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

Part of paid clinical trials in Sioux Falls, South Dakota.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT05382325
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Advanced or Metastatic Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MK-1484 — BIOLOGICAL
    Subcutaneous (SC) injection
  • Pembrolizumab — BIOLOGICAL
    Intravenous (IV) infusion

Study Details

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.

Key Dates

First listed
May 19, 2022
Start date
Jun 16, 2022
Status verified
Nov 2024
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
70 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MK-1484
    Participants will receive MK-1484 every 3 weeks (Q3W) or 21-day cycle at escalating dose levels from 0.2-60 mg for up to a total of 35 cycles (up to approximately 24 months).
  • Experimental: MK-1484 + Pembrolizumab
    Participants will receive MK-1484 Q3W at escalating dose levels from 10-60 mg plus pembrolizumab 200 mg once every 21-day cycle for up to a total of 35 cycles (up to approximately 24 months).

Primary Outcome Measure

Number of Participants with a Dose-Limiting Toxicity (DLT) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events (AEs) Version 5.0 [ Time Frame: Cycle 1 (Up to 21 days) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Sanford Cancer Center ( Site 0005)Sioux FallsSouth Dakota57104-
NEXT Oncology ( Site 0001)San AntonioTexas78229-

Find similar trials in Sioux Falls, SD

By research site
Sanford Cancer Center· Sioux Falls, SDNEXT Oncology· San Antonio, TX

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