CompletedNCT03745989Updated Jul 27, 2023Results posted

Study of MK-8353 + Selumetinib in Advanced/Metastatic Solid Tumors (MK-8353-014)

A Phase 1 interventional study of MK-8353 and Selumetinib in Solid Tumors, sponsored by Merck Sharp & Dohme LLC. Completed at 5 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-27.

Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 30
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

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.

Read the detailed description

As specified by Phase 1 protocol-flexible language, modifications to the dose or dosing regimen can be made to achieve the scientific goals of the trial objectives and/or ensure appropriate safety of the trial participants. The proposed doses may be adjusted based on evaluation of safety, tolerability, and pharmacokinetic data.

Conditions studied

Solid Tumors

Browse trials for

Neoplasms 9,365

Keywords

advanced/metastatic
solid tumors
Selumetinib

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 30 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Have a histologically- or cytologically-documented, locally-advanced or metastatic solid tumor by pathology report and have received, or been intolerant to, all treatment known to confer clinical benefit.
Provide an archival or newly obtained tumor tissue sample and blood samples for assessment of proto-oncogene rat sarcoma virus (RAS)/rapidly accelerated fibrosarcoma (RAF) mutation and for biomarker analysis.
Have at least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) on imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]) as assessed by the investigator/local radiology review.
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. (Obtain within 7 days prior to first dose of study treatment.)
Have the ability to swallow and retain oral medication.
Demonstrate adequate organ function.
Male participants must agree to use an acceptable contraception during the treatment period and for at least 120 days after the last dose of study intervention and refrain from donating sperm during this period.
Female participants must not be pregnant, not breastfeeding, and either not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the study's contraceptive guidance during the treatment period and for at least 120 days, after the last dose of study intervention.

Exclusion criteria

Exclusion Criteria:

Have had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) prior to the first dose of study treatment, or has not recovered to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier (this includes participants with previous immunomodulatory therapy with residual immune-related AEs).
Have clinically active central nervous system metastases and/or carcinomatous meningitis.
Have an active infection requiring therapy.
Have known human immunodeficiency virus (HIV) and/or Hepatitis B or C infections, or known to be positive for Hepatitis B antigen (HBsAg)/ Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) or Hepatitis C Antibody or ribonucleic acid (RNA).
Have clinically significant cardiovascular disease as defined by study criteria.
Have a history of thromboembolic or cerebrovascular events within 6 months prior to treatment start, including transient ischemic attacks (TIAs), cerebrovascular accidents (CVAs), deep vein thrombosis, or pulmonary embolism.
Have neuromuscular disorders associated with an elevated creatine kinase (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).
Have one or more study-defined ophthalmological findings/conditions.
Have a known history of Gilbert's Syndrome.
Have a history or current evidence of a gastrointestinal (GI) condition (e.g., inflammatory bowel disease, Crohn's disease, ulcerative colitis) or impaired liver function or diseases that in the opinion of the investigator may significantly alter the absorption or metabolism of oral medications.
Have a known psychiatric or substance abuse disorder, or any other cognitive disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the Screening Visit through 120 days after the last dose of study treatment.
Received prior therapy with a mitogen activated protein kinase (MEK) inhibitor (e.g., cobimetinib, trametinib), or an extracellular signal-regulated kinase (ERK) inhibitor (e.g., MK-8353, GCD-0994, ulixertinib), or a proto-oncogene BRAF inhibitor (e.g., dabrafenib, vemurafenib).
Is currently participating and receiving study treatment in a study of an investigational agent or has participated and received study treatment in a study of an investigational agent or has used an investigational device within 28 days of administration of selumetinib.
Have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to agents and/or excipients used in the study.
A WOCBP who has a positive urine pregnancy test within 24 hours before the first dose of study treatment

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 30 participants (actual)

Study arms

Experimental
MK-8353 and Selumetinib Dose Escalation
Participants will receive a combination MK-8353 and selumetinib for 4 days on and 3 days off until disease progression or discontinuation. MK-8353 will be escalated sequentially from 50 mg to 250 mg based on pharmacokinetic and safety data. Selumetinib will be escalated sequentially from 25 mg to 75 mg based on pharmacokinetic and safety data. Doses may be adjusted downward sequentially based on tolerability
Drug: MK-8353 · Drug: Selumetinib

Interventions

DrugMK-8353
Participants will receive MK-8353 orally twice daily (BID), escalated sequentially from 50 mg to 250 mg.
DrugSelumetinib
Participants will receive selumetinib orally BID, escalated sequentially from 25 mg to 75 mg.
Also known as: MK-5618

What researchers measure

Primary outcomes

Number of Participants Experiencing Dose Limiting Toxicities
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.
Time frame: Cycle 1 (3-week Cycle) (Up to 3 weeks)
Number of Participants Experiencing Adverse Events
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.
Time frame: ~90 days after last treatment dose (up to ~45 weeks)
Number of Participants Discontinuing Study Treatment Due to AEs
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.
Time frame: Up to ~33 weeks

Secondary outcomes

Area Under the Plasma Concentration-Time Curve for MK-8353 From Time 0 to 12 Hours
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.
Time frame: 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
AUC0-12 for Selumetinib
Blood samples were collected to determine the AUC0-12. AUC is a measure of the amount of drug in the blood over time.
Time frame: 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
Minimum Observed Plasma Concentration for MK-8353
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."
Time frame: 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
Cmin for Selumetinib
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."
Time frame: 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
Maximum Observed Plasma Concentration for MK-8353
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.
Time frame: 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
Cmax for Selumetinib
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.
Time frame: 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

Results

Posted Jan 25, 2023

Participant flow

Participant flow — Overall Study
Milestone	MK-8353 50 mg + Selumetinib 25 mg	MK-8353 100 mg + Selumetinib 50 mg	MK-8353 150 mg + Selumetinib 75 mg
Started	3	12	15
Completed	0	0	0
Not completed	3	12	15
Withdrew: Death	3	7	4
Withdrew: Lost to follow-up	0	2	0
Withdrew: Sponsor decision	0	2	8
Withdrew: Withdrawal by subject	0	1	3

Outcome measures

PrimaryNumber of Participants Experiencing Dose Limiting Toxicities

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.

Time frame:: Cycle 1 (3-week Cycle) (Up to 3 weeks)
Reported as:: Count of participants · Participants

Number of Participants Experiencing Dose Limiting Toxicities
Participants	MK-8353 50 mg + Selumetinib 25 mg	MK-8353 100 mg + Selumetinib 50 mg	MK-8353 150 mg + Selumetinib 75 mg
Number of Participants Experiencing Dose Limiting Toxicities	0	1	7

PrimaryNumber of Participants Experiencing Adverse Events

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.

Time frame:: ~90 days after last treatment dose (up to ~45 weeks)
Reported as:: Count of participants · Participants

Number of Participants Experiencing Adverse Events
Participants	MK-8353 50 mg + Selumetinib 25 mg	MK-8353 100 mg + Selumetinib 50 mg	MK-8353 150 mg + Selumetinib 75 mg
Number of Participants Experiencing Adverse Events	3	12	15

PrimaryNumber of Participants Discontinuing Study Treatment Due to AEs

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.

Time frame:: Up to ~33 weeks
Reported as:: Count of participants · Participants

Number of Participants Discontinuing Study Treatment Due to AEs
Participants	MK-8353 50 mg + Selumetinib 25 mg	MK-8353 100 mg + Selumetinib 50 mg	MK-8353 150 mg + Selumetinib 75 mg
Number of Participants Discontinuing Study Treatment Due to AEs	0	3	1

SecondaryArea Under the Plasma Concentration-Time Curve for MK-8353 From Time 0 to 12 Hours

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.

Time frame:: 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
Reported as:: Geometric mean · hr*μmol/liter

Area Under the Plasma Concentration-Time Curve for MK-8353 From Time 0 to 12 Hours
hr*μmol/liter	MK-8353 50 mg + Selumetinib 25 mg	MK-8353 100 mg + Selumetinib 50 mg	MK-8353 150 mg + Selumetinib 75 mg
MK-8353, Cycle 1, Day 1	14.3 ± 62.7	9.66 ± 50.7	13.7 ± 32.8
MK-8353, Cycle 1, Day 4	16.7 ± 365.7	19.0 ± 36.9	20.9 ± 60.6

SecondaryAUC0-12 for Selumetinib

Blood samples were collected to determine the AUC0-12. AUC is a measure of the amount of drug in the blood over time.

Time frame:: 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
Reported as:: Geometric mean · hr*μmol/liter

AUC0-12 for Selumetinib
hr*μmol/liter	MK-8353 50 mg + Selumetinib 25 mg	MK-8353 100 mg + Selumetinib 50 mg	MK-8353 150 mg + Selumetinib 75 mg
Selumetinib, Cycle 1, Day 1	2.99 ± 27.2	5.20 ± 63.2	10.9 ± 49.1
Selumetinib, Cycle 1, Day 4	3.80 ± 24.6	6.28 ± 75.3	12.7 ± 31.5

SecondaryMinimum Observed Plasma Concentration for MK-8353

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."

Time frame:: 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
Reported as:: Geometric mean · μmol/liter

Minimum Observed Plasma Concentration for MK-8353
μmol/liter	MK-8353 50 mg + Selumetinib 25 mg	MK-8353 100 mg + Selumetinib 50 mg	MK-8353 150 mg + Selumetinib 75 mg
MK-8353, Cycle 1, Day 1	NA ± NA	NA ± NA	NA ± NA
MK-8353, Cycle 1 Day 4	0.695 ± 222.6	1.10 ± 50.6	1.47 ± 455.5
MK-8353, Cycle 2 Day 1	0.0361 ± 173.2	0.0313 ± 191.0	0.0166 ± 189.7
MK-8353, Cycle 2 Day 4	0.598 ± 172.6	0.995 ± 90.7	1.47 ± 84.8

SecondaryCmin for Selumetinib

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."

Time frame:: 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
Reported as:: Geometric mean · μmol/liter

Cmin for Selumetinib
μmol/liter	MK-8353 50 mg + Selumetinib 25 mg	MK-8353 100 mg + Selumetinib 50 mg	MK-8353 150 mg + Selumetinib 75 mg
Selumetinib, Cycle 1, Day 1	NA ± NA	NA ± NA	NA ± NA
Selumetinib, Cycle 1, Day 4	0.101 ± 35.1	0.265 ± 38.9	0.456 ± 160.1
Selumetinib, Cycle 2, Day 1	NA ± NA	0.00202 ± 232.9	0.00124 ± 215.7
Selumetinib, Cycle 2, Day 4	0.127 ± 74.6	0.174 ± 80.3	0.257 ± 47.5

SecondaryMaximum Observed Plasma Concentration for MK-8353

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.

Time frame:: 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
Reported as:: Geometric mean · μmol/liter

Maximum Observed Plasma Concentration for MK-8353
μmol/liter	MK-8353 50 mg + Selumetinib 25 mg	MK-8353 100 mg + Selumetinib 50 mg	MK-8353 150 mg + Selumetinib 75 mg
MK-8353, Cycle 1, Day 1	1.24 ± 138.4	1.65 ± 60.9	2.95 ± 62.3
MK-8353, Cycle 1, Day 4	1.87 ± 149.4	2.53 ± 51.5	3.61 ± 80.9

SecondaryCmax for Selumetinib

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.

Time frame:: 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
Reported as:: Geometric mean · μmol/liter

Cmax for Selumetinib
μmol/liter	MK-8353 50 mg + Selumetinib 25 mg	MK-8353 100 mg + Selumetinib 50 mg	MK-8353 150 mg + Selumetinib 75 mg
Selumetinib, Cycle 1,Day 1	1.01 ± 29.7	1.96 ± 91.1	3.37 ± 57.1
Selumetinib, Cycle 1, Day 4	1.04 ± 13.3	1.44 ± 123.6	2.37 ± 107.5

Adverse events

Collected over Non-serious adverse events (NSAEs): Up to ~45 weeks; Serious adverse events (SAEs): Up to ~45 weeks. All-cause mortality: Up to 24 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
MK-8353 50 mg + Selumetinib 25 mg	3/3 (100%)	0/3 (0%)	3/3 (100%)
MK-8353 100 mg + Selumetinib 50 mg	8/12 (66.7%)	3/12 (25%)	11/12 (91.7%)
MK-8353 150 mg + Selumetinib 75 mg	6/15 (40%)	4/15 (26.7%)	15/15 (100%)

Most frequent serious events

Showing 10 of 11

Most frequent serious events
Event	MK-8353 50 mg + Selumetinib 25 mg	MK-8353 100 mg + Selumetinib 50 mg	MK-8353 150 mg + Selumetinib 75 mg
VomitingGastrointestinal disorders	0/3	0/12	2/15
PneumoniaInfections and infestations	0/3	1/12	2/15
AnaemiaBlood and lymphatic system disorders	0/3	1/12	0/15
AscitesGastrointestinal disorders	0/3	1/12	0/15
Pneumonia aspirationRespiratory, thoracic and mediastinal disorders	0/3	1/12	0/15
DiarrhoeaGastrointestinal disorders	0/3	0/12	1/15
Duodenal obstructionGastrointestinal disorders	0/3	0/12	1/15
Large intestinal obstructionGastrointestinal disorders	0/3	0/12	1/15
Abdominal infectionInfections and infestations	0/3	0/12	1/15
SepsisInfections and infestations	0/3	0/12	1/15

Most frequent other events

Showing 10 of 103

Most frequent other events
Event	MK-8353 50 mg + Selumetinib 25 mg	MK-8353 100 mg + Selumetinib 50 mg	MK-8353 150 mg + Selumetinib 75 mg
DiarrhoeaGastrointestinal disorders	1/3	7/12	12/15
ArthralgiaMusculoskeletal and connective tissue disorders	2/3	1/12	1/15
FatigueGeneral disorders	1/3	1/12	8/15
NauseaGastrointestinal disorders	0/3	5/12	7/15
Dermatitis acneiformSkin and subcutaneous tissue disorders	1/3	3/12	6/15
Dry eyeEye disorders	1/3	1/12	0/15
Abdominal painGastrointestinal disorders	1/3	3/12	5/15
ProctalgiaGastrointestinal disorders	1/3	1/12	0/15
StomatitisGastrointestinal disorders	1/3	1/12	0/15
PyrexiaGeneral disorders	1/3	1/12	1/15

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	MK-8353 50 mg + Selumetinib 25 mg	MK-8353 100 mg + Selumetinib 50 mg	MK-8353 150 mg + Selumetinib 75 mg	Total
Mean	57.0 ± 8.2	58.6 ± 13.3	60.2 ± 16.1	59.2 ± 14.1

Sex: Female, Male
Sex: Female, Male(Participants)	MK-8353 50 mg + Selumetinib 25 mg	MK-8353 100 mg + Selumetinib 50 mg	MK-8353 150 mg + Selumetinib 75 mg	Total
Female	0	7	7	14
Male	3	5	8	16

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	MK-8353 50 mg + Selumetinib 25 mg	MK-8353 100 mg + Selumetinib 50 mg	MK-8353 150 mg + Selumetinib 75 mg	Total
Hispanic or Latino	0	0	0	0
Not Hispanic or Latino	2	12	15	29
Unknown or Not Reported	1	0	0	1

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	MK-8353 50 mg + Selumetinib 25 mg	MK-8353 100 mg + Selumetinib 50 mg	MK-8353 150 mg + Selumetinib 75 mg	Total
American Indian or Alaska Native	0	0	0	0
Asian	1	0	2	3
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	0	0	0	0
White	2	11	13	26
More than one race	0	0	0	0
Unknown or Not Reported	0	1	0	1

Study locations

5 sites

Florida Cancer Specialists ( Site 7000)
Sarasota, Florida 34232, United States
Next Oncology ( Site 0001)
San Antonio, Texas 78229, United States
BC Cancer-Vancouver Center ( Site 0011)
Vancouver, British Columbia V5Z 4E6, Canada
Princess Margaret Cancer Centre ( Site 0012)
Toronto, Ontario M5G 2M9, Canada
Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 0020)
Bellinzona, Ticino 6500, Switzerland

References and documents

Publications

Stathis A, Tolcher AW, Wang JS, Renouf DJ, Chen LC, Suttner LH, Freshwater T, Webber AL, Nayak T, Siu LL. Results of an open-label phase 1b study of the ERK inhibitor MK-8353 plus the MEK inhibitor selumetinib in patients with advanced or metastatic solid tumors. Invest New Drugs. 2023 Jun;41(3):380-390. doi: 10.1007/s10637-022-01326-3. Epub 2023 Apr 11. PubMed 37040046 ↗

Study documents

Protocol and statistical analysis plan · Dec 19, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03745989
Lead sponsor: Merck Sharp & Dohme LLC
Responsible party: Sponsor
First posted: Nov 19, 2018
Start date: Feb 22, 2019
Primary completion: Mar 19, 2021
Completion: Mar 19, 2021
Results posted: Jan 25, 2023
Last update: Jul 27, 2023

Study contacts

Medical Director

study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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