clinical trial · NCT05017012
A Study to Evaluate the Bioavailability of Pembrolizumab (MK-3475) Via Subcutaneous (SC) Injection of Pembrolizumab Formulated With Berahyaluronidase Alfa (MK-5180) [MK-3475A] In Advanced Solid Tumors (MK-3475A-C18)
Merck Sharp & Dohme LLC·phase1·active not recruiting·n = 72
Advanced or Metastatic Solid TumorsPembrolizumab (+) Berahyaluronidase alfaPembrolizumabPemetrexedCarboplatinPaclitaxelNab-paclitaxelAxitinibCisplatin
brief summary
This is a study to assess the pharmacokinetics, safety, and tolerability of pembrolizumab formulated with berahyaluronidase when administered as a SC injection to participants with advanced solid tumors. Participants will receive SC injections of pembrolizumab (+) berahyaluronidase alfa containing one of 2 different concentrations (Conc) of pembrolizumab, Conc1 and Conc2, corresponding to a pembrolizumab dose level of dose 1 for Arms 1, 2, and 3 and dose 2 for Arm 4.
started
Sep 21, 2021
primary completion
May 19, 2026
completion
May 19, 2026
last updated
Mar 27, 2026
official title
A Phase 1 Clinical Study to Evaluate the Bioavailability of Pembrolizumab Via Subcutaneous Injection of MK-3475A, a Formulation of Pembrolizumab With MK-5180, in Participants With Advanced Solid Tumors
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol