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Small Molecule Inhibitor

MK-1084 + Pembrolizumab for Solid Cancers

Phase 1
Recruiting
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
Arm 2 participants must have untreated metastatic non-small cell lung cancer (NSCLC) with histological or blood-based confirmation of KRAS G12C mutation and histologic confirmation of programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1%
Arm 6 participants must have untreated locally advanced unresectable or metastatic colorectal adenocarcinoma with histological or blood-based confirmation of KRAS G12C mutation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at designated timepoints during the study in cycles 1, 2, 3, 5, 9, 13, 17, 21, 25, and every 6 weeks thereafter up to 56 months. cycle=3 weeks (arms 1-4) and 4 weeks (arms 5-6)
Awards & highlights

Study Summary

This trial is testing a new drug, MK-1084, on patients with solid tumors that have a specific mutation. The trial will also test MK-1084 in combination with another drug, pembrolizumab, on patients with lung cancer who have the same mutation.

Who is the study for?
This trial is for adults with advanced solid tumors that have a specific mutation (KRAS G12C). Participants must have measurable disease, proper organ function, and agree to contraception. It's not suitable for pregnant or breastfeeding women, those with active infections like HIV or hepatitis, certain eye conditions, recent vaccines, autoimmune diseases requiring treatment, CNS metastases/carcinomatous meningitis, or who can't take required supplements.Check my eligibility
What is being tested?
The study tests MK-1084 alone and combined with Pembrolizumab in patients with KRAS G12C mutant tumors. It aims to assess the effectiveness and safety of these treatments in different groups: some untreated NSCLC cases; others who've had systemic therapy; and various stages of colorectal cancer after previous therapies failed.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, fatigue, digestive issues like nausea and diarrhea from chemotherapy drugs (oxaliplatin/5-fluorouracil), nerve damage from oxaliplatin leading to numbness or tingling in hands/feet. Pembrolizumab may cause immune-related adverse effects such as skin rash or inflammation of organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My NSCLC is untreated, has a KRAS G12C mutation, and PD-L1 score of 1% or more.
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My colorectal cancer is advanced, cannot be surgically removed, and has a specific KRAS G12C mutation.
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My cancer can be measured and my organs work well.
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My advanced lung cancer has a KRAS G12C mutation and hasn't been treated yet.
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My cancer is advanced, can't be surgically removed, has a KRAS G12C mutation, and I've had at least one treatment.
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My colorectal cancer is advanced, can't be surgically removed, has a KRAS G12C mutation, and I have a specific treatment history.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at designated timepoints during the study in cycles 1, 2, 3, 5, 9, 13, 17, 21, 25, and every 6 weeks thereafter up to 56 months. cycle=3 weeks (arms 1-4) and 4 weeks (arms 5-6)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at designated timepoints during the study in cycles 1, 2, 3, 5, 9, 13, 17, 21, 25, and every 6 weeks thereafter up to 56 months. cycle=3 weeks (arms 1-4) and 4 weeks (arms 5-6) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Who Discontinue Study Treatment Due to an AE
Number of Participants Who Experience a Dose-Limiting Toxicity (DLT)
Number of Participants Who Experience an Adverse Event (AE)
Secondary outcome measures
Area Under the Concentration Time-Curve 0-12 Hours (AUC 0-12) of MK-1084
Area Under the Concentration Time-Curve 0-24 Hours (AUC 0-24) of MK-1084
Duration of Response (DOR)
+6 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Arm 6Experimental Treatment5 Interventions
Participants will receive MK-1084 daily oral dose. Additionally, participants receive an intravenous infusion of cetuximab (per label) every 2 weeks of each 28-day cycle, oxaliplatin (per label) for first 6 cycles, and leucovorin (per label) and 5-fluorouracil (per label) once every 14-days.
Group II: Arm 5Experimental Treatment2 Interventions
Participants will receive MK-1084 daily oral dose plus an intravenous infusion of cetuximab (per label) every 2 weeks of each 28-day cycle.
Group III: Arm 4Experimental Treatment4 Interventions
Participants will receive MK-1084 daily oral dose plus an intravenous infusion of pembrolizumab (200 mg) once every 21-day cycle for up to 35 cycles (up to ~24 months). Participants will also receive carboplatin (per label) and pemetrexed (per label) once every 21-day cycle for the first 4 cycles.
Group IV: Arm 3Experimental Treatment1 Intervention
Participants will receive alternate formulation of MK-1084 until progressive disease or discontinuation. Dosing regimen may be adjusted based on safety.
Group V: Arm 2Experimental Treatment2 Interventions
Participants will receive MK-1084 daily oral escalating dose of up to 800 mg plus pembrolizumab given as a 200 mg intravenous infusion once every 21-day cycle up to a total of 35 cycles (up to ~24 months). Treatment with MK-1084 will continue until progressive disease or discontinuation. Dosing regimen may be adjusted based on safety.
Group VI: Arm 1Experimental Treatment1 Intervention
Participants will receive daily oral escalating doses of up to 800 mg of MK-1084 until progressive disease or discontinuation. Dosing regimen may be adjusted based on safety.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
oxaliplatin
2002
Completed Phase 3
~6370
leucovorin
2005
Completed Phase 3
~1200
5-fluorouracil
2005
Completed Phase 4
~7960
Pembrolizumab
2017
Completed Phase 2
~2010
carboplatin
2010
Completed Phase 3
~4790
pemetrexed
2005
Completed Phase 3
~5000
cetuximab
2000
Completed Phase 3
~7290

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,780 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,892 Previous Clinical Trials
5,060,316 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,389 Total Patients Enrolled

Media Library

MK-1084 (Small Molecule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05067283 — Phase 1
Solid Tumors Research Study Groups: Arm 5, Arm 6, Arm 4, Arm 3, Arm 1, Arm 2
Solid Tumors Clinical Trial 2023: MK-1084 Highlights & Side Effects. Trial Name: NCT05067283 — Phase 1
MK-1084 (Small Molecule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05067283 — Phase 1

Frequently Asked Questions

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

What is the main purpose of this research project?

"According to Merck Sharp & Dohme LLC, the major assessment measure of this trial's success is Number of participants who experienced a dose-limiting toxicity (DLT). It will take up to ~50 months for completion. Secondary outcomes that are also being evaluated include Duration of response (DOR), Objective response rate (ORR) and Area under the plasma concentration-time curve (AUC) of MK-1084."

Answered by AI

What is the current enrollment quota for this research project?

"This clinical trial requires 264 qualified participants to enroll. Patients from Laura and Isaac Perlmutter Cancer Center ( Site 0270) in New york, New York or NEXT Virginia (Site 0271) in Fairfax, Virginia are eligible for this medical study."

Answered by AI

What medical conditions are commonly addressed with MK-1084?

"MK-1084 is a medication commonly used to manage malignant neoplasms. However, it can also be utilized to address unresectable melanoma, microsatellite instability high and cases where chemotherapy has been unsuccessful in halting disease progression."

Answered by AI

What other research has been done related to MK-1084?

"Since its initial study in 2010 at City of Hope, MK-1084 has been tried 251 times. Currently, 963 trials are recruiting participants with a concentration of them located in NYC."

Answered by AI

Are volunteers currently being accepted for this experiment?

"Evidenced on clinicaltrials.gov, this trial is actively engaging with participants and was initially posted in December of 2021. Most recently it has been updated on November 23rd 2022."

Answered by AI

In what locations are the trials for this investigation taking place?

"This investigation is recruiting patients from a total of seven sites, which are located in New york, Fairfax and Toronto among other cities. To reduce travel needs for participants, it would be wise to select the nearest location possible if you choose to take part."

Answered by AI

What deleterious effects could be caused by MK-1084?

"As MK-1084 is currently in Phase 1 testing, there is limited evidence to support its safety or efficacy. We at Power assign it a score of one on our scale from 1 to 3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of MK-1084 in KRAS Mutant Advanced Solid Tumors (MK-1084-001)
2021. "A Study of MK-1084 in KRAS Mutant Advanced Solid Tumors (MK-1084-001)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05067283.
~400 spots leftby Aug 2026
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