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MK-8353 for Tumors

Phase 1
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
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 27 months
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of a new drug, MK-8353, when used with another drug, pembrolizumab, to treat advanced malignancies (cancer). The study has two parts. In the first part, the recommended dose of MK-8353 will be determined. In the second part, the safety and effectiveness of the recommended dose will be checked in people with a certain type of advanced cancer (colorectal cancer that is microsatellite stable).

Eligible Conditions
  • Tumors
  • Colorectal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 27 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 27 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Who Discontinue Study Drug Due to an AE
Percentage of Participants Who Experience a Dose-limiting Toxicity (DLT)
Percentage of Participants Who Experience an Adverse Event (AE)
Secondary outcome measures
Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as Assessed by the Investigator

Side effects data

From 2021 Phase 1 trial • 30 Patients • NCT03745989
58%
Diarrhoea
42%
Nausea
25%
Dermatitis acneiform
25%
Abdominal pain
25%
Vomiting
17%
Decreased appetite
17%
Constipation
17%
Sciatica
17%
Cough
17%
Anaemia
17%
Dyspepsia
17%
Dehydration
8%
Pyrexia
8%
Proctalgia
8%
Localised oedema
8%
Hypercalcaemia
8%
Myalgia
8%
Mucosal inflammation
8%
Dizziness
8%
Hypophosphataemia
8%
Abdominal pain upper
8%
Fatigue
8%
Anal haemorrhage
8%
Spinal pain
8%
Periorbital oedema
8%
Ascites
8%
Pneumonia aspiration
8%
Flatulence
8%
Lip pain
8%
Stomatitis
8%
Oral herpes
8%
Vulvitis
8%
Arthralgia
8%
Pain in extremity
8%
Dysgeusia
8%
Anxiety
8%
Dysuria
8%
Pleural effusion
8%
Hyperhidrosis
8%
Urticaria
8%
Pneumonia
8%
Dry eye
8%
Abdominal distension
8%
Eye infection
8%
Headache
8%
Pollakiuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
MK-8353 100 mg + Selumetinib 50 mg
MK-8353 50 mg + Selumetinib 25 mg
MK-8353 150 mg + Selumetinib 75 mg

Trial Design

4Treatment groups
Experimental Treatment
Group I: D: MK-8353 QD Run-in→MK-8353 QD Continuous+PembroExperimental Treatment2 Interventions
Optional Arm: Participants undergo an MK-8353 PO QD run-in period from Day -14 to Day -1 prior to Cycle 1 during which they receive MK-8353 PO QD. After the run-in period, participants receive MK-8353 PO QD on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 36 cycles.
Group II: C: MK-8353 QD 1 Week On/1 Week Off+PembroExperimental Treatment2 Interventions
Optional Arm: Participants receive MK-8353 PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.
Group III: B: MK-8353 QD Continuous+PembroExperimental Treatment2 Interventions
Participants receive MK-8353 PO once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Group IV: A: MK-8353 BID Continuous+PembroExperimental Treatment2 Interventions
Participants receive MK-8353 orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MK-8353
2019
Completed Phase 1
~140
Pembrolizumab
FDA approved

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,173 Total Patients Enrolled
5 Trials studying Tumors
149 Patients Enrolled for Tumors
Merck Sharp & Dohme LLCLead Sponsor
3,888 Previous Clinical Trials
5,054,894 Total Patients Enrolled
11 Trials studying Tumors
2,324 Patients Enrolled for Tumors
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,754 Total Patients Enrolled
2 Trials studying Tumors
34 Patients Enrolled for Tumors

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of MK-8353 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Malignancies (MK-8353-013)
2017. "Study of MK-8353 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Malignancies (MK-8353-013)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02972034.
~13 spots leftby Apr 2025
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