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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
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 ~3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Therapeutic procedure
Number of participants experiencing a dose-limiting toxicity (DLT)
Number 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
ORR per Prostate Cancer Working Group (PCWG)-modified RECIST 1.1 as assessed by investigator
+1 moreSide effects data
From 2022 Phase 1 & 2 trial • 35 Patients • NCT0300346840%
FATIGUE
37%
INFUSION RELATED REACTION
37%
NAUSEA
23%
DIARRHEA
23%
BACK PAIN
23%
ABDOMINAL PAIN
23%
ANOREXIA
20%
ARTHRALGIA
20%
COUGH
20%
NON-CARDIAC CHEST PAIN
17%
DYSPNEA
17%
CONSTIPATION
17%
CHILLS
17%
MYALGIA
13%
DIZZINESS
13%
HEADACHE
13%
PRURITUS
13%
RASH MACULO-PAPULAR
10%
ANEMIA
10%
URTICARIA
10%
SINUS TACHYCARDIA
10%
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY
10%
EDEMA LIMBS
10%
ALLERGIC REACTION
10%
ANXIETY
10%
LUNG INFECTION
10%
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY
7%
TUMOR PAIN
7%
EAR AND LABYRINTH DISORDERS - OTHER, SPECIFY
7%
HYPERGLYCEMIA
7%
PAIN
7%
PELVIC PAIN
7%
PRODUCTIVE COUGH
7%
PLEURAL EFFUSION
7%
VOICE ALTERATION
7%
VOMITING
7%
FEVER
7%
FLATULENCE
7%
CREATININE INCREASED
7%
HYPERTHYROIDISM
7%
NECK PAIN
7%
DEPRESSION
7%
FLU LIKE SYMPTOMS
7%
LYMPHOCYTE COUNT DECREASED
7%
DYSPEPSIA
7%
FLUSHING
7%
HYPONATREMIA
7%
HYPOTHYROIDISM
7%
URINARY TRACT INFECTION
3%
MUSCLE WEAKNESS LOWER LIMB
3%
ALKALINE PHOSPHATASE INCREASED
3%
DYSPHAGIA
3%
ESOPHAGITIS
3%
GASTROESOPHAGEAL REFLUX DISEASE
3%
OSTEONECROSIS OF JAW
3%
BRONCHOSPASM
3%
PNEUMONITIS
3%
SORE THROAT
3%
BLURRED VISION
3%
GAIT DISTURBANCE
3%
HEMORRHOIDS
3%
POSTNASAL DRIP
3%
PRESYNCOPE
3%
ACUTE KIDNEY INJURY
3%
PERIPHERAL MOTOR NEUROPATHY
3%
DRY SKIN
3%
FLASHING LIGHTS
3%
HYPOMAGNESEMIA
3%
HYPERTENSION
3%
HYPOTENSION
3%
SINUSITIS
3%
SYNCOPE
3%
HEARING IMPAIRED
3%
RASH ACNEIFORM
3%
SOMNOLENCE
3%
COLITIS
3%
HOT FLASHES
3%
RESPIRATORY FAILURE
3%
CONJUNCTIVITIS
3%
MOVEMENTS INVOLUNTARY
3%
NASAL CONGESTION
3%
PARESTHESIA
3%
VAGINAL INFECTION
3%
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY
3%
NEUTROPHIL COUNT DECREASED
3%
ALLERGIC RHINITIS
3%
PAIN IN EXTREMITY
3%
SEPSIS
3%
BLOATING
3%
DEHYDRATION
3%
DRY MOUTH
3%
INSOMNIA
3%
MALAISE
3%
PAIN OF SKIN
3%
THROMBOEMBOLIC EVENT
3%
TREMOR
3%
WEIGHT GAIN
100%
80%
60%
40%
20%
0%
Study treatment Arm
Imprime PGG 4 mg/kg
Imprime PGG 2 mg/kg
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
~2070
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
3,950 Previous Clinical Trials
5,174,956 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,834 Previous Clinical Trials
8,079,753 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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