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MK-1088 for Solid Tumors
Phase 1 & 2
Waitlist Available
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~13 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new drug, MK-1088, alone and with another cancer drug, pembrolizumab, in patients with advanced solid tumors who haven't responded to standard treatments. It aims to see if MK-1088 is safe, tolerable, and effective in shrinking tumors. Pembrolizumab has shown efficacy in multiple cancer types.
Eligible Conditions
- Advanced Solid Tumors
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to ~13 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~13 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants Discontinuing Study Treatment Due to an AE
Percentage of Participants Experiencing a Dose-limiting Toxicity (DLT)
Percentage of Participants Experiencing an Adverse Event (AE)
Secondary study objectives
Area Under the Plasma Concentration-time Curve (AUC) of MK-1088
Maximum Plasma Concentration (Cmax) of MK-1088
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
6Treatment groups
Experimental Treatment
Group I: MK-1088 600 mgExperimental Treatment1 Intervention
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)
Group II: MK-1088 400 mgExperimental Treatment1 Intervention
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)
Group III: MK-1088 200 mg + PembrolizumabExperimental Treatment2 Interventions
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)
Group IV: MK-1088 200 mgExperimental Treatment1 Intervention
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)
Group V: MK-1088 100 mg + PembrolizumabExperimental Treatment2 Interventions
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)
Group VI: MK-1088 100 mgExperimental Treatment1 Intervention
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~3150
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
4,010 Previous Clinical Trials
5,185,216 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,885 Previous Clinical Trials
8,088,758 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had another type of cancer in the past, but it's okay if it has been treated completely and there has been no sign of it for at least 2 years.You have a stomach or liver condition that could affect how your body absorbs or processes oral medications.You have a history of a lung disease called interstitial lung disease.You have received a transplant of stem cells or a solid organ from another person in the past.You have been diagnosed with an advanced or metastatic solid tumor, and have either received, had issues with, or were not eligible for a treatment that is known to provide clinical benefit.You have recently had a major surgery and are still recovering from it.You have cancer that has spread to your brain or lining of the brain.You have an autoimmune disease that has needed treatment throughout your whole body in the last 2 years.You have a history of lung inflammation that needed treatment with steroids, or you currently have lung inflammation.
Research Study Groups:
This trial has the following groups:- Group 1: MK-1088 100 mg
- Group 2: MK-1088 200 mg
- Group 3: MK-1088 400 mg
- Group 4: MK-1088 600 mg
- Group 5: MK-1088 100 mg + Pembrolizumab
- Group 6: MK-1088 200 mg + Pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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