A Clinical Study of MK-1084 in People With Advanced Solid Tumors (MK-1084-014)

NCT ID: NCT07209111

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-04

Study Completion Date

2032-04-09

Brief Summary

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Researchers want to learn if MK-1084 given alone or with cetuximab can treat certain advanced solid tumors in people with the KRAS G12C mutation.

The goals of this study are to learn:

* How many people have the cancer respond (get smaller or go away) to MK-1084 alone or with cetuximab and how these responses compare
* About the safety of MK-1084 alone or with cetuximab and if people tolerate the treatments.

Detailed Description

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Conditions

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Neoplasm Malignant

Keywords

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KRAS NSCLC CRC Tumor-agnostic Pan Tumor KRAS G12C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MK-1084

Participants will receive MK-1084 orally. Per protocol treatment of MK-1084 has no maximum number of cycles. Participants will be treated until any of the criteria for discontinuation of study intervention are met.

Group Type EXPERIMENTAL

MK-1084

Intervention Type DRUG

Oral administration

MK-1084 + Cetuximab

Participants will receive MK-1084 orally. Participants will receive Cetuximab 500 mg/m\^2 via intravenous (IV) infusion once every 2 weeks (Q2W). Per protocol treatment of MK-1084 and Cetuximab has no maximum number of cycles. Participants will be treated until any of the criteria for discontinuation of study intervention are met.

Group Type EXPERIMENTAL

MK-1084

Intervention Type DRUG

Oral administration

Cetuximab

Intervention Type BIOLOGICAL

Intravenous administration

Interventions

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MK-1084

Oral administration

Intervention Type DRUG

Cetuximab

Intravenous administration

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Has locally advanced unresectable or metastatic solid tumor malignancy other than colorectal cancer and has progressed on, or following, standard of care systemic treatment
* Has a tumor that demonstrates the presence of Kirsten rat sarcoma (KRAS) G12C mutation

Exclusion Criteria

* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
* Has known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has known active central nervous system metastases and/or carcinomatous meningitis and/or primary brain tumors
* Has active infection, other than those permitted per protocol, requiring systemic therapy
* Has not adequately recovered from major surgery or has ongoing surgical complications
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Greater Baltimore Medical Center ( Site 1104)

Baltimore, Maryland, United States

Site Status RECRUITING

START Midwest ( Site 1103)

Grand Rapids, Michigan, United States

Site Status RECRUITING

START Mountain Region ( Site 1106)

West Valley City, Utah, United States

Site Status RECRUITING

Odense Universitetshospital ( Site 1401)

Odense, Region Syddanmark, Denmark

Site Status RECRUITING

Haukeland universitetssykehus ( Site 2102)

Bergen, Hordaland, Norway

Site Status RECRUITING

Oslo universitetssykehus, Radiumhospitalet ( Site 2101)

Oslo, , Norway

Site Status RECRUITING

Seoul National University Hospital ( Site 2301)

Seoul, , South Korea

Site Status RECRUITING

Asan Medical Center ( Site 2302)

Seoul, , South Korea

Site Status RECRUITING

Samsung Medical Center ( Site 2300)

Seoul, , South Korea

Site Status RECRUITING

Hospital Virgen de la Victoria ( Site 2403)

Málaga, Malaga, Spain

Site Status RECRUITING

Hospital Clinic de Barcelona ( Site 2402)

Barcelona, , Spain

Site Status RECRUITING

Karolinska Universitetssjukhuset Solna ( Site 2501)

Stockholm, Stockholm County, Sweden

Site Status RECRUITING

Countries

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United States Denmark Norway South Korea Spain Sweden

Central Contacts

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Toll Free Number

Role: CONTACT

Phone: 1-888-577-8839

Email: [email protected]

Facility Contacts

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Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Related Links

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https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

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MK-1084-014

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1320-8626

Identifier Type: REGISTRY

Identifier Source: secondary_id

2025-521737-91-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

1084-014

Identifier Type: -

Identifier Source: org_study_id