Malignant Neoplasm
Conditions
Brief summary
Researchers are looking for new ways to treat certain advanced or metastatic solid tumors. The goal of this study is to learn about the safety of MK-4716 and if people tolerate it when taken alone or with other treatments.
Interventions
DRUGMK-4716
Oral administration
BIOLOGICALPembrolizumab
Intravenous administration
BIOLOGICALCetuximab
Intravenous administration
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 rat sarcoma viral oncogene homolog (KRAS) alteration * Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Has received at least 1 prior line of systemic therapy for locally advanced unresectable or metastatic disease * Arm MK-4716 + Pembrolizumab: Has a confirmed diagnosis of metastatic non-small cell lung cancer * Arm MK-4716 + Pembrolizumab: Must demonstrate presence of KRAS alteration * Arm MK-4716 + Pembrolizumab: Must be untreated * Has measurable disease * Has the ability to swallow and retain oral medication
Exclusion criteria
* Arm MK-4716 + Pembrolizumab: Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention * Arm MK-4716 + Pembrolizumab: Has received any prior immunotherapy and was discontinued from that treatment * Arm MK-4716 + Pembrolizumab: Has active autoimmune disease that has required systemic treatment in the past 2 years. Hormonal supplementation (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed * History of human immunodeficiency virus infection * Has a known additional malignancy that is progressing or has required active treatment within the past 2 years * Has a known active central nervous system metastases and/or carcinomatous meningitis * History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Has active infection requiring systemic therapy * Has Hepatitis B or Hepatitis C virus infection * History of stem cell/solid organ transplant * Has not adequately recovered from major surgery or has ongoing surgical complications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLT) | Up to approximately 28 days | A DLT is defined as the occurrence of protocol-specified toxicities, unless clearly related to disease progression or intercurrent illness. |
| Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 4 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. 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. |
| Number of Participants Who Discontinue Study Intervention Due to an AE | Up to approximately 4 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. 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-Time Curve (AUC) of MK-4716 | At designated timepoints (up to approximately 58 days) | Blood samples will be collected to determine the AUC of MK-4716. |
| Maximum Plasma Concentration (Cmax) of MK-4716 | At designated timepoints (up to approximately 58 days) | Blood samples will be collected to estimate Cmax of MK-4716. |
| Trough Plasma Concentration (Ctrough) of MK-4716 | At designated timepoints (up to approximately 19 months) | Blood samples will be collected to determine the Ctrough of MK-4716. |
| Half-Life (t1/2) of MK-4716 | At designated timepoints (up to approximately 58 days) | Blood samples will be collected to determine the t1/2 of MK-4716. |
Countries
Australia, Canada, Chile, Israel, South Korea, Spain, United States
Contacts
CONTACTToll Free Number
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed