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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 weeks
Treatment ~ Varies
Follow Up ~up to ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~3 years for reporting.

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 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999
64%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Pneumonia aspiration
3%
Sepsis
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab + CRT Followed by Pembrolizumab
Placebo + CRT Followed by Placebo

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 3
~2850

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,966 Previous Clinical Trials
5,176,646 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,849 Previous Clinical Trials
8,080,853 Total Patients Enrolled

Media Library

MK-1088 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05394350 — Phase 1 & 2
Solid Tumors Research Study Groups: MK-1088, MK-1088 + Pembrolizumab
Solid Tumors Clinical Trial 2023: MK-1088 Highlights & Side Effects. Trial Name: NCT05394350 — Phase 1 & 2
MK-1088 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05394350 — Phase 1 & 2
~9 spots leftby Oct 2025
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