Actively Recruiting
Study of MK-0472 in Participants With Advanced/Metastatic Solid Tumors (MK-0472-001)
Led by Merck Sharp & Dohme LLC · Updated on 2026-03-13
178
Participants Needed
25
Research Sites
240 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess the efficacy, safety, and tolerability of MK-0472 administered as monotherapy and in combination with pembrolizumab (MK-3475) or MK-1084 in participants with histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumors.
CONDITIONS
Official Title
Study of MK-0472 in Participants With Advanced/Metastatic Solid Tumors (MK-0472-001)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has histologically or cytologically confirmed advanced or metastatic solid tumor
- Hepatitis B surface antigen (HBsAg) positive participants must have received antiviral therapy for at least 4 weeks and have undetectable HBV viral load before enrollment
- Participants with history of hepatitis C virus (HCV) infection must have undetectable HCV viral load at screening
- Participants with HIV must have well-controlled HIV on stable antiretroviral therapy for more than 4 weeks
- Arm 1: Oncogenic receptor tyrosine kinase (RTK) pathway alterations confirmed and have received or been intolerant to all available beneficial treatments
- Arm 2: Tumor types sensitive to anti-PD-1/L1 therapies including melanoma, NSCLC without EGFR/ALK/ROS1 mutations, renal cell carcinoma, urothelial carcinoma, Merkel cell carcinoma, MSI-high CRC, endometrial cancer, cervical cancer, small cell lung cancer, triple negative breast cancer, esophageal cancer, gastric cancer, biliary tract cancer, hepatocellular carcinoma, head and neck squamous cancer, cutaneous squamous cancer, anal squamous cancer, and mesothelioma
- Arm 3: Histological or blood-based confirmation of KRAS G12C mutation
You will not qualify if you...
- Has not recovered to CTCAE Grade 1 or better from adverse events due to cancer treatments administered more than 4 weeks earlier
- History of a second malignancy unless treated with no evidence of disease for 2 years
- History of hyperparathyroidism or hypercalcemia
- Ophthalmological conditions including intraocular pressure >21 mm Hg or diagnosis of glaucoma, central serous retinopathy, retinal vein or artery occlusion, or retinal degenerative disease
- Clinically significant cardiovascular disease
- Bullous exfoliative skin disorders of any grade
- Known hypersensitivity to MK-0472, MK-1084, pembrolizumab, or their ingredients
- Use of proton-pump inhibitors or H2 histamine blockers within 7 days before first study dose
- Discontinued prior anti-PD-1, anti-PD-L1, or related therapies due to adverse events
- Received systemic anticancer therapy or investigational agents within 4 weeks before first dose
- Received live or live-attenuated vaccines within 30 days before first dose
- Used investigational agents or devices within 4 weeks before study treatment
- Diagnosis of immunodeficiency or use of systemic steroids or immunosuppressive therapy within 7 days before first dose
- Known progressing additional malignancy requiring treatment within past 2 years
- Active central nervous system metastases or carcinomatous meningitis, unless stable for at least 4 weeks without steroids
- Active autoimmune disease requiring systemic treatment in past 2 years except replacement therapy
- History or current pneumonitis/interstitial lung disease requiring steroids
- Active infection needing systemic therapy
- History of allogeneic tissue or solid organ transplant
- Not recovered from major surgery or ongoing surgical complications
AI-Screening
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Trial Site Locations
Total: 25 locations
1
Northwestern Memorial Hospital ( Site 0002)
Chicago, Illinois, United States, 60611
Actively Recruiting
2
The University of Louisville, James Graham Brown Cancer Center ( Site 0004)
Louisville, Kentucky, United States, 40202
Actively Recruiting
3
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0001)
Hackensack, New Jersey, United States, 07601
Actively Recruiting
4
Rutgers Cancer Institute of New Jersey ( Site 0005)
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
5
Princess Margaret Cancer Centre ( Site 0101)
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
6
Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0100)
Montreal, Quebec, Canada, H2X 0A9
Actively Recruiting
7
Jewish General Hospital ( Site 0104)
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
8
Centro de Estudios Clínicos SAGA ( Site 0701)
Santiago, Region M. de Santiago, Chile, 7500653
Actively Recruiting
9
Fundacion Arturo Lopez Perez ( Site 0700)
Santiago, Region M. de Santiago, Chile, 7500921
Actively Recruiting
10
Centro de Investigacion Clinicadela Universidad Catolica ( Site 0703)
Santiago, Region M. de Santiago, Chile, 8330034
Actively Recruiting
11
Bradfordhill ( Site 0702)
Santiago, Region M. de Santiago, Chile, 8420383
Actively Recruiting
12
Rambam Health Care Campus ( Site 0304)
Haifa, Israel, 3109601
Actively Recruiting
13
Shaare Zedek Medical Center ( Site 0303)
Jerusalem, Israel, 9103102
Actively Recruiting
14
Rabin Medical Center ( Site 0301)
Petah Tikva, Israel, 4941492
Actively Recruiting
15
Sheba Medical Center ( Site 0300)
Ramat Gan, Israel, 5265601
Actively Recruiting
16
Sourasky Medical Center ( Site 0302)
Tel Aviv, Israel, 6423906
Actively Recruiting
17
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0401)
Warsaw, Masovian Voivodeship, Poland, 02-781
Actively Recruiting
18
Uniwersyteckie Centrum Kliniczne ( Site 0400)
Gdansk, Pomeranian Voivodeship, Poland, 80-214
Actively Recruiting
19
Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 0501)
L'Hospitalet de Llobregat, Catalonia, Spain, 08907
Actively Recruiting
20
Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid, ( Site 0504)
Madrid, Madrid, Comunidad de, Spain, 28050
Actively Recruiting
21
Hospital Universitari Vall d'Hebron ( Site 0500)
Barcelona, Spain, 08035
Actively Recruiting
22
Hospital Virgen del Rocio ( Site 0503)
Seville, Spain, 41013
Actively Recruiting
23
Hôpitaux Universitaires de Genève (HUG) ( Site 0202)
Geneva, Canton of Geneva, Switzerland, 1211
Actively Recruiting
24
Cantonal Hospital St.Gallen-Oncology & Hematology ( Site 0201)
Sankt Gallen, Canton of St. Gallen, Switzerland, 9000
Actively Recruiting
25
Ospedale Regionale Bellinzona e Valli ( Site 0200)
Bellinzona, Canton Ticino, Switzerland, 6500
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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