MedTrace Logo

Relative Bioavailability Study of Subcutaneous Injection Versus Intravenous Infusion of Pembrolizumab (MK-3475) in Participants With Advanced Melanoma (MK-3475-555/KEYNOTE-555)

NCT03665597 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2025-02-10

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to characterize the pharmacokinetic (PK) profile of pembrolizumab (MK-3475) following single subcutaneous (SC) injection of pembrolizumab Dose A versus pembrolizumab Dose C in adults with advanced melanoma. Additionally, the safety and tolerability of pembrolizumab SC injections will be assessed. And, finally, the efficacy of pembrolizumab intravenous (IV) infusion administration will be assessed.

Conditions

Interventions

BIOLOGICAL

Pembrolizumab Dose C

165 mg/mL administered to a final dose of 285 mg via subcutaneous injection

BIOLOGICAL

Pembrolizumab Dose A

130 mg/mL administered to a final dose of 285 mg via subcutaneous injection

BIOLOGICAL

Pembrolizumab Dose B

200 mg administered via intravenous infusion

BIOLOGICAL

Pembrolizumab Dose D

400 mg administered via intravenous infusion

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-19
Primary Completion
2023-12-04
Completion
2023-12-04

Countries

  • Australia
  • South Africa
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03665597 on ClinicalTrials.gov