A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001)
ConditionMalignant Neoplasm
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
MK-4716
DrugOral administration
Pembrolizumab
Biological/VaccineIntravenous administration
Cetuximab
Biological/VaccineIntravenous administration
Treatment groups
250 Participants
are divided into 3 treatment groupsGroup A: MK-4716 Dose EscalationExperimental treatment 1 intervention
Group B: MK-4716 + PembrolizumabExperimental treatment 2 interventions
Group C: MK-4716 + CetuximabExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLT)
A DLT is defined as the occurrence of protocol-specified toxicities, unless clearly related to disease progression or intercurrent illness.
Time frame
Up to approximately 28 days2
Number 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. 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.
Time frame
Up to approximately 4 years3
Number of Participants Who Discontinue Study Intervention 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. 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.
Time frame
Up to approximately 4 yearsSecondary outcomes
1
Area Under the Concentration-Time Curve (AUC) of MK-4716
Blood samples will be collected to determine the AUC of MK-4716.
Time frame
At designated timepoints (up to approximately 58 days)2
Maximum Plasma Concentration (Cmax) of MK-4716
Blood samples will be collected to estimate Cmax of MK-4716.
Time frame
At designated timepoints (up to approximately 58 days)3
Trough Plasma Concentration (Ctrough) of MK-4716
Blood samples will be collected to determine the Ctrough of MK-4716.
Time frame
At designated timepoints (up to approximately 19 months)4
Half-Life (t1/2) of MK-4716
Blood samples will be collected to determine the t1/2 of MK-4716.
Time frame
At designated timepoints (up to approximately 58 days)Sponsors and contacts
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Source ClinicalTrials.gov