Who is eligible for clinical trial NCT05382325?

Participants must meet protocol criteria for Advanced or Metastatic Solid Tumors. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05382325 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-07

A Study of MK-1484 as Monotherapy and in Combination With Pembrolizumab (MK-3475) In Advanced or Metastatic Solid Tumors (MK-1484-001) (NCT05382325)

🔵 Active, Not Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Merck Sharp & Dohme LLC

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (17 items).

Location: Sanford Cancer Center ( Site 0005) — Sioux Falls, South Dakota

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Has and chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study intervention, or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier (this includes participants with previous immunomodulatory therapy with residual immune-related AEs). Participants receiving ongoing replacement hormone therapy for endocrine immune-related AEs will not be excluded from participation in this study.
Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
Has clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody and/or components of the study interventions.
Has an active infection requiring therapy.
Has a history of interstitial lung disease.
Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis.
Has an active autoimmune disease that has required systemic treatment in the past 2 years except vitiligo or resolved childhood asthma/atopy.
Participants with known human immunodeficiency virus (HIV) and/or hepatitis B or C infections, or known to be positive for hepatitis B surface antigen (HBsAg)/hepatitis B virus (HBV) DNA or hepatitis C Antibody or ribonucleic acid (RNA).
Has a 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.
Has known psychiatric or substance abuse disorders that would interfere with the participant's ability to cooperate with the requirements of the study.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (8 Sites)

Sanford Cancer Center ( Site 0005) — Sioux Falls, South Dakota
NEXT Oncology ( Site 0001) — San Antonio, Texas
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0011) — Toronto, Ontario
Rambam Health Care Campus-Oncology ( Site 0021) — Haifa,
Sheba Medical Center-ONCOLOGY ( Site 0020) — Ramat Gan,
Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0035) — Amsterdam, North Holland
Erasmus Medisch Centrum-Medical Oncology ( Site 0036) — Rotterdam, South Holland
Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 0037) — Utrecht,

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗