Advanced or Metastatic Solid Tumors / Terminal cancer
Conditions
Interventions
This study has 2 intervention groups: participants in Arm 1 receive MK-1484
monotherapy and participants in Arm 2 receive MK-1484 in combination with
pembrolizumab. Each participant will receive ass
Sponsors
Merck Sharp & Dohme (MSD)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: # The participant has provided documented informed consent for this study. # Male or female of at least 18 years at the time of signing the informed consent form. # Histologically- or cytologically-confirmed advanced/metastatic solid tumor by pathology report and received, or intolerant to, all treatment known to confer clinical benefit. # Measurable disease by RECIST 1.1. # Performance status of 0 or 1 on the ECOG Performance Scale (within 7 days before the start of study intervention). # Normal cardiac function based on TTE or MUGA. # Presence of an evaluable archival or newly obtained tumor tissue sample for biomarker analysis. # Adequate organ function (within 7 days before the start of study intervention). # A male participant must agree to use contraception as detailed in the protocol. # A female participant is eligible to participate if not pregnant or breastfeeding, agrees to follow the contraceptive guidance as detailed in the protocol, or is not of child-bearing potential.
Exclusion criteria
Exclusion criteria: # Chemotherapy, definitive radiation or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study intervention. # Not recovered to CTCAE Grade 1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier. # Currently participating and receiving study intervention in a study of an investigational agent, or participated and received study intervention in a study of an investigational agent, or used an investigational device within 28 days of administration of MK-1484. # Received any prior IL-2 based therapy. # Allogeneic tissue/solid organ transplant in the last 5 years or evidence of graft-versus-host disease. # History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. # Clinically active CNS metastases and/or carcinomatous meningitis (exceptions per protocol). # History of severe hypersensitivity reaction to treatment with a monoclonal antibody and/or components of the study intervention(s). # Active infection requiring therapy. # Active autoimmune disease that required systemic treatment in the past 2 years (details per protocol). # History of interstitial lung disease, history of (noninfectious) pneumonitis that required steroids, or current pneumonitis. # Known HIV and/or hepatitis B or C infections, or known to be positive for HBsAg/HBV DNA or hepatitis C Antibody or RNA. # History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant*s participation for the full duration of the study, make administration of the study drugs hazardous, or make it difficult to monitor adverse effects such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of Dose-Limiting Toxicity (DLT), Adverse Events (AE), and discontinuation of study intervention due to an AE. | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters of MK-1484, including area under the curve (AUC), minimum concentration (Cmin), and maximum concentration (Cmax). | — |
Countries
Netherlands
Outcome results
None listed