Advanced or Metastatic Solid Tumors
Conditions
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)
Brief summary
The purpose of this study is to assess the safety and tolerability and to establish a preliminary recommended Phase 2 dose (RP2D) of MK-1484 administered as monotherapy and in combination with pembrolizumab (MK-3475) in adults with advanced or metastatic solid tumors.
Interventions
BIOLOGICALMK-1484
Subcutaneous (SC) injection
BIOLOGICALPembrolizumab
Intravenous (IV) infusion
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
The main inclusion and
Exclusion criteria
include but are not limited to the following: Inclusion Criteria: * Has a histologically- or cytologically-confirmed advanced/metastatic solid tumor by pathology report and has received, or been intolerant to, all treatment known to confer clinical benefit. * Has measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by the local site investigator/radiology. * Has normal cardiac function based on transthoracic echocardiogram (TTE) or multigated acquisition scan (MUGA) * Has provided an evaluable archival or newly obtained tumor tissue sample for biomarker analysis. * Has adequate organ function. * A male participant must agree to use contraception and should refrain from donating sperm during the specified period(s) of at least 120 days after study interventions. * A female participant is eligible to participate if she is not pregnant or breastfeeding and at least 1 of the following: not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the treatment period for at least 120 days after study intervention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with a Dose-Limiting Toxicity (DLT) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events (AEs) Version 5.0 | Cycle 1 (Up to 21 days) | DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment: Grade (Gr) 4 nonhematologic toxicity (not laboratory); Gr 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia: Gr 4 thrombocytopenia of any duration; Gr 3 thrombocytopenia associated with clinically significant bleeding; Gr 4 anemia regardless of duration; Nonhematologic AE Gr ≥3 in severity, with exceptions; Any Gr 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required, or if abnormality leads to hospitalization, persists for \>1 week or results in drug-induced liver injury with exceptions; Gr 3 or Gr 4 febrile neutropenia; Prolonged delay (\>2 weeks) in initiating Cycle 2 due to treatment-related toxicity; Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1; Missing \>25% of the MK-1484 dose during Cycle 1 resulting from treatment-related AE; Gr 5 toxicity. |
| Number of Participants Who Experience At Least One AE | Up to approximately 27 months | 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. The number of participants who experienced an AE will be reported. |
| Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 24 months | 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. The number of participants who discontinued study treatment due to an AE will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve (AUC) of MK-1484 | At designated time points (Up to approximately 24 months) | Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine AUC. |
| Minimum Serum Concentration (Cmin) of MK-1484 | At designated time points (Up to approximately 24 months) | Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Cmin. |
| Maximum Serum Concentration (Cmax) of MK-1484 | At designated time points (Up to approximately 24 months) | Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Cmax. |
Countries
Canada, Israel, Netherlands, United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed