Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-7162 · 1 trial · 1 indication
The following events, if considered drug related by the investigator, are considered a DLT: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Grade 4 thrombocytopenia of any duration; Grade 3 thrombocytopenia associated with bleeding; Nonhematologic Adverse Events (AE) ≥Grade 3 with exceptions; Grade 3 or Grade 4 non-hematologic laboratory values if requires medical intervention, leads to hospitalization, persists for \>1 week, or results in a Drug-induced Liver Injury with exceptions; Grade 3 of 4 febrile neutropenia; Treatment-related toxicities that lead to discontinuation of study treatment during Cycles 1 or 2; Prolonged delay (\>2 weeks) in initiating Cycles 2 or 3 due to treatment-related toxicity; Missing \>25% of MK-7162 doses as a result of treatment-related AE during Cycles 1 or 2; Grade 5 toxicity.
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
| Arm | Type | Description |
|---|---|---|
| MK-7162 25 mg +Pembrolizumab (Pembro) | EXPERIMENTAL | Participants receive MK-7162 25 mg via oral tablets once daily (QD) throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 25 mg orally QD PLUS pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (every 3 weeks \[Q3W\]). |
| MK-7162 50 mg + Pembro | EXPERIMENTAL | Participants receive MK-7162 50 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-71625 50 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W |
| MK-7162 100 mg + Pembro | EXPERIMENTAL | Participants receive MK-7162 100 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 100 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W |
| MK-7162 200 mg + Pembro | EXPERIMENTAL | Participants receive MK-7162 200 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 200 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W |
| Name | Type | Description |
|---|---|---|
| MK-7162 | DRUG | oral tablets |
| Pembrolizumab | BIOLOGICAL | IV infusion |
Inclusion Criteria: * Has a histologically- or cytologically-confirmed advanced/metastatic solid tumor by pathology report and have received, or been intolerant to, or been ineligible for all treatment known to confer clinical benefit. Participants with solid tumors of any type are eligible for enr...
MK-7162 is an investigational small molecule being studied for the treatment of advanced solid tumors, specifically solid neoplasms. It is currently in Phase 1 clinical development as a potential oncology therapy.
MK-7162 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical research on this investigational oncology drug.
MK-7162 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being evaluated for safety and tolerability in patients with advanced solid tumors.
MK-7162 has been studied in one completed Phase 1 clinical trial, identified as NCT03364049. This trial evaluated MK-7162 in combination with pembrolizumab (MK-3475) in adult participants with advanced solid tumors, enrolling 33 participants across the United States, Canada, Israel, and South Korea.
In the completed Phase 1 clinical trial NCT03364049, MK-7162 was studied in combination with pembrolizumab. The trial enrolled adults aged 18 years and older with advanced solid tumors, and it was a controlled study, though it was not randomized or double-blinded.