Malignant Neoplasm
Conditions
Keywords
Head and Neck Squamous Cell Carcinoma, Melanoma, Non-small Cell Lung Cancer, Cervical Cancer, Triple Negative Breast Cancer, Urothelial Carcinoma, Renal Cell Carcinoma
Brief summary
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.
Interventions
BIOLOGICALMK-4700
Administered via subcutaneous (SC) injection
BIOLOGICALPembrolizumab
Administered via intravenous infusion
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The key inclusion criteria include but are not limited to the following: * Has histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report who have experienced disease progression on or after prior anti-cancer treatments, or been intolerant to, or refused all treatment known to confer clinical benefit * Has head and neck squamous cell carcinoma (HNSCC), melanoma (cutaneous), non-small cell lung cancer (NSCLC), cervical cancer, triple negative breast cancer (TNBC), urothelial carcinoma (UC), or renal cell carcinoma (RCC; clear cell, papillary) * If human immunodeficiency virus (HIV) infected, must have well controlled HIV on antiretroviral therapy (ART) * Has normal cardiac function
Exclusion criteria
The key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-Limiting Toxicity (DLT) | Cycle 1 (up to 21 days) | 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 |
| Percentage of Participants Who Experience an Adverse Event (AE) | Up to approximately 4.5 years | 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. |
| Percentage of Participants who Discontinue Study Treatment Due to an AE | Up to approximately 4.5 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-Time Curve of MK-4700 | 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) | AUC is defined as the area under the concentration versus time curve. Blood samples will be collected at pre-specified timepoints to determine AUC. |
| Maximum Plasma Concentration (Cmax) of MK-4700 | 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) | 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. |
| Minimum Plasma Concentration (Cmin) of MK-4700 | 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) | 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. |
Countries
Canada, Israel, United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed