Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-4716 · 1 trial · 1 indication
A DLT is defined as the occurrence of protocol-specified toxicities, unless clearly related to disease progression or intercurrent illness.
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.
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-4716 Dose Escalation | EXPERIMENTAL | Participants receive MK-4716 at varying dose levels and schedules. |
| MK-4716 + Pembrolizumab | EXPERIMENTAL | Participants will receive MK-4716 + Pembrolizumab |
| MK-4716 + Cetuximab | EXPERIMENTAL | Participants will receive MK-4716 + Cetuximab |
| Name | Type | Description |
|---|---|---|
| MK-4716 | DRUG | Oral administration |
| Pembrolizumab | BIOLOGICAL | Intravenous administration |
| Cetuximab | BIOLOGICAL | Intravenous administration |
Inclusion Criteria: * Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Has a confirmed diagnosis of locally advanced unresectable or metastatic solid tumor * Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Must demonstrate presence of Kirsten...
MK-4716 is an investigational small molecule being developed for the treatment of malignant neoplasms, which are cancerous tumors. It is currently in Phase 1 clinical development, meaning it is being studied in humans for the first time to evaluate its safety, tolerability, and preliminary efficacy in people with certain solid tumors.
MK-4716 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. Merck is conducting the clinical development program for this investigational oncology drug.
MK-4716 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The ongoing Phase 1 trial is currently recruiting participants to evaluate the drug in people with certain solid tumors.
MK-4716 is being studied in one active clinical trial, identified as NCT07247110, titled "A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001)." This Phase 1 trial is recruiting 250 participants across the United States, Australia, Canada, Chile, Israel, South Korea, and Spain.
Yes, MK-4716 is being studied in a controlled clinical trial, meaning there is a control group for comparison. However, the trial is not randomized and is not double-blinded, and it does not use biomarker selection for participants. The study is open to adults aged 18 years and older of all sexes.