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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 ~3 years
Awards & highlights
Study Summary
This trial will study the safety and effectiveness of the drug MK-1088 as a possible treatment for advanced solid tumors.
Eligible Conditions
- Advanced Solid Tumors
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to ~3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Therapeutic procedure
Number of participants experiencing a dose-limiting toxicity (DLT)
Number of participants experiencing an adverse event (AE)
Secondary outcome measures
Area under the plasma concentration-time curve (AUC) of MK-1088
Maximum plasma concentration (Cmax) of MK-1088
ORR per Prostate Cancer Working Group (PCWG)-modified RECIST 1.1 as assessed by investigator
+1 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Group I: MK-1088 + PembrolizumabExperimental Treatment2 Interventions
Participants will receive MK-1088 daily (QD) orally at specified dose 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 II: MK-1088Experimental Treatment1 Intervention
Participants will receive MK-1088 daily (QD) orally at specified dose 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 2
~2010
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
3,907 Previous Clinical Trials
5,066,069 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,789 Previous Clinical Trials
8,067,303 Total Patients Enrolled
Media Library
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
- Group 2: MK-1088 + 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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