Last updated 19 days ago
A Study of MK-1084 in KRAS Mutant Advanced Solid Tumors (MK-1084-001)
830 patients around the world
Available in Chile
Merck Sharp & Dohme Corp.
3Research sites
830Patients around the world
This study is for people with
Solid tumors
Advanced tumors
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Has measurable disease by RECIST 1.1 criteria.Has adequate organ function.Male participants must be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent OR must agree to use contraception unless confirmed to be azoospermic.Female participants must not be pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of child-bearing potential (WOCBP); is a WOCBP and uses a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle and must have a negative highly sensitive pregnancy test within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention.For Arm 1 - Has locally advanced unresectable or metastatic solid-tumor malignancy with histologically OR blood-based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease.For Arm 2 - Has an untreated metastatic non-small cell lung cancer (NSCLC) with histologically OR blood-based confirmation of KRAS G12C mutation and histologic confirmation of programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1%.For Arm 3 - Has locally advanced unresectable or metastatic solid-tumor malignancy with histologically or blood-based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease Expansion Group A: 3L/4L metastatic colorectal cancer (mCRC).Has histologically or cytologically confirmed diagnosis of unresectable and metastatic colorectal adenocarcinoma with histological or blood-based confirmation of KRAS G12C mutation.Previous treatment failure of 2 or 3 previous lines of systemic therapy Expansion Group B.Has locally advanced unresectable or metastatic solid-tumor malignancy, excluding NSCLC or CRC, with histologically or blood- based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease.Arm 4 only - Has an untreated advanced or metastatic nonsquamous NSCLC with histologically or blood-based confirmation of KRAS G12C mutation.Arm 5 only - Histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic colorectal adenocarcinoma and with histologically or blood-based confirmation of KRAS G12C mutation.Previous treatment failure of one or 2 previous line(s) of systemic therapy.Arm 6 only - Locally advanced unresectable or metastatic colorectal adenocarcinoma with histologically or blood-based confirmation of KRAS G12C mutation.
- Has received chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before first dose of study intervention.Has a history of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 5 years.Has clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis.Has an active infection requiring systemic therapy.Known history of HIV infection or has a known history of Hepatitis B virus or known active Hepatitis C virus infection.Has a history of interstitial lung disease, noninfectious pneumonitis requiring active steroid therapy, or ongoing pneumonitis.Has an active autoimmune disease requiring systemic therapy.Has not fully recovered from any effects of major surgical procedure without significant detectable infection.Has one or more of the following ophthalmological findings/conditions: intraocular pressure >21 mm Hg and/or any diagnosis of glaucoma; diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion and/or a diagnosis of retinal degenerative disease.Has received live or live-attenuated vaccine within 4 weeks of study start.Arm 4 Only - Is unable to interrupt aspirin or other nonsteroidal anti-inflammatories (NSAIDs), other than an aspirin dose ≤1.3 grams per day, for at least 2 days (5 days for long-acting agents for example, piroxicam) before, during, and for at least 2 days after administration of pemetrexed.Arm 4 Only - Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone.
Sites
Centro de Investigación Clínica Bradford Hill - Santiago, Región Metropolitana
Recruiting
Instituto Oncológico FALP - UIDO
Recruiting
Centro de Estudios Clínicos SAGA - CECSAGA
Recruiting
StudyMK-1084-001
SponsorMerck Sharp & Dohme Corp.
Study typeInterventional
Conditions
Solid tumorsAdvanced tumors
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05067283
