← Back to Search

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
Must not have
Participants must not have an active infection requiring systemic therapy
Participants must not have specific infectious diseases or conditions
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
No Placebo-Only Group

Summary

This trial is testing a new drug called MK-1084, alone or with other treatments, in patients with advanced cancers that have a specific mutation. The drug aims to block this mutation to stop or slow down the cancer. Another drug, Sotorasib, was the first approved treatment for this type of cancer.

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.
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.
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
Select...
My NSCLC is untreated, has a KRAS G12C mutation, and PD-L1 score of 1% or more.
Select...
My colorectal cancer is advanced, cannot be surgically removed, and has a specific KRAS G12C mutation.
Select...
My cancer can be measured and my organs work well.
Select...
My advanced lung cancer has a KRAS G12C mutation and hasn't been treated yet.
Select...
My cancer is advanced, can't be surgically removed, has a KRAS G12C mutation, and I've had at least one treatment.
Select...
My colorectal cancer is advanced, can't be surgically removed, has a KRAS G12C mutation, and I have a specific treatment history.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have an infection that needs treatment with drugs.
Select...
I do not have any infectious diseases.
Select...
I do not have any specific eye conditions.
Select...
I do not have active brain metastases or cancer in the lining of my brain.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
cetuximab
2000
Completed Phase 3
~7290
leucovorin
2005
Completed Phase 3
~1200
oxaliplatin
2002
Completed Phase 3
~6370
5-fluorouracil
2005
Completed Phase 4
~7960
carboplatin
2010
Completed Phase 3
~4790
Pembrolizumab
2017
Completed Phase 3
~2810
MK-1084
2023
Completed Phase 1
~60
pemetrexed
2005
Completed Phase 3
~5000

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for solid tumors include targeted therapies, immunotherapies, and traditional chemotherapies. Targeted therapies, such as KRAS G12C inhibitors like MK-1084, work by specifically targeting and inhibiting the function of mutated proteins that drive cancer growth, thereby halting tumor progression. Immunotherapies boost the body's immune system to recognize and destroy cancer cells, while traditional chemotherapies kill rapidly dividing cells, including cancer cells, but can also affect normal cells. For patients with solid tumors, these treatments are crucial as they offer more personalized and potentially more effective options, especially for those with specific genetic mutations like KRAS G12C.

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,666 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
4,001 Previous Clinical Trials
5,184,081 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,881 Previous Clinical Trials
8,087,372 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 4, Arm 5, Arm 6, 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
~311 spots leftby Aug 2026