 2, 4, 6 hours, and between 8 and 12 hours post-dose
Blood samples were collected to determine the Cmax which is the measure of the maximum amount of drug in the plasma after the dose is given.
Selumetinib, Cycle 1,Day 1
Group
Value
95% CI
MK-8353 50 mg + Selumetinib 25 mg
1.01
± 29.7
MK-8353 100 mg + Selumetinib 50 mg
1.96
± 91.1
MK-8353 150 mg + Selumetinib 75 mg
3.37
± 57.1
Selumetinib, Cycle 1, Day 4
Group
Value
95% CI
MK-8353 50 mg + Selumetinib 25 mg
1.04
± 13.3
MK-8353 100 mg + Selumetinib 50 mg
1.44
± 123.6
MK-8353 150 mg + Selumetinib 75 mg
2.37
± 107.5
Adverse events — posted to ClinicalTrials.gov
Time frame: Non-serious adverse events (NSAEs): Up to ~45 weeks; Serious adverse events (SAEs): Up to ~45 weeks. All-cause mortality: Up to 24 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
MK-8353 50 mg + Selumetinib 25 mg
Serious: 0/3 (0%)
Deaths: 3/3
MK-8353 100 mg + Selumetinib 50 mg
Serious: 3/12 (25%)
Deaths: 8/12
MK-8353 150 mg + Selumetinib 75 mg
Serious: 4/15 (27%)
Deaths: 6/15
Serious adverse events (11 terms)
Reaction
System
MK-8353 50 mg + Selumetini…
MK-8353 100 mg + Selumetin…
MK-8353 150 mg + Selumetin…
Vomiting
Gastrointestinal disorders
—
—
—
Pneumonia
Infections and infestations
—
—
—
Anaemia
Blood and lymphatic system disorders
—
—
—
Ascites
Gastrointestinal disorders
—
—
—
Diarrhoea
Gastrointestinal disorders
—
—
—
Duodenal obstruction
Gastrointestinal disorders
—
—
—
Large intestinal obstruction
Gastrointestinal disorders
—
—
—
Abdominal infection
Infections and infestations
—
—
—
Sepsis
Infections and infestations
—
—
—
Dyspnoea
Respiratory, thoracic and mediastinal disorders
—
—
—
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
—
—
—
Other adverse events (103 terms — click to expand)
This is a multicenter, worldwide, open-label study of MK-8353 in combination with selumetinib in participants with histologically or cytologically confirmed diagnosis of advanced solid tumor. This study will evaluate the safety, tolerability, and exploratory efficacy of MK-8353 in combination with selumetinib.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02972034 — Study of MK-8353 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Malignancies (MK-8353-013)
· Phase 1
· terminated
NCT01358331 — A Study of the Safety, Tolerability, and Efficacy of MK-8353 in Participants With Advanced Solid Tumors (MK-8353-001)
· Phase 1
· terminated
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 27 July 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03745989.