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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 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

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 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
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%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
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
3,886 Previous Clinical Trials
5,054,544 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,453 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are included in this experiment?

"In order to conduct this research, we need 80 individuals who fit the bill of our inclusion criteria. Those chosen can come from various locations, such as Laura and Isaac Perlmutter Cancer Center ( Site 0102) in New york or University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0103) down in Florida."

Answered by AI

In how many different medical institutions is this research project being conducted presently?

"So far, there are 5 locations that are running this trial. For example, in New york there is the Laura and Isaac Perlmutter Cancer Center (Site 0102). Additionally, University of Miami Hospital and Clinics, Sylvester Cancer Center (Site 0103) in Miami, Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0201) in Toronto are also participating. There are 5 other locations not mentioned."

Answered by AI

What are the key goals that researchers are hoping to achieve with this clinical trial?

"The primary goal of this trial, which will last for approximately 24 months, is to evaluate the number of patients experiencing an adverse event. Additionally, the study team will also be measuring the objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1). ORR is defined as the percentage of participants who have a Complete Response or Partial Response according to RECIST 1.1 guidelines. Lastly, they will also report on the maximum plasma concentration (Cmax) of MK-1088 and ORR per Prostate cancer Working Group (PCWG)-modified RECIST 1"

Answered by AI

Are people currently being accepted into this experiment?

"This study, which was originally posted on July 7th 2022, is currently seeking patients. The clinical trial was last edited on October 20th 2022."

Answered by AI
~10 spots leftby Apr 2025