The goal of this study is to learn about the safety of different doses of MK-4700 and if people tolerate them. The study will also measure what happens in a person's body over time when MK-4700 is given alone or with pembrolizumab (MK-3475) in order to find a dose that is safe, tolerated, and may work to treat certain types of cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Administered via subcutaneous (SC) injection
Administered via intravenous infusion
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0301)
Hackensack, New Jersey, United States
NEXT Oncology ( Site 0300)
San Antonio, Texas, United States
Princess Margaret Cancer Center ( Site 0101)
Toronto, Ontario, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0102)
Dose-Limiting Toxicity (DLT)
The occurrence of any of the following toxicities during Cycle 1 will be considered a DLT, if assessed by the investigator related to study intervention administration: * Grade 4 nonhematologic toxicity * Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia * Any nonhematologic AE ≥Grade 3 in severity, with exceptions * Any Grade 3 or Grade 4 nonhematologic laboratory value, as with pre-specified exceptions * Any Grade 3 or Grade 4 laboratory abnormalities, with the exceptions * Febrile neutropenia Grade 3 or Grade 4 * Prolonged delay (\>2 weeks) in initiating Cycle 2 due to intervention-related toxicity * Any study drug toxicity that causes the participant to discontinue study drug during Cycle 1 * Missing \>25% of MK-4700 doses as a result of drug-related AEs during the first cycle * Grade 5 toxicity
Time frame: Cycle 1 (up to 21 days)
Percentage of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Up to approximately 4.5 years
Percentage of Participants who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Up to approximately 4.5 years
Area Under the Concentration-Time Curve of MK-4700
AUC is defined as the area under the concentration versus time curve. Blood samples will be collected at pre-specified timepoints to determine AUC.
Time frame: Predose and at prespecified time points during Cycles 1, 2, 3, 4, 5, 6, 7, and 10 up to approximately 7 months (Cycle length is 21 days)
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Québec, Quebec, Canada
Rambam Health Care Campus ( Site 0201)
Haifa, Israel
Rabin Medical Center ( Site 0202)
Petah Tikva, Israel
Sheba Medical Center ( Site 0200)
Ramat Gan, Israel
Maximum Plasma Concentration (Cmax) of MK-4700
Cmax is defined as the maximum concentration of MK-4700 observed in plasma after its administration and just prior to administration of the next dose. Blood samples will be collected at pre-specified timepoints to determine Cmax.
Time frame: Predose and at prespecified time points during Cycles 1, 2, 3, 4, 5, 6, 7, and 10 up to approximately 7 months (Cycle length is 21 days)
Minimum Plasma Concentration (Cmin) of MK-4700
Cmin is defined as the minimum concentration of MK-4700 observed in plasma after its administration and just prior to administration of the next dose. Blood samples will be collected at pre-specified timepoints to determine Cmin.
Time frame: Predose and at prespecified time points during Cycles 1, 2, 3, 4, 5, 6, 7, and 10 up to approximately 7 months (Cycle length is 21 days)