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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
95
Number of Participants Who Experience a Dose Limiting Toxicity (DLT) as Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
DLT will be defined as any drug-related AE observed during the DLT evaluation period (e.g. Cycle 1) that results in a change to a given dose or a delay in initiating the next cycle.
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience one or more AE's will be reported.
Time frame: Up to approximately 60 months
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Time frame: Up to approximately 60 months
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Northwestern Memorial Hospital ( Site 0002)
Chicago, Illinois, United States
The University of Louisville, James Graham Brown Cancer Center ( Site 0004)
Louisville, Kentucky, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0001)
Hackensack, New Jersey, United States
Rutgers Cancer Institute of New Jersey ( Site 0005)
New Brunswick, New Jersey, United States
Princess Margaret Cancer Centre ( Site 0101)
Toronto, Ontario, Canada
Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0100)
Montreal, Quebec, Canada
Département clinique de médecine de laboratoire du CHUM ( Site 0104)
Montreal, Quebec, Canada
Centro de Estudios Clínicos SAGA ( Site 0701)
Santiago, Region M. de Santiago, Chile
Fundacion Arturo Lopez Perez ( Site 0700)
Santiago, Region M. de Santiago, Chile
Centro de Investigacion Clinicadela Universidad Catolica ( Site 0703)
Santiago, Region M. de Santiago, Chile
...and 15 more locations