A Study of MK-1088 as Monotherapy and in Combination With... | NCT05394350 | Trialant
NCT05394350
Sponsor
Merck Sharp & Dohme LLC
Status
Terminated
Last Update Posted
Nov 8, 2024Actual
Enrollment
27Actual
Phase
Phase 1Phase 2
Conditions
Advanced Solid Tumors
Interventions
MK-1088
Pembrolizumab
Countries
United States
Canada
Denmark
Israel
Switzerland
Protocol Section
Identification Module
NCT ID
NCT05394350
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1088-002
Secondary IDs
ID
Type
Description
Link
MK-1088-002
Other Identifier
Merck
2022-502288-40-00
Registry Identifier
CTIS (EU)
2021-006712-93
EudraCT Number
Brief Title
A Study of MK-1088 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (MK-1088-002)
Official Title
A Phase 1/Phase 2 Study to Evaluate the Safety and Tolerability of MK-1088 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Nov 2024
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Business Reasons
Expanded Access Info
No
Start Date
Jul 7, 2022Actual
Primary Completion Date
Sep 7, 2023Actual
Completion Date
Sep 7, 2023Actual
First Submitted Date
May 23, 2022
First Submission Date that Met QC Criteria
May 23, 2022
First Posted Date
May 27, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Aug 19, 2024
Results First Submitted that Met QC Criteria
Sep 25, 2024
Results First Posted Date
Oct 4, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 7, 2024
Last Update Posted Date
Nov 8, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The study will evaluate the safety, tolerability, and pharmacokinetics (PK) of MK-1088 in monotherapy and in combination with pembrolizumab in participants with advanced solid tumors who have not responded to conventional therapy. The effect of MK-1088 on tumor size will also be examined.
Detailed Description
Not provided
Conditions Module
Conditions
Advanced Solid Tumors
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
27Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
MK-1088 100 mg
Experimental
Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months).
Drug: MK-1088
MK-1088 200 mg
Experimental
Participants received MK-1088 (QD) orally at 200 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
Drug: MK-1088
MK-1088 400 mg
Experimental
Participants received MK-1088 (QD) orally at 400 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
Drug: MK-1088
MK-1088 600 mg
Experimental
Participants received MK-1088 (QD) orally at 600 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
Drug: MK-1088
MK-1088 100 mg + Pembrolizumab
Experimental
Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to ~24 months)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MK-1088
Drug
Oral Tablet
MK-1088 100 mg
MK-1088 100 mg + Pembrolizumab
MK-1088 200 mg
MK-1088 200 mg + Pembrolizumab
MK-1088 400 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Experiencing a Dose-limiting Toxicity (DLT)
A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0). Per protocol participants who switched over from MK-1088 monotherapy into MK-1088 100 mg + Pembrolizumab combination therapy completed the DLT evaluation period in the monotherapy arm assigned. Percentage of participants who experienced a DLT are presented.
Up to 21 days
Percentage of Participants Experiencing an Adverse Event (AE)
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. Safety data from participants who experienced disease progression in the monotherapy arm and crossed over into the combination arm are summarized in their initial monotherapy dose group until the time of cross over and are summarized separately thereafter. The percentage of participants who experienced an AE are presented.
Up to ~13 months
Percentage of Participants Discontinuing Study Treatment Due to an AE
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. Safety data from participants who experienced disease progression in the monotherapy arm and crossed over into the combination arm are summarized in their initial monotherapy dose group until the time of cross over and are summarized separately thereafter. The percentage of participants who discontinued study treatment due to an AE is presented.
Up to ~10 months
Secondary Outcomes
Measure
Description
Time Frame
Area Under the Plasma Concentration-time Curve (AUC) of MK-1088
AUC of MK-1088 determined by blood samples collected pre-dose and at designated timepoints post-dose are presented.
Pre-dose and 1, 2, 4, and 8 hours post-dose on Cycle 1 Day 1 and Cycle 2 Day 1; Pre-dose on Cycle 1 Day 2 and Cycle 2 Day 2; Pre-dose on Cycle 3, Cycle 4 and every 4 cycles up to ~3.5 months. Each cycle = 21 days
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
Has a histologically- or cytologically-confirmed diagnosis of advanced/metastatic solid tumor by pathology report and have received, have been intolerant to, or have been ineligible for treatment known to confer clinical benefit
For metastatic castrate-resistant prostate cancer (mCRPC) only: (1) Must have previously received docetaxel, prior treatment with one other chemotherapy is allowed as well as up to 2 second-generation hormonal manipulations and (2) have prostate cancer progression within 6 months before screening, as determined by the investigator
If human immunodeficiency virus (HIV) positive, has well-controlled HIV on anti-retroviral therapy (ART)
Exclusion Criteria:
Has had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study intervention
Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
Has clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has an active infection requiring therapy
Has a history of interstitial lung disease
Has a history of (noninfectious) pneumonitis that required steroids or current pneumonitis
Has an active autoimmune disease that has required systemic treatment in the past 2 years
Has concurrent active Hepatitis B and Hepatitis C virus infection
Has HIV with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Has not fully recovered from any effects of major surgery without significant detectable infection
Has a history or current evidence of a gastrointestinal (GI) condition or impaired liver function or diseases that in the opinion of the investigator may significantly alter the absorption or metabolism of oral medications
Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Health Association (NYHA) Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability
Has a corrected QT interval using Fridericia's Correction Formula (QTcF) >470 msec
Has history of an allogeneic stem cell transplant or a solid organ transplant.
Has received prior systemic anticancer therapy including investigational agents within 4 weeks before allocation
Has received prior radiotherapy within 2 weeks of start of study intervention, or had radiation-related toxicities requiring corticosteroids
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
Has a "superscan" bone scan
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Medical Director
Merck Sharp & Dohme LLC
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0103)
Per protocol two participants who progressed by radiographic evaluation on monotherapy with MK-1088 at the investigator's discretion and after consultation with the Sponsor, switched over to combination treatment arm of MK-1088 and pembrolizumab.
Recruitment Details
The study was closed to enrollment on 04-MAY-2023 for all participants, and no participants remain on treatment with MK-1088. Part 2 of the study was not initiated.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
MK-1088 100 mg
Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
FG001
MK-1088 200 mg
Participants received MK-1088 (QD) orally at 200 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Jun 29, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: MK-1088
Biological: Pembrolizumab
MK-1088 200 mg + Pembrolizumab
Experimental
Participants received MK-1088 daily (QD) orally at 200 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to ~24 months)
Drug: MK-1088
Biological: Pembrolizumab
MK-1088 600 mg
Pembrolizumab
Biological
IV Infusion
MK-1088 100 mg + Pembrolizumab
MK-1088 200 mg + Pembrolizumab
MK-3475
KEYTRUDA®
Maximum Plasma Concentration (Cmax) of MK-1088
Cmax of MK-1088 determined by blood samples collected pre-dose and at designated timepoints post-dose are presented.
Pre-dose and 1, 2, 4, and 8 hours post-dose on Cycle 1 Day 1 and Cycle 2 Day 1; Pre-dose on Cycle 1 Day 2 and Cycle 2 Day 2; Pre-dose on Cycle 3, Cycle 4 and every 4 cycles up to ~3.5 months. Each cycle = 21 days
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or Prostate Cancer Working Group (PCWG)-Modified RECIST 1.1 as Assessed by Investigator
ORR is defined as the percentage of participants 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) per RECIST 1.1 or Prostate Cancer Working Group (PCWG)-modified RECIST 1.1 as assessed by investigator. Efficacy data from participants who experienced disease progression in the monotherapy arm and crossed over into the combination arm will be summarized in their initial monotherapy dose group until the time of cross over and will be summarized separately thereafter. The percentage of participants who experience a CR or PR as assessed by the investigator based on RECIST 1.1 is presented.
Up to ~13 months
Laura and Isaac Perlmutter Cancer Center ( Site 0102)
New York
New York
10016
United States
South Texas Accelerated Research Therapeutics (START) ( Site 0101)
San Antonio
Texas
78229
United States
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0201)
Toronto
Ontario
M5G 2M9
Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
Québec
Quebec
G1J 1Z4
Canada
Rigshospitalet ( Site 0500)
Copenhagen
Capital Region
2100
Denmark
Herlev and Gentofte Hospital ( Site 0501)
Copenhagen
Capital Region
2730
Denmark
Odense Universitetshospital ( Site 0502)
Odense
Region Syddanmark
5000
Denmark
Rambam Health Care Campus-Oncology Division ( Site 0300)
Haifa
3109601
Israel
Hadassah Medical Center ( Site 0302)
Jerusalem
9112001
Israel
Cantonal Hospital St.Gallen ( Site 0403)
Sankt Gallen
Canton of St. Gallen
9007
Switzerland
Ospedale Regionale Bellinzona e Valli ( Site 0400)
Bellinzona
Canton Ticino
6500
Switzerland
Kantonsspital Graubünden-Medizin ( Site 0402)
Chur
Kanton Graubünden
7000
Switzerland
FG002
MK-1088 400 mg
Participants received MK-1088 (QD) orally at 400 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
FG003
MK-1088 600 mg
Participants received MK-1088 (QD) orally at 600 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
FG004
MK-1088 100 mg + Pembrolizumab
Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to ~24 months)
FG005
MK-1088 200 mg + Pembrolizumab
Participants received MK-1088 daily (QD) orally at 200 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to ~24 months)
FG0003 subjects
FG0013 subjects
FG00211 subjects
FG0033 subjects
FG0043 subjects
FG0054 subjects
Switch Over to MK-1088 100 mg + Pembrolizumab
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG0003 subjects
FG0013 subjects
FG00211 subjects
FG0033 subjects
FG0043 subjects
FG0054 subjects
Type
Comment
Reasons
Death
FG0002 subjects
FG0012 subjects
FG0024 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
Study terminated by sponsor
FG0001 subjects
FG0011 subjects
FG0027 subjects
FG0033 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
MK-1088 100 mg
Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
BG001
MK-1088 200 mg
Participants received MK-1088 (QD) orally at 200 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
BG002
MK-1088 400 mg
Participants received MK-1088 (QD) orally at 400 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
BG003
MK-1088 600 mg
Participants received MK-1088 (QD) orally at 600 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
BG004
MK-1088 100 mg + Pembrolizumab
Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to ~24 months)
BG005
MK-1088 200 mg + Pembrolizumab
Participants received MK-1088 daily (QD) orally at 200 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to ~24 months)
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0013
BG00211
BG0033
BG0043
BG0054
BG00627
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00066.7± 13.6
BG00158.7± 24.8
BG00259.5± 13.5
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0010
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants Experiencing a Dose-limiting Toxicity (DLT)
A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0). Per protocol participants who switched over from MK-1088 monotherapy into MK-1088 100 mg + Pembrolizumab combination therapy completed the DLT evaluation period in the monotherapy arm assigned. Percentage of participants who experienced a DLT are presented.
All participants who received at least one dose of study intervention and met the criteria for DLT evaluability
Posted
Number
Percentage of Participants
Up to 21 days
ID
Title
Description
OG000
MK-1088 100 mg
Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
OG001
MK-1088 200 mg
Participants received MK-1088 (QD) orally at 200 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
OG002
MK-1088 400 mg
Participants received MK-1088 (QD) orally at 400 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
OG003
MK-1088 600 mg
Participants received MK-1088 (QD) orally at 600 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
OG004
MK-1088 100 mg + Pembrolizumab
Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to ~24 months)
OG005
MK-1088 200 mg + Pembrolizumab
Participants received MK-1088 daily (QD) orally at 200 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to ~24 months)
OG006
MK-1088 100 mg + Pembrolizumab Switchover
Participants who progressed by radiographic evaluation on monotherapy with MK-1088 and switched over to combination therapy received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to ~24 months)
Units
Counts
Participants
OG0003
OG0013
OG00211
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.0
OG0010.0
OG0029.09
OG003
Primary
Percentage of Participants Experiencing an Adverse Event (AE)
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. Safety data from participants who experienced disease progression in the monotherapy arm and crossed over into the combination arm are summarized in their initial monotherapy dose group until the time of cross over and are summarized separately thereafter. The percentage of participants who experienced an AE are presented.
All participants who received at least one dose of study intervention
Posted
Number
Percentage of participants
Up to ~13 months
ID
Title
Description
OG000
MK-1088 100 mg
Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
OG001
MK-1088 200 mg
Participants received MK-1088 (QD) orally at 200 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
OG002
MK-1088 400 mg
Primary
Percentage of Participants Discontinuing Study Treatment Due to an AE
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. Safety data from participants who experienced disease progression in the monotherapy arm and crossed over into the combination arm are summarized in their initial monotherapy dose group until the time of cross over and are summarized separately thereafter. The percentage of participants who discontinued study treatment due to an AE is presented.
All participants who received at least one dose of study intervention
Posted
Number
Percentage of participants
Up to ~10 months
ID
Title
Description
OG000
MK-1088 100 mg
Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
OG001
MK-1088 200 mg
Participants received MK-1088 (QD) orally at 200 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
OG002
MK-1088 400 mg
Secondary
Area Under the Plasma Concentration-time Curve (AUC) of MK-1088
AUC of MK-1088 determined by blood samples collected pre-dose and at designated timepoints post-dose are presented.
All participants who complied with the protocol sufficiently to ensure that their data will be likely to show the effects of treatment, according to the underlying scientific model. Only the per protocol analysis set (excluding the data from the participants after switching over to MK-1088 100 mg and Pembrolizumab) were analyzed for pharmacokinetic (PK) data.
Posted
Geometric Mean
Geometric Coefficient of Variation
hr*μmol/L
Pre-dose and 1, 2, 4, and 8 hours post-dose on Cycle 1 Day 1 and Cycle 2 Day 1; Pre-dose on Cycle 1 Day 2 and Cycle 2 Day 2; Pre-dose on Cycle 3, Cycle 4 and every 4 cycles up to ~3.5 months. Each cycle = 21 days
ID
Title
Description
OG000
MK-1088 100 mg
Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
OG001
MK-1088 200 mg
Participants received MK-1088 (QD) orally at 200 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
OG002
MK-1088 400 mg
Participants received MK-1088 (QD) orally at 400 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
Secondary
Maximum Plasma Concentration (Cmax) of MK-1088
Cmax of MK-1088 determined by blood samples collected pre-dose and at designated timepoints post-dose are presented.
All participants who complied with the protocol sufficiently to ensure that their data will be likely to show the effects of treatment, according to the underlying scientific model. Only the per protocol analysis set (excluding the data from the participants after switching over to MK-1088 100 mg and Pembrolizumab) were analyzed for pharmacokinetic (PK) data.
Posted
Geometric Mean
Geometric Coefficient of Variation
μmol/L
Pre-dose and 1, 2, 4, and 8 hours post-dose on Cycle 1 Day 1 and Cycle 2 Day 1; Pre-dose on Cycle 1 Day 2 and Cycle 2 Day 2; Pre-dose on Cycle 3, Cycle 4 and every 4 cycles up to ~3.5 months. Each cycle = 21 days
ID
Title
Description
OG000
MK-1088 100 mg
Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
OG001
MK-1088 200 mg
Participants received MK-1088 (QD) orally at 200 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
OG002
MK-1088 400 mg
Participants received MK-1088 (QD) orally at 400 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
Secondary
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or Prostate Cancer Working Group (PCWG)-Modified RECIST 1.1 as Assessed by Investigator
ORR is defined as the percentage of participants 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) per RECIST 1.1 or Prostate Cancer Working Group (PCWG)-modified RECIST 1.1 as assessed by investigator. Efficacy data from participants who experienced disease progression in the monotherapy arm and crossed over into the combination arm will be summarized in their initial monotherapy dose group until the time of cross over and will be summarized separately thereafter. The percentage of participants who experience a CR or PR as assessed by the investigator based on RECIST 1.1 is presented.
All participants with a screening/baseline scan that showed measurable disease by the investigator's assessment, and received at least 1 dose of study intervention
Posted
Number
95% Confidence Interval
Percentage of participants
Up to ~13 months
ID
Title
Description
OG000
MK-1088 100 mg
Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
OG001
MK-1088 200 mg
Participants received MK-1088 (QD) orally at 200 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
Time Frame
Death and adverse events up to ~13 months
Description
Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
MK-1088 100 mg
Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
2
3
2
3
3
3
EG001
MK-1088 200 mg
Participants received MK-1088 (QD) orally at 200 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
2
3
2
3
3
3
EG002
MK-1088 400 mg
Participants received MK-1088 (QD) orally at 400 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
4
11
6
11
11
11
EG003
MK-1088 600 mg
Participants received MK-1088 (QD) orally at 600 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
0
3
1
3
3
3
EG004
MK 1088 100 mg + Pembrolizumab
Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to ~24 months)
1
3
2
3
3
3
EG005
MK-1088 200 mg + Pembrolizumab
Participants received MK-1088 daily (QD) orally at 200 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to ~24 months)
0
4
2
4
4
4
EG006
MK-1088 100 mg + Pembrolizumab Swicthover
Participants who progressed by radiographic evaluation on monotherapy with MK-1088 and switched over to combination therapy received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to ~24 months)
0
2
0
2
2
2
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
Cardiac failure congestive
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Incarcerated umbilical hernia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Complication associated with device
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Immune-mediated hepatitis
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Viral labyrinthitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected3 at risk
EG0011 events1 affected3 at risk
EG0023 events3 affected11 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Ureteric stenosis
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
Sinus tachycardia
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Dry eye
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected11 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected11 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0023 events3 affected11 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0013 events3 affected3 at risk
EG0023 events2 affected11 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected3 at risk
EG0026 events4 affected11 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected11 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events2 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Chest pain
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Early satiety
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Fatigue
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected3 at risk
EG0024 events4 affected11 at risk
EG003
Feeling cold
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
General physical health deterioration
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Influenza like illness
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Localised oedema
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected11 at risk
EG003
Oedema
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected11 at risk
EG003
Oedema peripheral
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Pain
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Pyrexia
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected11 at risk
EG003
Allergy to arthropod bite
Immune system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Cystitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected11 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0022 events2 affected11 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events2 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Blood urine present
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected11 at risk
EG003
Weight decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Weight increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected3 at risk
EG0022 events2 affected11 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0026 events4 affected11 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected3 at risk
EG0022 events2 affected11 at risk
EG003
Headache
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Syncope
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Chromaturia
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Urine odour abnormal
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Painful respiration
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Pulmonary pain
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Onychoclasis
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Haematoma
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Hot flush
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Hypertension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Hypotension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Intermittent claudication
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG003
The decision to close study enrollment was based on review of data from the dose escalation phase and Sponsor prioritization. The decision to stop enrollment was not due to any safety concerns, and there were no safety signals observed during the study.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Participants received MK-1088 (QD) orally at 400 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
OG003
MK-1088 600 mg
Participants received MK-1088 (QD) orally at 600 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
OG004
MK-1088 100 mg + Pembrolizumab
Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to ~24 months)
OG005
MK-1088 200 mg + Pembrolizumab
Participants received MK-1088 daily (QD) orally at 200 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to ~24 months)
OG006
MK-1088 100 mg + Pembrolizumab Switchover
Participants who progressed by radiographic evaluation on monotherapy with MK-1088 and switched over to combination therapy received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to ~24 months)
Units
Counts
Participants
OG0003
OG0013
OG00211
OG0033
OG0043
OG0054
OG0062
Title
Denominators
Categories
Title
Measurements
OG000100.0
OG001100.0
OG002100.0
OG003100.0
OG004100.0
OG005100.0
OG006100.0
Participants received MK-1088 (QD) orally at 400 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
OG003
MK-1088 600 mg
Participants received MK-1088 (QD) orally at 600 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
OG004
MK-1088 100 mg + Pembrolizumab
Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to ~24 months)
OG005
MK-1088 200 mg + Pembrolizumab
Participants received MK-1088 daily (QD) orally at 200 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to ~24 months)
OG006
MK-1088 100 mg + Pembrolizumab Switchover
Participants who progressed by radiographic evaluation on monotherapy with MK-1088 and switched over to combination therapy received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to ~24 months)
Units
Counts
Participants
OG0003
OG0013
OG00211
OG0033
OG0043
OG0054
OG0062
Title
Denominators
Categories
Title
Measurements
OG0000.0
OG0010.0
OG0029.1
OG0030.0
OG00466.7
OG00575.0
OG0060.0
OG003
MK-1088 600 mg
Participants received MK-1088 (QD) orally at 600 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
OG004
MK-1088 100 mg + Pembrolizumab
Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to ~24 months)
OG005
MK-1088 200 mg + Pembrolizumab
Participants received MK-1088 daily (QD) orally at 200 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to ~24 months)
OG006
MK-1088 100 mg + Pembrolizumab Switchover
Participants who progressed by radiographic evaluation on monotherapy with MK-1088 and switched over to combination therapy received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to ~24 months)
Units
Counts
Participants
OG0003
OG0013
OG00211
OG0033
OG0043
OG0054
OG0060
Title
Denominators
Categories
Cycle 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0054
ParticipantsOG0060
Title
Measurements
OG00031.9± 105.2
OG00126.1± 95.1
OG00298.4± 38.5
OG003
Cycle 2
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0025
ParticipantsOG0033
OG003
MK-1088 600 mg
Participants received MK-1088 (QD) orally at 600 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
OG004
MK-1088 100 mg + Pembrolizumab
Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to ~24 months)
OG005
MK-1088 200 mg + Pembrolizumab
Participants received MK-1088 daily (QD) orally at 200 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to ~24 months)
OG006
MK-1088 100 mg + Pembrolizumab Switchover
Participants who progressed by radiographic evaluation on monotherapy with MK-1088 and switched over to combination therapy received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to ~24 months)
Units
Counts
Participants
OG0003
OG0013
OG00211
OG0033
OG0043
OG0054
OG0060
Title
Denominators
Categories
Cycle 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0054
ParticipantsOG0060
Title
Measurements
OG0002.58± 61.8
OG0012.17± 50.8
OG0026.63± 36.7
OG003
Cycle 2
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0025
ParticipantsOG0033
OG002
MK-1088 400 mg
Participants received MK-1088 (QD) orally at 400 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
OG003
MK-1088 600 mg
Participants received MK-1088 (QD) orally at 600 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months)
OG004
MK-1088 100 mg + Pembrolizumab
Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to ~24 months)
OG005
MK-1088 200 mg + Pembrolizumab
Participants received MK-1088 daily (QD) orally at 200 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to ~24 months)
OG006
MK-1088 100 mg + Pembrolizumab Switchover
Participants who progressed by radiographic evaluation on monotherapy with MK-1088 and switched over to combination therapy received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to ~24 months)